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Volume 27, Number 1

June 2016, Pages 01–100

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Face-to-Face with the Winners of Dr BC Roy National Awards 2008-2010

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American Family Physician

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Dermatology

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IJCP Group of Publications Dr Sanjiv Chopra Prof. of Medicine & Faculty Dean Harvard Medical School Group Consultant Editor Dr Deepak Chopra Chief Editorial Advisor

Dr KK Aggarwal Group Editor-in-Chief

Volume 27, Number 1, June 2016 FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

5

Lifestyle Modifications to Manage Hypertension

6

Revisiting Cardiology 2015

7

All About Depression and Suicide

8

Harvard’s Medical School’s 4 Exercising Tips for People with Diabetes

8

Child Sexual Abuse: An Epidemic

9

Opinion on Registered Pharmacist

IJCP Group, eMedinewS and eMediNexus Dr Veena Aggarwal MD, Group Executive Editor

IJCP Editorial Board Obstetrics and Gynaecology Dr Alka Kriplani, Dr Thankam Verma, Dr Kamala Selvaraj Cardiology Dr Praveen Chandra, Dr SK Parashar Paediatrics Dr Swati Y Bhave Diabetology Dr CR Anand Moses, Dr Sidhartha Das, Dr A Ramachandran, Dr Samith A Shetty, Dr Vijay Viswanathan, Dr V Mohan, Dr V Seshiah, Dr Vijayakumar ENT Dr Jasveer Singh, Dr Chanchal Pal Dentistry Dr KMK Masthan, Dr Rajesh Chandna Gastroenterology Dr Ajay Kumar, Dr Rajiv Khosla, Dr JS Rajkumar Dermatology Dr Hasmukh J Shroff, Dr Pasricha, Dr Koushik Lahiri, Dr Jayakar Thomas Nephrology Dr Georgi Abraham Neurology Dr V Nagarajan, Dr Vineet Suri, Dr AV Srinivasan Oncology Dr V Shanta Orthopedics Dr J Maheshwari

10 Tackling Obesity in Children 13 Protection of Children from Sexual Offences Act 14 New Hands-only CPR Guidelines 17 CDC Zika Updated Recommendations 17 ACP Calls Upon Physicians to Combat Health Problems Associated with Climate Change FACE-TO-FACE WITH THE WINNERS OF DR BC ROY NATIONAL AWARDS 2008-2010

18 Dr BC Roy National Awards for the Year 2008-2010 Announced AMERICAN FAMILY PHYSICIAN

26 Potassium Disorders: Hypokalemia and Hyperkalemia

38 Practice Guidelines

Anand Gopal Bhatnagar Editorial Anchor Advisory Bodies Heart Care Foundation of India Non-Resident Indians Chamber of Commerce & Industry World Fellowship of Religions

This journal is indexed in IndMED (http://indmed.nic.in) and full-text of articles are included in medIND databases (http://mednic.in) hosted by National Informatics Centre, New Delhi.

Anthony J. Viera, Noah Wouk

DERMATOLOGY

55 Efficacy and Tolerability of an Oatmeal Moisturizer Containing Colloidal Oatmeal for Dry Skin Conditions: A Post-marketing Study

Varsha Narayanan, Anil Ganjoo, Ganesh Kadhe

63 Biotinyl-GHK and Hair Growth

Philippe Mondon

DRUGS

Published, Printed and Edited by Dr KK Aggarwal, on behalf of IJCP Publications Ltd. and Published at E - 219, Greater Kailash, Part - 1 New Delhi - 110 048 E-mail: editorial@ijcp.com

70 Efficacy and Safety of Fixed-dose Combination of Cefpodoxime 200 mg plus Clavulanic Acid 125 mg versus Cefpodoxime 200 mg in Lower Respiratory Tract Infections

Printed at New Edge Communications Pvt. Ltd., New Delhi E-mail: edgecommunication@gmail.com

Deepak Talwar, Sandeep R Saboo, RN Sarkar, J Salve, Manu HC, Swati Biswas

ORTHOPEDICS

76 Role of Medial Open-wedge Osteotomy Fixed with Angle Stable Locking Plate Device System in Variable Degrees of Osteoarthritis Knee: A Case Series

Copyright 2016 IJCP Publications Ltd. All rights reserved.

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A Swaroop, Sachin Avasthi, Vineet Kumar, Sanjay Kumar, Vikas Gahlot

CONFERENCE PROCEEDINGS

Editorial Policies

82 60th Annual Conference of the Indian Orthopaedic Association (IOACON 2015)

The purpose of IJCP Academy of CME is to serve the medical profession and provide print continuing medical education as a part of their social commitment. The information and opinions presented in IJCP group publications reflect the views of the authors, not those of the journal, unless so stated. Advertising is accepted only if judged to be in harmony with the purpose of the journal; however, IJCP group reserves the right to reject any advertising at its sole discretion. Neither acceptance nor rejection constitutes an endorsement by IJCP group of a particular policy, product or procedure. We believe that readers need to be aware of any affiliation or financial relationship (employment, consultancies, stock ownership, honoraria, etc.) between an author and any organization or entity that has a direct financial interest in the subject matter or materials the author is writing about. We inform the reader of any pertinent relationships disclosed. A disclosure statement, where appropriate, is published at the end of the relevant article.

86 62nd Annual Conference of Cardiological Society of India (CSI 2016) 89 India Live 2016 IJCP HIGHLIGHTS

92 Highlights of 2015-2016

LIGHTER READING

96 Lighter Side of Medicine

Note: Indian Journal of Clinical Practice does not guarantee, directly or indirectly, the quality or efficacy of any product or service described in the advertisements or other material which is commercial in nature in this issue.

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FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

BEST OF 2015-2016

Prof. Dr KK Aggarwal

Group Editor-in-Chief IJCP Group, eMedinewS and eMediNexus

Lifestyle Modifications to Manage Hypertension ÂÂ

Treatment of hypertension should involve nonpharmacologic therapy (also called lifestyle modification) alone or in concert with antihypertensive drug therapy.

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The overall impact of moderate sodium reduction is a fall in blood pressure (BP) in hypertensive and normotensive individuals of 4.8/2.5 and 1.9/1.1 mmHg, respectively.

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A high dietary intake of sodium is associated with the development of hypertension.

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Some individuals are particularly sensitive to sodium in the diet, and are referred to as being sodium sensitive.

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Sodium-sensitive individuals obtain a greater degree of BP reduction with dietary sodium restriction.

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Dietary sodium reduction can lower BP in both hypertensive and normotensive individuals, and enhances the response to most antihypertensive therapies.

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Dietary sodium reduction may decrease the risk of cardiovascular disease, potentially though, in part, a reduction in BP.

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In all hypertensive individuals, reduce dietary sodium intake. A reasonable goal is to reduce daily sodium intake to <100 mEq/day (2.3 g of sodium or 6 g of sodium chloride [1 g of sodium = 44 mEq; 1 g of sodium chloride contains 17 mEq of sodium]). Reduce dietary sodium intake to similar levels in the general population with the goal of preventing hypertension and decreasing the risk of adverse cardiovascular events.

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Weight loss in overweight or obese individuals can lead to a significant fall in BP independent of exercise.

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The decline in BP induced by weight loss can also occur in the absence of dietary sodium restriction, but even modest sodium restriction may produce an additive antihypertensive effect.

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The weight loss-induced decline in BP generally ranges from 0.5 to 2 mmHg for every 1 kg of weight lost, or about 1 mmHg for every 1 pound lost.

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The Dietary Approaches to Stop Hypertension (DASH) dietary pattern is high in vegetables, fruits, low-fat dairy products, whole grains, poultry, fish and nuts and low in sweets, sugarsweetened beverages, and red meats. The DASH dietary pattern is consequently rich in potassium, magnesium, calcium, protein and fiber, but low in saturated fat, total fat and cholesterol. DASH dietary pattern reduced BP by 6/4 mmHg compared with typical American-style diet that contained the same amount of sodium and the same number of calories.

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DASH diet can reduce the upper BP by 8-14 mmHg.

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Combining the DASH dietary pattern with modest sodium restriction produced an additive antihypertensive effect.

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Aerobic exercise, and possibly resistance training, can decrease systolic and diastolic pressure by, on average, 4-6 mmHg and 3 mmHg, respectively, independent of weight loss (three to four sessions of moderate-intensity aerobic exercise lasting approximately 40 minutes for a period of 12 weeks.)

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

5

FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF ÂÂ

Women who consume two or more alcoholic beverages per day and men who have three or more drinks per day have a significantly increased incidence of hypertension compared with nondrinkers. This effect is dose related and is most prominent when intake exceeds 5 drinks per day.

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Decreasing alcohol intake in individuals who drink excessively significantly lowers BP.

ÂÂ

Moderate alcohol use (1 drink per day for women and 1-2 drinks per day for men) has a limited

effect on BP, associated with a modest decrease in cardiovascular risk as compared with no alcohol consumption. ÂÂ

The benefits of comprehensive lifestyle modification, including the DASH diet and increased exercise are much more than managing a single lifestyle intervention.

ÂÂ

Patient education has been demonstrated to result in improved BP.

■■■■

Revisiting Cardiology 2015 ÂÂ

PCSK9 inhibitors released into the real world: FDA approved the injectable monoclonal antibodies evolocumab and alirocumab, which induce dramatic drops in low-density lipoprotein (LDL) cholesterol.

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SPRINT: SPRINT compared lowering blood pressure (BP) to 120 mmHg against a more lenient goal of 140 mmHg in high-risk older adults. The data safety monitoring board stopped the trial early because of an increased number of cardiac events in the lenient-BP arm. Efficacy of intense BP control came at a cost: more drugs were required and more subjects in the intense-BP arm experienced syncope, acute kidney injury and electrolyte abnormalities.

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Coffee and fat are back: Two major reversals included the allowance of moderate caffeine intake and removal of limits on dietary cholesterol. In 2015, a consensus grew that refined sugars promote illness.

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AF treatment: STAR-AF 2 trial found that additional ablation beyond pulmonary-vein isolation in patients with advanced forms of AF did not improve outcomes.

ÂÂ

LEGACY trial and CARDIO-FIT trials showed that both weight loss and gains in cardiorespiratory fitness delivered potent antiarrhythmic effects.

ÂÂ

ARREST-AF substrate study, showed that riskfactor modification worked by improving electrical and structural properties of human atria.

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The EMPA-REG outcome trial has been hailed as a landmark trial because it's the first time a drug

for diabetes, empagliflozin (a sodium glucose cotransporter-2 [SGLT-2] inhibitor), has lowered death rates in patients with type 2 diabetes. However, the FDA has issued a warning about ketoacidosis and bone fractures with these drugs. ÂÂ

Idarucizumab (Praxbind, Boehringer Ingelheim), the dabigatran reversal agent received FDA approval in October.

ÂÂ

Andexanet alfa, the factor Xa reversal agent safely reversed the anticoagulant effect of apixaban and rivaroxaban in older volunteers (November issue of New England Journal of Medicine).

ÂÂ

A wireless revolution in cardiac pacing began this year with both the NanoStim LP leadless pacemaker (St Jude Medical) and the Micra TPS (Medtronic) performing well. Both devices have earned CE Mark in Europe, and FDA approval is likely.

ÂÂ

Five clinical trials demonstrated clear benefit for the use of endovascular treatments alone or as an add-on to tPA in patients who present with acute stroke.

ÂÂ

Periprocedural bridging with LMWH in patients taking warfarin and undergoing elective surgery resulted in higher bleeding rates and no lowering in thrombotic events. But, the BRIDGE trial researchers excluded high-risk patients with mechanical valves and previous stroke. So, we don't know the answer for these patients. For most, though, less is clearly more.

■■■■

6

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

All About Depression and Suicide ÂÂ

Depression, a leading predictor of functional disability and mortality is a major public health problem.

ÂÂ

Optimal depression treatment improves outcome for most patients.

ÂÂ

Most adults with clinical significant depression never see a mental health professional but they often see a primary care physician.

ÂÂ

A physician who is not a psychiatrist misses the diagnosis of depression 50% of times.

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All depressed patients must be specifically enquired about suicidal ideations.

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Suicidal ideation is a medical emergency.

ÂÂ

Risk factors for suicide are known psychiatric disorders, medical illnesses, prior history of suicidal attempts or family history of attempted suicide.

ÂÂ

The demographic reasons include older age, male gender, marital status (widowed or separated) and living alone.

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About 1 million people commit suicide every year globally.

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Around 79% of patients who commit suicide contact their primary care provider in the last 1 year before their death and only one-third contact a mental health service provider.

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Twice as many suicidal victims had contacted their primary care provider as against the mental health provider in the last month before suicide.

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Suicide is the 10th leading cause of death worldwide and accounts for 1.2% of all deaths.

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The suicide rate in the US is 10.5 per 1,00,000 people.

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In the US, suicide is increasing in middle-aged adults.

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There are 10-40 nonfatal suicide attempts for everyone completed suicide.

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The majority of suicides completed in US are accomplished with fire arm (57%); the second

leading method of suicide in US is hanging for men and poisoning in women. ÂÂ

Patients with prior history of attempted suicide are 5-6 times more likely to make another attempt.

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Fifty percent of successful victims have made prior attempts.

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One of every 100 suicidal attempt survivors will die by suicide within 1 year of the first attempt.

ÂÂ

The risk of suicide increases with increase in age; however, young adults and adolescents attempt suicide more than the older.

ÂÂ

Females attempt suicide more frequently than males but males are successful three times more often.

ÂÂ

The highest suicidal rate is amongst those individuals who are unmarried followed by those who are widowed, separated, divorced, married without children and married with children in descending order.

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Living alone increases the risk of suicide.

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Unemployed and unskilled patients are at higher risk of suicide than those who are employed.

ÂÂ

A recent sense of failure may lead to higher risk.

ÂÂ

Clinicians are at higher risk of suicide.

ÂÂ

The suicidal rate in male clinicians is 1.41 and in female clinicians it is 2.27.

ÂÂ

Adverse childhood abuse and adverse childhood experiences increase the risk of suicidal attempts.

ÂÂ

The first step in evaluating suicidal risk is to determine presence of suicidal thoughts including their concerns and duration.

ÂÂ

Management of suicidal individual includes reducing mortality risk, underlying factors and monitoring and follow-up.

ÂÂ

Major risk for suicidal attempts is in psychiatric disorder, hopelessness and prior suicidal attempts or threats.

ÂÂ

High impulsivity or alcohol or other substance abuse increase the risk.

■■■■

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

7

FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

Harvard’s Medical School’s 4 Exercising Tips for People with Diabetes If you use insulin, it’s important to test your blood sugar before exercising. If it is below 100 mg/dL, eat a piece of fruit or have a small snack to boost it and help you avoid hypoglycemia. Test again 30 minutes later to see if your blood sugar level is stable.

1. Get a "preflight" check Talk with your doctor before you start or change a fitness routine, especially if you are overweight or have a history of heart disease, peripheral vascular disease or diabetic neuropathy.

Go for a complete physical exam and an exercise stress test if you are 35 or older and you have had diabetes for more than 10 years. The results can help determine the safest way for you to increase physical activity.

Check your blood sugar after any particularly grueling workout or activity.

If you use insulin, your risk of developing hypoglycemia may be highest 6-12 hours after exercising.

Do not exercise if your blood sugar is too high (over 250).

2. Spread your activity throughout the week Adults should aim for a weekly total of at least 160 minutes of moderate aerobic activity, or 80 minutes of vigorous activity or an equivalent mix of the two.

4. Be prepared Should you experience a medical problem while exercising (or at any time) it is important that the people who care for you know that you have diabetes.

Be active at least 3-5 days a week.

3. Time your exercise wisely

Keep card handy or glucose tablets with you while exercising in case your blood sugar takes a sudden nosedive.

The best time to exercise is 1-3 hours after eating, when your blood sugar level is likely to be higher.

■■■■

Child Sexual Abuse: An Epidemic QUOTES FROM A DELHI HIGH COURT CASE The Court termed child sexual abuse as an "epidemic".

Court: “Not only parents, but even trial courts dealing with such cases, should create an atmosphere where the victims can depose truthfully against "sexual perpetrators".

because of the sheer frequency with which it occurs and because of the trauma brought to the lives of the children who have experienced this crime. Child sexual abuse is an epidemic". The trial court should "ensure the examination of the child witness by giving due protection to him and bringing the child out of the pressure".

Justice PS Teji: "Children who have suffered sexual abuse at the hands of the sexual perpetrators do not only suffer from physical pain but are also subjected to mental and emotional trauma. The results of child sex abuse are severe and far reaching".

"The parents of such victims have even a greater role to play in helping and aiding the child in overcoming the trauma".

"Child sexual abuse is one of the most pervasive social problems faced by our society. Its impact is profound

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8

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

SOME FACTS A study conducted by Aram Foundation, an NGO working for child rights, has found that about

FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF 29% of students studying in 71 schools and 56 colleges in Coimbatore, Erode, Salem, Tirupur and Dharmapuri had suffered sexual abuse. ÂÂ

As per a study conducted by Tulir CPHCSA in 2006, in which more than 2,211 school-going children in Chennai were interviewed, child sexual abuse prevalence rate was 42%.

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Another study conducted in 2007 backed by the Government of India, in which 1,25,000 children were interviewed in 13 states, more than half (53%) said that they had been subjected to one or more forms of sexual abuse.

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Eight cases of sex crimes against children have been registered every day in the last 2 years.

About 6,816 police cases were registered from November, 2012—when the Protection of Children against Sexual Offences Act (POCSO)—came into force up to March, 2015. The highest number of FIRs has been registered in Rajasthan followed

by Maharashtra, Uttar Pradesh, Madhya Pradesh and Kerala according to data available with the National Commission for Protection of Child Rights (NCPCR). The number of convictions is only 166 that is, 2.4% of the total cases registered while in 389 cases accused were acquitted.

Source: Times of India

■■■■

Opinion on Registered Pharmacist PHARMACY PRACTICE REGULATIONS, 2015 According to Regulation 2(b) of the Pharmacy Practice Regulations, 2015, ‘Practice of Pharmacy’ means: i. Interpretation, evaluation and implementation of medical orders; dispensing of prescriptions, drug orders; ii. Participation in drug and device selection, drug administration, drug regimen reviews and drug or drug related research; iii. Provisions of patient counseling and the provision of those acts or services necessary to provide pharmaceutical care in all areas of patient care including primary care; and iv. Responsibility for compounding and labeling of drugs and devices (except labeling by a manufacturer, repacker or distributor of nonprescription drugs and commercially packaged legend drugs and devices) proper and safe storage of drugs and devices and maintenance of proper records for them.

According to Regulation 2(h) of the Pharmacy Practice Regulations, 2015, ‘Pharmacy Practitioner’ means an individual (Community Pharmacist/Hospital Pharmacist/Clinical Pharmacist/Drug information Pharmacist) currently licensed, registered or otherwise authorized under the Act to counsel or otherwise and administer drugs in the course of professional practice.

According to Regulation 2(i) of the Pharmacy Practice Regulations, 2015, Registered Pharmacist means a

person whose name is for the time being entered in the register of the State in which he is for the time being residing or carrying on his profession or business of pharmacy under the Pharmacy Act, 1948.

According to Regulation 2(j) of the Pharmacy Practice Regulations, 2015, ‘Prescription’ means a written or electronic direction from a Registered Medical Practitioner or other properly licensed practitioners such as Dentist, Veterinarian, etc. to a Pharmacist to compound and dispense a specific type and quantity of preparation or prefabricated drug to a patient.

According to Regulation 3.3 of the Pharmacy Practice Regulations, 2015, ‘Displaying name of owner and registered pharmacist’: (a) Name of the owner of pharmacy business shall be displayed at or near the main entrance of each premises in which the business is carried on. (b) Name of the registered pharmacist along with his registration number and qualification along with his/her photograph shall be displayed adjacent to the area where dispensing is carried on in the pharmacy. Registered pharmacist shall also comply with a dress code of being dressed formally and wearing clean white overall (coat/apron) with a badge displaying the name and registration number. (c) Registered pharmacists shall display as suffix to their names only recognized pharmacy qualification/degrees or such certificates/

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

9

FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF instructed in the art of medicines. He shall keep himself pure in character and be diligent in caring for the sick; he should be modest, sober, patient, prompt in discharging his duty without anxiety; conducting himself with propriety in his profession and in all the actions of his life.

diplomas and memberships/honours which confer professional knowledge or recognizes any exemplary qualification/achievements.

According to Regulation 4.1 ‘Character of registered pharmacist’: (a) The prime object of the pharmacy profession is to render service to humanity; reward or financial gain is a subordinate consideration. Who-so-ever chooses his profession, assumes the obligation to conduct himself in accordance with its ideals.

A registered pharmacist should be an upright man,

(b) A person having qualification in any other system of pharmacy is not allowed to practice modern system of pharmacy in any form. (c) A registered pharmacist shall uphold the dignity and honor of his profession.

■■■■

Tackling Obesity in Children More than 30% people of the society including children have potbelly abdominal obesity. The incidence of metabolic syndrome, characterized by abdominal obesity, high triglyceride, low good cholesterol, high blood pressure and high blood sugar is rising in India.

Abdominal girth of >90 cm in men and 80 cm in women indicates that the person is vulnerable to future heart attack.

Normal weight obesity is the new epidemic. A person could be obese even if his body weight was within the normal range. An extra inch of fat around the abdomen increases the chances of heart disease by 1.5 times.

Normally once the height stops growing, most of the organs will also stop growing. The weight of the heart, liver of kidney cannot increase after that. Only muscles can build-up to some extent. The only thing, after that stage, which can increase the weight of the body, is deposition of fat. Therefore, any weight gain after puberty is invariably due to fat. Though the overall weight can be in the acceptable normal range but any weight gain within that range will be abnormal for that person. One should not gain weight of >5 kg after the age of 20 years in males and 18 years in females.

After the age of 50, the weight should reduce and not increase.

Potbelly obesity is linked to eating refined carbohydrates and not animal fats. General obesity is linked to eating animal fats.

Refined carbohydrate includes white rice, white maida and white sugar. Brown sugar is better than white sugar. Refined carbohydrates are called 'bad carbohydrates' and animal fat is called bad fat.

Trans fat or vanaspati is bad for health. It increases the levels of bad cholesterol and reduces good cholesterol in the body.

Losing weight can reduce snoring, pain of arthritis, blood pressure and also check uncontrolled diabetes.

SOME TIPS ÂÂ

Skip carbohydrates once in a week.

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Combine a sweet food with bitter food (prefer aloo methi over aloo matar).

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Walk, walk and walk…

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Consume green bitter items in foods such as karela, methi, palak, bhindi, etc.

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Do not eat trans fats (vanaspati).

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Do not consume >80 mL of soft drink in a day.

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Do not consume sweets with more than 30% sugar.

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Avoid maida, rice and white sugar.

■■■■

10

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

Protection of Children from Sexual Offences Act ÂÂ

Child means any one below the age of 18 years.

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The act applies to all cases of sexual assault to a child.

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Any sexual activity with a child (boy or girl) is a crime.

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The act defines sexual offences against children and prescribes the punishment for the same.

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Sexual offences can be penetrative sexual assault (Sec 3), sexual assault (nonpenetrative - Sec 7), sexual harassment (Sec 11), and use of a child for pornography (Sec 13).

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A person commits penetrative sexual assault of a child below 18 years if he inserts his penis or any other object into the vagina, anus, urethra or any part of the body of the child, or causes any other person to do so to the child, or applies his mouth to any such part of the body of the child.

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Penetrative sexual assault of a child below 18 years is punishable with imprisonment of a minimum of 7 years, up to imprisonment for life and is also liable to fine.

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If a person touches the penis, vagina, anus, breast or any other part of the body of a child below 18 years of age with sexual intent, or causes any other person to do so, or causes the child to do so to him or any other person, he is said to commit (nonpenetrative) sexual assault.

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Nonpenetrative sexual assault of a child below 18 years is punishable with imprisonment for 3-5 years and is also liable to fine.

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Sexual assault and penetrative sexual assault of a child below 18 years of age are considered to be aggravated when committed by a person in a position of trust or authority such as police/ army/security personnel, public servants or family member, persons in management or staff of educational, medical or religious institution or persons in management or staff of jail, remand

home, protection home observation home, or any other place of custody or care and protection. ÂÂ

Aggravated penetrative sexual assault of a child below 18 years is punishable with rigorous imprisonment of a minimum of 10 years, up to imprisonment for life and is also liable to fine.

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Aggravated sexual assault of a child below 18 years is punishable with imprisonment for 5-7 years and is also liable to fine.

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A person commits sexual harassment when, with sexual intent, in respect of child below 18 years of age, he utters a word or makes a sound or a gesture or exhibits a part of his body or any other object or makes the child exhibit a part of his body, or shows an object or any form of media to the child for pornographic purposes, or repeatedly follows the child or watches him directly or through digital, electronic or other means, or threatens to use any part of the body of the child or the involvement of the child in a sexual act in any form of media, or entices the child for pornographic purposes or gives the child gratification for this.

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Sexual harassment of a child below 18 years of age is punishable with imprisonment of 3 years and is also liable to fine.

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A person commits the offence of pornography if he uses a child below 18 years of age in any form of media for sexual gratification. This includes the representation of the sexual organs of the child, images showing the child in real or simulated sexual acts, or the indecent or obscene representation of the child.

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Use of a child below 18 years of age for pornographic purposes is punishable with imprisonment of 5 years and is also liable to fine.

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

13

FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

New Hands-only CPR Guidelines ÂÂ

Bystanders CPR 10.

should

initiate

compression-only

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CPR providers should perform chest compressions for all victims in cardiac arrest.

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Chest compression should be done at the rate of 100-120 per minute (updated from “at least” 100 per minute).

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CPR providers trained and able to perform rescue breaths should combine chest compressions and rescue breaths.

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Compression depth should be 2-2.5 inches (upper limit added) but no more than 6 cm.

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High-quality CPR remains essential to improving outcomes.

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Compression time should be maximized.

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After each compression allow the chest to recoil completely and minimize interruptions in compressions.

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Feedback devices may be used to optimize compression rate and depth.

When providing rescue breaths/ventilations spend approximately 1 second inflating the chest with sufficient volume to ensure the chest rises visibly.

The ratio of chest compressions to ventilations remains 30:2.

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The bystander who is trained and able should assess the collapsed victim rapidly to determine if the victim is unresponsive and not breathing normally and then immediately alert the emergency services.

Do not interrupt chest compressions for more than 10 seconds to provide ventilations.

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The victim who is unresponsive and not breathing normally is in cardiac arrest and requires CPR.

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The emergency medical dispatcher plays an important role in the early diagnosis of cardiac arrest, the provision of dispatcher-assisted CPR (also known as telephone CPR), and the location and dispatch of an automated external defibrillation (AED).

Defibrillation within 3-5 minutes of collapse can produce survival rates as high as 50-70%.

Early defibrillation can be achieved through CPR providers using public access and on-site AEDs. Public access AED programs should be actively implemented in public places that have a highdensity of citizens.

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Social media may be used to summon rescuers to perform CPR.

The adult CPR sequence can be used safely in children who are unresponsive and not breathing normally.

Chest compression depths in children should be at least onethird of the depth of the chest (for infants that is 4 cm, for children 5 cm).

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Bystanders and emergency medical dispatchers should be suspicious of cardiac arrest in any patient presenting with seizures and should carefully assess whether the victim is breathing normally.

A foreign body causing severe airway obstruction is a medical emergency and requires prompt treatment with back blows and, if that fails to relieve the obstruction, abdominal thrusts. If the victim becomes unresponsive CPR should be started immediately whilst help is summoned.

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

CDC Zika Updated Recommendations ÂÂ

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Women with confirmed cases of the Zika virus or who have had symptoms of the virus should wait at least 8 weeks after the start of their symptoms before trying to get pregnant.

Men with confirmed cases of the virus or who have had symptoms of the virus are now advised to wait at least 6 months after their symptoms begin before having unprotected sex.

Women and men without symptoms who have traveled to or had sex with someone who has traveled to a Zika-infected area are now advised to wait at least 8 weeks after possible exposure to the virus before the woman tries to become pregnant.

Men who have traveled to a Zika-infected area who have not had symptoms of the virus are now

advised to abstain from sex or use a condom for at least 8 weeks after returning from the area. ÂÂ

Men who live in a Zika-infected area should use condoms or abstain from sex as long as the Zika virus is circulating there.

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Women and men who do not have the virus but who live in areas where the virus is being transmitted are now advised to talk with their healthcare providers about plans for pregnancy during the ongoing outbreak.

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The virus can remain in semen for as long as 2 months.

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The guidelines apply to sexual intercourse, as well as oral and anal sex.

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ACP Calls Upon Physicians to Combat Health Problems Associated with Climate Change The changing climate is one of the most important environmental concerns today. Climate change directly affects five components of the environment: Water, air, weather, oceans and ecosystems. And, through changes in the environment such as heat waves, droughts, storms, worsening air quality, floods, etc. it also adversely affects human health. With rise in temperatures, vector-borne diseases such as dengue are increasing in number making them more difficult and challenging to control. What is more, climate change may potentially spread the disease to areas that are currently not endemic for the disease.

The relationship between climate and human health has for long been a much studied topic. A report published in April 2010 by National Institute of Environmental Health Science, USA “A Human Health Perspective on Climate Change: A Report Outlining the Research Needs on the Human Health Effects of Climate Change” categorized health consequences of climate change into: Asthma, respiratory allergies and airway diseases; cancer; cardiovascular disease and stroke; foodborne diseases and nutrition; heat-related morbidity and mortality;

human developmental effects; mental health and stressrelated disorders; neurological diseases and disorders; vector-borne and zoonotic diseases; water-borne diseases; weather-related morbidity and mortality.

In a position paper published online April 19 in the Annals of Internal Medicine, the American College of Physicians (ACP) has focused on the consequences of climate change on human health including more respiratory and heat-related illness, vector-borne diseases, water-borne diseases, food and water insecurity, malnutrition, behavioral health problems.

ACP has called for urgent "aggressive, concerted" action to fight climate change to counter the “devastating” health consequences.

The position paper emphasizes the crucial role that physicians can play in tackling them by educating themselves, their patients, community, policy makers about the adverse health effects of climate change and also support efforts to alleviate them.

The ACP also recommends that medical schools and continuing medical education (CME) providers include climate change-related coursework in their syllabus.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

17

FACE-TO-FACE WITH THE WINNERS OF DR BC ROY NATIONAL AWARDS 2008-2010

Dr BC Roy National Awards for the Year 2008-2010 Announced

D

eMedinewS. The first of these conversations features Dr Neelam Mohan, a pioneering and dynamic Pediatric Gastroenterologist in the country in conversation with Dr KK Aggarwal.

2008

PASSION, DEDICATION AND PERSONAL ATTENTION ARE KEYS TO SUCCESS, SAYS DR NEELAM MOHAN

r BC Roy National Awards for the years 2008, 2009 and 2010 have been announced. Indian Medical Association (IMA) and eMedinewS congratulate all the winners of the prestigious Dr BC Roy National Awards. Here is a list of the winners under various categories.

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Eminent Medical Person: Dr Mammen Chandy

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Eminent Medical Teacher: Dr Rajeshwar Dayal, Dr Rohit V Bhatt, Dr Jagdish Chand Sharma

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Best talents in encouraging the development of specialties in different branches in Medicine: Dr Neelam Mohan, Dr Mohan Kameshwaran, Dr Harsha Jauhari

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Outstanding services in the field of Socio-Medical Relief: Dr Ashok Thakur, Dr Gopal Badlani, Dr Yash Gulati

2009 ÂÂ

Medical man-cum-Statesman: Dr KH Sancheti

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Eminent Medical Person: Dr Nikhil C Munshi

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Eminent Medical Teacher: Dr Atul Kumar, Dr Renu Saxena, Dr Kanan A Yelikar

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Best talents in encouraging the development of specialties in different branches in Medicine: Dr AK Kriplani, Dr GV Rao, Dr HS Bhanushali

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Outstanding services in the field of Socio-Medical Relief: Dr Motilal Singh, Dr CN Purandare

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Oration: Dr CV Harinarayan

It’s like asking an actor getting an Oscar Award or Filmfare Award … it’s really a lovely feeling. You feel good that all hard work and efforts are appreciated.

Dr KK: What motivated you to choose an unconventional specialty like Liver transplant, Pediatric Gastroenterology and Hepatology in the 90s?

I was keen to pursue a career in medicine that was new, different and unique. After completing my Postgraduation in Pediatrics, I had shortlisted three choices - Cardiology, Gastroenterology and Genetics.

Cardiology was a field everyone seemed to be opting for and Genetics though an exciting field, did not involve a high-degree of patient interaction. I finally opted for Gastroenterology. I was fascinated by the liver as an organ and given the lack of awareness that existed about liver diseases in the 90s, I truly believed that I could help make a difference in the field and help save lives. I was also deeply inclined towards understanding endoscopic procedures that were beyond the purview of surgeons.

Dr KK: What were the challenges that you faced early in your career? How did you manage to overcome them?

2010 ÂÂ

Eminent Medical Teacher: Dr Tejinder Singh, Dr OP Kalra, Dr Amrenderjit Kanwar

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Best talents in encouraging the development of specialties in different branches in Medicine: Dr Subhash Gupta, Dr Rajendra Prasad

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Outstanding services in the field of Socio-Medical Relief: Dr Glory Alexander

We will be presenting conversations with the winners of the Dr BC Roy National Awards regularly in

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Dr KK: How does it feel to be conferred with one of the most prestigious awards in the medical field?

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

During the 90s, there was no training program in Pediatric Gastroenterology in India. At best, AIIMS did good work in that field then. I worked there for more than a year. Subsequently, I decided to leave for UK to learn from the masters in that domain.

Between 1997 and 1999, I obtained specialized training in Pediatric Gastroenterology and Liver Transplantation at the Birmingham Children’s Hospital. I vividly remember one of my senior colleagues telling me

FACE-TO-FACE WITH THE WINNERS OF DR BC ROY NATIONAL AWARDS 2008-2010 “Nobody dies of hard work”. I made this my motto and did double shifts as a ‘Clinical fellow’ during the day from 8 to 5 pm and ‘Research fellow’ from 5:30 to 10:30 pm.

I returned to India in 1999 as an expert of liver transplants, pediatric liver and gastrointestinal diseases. Finding a job was an arduous task then as no one was interested in my precise domain. But, I stood by my resolve, as I knew that the time had arrived to establish the field of gastroenterology and liver in the country. Luck was by my side, and finally, my relentless pursuit paid off when I got my first break at Sir Ganga Ram Hospital, thanks to the vision of Dr SC Arya (Pediatrician) and Dr SK Sama (Chairman, SGRH).

I worked at Sir Ganga Ram Hospital for over a decade and was given the opportunity to live the dream of advancing endoscopic procedures for the betterment of healthcare in India. I became the first doctor in the country to initiate endoscopic procedures in newborn babies. I worked not only in diagnostics but also in therapeutic endoscopy. All these tremendously boosted my confidence and morale.

Dr KK: You have taken many pioneering initiatives that have brought India at the global forefront in this domain. Please illuminate.

I humbly say that I created India’s first unit of Pediatric Gastroenterology, Hepatology and Liver Transplantation Division at Medanta–The Medicity under support of Dr Naresh Trehan (Chairman and Managing Director, Medanta–The Medicity) and visionary in medical field. I became a part of a horizontal expansion, and we expanded into various verticals besides liver transplantation and liver/gastrointestinal diseases such as motility, endoscopy, capsule endoscopy, manometry and diagnostic and curative work, making it the first such department in the country that provides comprehensive A to Z facilities for newborns, children and adolescents with Gastrointestinal and Liver Diseases including the highest level of liver care that is Liver Transplantation. Today, we have more than 200 successful pediatric liver transplants in India and we can claim to be at par with America and UK, for results if not better.

After being credited to be India’s first doctor to initiate curative Endoscopy in newborns and young infants, I consider myself fortunate to have given several other firsts in India and world in the field of Liver Transplantation, such as: ÂÂ

World’s first living related liver transplant in a baby with factor VII deficiency (2010)

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World’s youngest domino liver transplant (2009)

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South Asia’s first successful combined liver and kidney transplant from two live donors (2007)

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India’s first youngest liver transplant in a 3 months old baby (2015)

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India’s first living related liver transplant which cured a baby with Citrullinemia (2013)

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India’s first ABO-incompatible liver transplant in a child (2012)

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India’s first Robotic donor hepatectomy in liver transplant in a child (2011)

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India’s first Swap liver transplantation (2009)

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India’s first Bloodless liver transplant (2006)

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India’s first Successful survival of liver transplant in a fulminant liver failure (2004)

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India’s first Successful pediatric cadaveric reduced liver transplant (2003)

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India’s first successful liver transplantation in patient with both liver and lung failure due to hepatopulmonary syndrome (2016).

In the last decade, my services to the medical profession and the community have been recognized at both National and International level and this has been quite a humbling experience for me.

I have been honored with prestigious awards and accolades such as FIAP Award by Indian Academy of Pediatrics and FACG by American College of Gastroenterology, SGRH Alumni Award.

I have been appreciated by the medical fraternity and received the“DMA Centenary Award - 2014”given by Finance Minister Arun Jaitley for my contribution in the field of child health, “ZEE Swastha Bharat Samman Award” in 2012 by the former Health Minister Ghulam Nabi Azad.

Besides these, I have been honored with the Distinguished Service Award by Indian Medical Association and Eminent Doctor of the Year Award by eMedinews amongst various others.

Dr KK: What advice would you give to the youngsters today?

Passion, dedication and personal attention are the keys to success.

I would like to sincerely thank my family (Husband, Children, in laws and Parents), patients, their parents, my team of doctors, staff and my Mentors.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

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FACE-TO-FACE WITH THE WINNERS OF DR BC ROY NATIONAL AWARDS 2008-2010 THE DIVISION BETWEEN PRIVATE AND PUBLIC MUST GO: DR SUBHASH GUPTA Dr KK Aggarwal, Editor-in-Chief, eMedinewS and IMA News in conversation with Dr Subhash Gupta, Founder and Chief of Centre for Liver and Biliary Sciences (CLBS) at Indraprastha Apollo Hospitals in New Delhi About Dr Subhash Gupta Dr Subash Gupta is the Founder and Chief of Centre for Liver and Biliary Sciences (CLBS) at Indraprastha Apollo Hospital in New Delhi, India. The CLBS group is actively engaged in Liver Transplant and complex hepatopancreatobiliary (HPB) surgery. His center conducts over 300 transplants every year. He is one of the pioneers of living donor liver transplantation in India.

Dr Gupta graduated as a National Talent Scholar from AIIMS, New Delhi. After spending 6 years in the UK at Queen Elizabeth Hospital in Birmingham and later at St James’s University Hospital in Leeds, he joined Sir Ganga Ram Hospital in New Delhi as a Consultant in Liver Transplant and Gastrointestinal Surgery in 1998.

As cadaveric donations were rare, Dr Gupta introduced right lobe adult-to-adult liver transplantation to the hospital.

The CLBS group has introduced many innovations such as middle hepatic vein and right hepatic artery clamp test, new techniques in transplants for small children, methods to avoid dual lobe transplant in obese recipients, sequential liver kidney transplant as compared to combined liver kidney transplant and techniques for splitting cadaveric liver into two valves for transplanting in two recipients.

He has been credited for performing liver transplants in patients with unusual and difficult conditions, such as portal biliopathy, co-existing HIV infections and donors/recipients with situs inversus. In 2009, his team introduced the posterior sector graft for increased donor safety in India, and was instrumental in pioneering hepatic transplantation in babies under 6 months of age in India. His team has also developed guidelines on liver transplantation and the treatment of liver diseases in India. CLBS has trained many teams and surgeons from around the world in liver transplantation.

Their group has helped start liver transplant in Institute of Liver and Biliary Sciences, New Delhi, Sheikh Zayyad Hospital, Lahore, Seventh Hospital, Almaty, Kazakhstan and Dow Medical College, Karachi. Since 2010, he is a Visiting Professor of Liver Transplantation at the Institute of Postgraduate Education and Medical Research in Kolkata, India.

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

In 2012, he was honored by the Rotary Association of India for Excellence in Clinical Medicine, and in the same year, he was the recipient of the Vishist Chikitsak Rattan (distinguished clinician) awarded by Delhi Medical Association. In 2016, He was awarded the prestigious “YASH BHARTI” by the Uttar Pradesh Government.

Dr Gupta has published over 30 papers in surgery and transplantation, and his research focuses on improving postoperative management of sick recipients.

Dr KK: How important is the role of your family in your journey?

My family has been very supportive all through my life. In 1998, when I was a Consultant in St. James’s University Hospital, Leeds, I chose to return to India and join Sir Ganga Ram Hospital to start liver transplantation in India. At that time, it did not seem like a good idea and for years I had to struggle to get recognized as a talented surgeon in India. All through this period, my family stood by me and supported me on all my decisions.

Dr KK: What are your feelings on receiving the award?

Receiving this award is a great honor and I feel that I must do more to improve medical education in our country, so that we end up having universal health coverage for every Indian citizen.

Dr KK: What is your message to the community?

My message to the community is that each one of us should direct efforts to improve the Island that one is working in and the efforts of everyone will multiply to bring about a major change in our society.

Dr KK: What changes do you suggest with regard to health policies?

I feel major changes in health policies are needed.

The division between private and public must go.

Fresh graduates are not willing to work at low salaries in the government sector and patients are not willing to see new doctors in the private sector.

Nowhere in the world does this dichotomy exist.

It is time that this should be changed. Those who work in the government sector must be allowed private practice. A time will come when it will be difficult to get teachers in medical colleges.

STRENGTHEN DISTRICT HEALTH SOCIETIES Dr KK Aggarwal, Editor-in-Chief, eMedinewS and IMA News in conversation with Dr Atul Kumar, Chief & Professor of Ophthalmology, Dr RP Centre for Ophthalmic Sciences, AIIMS, New Delhi.

FACE-TO-FACE WITH THE WINNERS OF DR BC ROY NATIONAL AWARDS 2008-2010 Dr Atul Kumar has been honored with Dr BC Roy National Award for the year 2009 under the category of Eminent Medical Teacher.

Dr KK: How has your journey been so far?

It has been a total rollercoaster ride. I come from a nonmedico family and struggled against all odds to get a meritorious seat at Maulana Azad Medical College, Delhi. Then another nervous ‘do or die’ attempt got me into AIIMS, and MD at the RP Centre for Ophthalmic Sciences. There was no looking back then, when as a Senior Resident, I realized that besides my clinical work, I also liked academics and teaching. The Almighty was with me as I managed a faculty position at AIIMS, and now finally I am the Chief of the Ophthalmic Center in this institute.

Dr KK: You also have several achievements to your credits. Tell us about them.

Yes, I have been lucky that being a workaholic and having an obsession for finesse, whether retinal surgery or medical retinal ailments, got me laurels.

I was awarded the Padma Shri in 2007 and was also appointed Hony Consultant to the Armed Forces. This year, in 2016, I was elevated as the Chief and Professor, Dept. of Ophthalmology at RP Centre.

Dr KK: What are your feelings on receiving the award?

I feel on top of the world, as it justifies what I have done all these years.

Dr KK: What about your family. Tell us something about them.

We are middle class people. My father was an engineer and mother a housewife. My wife works for an NGO for poor women. My son is an intern in Delhi and daughter is pursuing her CA, after B.Com (Hons). Of course, I have been in AIIMS throughout and so in a Govt. job, about which I have no regrets as I handle state of art equipment besides teaching residents and research.

incentive in the form of early promotions, etc. can also be thought of.

ORGAN DONATION AWARENESS MUST START IN SCHOOLS Dr Harsha Jauhari, Recipient of Dr BC Roy National Award in conversation with Dr KK Aggarwal Dr KK: How does it feel to be conferred with one of the most prestigious awards in the medical field?

Many professionals have been working tirelessly and selflessly in the field of Transplantation. I can only humbly accept this award on their behalf.

Dr KK: Tell me about your journey so far.

After graduating from Armed Forces Medical College (Pune) in 1972, and completing my MS in General Surgery in 1976, from GSVM Medical College, Kanpur, I went to UK, where after FRCS, I underwent training, at the Institute of Urology, London, in Transplantation Surgery, which was still in a nascent stage. I came back to India in 1988 and set up Transplant Centers in three states, first at Sir Ganga Ram Hospital, New Delhi; followed by one at Noida Medicare Center, Noida, UP and then at Artemis Healthcare Institute, Gurgaon.

Dr KK: What has been your experience regarding kidney transplants.

I have been involved in almost 5,000 kidney transplants and have pioneered transplant in diabetes, postCABG, HBsAg-positive and hepatitis C patients. I have also been instrumental in a number of surgical innovations, which are now standard practice.

Academically, I have presented and authored over 100 National as well as International Lectures and Presentations. I started the Transplant Program at Dr Ram Manohar Lohia Hospital in New Delhi. I have also trained a number of Postgraduate Students in Transplant Surgery, who have then started their own programs.

Dr KK: What changes do you suggest as a health policy?

Dr KK: You were appointed by Hon’ble Delhi High Court to review the provisions of the Transplantation of Human Organ Act (THOA) 1994. Please illuminate.

I am a staunch supporter of the Prime Minister’s Clean and Hygienic Surrounding Campaign as this form of prevention can take care of many of ailments in our country. Then, population control as a voluntary method, strengthening District Health Societies so that paramedics and social workers work in tandem with the District Medical Officer and proper funds being available to them to carry out their duties, some sort of

Yes, I was appointed by the Hon’ble Delhi High Court to review the provisions of the Transplantation of Human Organ Act, (THOA) 1994. Many of the recommendations, including creation of National Organ Transplant Program (NOTP), were accepted and are now being implemented. I was also a member of a large member of Expert Committees on Transplants and Nephrology at Union Ministry of Health and

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

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FACE-TO-FACE WITH THE WINNERS OF DR BC ROY NATIONAL AWARDS 2008-2010 Family Welfare. I am serving as a Technical Advisor (Organ Transplant) to Union Ministry of Health & Family Welfare, since August 2014 and helping to create, develop and operationalize the National Organ & Tissues Transplant Organization (NOTTO). I have been the President of the Delhi Nephrology Society and presently, I am President of Association of Surgeons of India (Delhi Chapter).

Dr KK: Tell me about your family.

My wife is a Professor of English and I have two children, both of whom are lawyers.

Dr KK: If you had to give a message to the community, what would it be?

My message to the community is very simple. It’s a oneline message: “Ang Daan Jeevan Daan/Donate Organs, Save Lives”.

Dr KK: Given a chance, what changes would you like to bring about in health policies?

I have been involved in many changes in organ transplant over the years. I would like to include a lecture or two, on Organ Donation in schools and colleges, to create awareness.

BE SYMPATHETIC AND HELPFUL TO PATIENTS Dr KK Aggarwal, Editor-in-Chief, eMedinewS and IMA News in conversation with Dr AK Kriplani, Director and Head of the Dept. of Minimal Access, Bariatric and GI Surgery at the Fortis Memorial Research Institute, Gurgaon Dr AK Kriplani has been honored with Dr BC Roy National Award for the year 2009 under the category of Best talents in encouraging the development of specialties in different branches in Medicine.

As the Director and Head of the Dept. of Minimal Access, Bariatric and GI Surgery at the Fortis Memorial Research Institute, Gurgaon, Dr AK Kriplani has shaped up the department, with core strengths being advanced minimally invasive surgery e.g., laparoscopic colorectal and Hepatobiliopancreatic surgeries, single incision laparoscopic surgery for gallstones and laparoscopic bariatric surgeries.

Dr Kriplani graduated from Pt JNM Medical College, Raipur, Chhattisgarh (previously MP) in 1977 with 2 gold medals and passed MS in Surgery in 1981.

He then joined AIIMS, New Delhi and served under various faculty positions including Additional Professor till 1996. He was amongst the first few surgeons in the country and the first in the Government sector to perform laparoscopic surgery. Always remaining in

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

the forefront of this cutting edge technology, he was the first to perform laparoscopic adrenalectomy in India and the first to perform laparoscopic Whipple pancreaticoduodenectomy in North India. Dr Kriplani started and was the Chief of the Center of Weight Loss Surgery at the Indraprastha Apollo Hospitals, New Delhi during his stint, there as senior consultant from 1996 to 2014, before joining Fortis Hospital, Gurgaon.

The Minimal Access Surgery Department at Fortis Hospital today perhaps performs the largest number of scarless single incision laparoscopic cholecystectomies in India under his leadership.

Dr Kriplani has been an enthusiastic teacher from the beginning and his teachings go beyond institutional boundaries to even the surgeons serving in the society. He has traveled the length and width of the country and has been invited for more than 455 live surgical demonstrations, guest lectures, key note addresses, panel discussions, etc. in India and other Asian, European and American conferences. He has served as the President of the Indian Association of Gastrointestinal Endosurgeons (IAGES), the National Association of Laparoscopic Surgeons in India for the years 2008-2010 and is currently amongst the trustees. He started fellowship Courses of the IAGES in 2007, which are still amongst the most popular and prestigious fellowship courses in laparoscopic surgery in India. He has trained hundreds of surgeons from India and other countries.

Dr Kriplani has been conferred with 28 Awards/ Honors/Orations of National and International levels including, Best Video Award 12th Asia Pacific Congress of Endoscopic and Laparoscopic Surgery 2015, Daegu, South Korea; “eMedinews Distinguished Speaker of the Year 2009”, Dr BN Balakrishna Rao Oration 2008, Bangalore; “Distinguished Services Award”, IMA Academy of Medical Sciences, 2007; Honorary fellowships like FIAGES, FALS, FICS, FAIS, etc.

He has organized 10 National Conferences/CMEs/ Workshops. His teaching videos on laparoscopic surgical procedures are extremely popular and in a short span of 3 years, more than 2,00,000 surgeons from all over the world have visited his channel and benefitted by watching his techniques with current average of 350 per day. He is editor of a textbook “Comprehensive Laparoscopic Surgery”. He has contributed 28 scientific publications/invited chapters in Books.

Dr KK: What are your feelings on receiving the award?

Receiving the award is a great feeling and makes me more humble. It motivates me to be more dedicated to

FACE-TO-FACE WITH THE WINNERS OF DR BC ROY NATIONAL AWARDS 2008-2010 the profession that has given me recognition. However, I know that many persons have contributed to my achievements. My parents, who have inspired me and passed on the social and ethical values of the highest standards by example; my spouse and kids who have made personal sacrifices to help me fulfil my dreams; my teachers who have devoted their time to guide, groom and shape me and my colleagues and team members without whom I wouldn’t be what I am today and my juniors who have energised me. I take this opportunity to thank all of them and dedicate this award to them.

Dr KK: What about your family? Tell us something about them.

My family has been very understanding and supporting.

My wife, Padma Shri Prof Dr Alka Kriplani is Head of Dept. of Obstetrics and Gynecology at the All India Institute of Medical Sciences, New Delhi and is herself a great academician and President of FOGSI. Her support has been unconditional. Both my daughters are postgraduate doctors and are not only understanding but very encouraging.

DO NOT DISCRIMINATE AGAINST PEOPLE LIVING WITH HIV/AIDS Dr KK Aggarwal, Editor-in-Chief, eMedinewS and IMA News in conversation with Dr Glory Alexander, DirectorASHA Foundation, Bangalore Dr Glory Alexander has been honored with Dr BC Roy National Award for the year 2010 under the category of "Outstanding services in the field of Socio-Medical Relief".

Dr KK: Tell us about your journey so far.

I completed my graduate (MBBS) and postgraduate training in Internal Medicine from Christian Medical College and Hospital, Vellore in 1986. Then I worked in the Bangalore Baptist Mission Hospital till 1998.

During the 90s, there was much concern in India about HIV/AIDS. There was huge stigma and discrimination towards this disease. At this time, I moved full time into working in the field of HIV/AIDS and founded the ASHA Foundation in 1998.

The ASHA Foundation provides a range of services in the field of HIV/AIDS. ÂÂ

Counseling and testing services: We started the first private automated AIDS Helpline in the Country which received almost 40,000 calls; more than 20,000 manual telephone calls; 8000 counseling sessions. In addition, there are email queries and awareness programs among vulnerable communities conducted under this component.

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Adolescent health education: A Teachers’ manual was developed in-house and taught to students by trained teachers. So far more than 2,500 teachers have been trained all over the country. About 1 lakh students have used the curriculum in the past and currently more than 300 schools, colleges and other institutions are participating in the program. About 40,000 students in Pune, Mumbai, Nagpur, Tamil Nadu, Andhra Pradesh, Bangalore, Mangalore, Mysore, Kolar, Hunsur, HB Kote, Koppal, Shimoga, Dakshin Kannada and Hubli are doing the program. The students have student workbooks and a parents manual has also been developed.

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Prevention of Mother-to-Child Transmission of HIV (PMTCT): In partnership with some hospitals in Kerala, Andhra Pradesh, Tamil Nadu and Karnataka, ASHA Foundation has worked in the field of PMTCT. So far 1,64,064 pregnant mothers have been tested for HIV; of these, 855 were diagnosed as HIV-positive and treated with

Dr KK: If you had to give a message to the community, what would it be?

Our profession is the noblest and the most respected profession even today. However, changing trends in the society, inadequate, incomplete and sometimes inaccurate information on social media, increasing cost of treatment due to newer technologies, etc. sometimes lead to stress, frustration and mistrust in the minds of the patients and their families.

These are challenging and testing times for our profession. We all must be more careful and cautious in our approach, at the same time being sympathetic and helpful to our patients. We have to learn to balance these contradictions. The patients may behave like consumers, but we must still remain doctors.

Dr KK: What changes do you suggest in health policies?

Today, tertiary medical care is still a far-fetched dream for distant areas and the economically deprived. Health should be a fundamental right. Quality healthcare should be available to every citizen whenever needed.

Distance and affordability should not be a factor.

Initiatives are required to provide medical insurance to all and optimal medical care should be available even in interior areas of the country.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

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FACE-TO-FACE WITH THE WINNERS OF DR BC ROY NATIONAL AWARDS 2008-2010 antiretroviral therapy (ART) and other measures, so that the children would be born HIV-negative.

In our cohort, we have brought down the risk of transmission from 30% to less than 2%. So far in our partner hospitals, we have trained more than 100 nurses and 40 other staff as counselors, sensitized around 2000 doctors and other staff on PMTCT, and around 20,000 other nurses, nursing and medical students, ward aides, paramedical workers. Community health workers and community have been sensitized about HIV/AIDS and PMTCT. ÂÂ

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Camp Rainbow: This is a psychosocial intervention where we take HIV-positive children, between 10 and 16 years of age, to a residential summer camp for 5 days and teach them life skills, health and hygiene, arts and crafts, knowledge of HIV/ AIDS, environment preservation, etc. These camps have improved their self-esteem, confidence, ART adherence and social behavior. Children from Bangalore, Mysore, Mandya, Kolar, Ramnagara and Andhra Pradesh have attended these camps.

We also train volunteers from colleges who give 3 weeks of their time night and day to help in these camps.

Support for children and their families: The care component includes medical care and support to a large number of HIV-positive individuals and their families through provision of ART, treatment for TB and opportunistic infections, care for HIV-infected and affected children through educational support, nutritional support and ART, empowerment of women through knowledge creation, vocational training, job placements, micro-credit and formation of Self Help Groups (SHGs), with SHG bank accounts.

HIV Research: ASHA Foundation is recognized as a Scientific and Industrial Research Organization by the Dept. of Science and Technology, Government of India, focusing on Clinical Research in PMTCT of HIV infection, adults with HIV, children with HIV, adolescent health education, counseling in HIV, and socioeconomic aspects of HIV. Currently, six research projects are in progress.

Advocacy: Facilitation of free legal services for HIV infected women, facilitation of free housing for women under Rajiv Gandhi Housing, facilitating access to government schemes such as widows’ pension and facilitating educational support for children through Child Welfare Committee (CWC).

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

Dr KK: You have also received numerous honors and awards.

I received RV Rajam 81st Birthday Commemoration Gold Medal 1986 from Madras University for the first rank in MD Internal Medicine. ÂÂ

International Ashoka Fellowship innovative work in HIV/AIDS.

Award

for

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National Rajiv Gandhi Rashtriya Ekta Award for services rendered in the field of HIV/AIDS.

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Best Research Paper Award in National AIDS Conference held in Hyderabad in 2010.

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Karamveer Global Fellowship Award

I have been an advisor for WHO and member of the draft committee of WHO to draft a policy on "provider initiated testing and counseling" and have been an Invitee to many expert National and State Technical Committees. I have also been a resource person at State, National and International fora and made numerous presentations. I have served as the Vice President of the AIDS Society of India, member of the Governing Council of the AIDS Society of India and member of the International AIDS Society besides being on the boards of other organizations. I have been interviewed on BBC’s Health Program, and several radio programs and several articles about my work and the ASHA Foundation have appeared in newspapers over the years.

Dr KK: Tell us about your family?

My husband is an orthopedic surgeon and presently consultant at World Bank. He is also the Founder Executive Director of AHPI. I have two children, one son-in-law and one granddaughter.

Dr KK: How does it feel to receive this prestigious award?

I feel elated, humbled and grateful to God. Dr KK: What would be your message to the community?

With advent of ART, people living with HIV/AIDS have an almost normal lifespan and contribute in meaningful ways to society, so they should not be discriminated against.

Dr KK: What changes do you suggest in health policies?

To provide quality and affordable healthcare to all section of society by training adequate number of doctors, nurses and allied health professionals, increasing the number of seats UG and PG and allied health professionals.

FACE-TO-FACE WITH THE WINNERS OF DR BC ROY NATIONAL AWARDS 2008-2010 BE PREPARED FOR HARD WORK, TREMENDOUS SACRIFICES AND FOLLOW ETHICS

Dr KK: Tell us about your family. How important has been the role of your family in your journey?

Dr KK Aggarwal, Editor-in-Chief, eMedinewS and IMA News in conversation with Dr Renu Saxena, Professor and Head, Dept. of Hematology, AIIMS, New Delhi

My parents have always been extremely supporting of my profession. My husband, also in the medical profession, was a constant source of support and encouragement in maintenance and progression of my profession. My children have always been big support to my achievements. My mother-in-law was a big support to me, especially in handling my family when I was traveling for profession. She also was extremely proud of my achievements, as also my husband. In fact I feel, I was able to do justice to my profession largely because of my family support.

Dr Renu Saxena has been honored with Dr BC Roy National Award for the year 2009 under the category of Eminent Medical Teacher.

Dr KK: How does it feel being conferred with one of the most prestigious awards in the medical field?

I feel very honored and humbled. Having spent 36 years in the field of Hematology and enjoying every minute of the same, the award comes as recognition of our work. Needless to say, this gives me tremendous encouragement to continue working with the same zeal and enthusiasm.

Dr KK: Tell us about your journey so far.

I have been a medical graduate, postgraduate and faculty at AIIMS, New Delhi. I feel that training from AIIMS and the work atmosphere here in AIIMS have helped me inculcate academic, ethics and research values, in addition to patient care. My seniors and teachers at AIIMS have been my role models and have mentored me regarding approach to academics and ideal patient care. I have strived to work with sustained dedication, hard work and sincerity towards my profession. In addition, I have always enjoyed teaching and grooming budding doctors and mentoring them in building their careers.

Dr KK: What were the early challenges faced by you in your career? How did you manage to overcome them?

Some early challenges included balancing of family life with profession and the struggle to do quality work.

These were overcome by my constant strive for trying to do justice in whatever work I was involved in and my husband’s support, whether it was home or profession.

I thoroughly enjoyed both my roles as a hematologist and a homemaker.

Dr KK: What would be your message to the community?

I feel, dedicated work, coupled with honesty and diligence, goes a long way in achieving goals in whichever field you are committed to. One should be a hard working person with clear and specific goals and try to remain focused in achieving his or her dreams.

Dr KK: Given a chance, what changes would you like to bring about in health policies?

I feel, we should develop good health insurance systems or mechanisms by which everyone should have access to basic medical and emergency medical care at affordable price, which I believe the government is actively trying to do. At the same time, promoting quality and innovative research in medical institutes will go a long way in advancing healthcare in our country and giving our medical institutes the international recognition they deserve.

Dr KK: What advice would you give to youngsters?

Youngsters are the pillars of tomorrow. In today’s world I feel instead of trying to take shortcuts to reach the top, one should be prepared for hard work and tremendous sacrifices to acquire knowledge and experience. They should strive to grasp the in-depth knowledge of their profession, be prepared to put in hard work, follow ethics and be honest to themselves and the profession.

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

25

AMERICAN FAMILY PHYSICIAN

Potassium Disorders: Hypokalemia and Hyperkalemia ANTHONY J. VIERA, NOAH WOUK

ABSTRACT Hypokalemia and hyperkalemia are common electrolyte disorders caused by changes in potassium intake, altered excretion, or transcellular shifts. Diuretic use and gastrointestinal losses are common causes of hypokalemia, whereas kidney disease, hyperglycemia, and medication use are common causes of hyperkalemia. When severe, potassium disorders can lead to life-threatening cardiac conduction disturbances and neuromuscular dysfunction. Therefore, a first priority is determining the need for urgent treatment through a combination of history, physical examination, laboratory, and electrocardiography findings. Indications for urgent treatment include severe or symptomatic hypo­kalemia or hyperkalemia; abrupt changes in potassium levels; electrocardiography changes; or the presence of certain comorbid conditions. Hypokalemia is treated with oral or intravenous potassium. To prevent cardiac conduction dis­turbances, intravenous calcium is administered to patients with hyperkalemic electrocardiography changes. Insulin, usually with concomitant glucose, and albuterol are preferred to lower serum potassium levels in the acute setting; sodium polystyrene sulfonate is reserved for subacute treatment. For both disorders, it is important to consider poten­tial causes of transcellular shifts because patients are at increased risk of rebound potassium disturbances.

Keywords: Hypokalemia, hyperkalemia, cardiac conduction disturbances, neuromuscular dysfunction, oral or intravenous potassium, intravenous calcium

P

otassium disorders are common. Hypokalemia (serum potassium level less than 3.6 mEq per L [3.6 mmol per L]) occurs in up to 21% of hospitalized patients and 2% to 3% of outpatients.1-3 Hyperkalemia (serum potas­ sium level more than 5 mEq per L [5 mmol per L] in adults, more than 5.5 mEq per L [5.5 mmol per L] in children, and more than 6 mEq per L [6 mmol per L] in neonates) occurs in up to 10% of hospitalized patients and approximately 1% of outpatients.4,5 The body’s plasma potassium concentration is closely regulated by a variety of mechanisms.

CAUSES OF HYPOKALEMIA Hypokalemia results from abnormal losses, transcellular shifts, or insufficient intake (Table 1).6-8 Abnormal losses are most com­ mon.9 Because the kidney can significantly lower potassium excretion in response to decreased intake, insufficient intake is rarely the sole cause of hypokalemia, but it often contrib­utes to hypokalemia in hospitalized patients.9

Renal Losses Diuretic use is a common cause of renally mediated hypokalemia.10 When given in the same dosage, chlorthalidone is more likely to induce hypokalemia than hydrochlorothia­zide, which is more often implicated because of its widespread use.11,12 Diureticinduced hypokalemia is dose-dependent and tends to be mild (3 to 3.5 mEq per L [3 to 3.5 mmol per L]), although it can be more severe when accompanied by other causes (e.g., gastroin­testinal [GI] losses).13

GI Losses GI losses are another common cause of hypokalemia, particularly among hospital­ized patients.9 The mechanism by which upper GI losses induce hypokalemia is indi­rect and stems from the kidney’s response to the associated alkalosis. As a portion of daily potassium is excreted in the colon, lower GI losses in the form of persistent diarrhea can also result in hypokalemia and may be accompanied by hyperchloremic acidosis.6 EVALUATION AND MANAGEMENT OF HYPOKALEMIA

ANTHONY J. VIERA, MD, MPH, is an associate professor in the Depart­ment of Family Medicine at the University of North Carolina at Chapel Hill School of Medicine.

NOAH WOUK, MD, is a resident in the Department of Family Medicine at the University of North Carolina at Chapel Hill School of Medicine.

Source: Adapted from Am Fam Physician. 2015;92(6):487-495.

26

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

General Principles Hypokalemia is often asymptomatic. Evalu­ation begins with a search for warning signs or symptoms warranting

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AMERICAN FAMILY PHYSICIAN Table 1. Causes of Hypokalemia Abnormal losses Medications Diuretics Laxatives and enemas Corticosteroids Gastrointestinal losses Renal losses Osmotic diuresis Mineralocorticoid excess Types I and II renal tubular acidosis

Transcellular shifts (continued) Alkalosis Refeeding syndrome Increased beta2 adrenergic stimulation Delirium tremens Head injury Myocardial ischemia Thyrotoxicosis Familial hypokalemic periodic

Polydipsia

paralysis

Intrinsic renal transport defects

Inadequate intake

Hypothermia

Hypomagnesemia

Anorexia

Dialysis/plasmapheresis

Dementia

Transcellular shifts

Starvation

Medications

Total parenteral nutrition

Insulin overdose

Pseudohypokalemia

Beta2 sympathomimetics

Delayed sample analysis

Decongestants Xanthines

Amphotericin B

Significant leukocytosis (> 75,000 cells per mm3 [75.0 × 109 per L])

Verapamil intoxication Chloroquine intoxication Barium intoxication Cesium intoxication Note: Listed in approximate order of frequency.

Information from references 6 through 8.

urgent treatment (Figure 1).7,14 These include weakness or pal­pitations, changes on electrocardiography (ECG), severe hypokalemia (less than 2.5 mEq per L [2.5 mmol per L]), rapid-onset hypokalemia, or underlying heart disease or cirrhosis.7,15 Most cases of hypokalemiainduced rhythm disturbances occur in individuals with underlying heart disease.10 Early identification of transcellular shifts is important because management may differ. Identification and treatment of concurrent hypomagnesemia are also important because magnesium depletion impedes potassium repletion and can exacerbate hypokalemia-induced rhythm disturbances.16,17

History and Physical Examination A focused history includes evaluation for possible GI losses, review of medications, and assessment

for underlying cardiac comorbidities. A history of paralysis, hyper­thyroidism, or use of insulin or beta agonists suggests possible transcellular shifts leading to redistributive hypokalemia. The physical examination should focus on identifying cardiac arrhythmias and neurologic mani­festations, which range from generalized weakness to ascending paralysis.

Laboratory Analysis and ECG The diagnosis should be confirmed with a repeat serum potassium measurement. Other laboratory tests include serum glucose and magnesium levels, urine electrolyte and creatinine levels, and acid-base balance. The most accurate method for evaluating urinary potassium excre­tion is a 24-hour timed urine potassium collection; nor­mal kidneys excrete no more than 15 to 30 mEq per L (15 to 30 mmol per L) of potassium per day in response to hypokalemia. A more practical approach is calculation of the urine potassium-to-creatinine ratio from a spot urine specimen; a ratio greater than 1.5 mEq per mmol (13 mEq per g) is indicative of renal potassium wasting.18 If no cause is identified with the initial workup, assessment of thyroid and adrenal function should be considered.

Typically, the first ECG manifestation of hypokale­mia is decreased T-wave amplitude. Further progression can lead to ST-interval depression, T-wave inversions, PR-interval prolongation, and U waves. Arrhythmias associated with hypokalemia include sinus bradycardia, ventricular tachycardia or fibrillation, and torsade de pointes.19 Although the risk of ECG changes and arrhythmias increases as serum potassium concentration decreases, these findings are not reliable because some patients with severe hypokalemia do not have ECG changes.20 TREATMENT OF HYPOKALEMIA The immediate goal of treatment is the prevention of potentially life-threatening cardiac conduction disturbances and neuromuscular dysfunction by raising serum potassium to a safe level. Further replenishment can pro­ceed more slowly, and attention can turn to the diagnosis and management of the underlying disorder.15 Patients with a history of congestive heart failure or myocardial infarction should maintain a serum potassium concen­tration of at least 4 mEq per L (4 mmol per L), based on expert opinion.15 Careful monitoring during treatment is essential because supplemental potassium is a common cause of hyperkalemia in hospitalized patients.21 The risk of

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

29

AMERICAN FAMILY PHYSICIAN Evaluation of Hypokalemia Potassium < 3.6 mEq per L (3.6 mmol per L) Check magnesium and replace if low Yes

Warning signs present?* No

Yes

Pseudohypokalemia?

Urgent therapy No further action

No Evidence of decreased intake or transcellular shifts?

Yes

No Urine potassiumto-creatinine ratio

≤ 1.5 mEq per mmol (13 mEq per g)

Treat according to etiology of transcellular shifts

> 1.5 mEq per mmol Renal losses

Extrarenal losses (e.g., gastrointestinal, inadequate intake, discontinued diuretic, transcellular shifts)

Elevated blood pressure or hypervolemia?

No Check acid-base status

Acidosis (e.g., types I and II renal tubular acidosis)

Variable (e.g., hypomagnesemia)

Yes

Evaluate for conditions associated with mineralocorticoid excess (e.g., primary and secondary hyperaldosteronism, renal artery stenosis, Cushing syndrome, congenital adrenal hyperplasia)

Alkalosis (e.g., emesis, diuretic use, Bartter and Gitelman syndromes†)

*Symptoms of hypokalemia, changes on electrocardiography, severe hypokalemia (less than 2.5 mEq per L [2.5 mmol per L]), rapid-onset hypokalemia, or underlying heart disease or cirrhosis. †Autosomal

recessive disorders of renal tubular transport.

Figure 1. Suggested algorithm for the evaluation of hypokalemia.

Information from references 7 and 14.

rebound hyperkalemia is higher when treating redis­ tributive hypokalemia. Because serum potassium concentration drops approximately 0.3 mEq per L (0.3 mmol per L) for every 100-mEq (100-mmol) reduction in total body potassium, the approximate potassium deficit can be estimated in patients with abnormal losses and decreased intake. For example, a decline in serum potassium from 3.8 to 2.9 mEq per L (3.8 to 2.9 mmol per L) roughly corresponds to a 300-mEq (300-mmol) reduc­tion in total body potassium.

Additional potassium will be required if losses are ongoing. Concomitant hypomag­ nesemia should be treated concurrently.

For hypokalemia associated with diuretic use, stopping the diuretic or reducing its dosage may be effective.15 Another strategy, if otherwise indicated to treat a comor­bid condition, is use of an angiotensin-converting enzyme (ACE) inhibitor, angiotensin receptor blocker (ARB), beta blocker, or potassium-sparing diuretic

30

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

because each of these drugs is associated with an elevation in serum potassium.

It is appropriate to increase dietary potassium in patients with low-normal and mild hypokalemia, particularly in those with a history of hypertension or heart disease.15 The effectiveness of increased dietary potassium is limited, however, because most of the potassium contained in foods is coupled with phosphate, whereas most cases of hypokalemia involve chloride depletion and respond best to supplemen­tal potassium chloride.6,15 Because use of intravenous potassium increases the risk of hyperkalemia and can cause pain and phlebitis, intravenous potassium should be reserved for patients with severe hypokalemia, hypokalemic ECG changes, or physical signs or symp­toms of hypokalemia, or for those unable to tolerate the oral form. Rapid correction is possible with oral potassium; the fastest results are

AMERICAN FAMILY PHYSICIAN likely best achieved by combin­ing oral (e.g., 20 to 40 mmol) and intrave­nous administration.22 When intravenous potassium is used, standard administration is 20 to 40 mmol of potassium in 1 L of normal saline. Correction typically should not exceed 20 mmol per hour, although higher rates using central venous catheters have been successful in emergency situations.22 Con­tinuous cardiac monitoring is indicated if the rate exceeds 10 mmol per hour. In chil­dren, dosing is 0.5 to 1.0 mmol per L per kg over one hour (maximum of 40 mmol).23 Potassium should not be given in dextrose-containing solutions because dextrose-stimulated insulin secretion can exacerbate hypokalemia.

Nonurgent hypokalemia is treated with 40 to 100 mmol of oral potassium per day over days to weeks. For the pre­vention of hypokalemia in patients with persistent losses, as with ongoing diuretic therapy or hyper­ aldosteronism, 20 mmol per day is usually sufficient.15 CAUSES OF HYPERKALEMIA Hyperkalemia is caused by excess potassium intake, impaired potassium excretion, or transcellular shifts (Table 2).8,24 The etiology of hyperkalemia is often multifactorial, with impaired renal function, medication use, and hyperglycemia as the most common contributors.25 Because healthy individuals can adapt to excess potassium consumption by increasing excretion, increased potas­sium intake is rarely the sole cause of hyper­kalemia, and underlying renal dysfunction is common.24

Impaired Potassium Excretion Renally mediated hyperkalemia results from derangement of one or more of the following processes: rate of flow in the distal nephron, aldosterone secretion and its effects, and functioning potassium secretory pathways. Hyperkalemia secondary to decreased distal delivery of sodium and water occurs with congestive heart failure, cirrhosis, acute kid­ney injury, and advanced chronic kidney disease. Conditions that cause hypoaldoste­ronism, such as adrenal insufficiency and hyporeninemic hypoaldosteronism (a com­mon complication of diabetic nephropathy and tubulointerstitial diseases), can lead to hyperkalemia.

Transcellular Shifts Various mechanisms promote the exit of potassium from cells or impede its entrance, thereby raising the plasma potassium concentration (redistributive

hyper­kalemia). Increased plasma osmolality, such as with uncontrolled diabetes mellitus, establishes a concentra­ tion gradient wherein potassium follows Table 2. Causes of Hyperkalemia Impaired excretion

Transcellular shifts

Acute kidney injury/chronic kidney disease

Insulin deficiency/resistance

Medications

Hypertonicity

Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers

Acidosis Hyperglycemia Mannitol Medications

Nonsteroidal antiinflammatory drugs

Beta blockers

Potassium-sparing diuretics

Somatostatin

Trimethoprim Heparin Lithium Calcineurin inhibitors Decreased distal renal flow

Digoxin toxicity Succinylcholine Cell breakdown/leakage Hyperkalemic periodic paralysis Increased intake

Acute kidney injury/chronic kidney disease

Potassium supplementation

Congestive heart failure

Foods high in potassium*

Cirrhosis Hypoaldosteronism

Red blood cell transfusion Potassium-containing salt substitutes

Hyporeninemic hypoaldosteronism

Protein calorie supplements

Adrenal insufficiency

Certain forms of pica

Adrenocorticotropic hormone deficiency Primary hyporeninemia Primary renal tubular defects Sickle cell disease Systemic lupus erythematosus Obstructive uropathy Hereditary tubular defects Amyloidosis

Penicillin G potassium Pseudohyperkalemia Hemolysis Tourniquet use Fist clenching Blood sample cooling Intravenous fluids with potassium Cell hyperplasia Significant leukocytosis (> 75,000 cells per mm3 [75.0 × 109 per L]) Erythrocytosis Thrombocytosis Familial pseudohyperkalemia

Note: Listed in approximate order of frequency. *Dietary-induced hyperkalemia usually involves concurrent renal insufficiency.

Information from references 8 and 24.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

31

AMERICAN FAMILY PHYSICIAN water out of cells. Relative insulin deficiency or insulin resistance, which also occurs in persons with diabetes, prevents potassium from entering cells. In response to acidosis, extracellular hydrogen is exchanged for intracellular potassium, although the net result is highly variable and depends in part on the type of acidosis; metabolic acidosis produces the greatest effect.26 Because 98% of total body potassium is intracellular, any process that increases cell turnover, such as rhabdomyolysis, tumor lysis syndrome, or red blood cell transfusions, can result in hyperkalemia.

Medication-induced Hyperkalemia Medication use is a common cause of hyperkalemia, particularly in patients with baseline renal dysfunction or hypoaldosteronism.27 Medicationinduced hyperkalemia is most often a result of the medication interfering with potassium excretion. Also, the administration of potassium to treat or prevent hypokalemia can inadver­tently cause hyperkalemia.19 ACE inhibitors contributed to one-half of all cases of drug-induced hyperkalemia in one sample, and approxi­mately 10% of outpatients who start an ACE inhibitor or an ARB will develop hyperkalemia within one year.23,28 The incidence of hyperkalemia associated with use of potassium-sparing diuretics has risen since adding spi­ronolactone to standard therapy was shown to reduce morbidity and mortality in patients with congestive heart failure.29 Dual treatment with an ACE inhibitor and an ARB increases the risk of harmful adverse effects, including hyperkalemia, and should be avoided.11 Other commonly used medications known to cause hyperkalemia include trimethoprim, heparin, beta blockers, digoxin, and nonsteroidal anti-inflammatory drugs.3 EVALUATION AND MANAGEMENT OF HYPERKALEMIA

General Principles As with hypokalemia, the immediate danger of hyperkalemia is its effect on cardiac conduction and muscle strength, and initial efforts should focus on determining the need for urgent intervention (Figure 2).14,30 The absence of symptoms does not exclude severe hyperkalemia, because hyperkalemia is often asymptomatic. Because of their increased risk of developing hyperkalemia, patients with underlying renal dysfunction merit special attention.22

32

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

Evaluation of Hyperkalemia Potassium > 5 mEq per L (5 mmol per L) Yes

Warning signs present?* No Pseudohyperkalemia?

Urgent therapy (Figure 3)

Yes

No further action

No Evidence of increased intake or transcellular shifts?

Yes

No Urine sodium > 25 mEq per L (25 mmol per L)?

Treat according to etiology of transcellular shifts Yes

No Decreased distal renal flow (e.g., acute kidney injury/chronic kidney disease, congestive heart failure, cirrhosis)

Low serum aldosterone?

Yes

No Medication use, pseudohypoaldosteronism, amyloidosis, systemic lupus erythematosus, sickle cell disease, primary renal tubular defects

Low serum renin?

Yes

No Primary adrenal insufficiency Medication use (e.g., angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, heparin)

Hyperglycemia, primary renal tubular defects, medication use (e.g., nonsteroidal antiinflammatory drugs, beta blockers)

*Symptoms of hyperkalemia, changes on electrocardiography, severe hyperkalemia (greater than 6.5 mEq per L [6.5 mmol per L]), rapid-onset hyperkalemia, or underlying heart disease, cirrhosis, or kidney disease.

Figure 2. Suggested algorithm for the evaluation of hyperkalemia.

Information from references 14 and 30.

History and Physical Examination Severe hyperkalemia (more than 6.5 mEq per L [6.5 mmol per L]) can cause muscle weakness, ascending paralysis, heart palpitations, and paresthesias. Chronic kidney dis­ease, diabetes, heart failure, and liver disease all increase the risk of hyperkalemia. Clinicians should review patients’ medications to identify those known to cause hyperkalemia, and ask patients about the use of salt sub­stitutes that contain potassium.

The physical examina­tion should include assessment of blood pressure and intravascular volume status to identify potential causes of kidney hypoperfusion, which can lead to hyperkale­ mia. Neurologic signs

AMERICAN FAMILY PHYSICIAN of hypokalemia include general­ized weakness and decreased deep tendon reflexes.11

kidney disease, heart disease, or cirrhosis who have a new case of hyperkalemia. Find­ings on ECG are neither sensitive nor spe­cific for hyperkalemia. Therefore, although ECG changes should trigger urgent treatment, treatment decisions should not be based solely on the presence or absence of ECG changes.32

Laboratory Analysis and ECG Repeat measurement of serum potassium can help identify pseudohyperkalemia, which is common and typi­cally results from potassium moving out of cells during or after sample collection.31 Other laboratory studies include measurement of serum blood urea nitrogen and creatinine, measure­ment of urine electrolytes and creatinine, and assessment of acid-base status. Fur­ther evaluation may include measurement of serum glucose to evaluate for hyperglycemia, and measurement of serum renin, aldosterone, and cortisol to further inves­tigate kidney and adrenal function.

Peaked T waves are the prototypical, and generally the earliest, ECG sign of hyperkalemia. Other ECG changes include P-wave flattening, PR-interval prolongation, widening of the QRS complex, and sine waves.19 Hyperkalemia-induced arrhythmias include sinus bradycardia, sinus arrest, ventricular tachycardia, ventricular fibrillation, and asystole.19 TREATMENT OF HYPERKALEMIA

ECG should be considered if the potas­sium level is greater than 6 mEq per L; if there are symptoms of hyperkalemia; if there is suspicion of rapid-onset hyperka­ lemia; or among patients with underlying

General Principles The goals of acute treatment are to pre­vent potentially life-threatening cardiac conduction and neuromuscular

Management of Hyperkalemia Potassium > 5 mEq per L (5 mmol per L) Potassium 5 to 5.9 mEq per L (5 to 5.9 mmol per L) and no risk factors?*

Yes

No

Evaluate potential causes (Figure 2) Consider dietary modification Consider medication adjustments

Potassium > 6 mEq per L (6 mmol per L) or risk factors?*

Consider sodium polystyrene sulfonate†

ECG changes present?

Yes

No A

Administer insulin with glucose, with or without nebulized albuterol Consider dialysis

Administer intravenous calcium in addition to A

Serial ECG and continuous cardiac monitoring

Monitor serum potassium, glucose Potassium < 6 mEq per L? No Return to A

Yes Continue to monitor potassium Consider more continuous cardiac monitoring Evaluate potential causes (Figure 2) Consider dietary modifications Consider medication adjustments Consider sodium polystyrene sulfonate†

Note: See Table 3 for a summary of medication therapy for hyperkalemia. *Symptoms of hyperkalemia, rapid-onset hyperkalemia, or underlying heart disease, cirrhosis, or kidney disease. †Avoid in patients with or at risk of developing abnormal bowel function.

Figure 3. Suggested algorithm for the management of hyperkalemia.

ECG = Electrocardiography.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

33

AMERICAN FAMILY PHYSICIAN dis­turbances, shift potassium into cells, eliminate excess potassium, and resolve the underlying disturbance.

Patients with chronic hyperkalemia should be counseled to reduce dietary potassium. Although redistributive hyperkalemia is uncommon, a cautious approach is warranted because treatment may not involve attempts to eliminate potassium, and correction of the underlying problem can provoke rebound hypokalemia. Indications for prompt intervention are symptoms of hyperkalemia, changes on ECG, severe hyperkalemia (greater than 6.5 mEq per L), rapid-onset hyperkalemia, or underlying heart disease, cir­rhosis, or kidney disease.24,30,33-35 Potassium should be monitored often because patients are at risk of rede­ veloping hyperkalemia until the underlying disorder is corrected and excess potassium is eliminated.

Figure 3 is an algorithm for the management of hyperkalemia, and Table 322,30,36 summarizes medications used in the treat­ment of the condition.

Urgent Treatment Intravenous Calcium Intravenous calcium, which helps prevent lifethreatening conduction disturbances by stabilizing the cardiac muscle cell membrane, should be administered if ECG changes are present.24,25,35 Intravenous calcium has no effect on plasma potassium concentration. If after five minutes, follow-up ECG con­tinues to show signs of hyperkalemia, the dose should be repeated.37 Clinicians should be aware that intrave­nous calcium has a short duration, ranging from 30 to 60 minutes.

Insulin and Glucose The most reliable method for shifting potassium intracellularly is administration of glucose and insulin.

Typically, 10 units of insulin are administered, followed by 25 g of glucose to prevent hypoglycemia.37 Because hypoglycemia is a common adverse effect even with the provision of glucose, serum glucose levels should be monitored regularly. Patients with a serum glucose level of more than 250 mg per dL (13.9 mmol per L) typically do not require coadministra­tion of glucose.

Inhaled Beta Agonists Albuterol, a beta2 agonist, is an underutilized adjuvant for shifting potassium intracellularly.24,37 All forms of administration (i.e., inhaled, nebulized, and intravenous where available) are effective. It should be noted that the recommended dose of nebulized albuterol (10 to 20 mg) is four to eight times greater than the typical respiratory dose. There

34

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

is an additive effect when albuterol is combined with insu­lin.38 Albuterol’s potassium-lowering effect is mitigated in some patients, particularly those with end-stage kid­ney disease; therefore, albuterol should not be used as monotherapy.30 Sodium Bicarbonate Although sodium bicarbonate is often used to treat hyperkalemia, the evidence to sup­port this use is equivocal, showing minimal to no ben­efit.39 Therefore, sodium bicarbonate should not be used as monotherapy. It may have a role as adjuvant therapy, particularly among patients with concurrent metabolic acidosis.24,39,40

Lowering Total Body Potassium Potassium can be removed via the GI tract or the kid­neys, or directly from the blood with dialysis.

Dialysis should be considered in patients with kidney failure or life-threatening hyperkalemia, or when other treatment strategies fail.23,37 Other modalities are not rapid enough for urgent treatment of hyperkalemia.39 Currently available cation exchange resins, typically sodium polystyrene sulfonate in the United States, are not beneficial for the acute treatment of hyperkalemia but may be effective in lowering total body potassium in the subacute setting.25,39 Because sodium polystyrene sulfonate can be constipating, many formulations include sorbitol for its laxative effects. However, case reports linking the concomitant use of sodium polystyrene sulfonate and sorbitol to GI injury prompted a U.S. Food and Drug Administration boxed warning.41,42 More recent reports implicate sodium poly­styrene sulfonate alone.43 Therefore, use of the drug with or without sorbitol should be avoided in patients with or at risk of abnormal bowel function, such as postopera­tive patients and those with constipation or inflamma­tory bowel disease.42 There is no evidence supporting the use of diuret­ics for the acute treatment of hyperkalemia. However, diuretics, particularly loop diuretics, may play a role in the treatment of some forms of chronic hyperkalemia, such as that caused by hyporeninemic Fludrocortisone is hypoaldosteron­ism.39,44 an option for hyperkalemia associated with mineralocorticoid deficiency, including hyporeninemic hypoaldosteronism.29 Strategies to prevent chronic hyperkalemia include instructing patients to eat a lowpotassium diet, discontinuing or adjusting medications, avoiding nonsteroidal anti-inflammatory drugs, and adding a diuretic if the patient has sufficient renal function.

AMERICAN FAMILY PHYSICIAN Table 3. Medications for the Treatment of Hyperkalemia Medication

Dosage

Onset

Duration

Approximate Mechanism potassium-lowering effect

Cautions

Calcium

Calcium chloride, 10 mL of 10% solution IV over 5 to 10 minutes, or calcium gluconate, 30 mL of 10% solution IV over 5 to 10 minutes

Immediate

30 to 60 minutes

—

Stabilizes cardiac muscle cell membrane; no effect on serum potassium or total body potassium

May potentiate digoxin toxicity; calcium chloride can cause phlebitis and tissue necrosis

Insulin

Regular insulin, 15 minutes 10 units IV followed immediately by 50 mL of 50% glucose (25 g) IV

≥ 2 hours

0.7 to 1 mEq per L (0.7 to 1 mmol per L)

Shifts potassium into cells; no effect on total body potassium

May cause hypoglycemia; glucose is unnecessary if serum glucose level is > 250 mg per dL (13.9 mmol per L); additive effect when combined with albuterol

Albuterol

10 to 20 mg nebulized

30 minutes

≥ 2 hours

0.5 to 1 mEq per L (0.5 to 1 mmol per L)

Shifts potassium into cells; no effect on total body potassium

Can cause tachycardia and thus should be used with caution in patients with underlying heart disease; potassiumlowering effect not reliable in all patients; additive effect when combined with insulin

2 to 24 hours

Variable

Variable

Binds potassium in exchange for sodium; lowers total body potassium

Association with gastrointestinal complications, particularly when combined with sorbitol; should be avoided in patients at risk of abnormal bowel function

Acute treatment

Subacute treatment Sodium polystyrene sulfonate

Oral: 15 g, 1 to 4 times daily Rectal: 30 to 50 g every 6 hours in a retention enema

IV = Intravenously.

Information from references 22, 30, and 36.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

35

AMERICAN FAMILY PHYSICIAN REFERENCES 1. Paice BJ, Paterson KR, Onyanga-Omara F, Donnelly T, Gray JM, Law­son DH. Record linkage study of hypokalaemia in hospitalized patients. Postgrad Med J. 1986;62(725):187-191.

2. Lippi G, Favaloro EJ, Montagnana M, Guidi GC. Prevalence of hypo­kalaemia: the experience of a large academic hospital. Intern Med J. 2010;40(4):315-316.

3. Liamis G, Rodenburg EM, Hofman A, Zietse R, Stricker BH, Hoorn EJ. Electrolyte disorders in community subjects: prevalence and risk factors. Am J Med. 2013;126(3):256-263.

4. Shemer J, Modan M, Ezra D, Cabili S. Incidence of hyperkalemia in hos­pitalized patients. Isr J Med Sci. 1983;19(7):659-661.

5. Paice B, Gray JM, McBride D, Donnelly T, Lawson DH. Hyperkalaemia in patients in hospital. Br Med J (Clin Res Ed). 1983;286(6372):1189-1192.

18. Kamel KS, Ethier JH, Richardson RM, Bear RA, Halperin ML. Urine elec­trolytes and osmolality: when and how to use them. Am J Nephrol. 1990;10(2):89-102.

19. Diercks DB, Shumaik GM, Harrigan RA, Brady WJ, Chan TC. Electro­cardiographic manifestations: electrolyte abnormalities. J Emerg Med. 2004;27(2):153-160.

20. Weaver WF, Burchell HB. Serum potassium and the electrocardiogram in hypokalemia. Circulation.

1960;21:505-521.

21. Crop MJ, Hoorn EJ, Lindemans J, Zietse R. Hypokalaemia and subse­quent hyperkalaemia in hospitalized patients.

Nephrol Dial Transplant. 2007;22(12):3471-3477.

22. Kim GH, Han JS. Therapeutic approach to hypokalemia.

Nephron. 2002;92(suppl 1):28-32.

23. Ingram TC, Olsson JM. In brief: hypokalemia. Pediatr Rev. 2008;29(9):e50-e51.

24. Evans KJ, Greenberg A. Hyperkalemia: a review.

J Intensive Care Med. 2005;20(5):272-290.

6. Gennari FJ. Hypokalemia. N Engl J Med. 1998;339(7): 451-458.

25. Fordjour KN, Walton T, Doran JJ. Management of hyperkalemia in hos­pitalized patients. Am J Med Sci. 2014;347(2):93-100.

7. Weiner ID, Wingo CS. Hypokalemia—consequences, causes, and cor­rection. J Am Soc Nephrol. 1997;8(7): 1179-1188.

26. Aronson PS, Giebisch G. Effects of pH on potassium: new explanations for old observations. J Am Soc Nephrol.

2011;22(11):1981-1989.

8. Gennari FJ. Disorders of potassium homeostasis.

Hypokalemia and hyperkalemia. Crit Care Clin.

2002;18(2):273-288.

9. Reid A, Jones G, Isles C. Hypokalaemia: common things occur com­monly - a retrospective survey. JRSM Short Rep. 2012;3(11):80.

10. Schulman M, Narins RG. Hypokalemia and cardiovascular disease. Am J Cardiol. 1990;65(10):4E-9E. 11. Greenberg A. Diuretic complications. Am J Med Sci. 2000;319(1):10-24.

12. Dhalla IA, Gomes T, Yao Z, et al. Chlorthalidone versus hydrochlorothia­zide for the treatment of hypertension in older adults: a population-based cohort study. Ann Intern Med. 2013;158(6):447-455.

13. Morgan DB, Davidson C. Hypokalaemia and diuretics: an analysis of publications. Br Med J. 1980;280(6218):905-908.

14. Mount DB, Zandi-Nejad K. Disorders of potassium balance. In: Taal MW, Chertow GM, Marsden PA, Brenner BM, Rector FC, eds. Brenner and Rector’s The Kidney.

Philadelphia, Pa.: Elsevier/Saunders; 2012.

15. Macdonald JE, Struthers AD. What is the optimal serum potassium level in cardiovascular patients? J Am Coll Cardiol. 2004;43(2):155-161.

16. Whang R, Whang DD, Ryan MP. Refractory potassium repletion. A conse­quence of magnesium deficiency. Arch Intern Med. 1992;152(1):40-45.

17. Millane TA, Ward DE, Camm AJ. Is hypomagnesemia arrhythmogenic? Clin Cardiol. 1992;15(2):103-108.

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27. Perazella MA. Drug-induced hyperkalemia: old culprits and new offend­ers. Am J Med. 2000;109(4):307-314.

28. Raebel MA. Hyperkalemia associated with use of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers. Car­diovasc Ther. 2012;30(3):e156-e166.

29. Gross P, Pistrosch F. Hyperkalaemia: again. Nephrol Dial Transplant. 2004;19(9):2163-2166.

30. Alfonzo A, Soar J, MacTier R, et al. Treatment of acute hyperka­laemia in adults. March 1, 2014. http://www. renal.org/guidelines/ joint-guidelines/treatment-ofacute-hyperkalaemia-in-adults#sthash. o9MgdJbw.dpbs.

Accessed September 1, 2014.

31. Smellie WS. Spurious 2007;334(7595):693-695.

hyperkalaemia.

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32. Montague BT, Ouellette JR, Buller GK. Retrospective review of the frequency of ECG changes in hyperkalemia.

Clin J Am Soc Nephrol. 2008;3(2):324-330.

33. Maxwell AP, Linden K, O’Donnell S, Hamilton PK, McVeigh GE. Manage­ment of hyperkalaemia. J R Coll Physicians Edinb. 2013;43(3):246-251.

34. Charytan D, Goldfarb DS. Indications for hospitalization of patients with hyperkalemia. Arch Intern Med. 2000;160(11):1605-1611.

35. Soar J, Perkins GD, Abbas G, et al. European Resuscitation Council guidelines for resuscitation 2010 section 8.

Cardiac arrest in special cir­cumstances: electrolyte abnormalities, poisoning, drowning, acciden­tal hypothermia, hyperthermia, asthma, anaphylaxis, cardiac surgery, trauma, pregnancy, electrocution. Resuscitation.

2010;81(10):1400-1433.

AMERICAN FAMILY PHYSICIAN 36. Lexicomp online. https://online.lexi.com/crlsql/servlet/ crlonline [sub­scription required]. Accessed September 23, 2014.

sodium polystyrene (Kayexalate) in sorbitol enemas: clinical and experimental support for the hypothesis.

Surgery. 1987;101(3):267-272.

37. Weisberg LS. Management of severe hyperkalemia. Crit Care Med. 2008;36(12):3246-3251.

42. U.S. Food and Drug Administration. MedWatch.

Kayexalate (sodium polystyrene sulfonate) powder.

January 2011. http://www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm186845.htm. Accessed Sep­tember 23, 2014.

38. Lens XM, Montoliu J, Cases A, Campistol JM, Revert L. Treatment of hyperkalaemia in renal failure: salbutamol v. insulin. Nephrol Dial Trans­plant. 1989;4(3):228-232.

39. Mahoney BA, Smith WA, Lo DS, Tsoi K, Tonelli M, Clase CM. Emer­gency interventions for hyperkalaemia.

Cochrane Database Syst Rev. 2005;(2):CD003235.

40. Allon M, Shanklin N. Effect of bicarbonate administration on plasma potassium in dialysis patients: interactions with insulin and albuterol. Am J Kidney Dis. 1996;28(4):508-514.

43. Harel Z, Harel S, Shah PS, Wald R, Perl J, Bell CM. Gastrointestinal adverse events with sodium polystyrene sulfonate (Kayexalate) use: a systematic review. Am J Med. 2013;126(3):264.e9-e24.

44. Sebastian A, Schambelan M, Sutton JM. Amelioration of hyper­chloremic acidosis with furosemide therapy in patients with chronic renal insufficiency and type 4 renal 41. Lillemoe KD, Romolo JL, Hamilton SR, Pennington LR, Burdick JF, Wil­liams GM. Intestinal necrosis due to tubular acidosis. Am J Nephrol. 1984;4(5):287-300.

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Practice Guidelines JNC 8 GUIDELINES FOR THE MANAGEMENT OF HYPERTENSION IN ADULTS Hypertension is one of the most important preventable contributors to disease and death in the United States, leading to myocardial infarction, stroke, and renal failure when it is not detected early and treated appropriately. The Eighth Joint National Committee (JNC 8) recently released evidence-based recommendations on treatment thresholds, goals, and medications in the management of hypertension in adults.

In the general population of adults 60 years and older, pharmacologic treatment should be initiated when the systolic pressure is 150 mm Hg or higher, or when the diastolic pressure is 90 mm Hg or higher. Patients should be treated to a target systolic pressure of less than 150 mm Hg and a target diastolic pressure of less than 90 mm Hg. Treatment does not need to be adjusted if it results in a systolic pressure lower than 140 mm Hg, as long as it is not associated with adverse effects on health or quality of life.

In the general population younger than 60 years, pharmacologic treatment should be initiated when the systolic pressure is 140 mm Hg or higher, or when the diastolic pressure is 90 mm Hg or higher. The target systolic pressure in this population is less than 140 mm Hg, and the target diastolic pressure is less than 90 mm Hg.

Hypertension in Patients with CKD or Diabetes For persons 18 years or older with chronic kidney disease (CKD) or diabetes mellitus, the treatment threshold and target blood pressures are the same as those for the general population younger than 60 years (i.e., threshold systolic pressure of 140 mm Hg or threshold diastolic pressure of 90 mm Hg; target systolic pressure of less than 140 mm Hg; target diastolic pressure of less than 90 mm Hg).

There is no evidence that treating patients with CKD to a lower blood pressure goal slows the progression of the disease. Similarly, there is no evidence from randomized controlled trials showing that treatment to a systolic pressure of less than 140 mm Hg improves health outcomes in adults with diabetes and hypertension.

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Pharmacologic Treatment In the general nonblack population, including those with diabetes, initial antihypertensive treatment should include a thiazide diuretic, calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitor, or angiotensin receptor blocker (ARB). In the general black population, including those with diabetes, initial treatment should include a thiazide diuretic or calcium channel blocker. If the target blood pressure is not reached within one month after initiating therapy, the dosage of the initial medication should be increased or a second medication should be added (thiazide diuretic, calcium channel blocker, ACE inhibitor, or ARB; do not combine an ACE inhibitor with an ARB).

Blood pressure should be monitored and the treatment regimen adjusted until the target blood pressure is reached. A third drug should be added if necessary; however, if the target blood pressure cannot be achieved using only the drug classes listed above, antihypertensive drugs from other classes can be used (e.g., beta blockers, aldosterone antagonists). Referral to a physician with expertise in treating hypertension may be necessary for patients who do not reach the target blood pressure using these strategies.

Adults with CKD and hypertension should receive an ACE inhibitor or ARB as initial or add-on therapy, based on moderate evidence that these medications improve kidney-related outcomes in these patients.

Source: Adapted from Am Fam Physician. 2014;90(7):503-504.

AHA AND ASA RELEASE GUIDELINE FOR PREVENTION OF FUTURE STROKE IN PATIENTS WITH STROKE OR TIA The American Heart Association (AHA) and American Stroke Association (ASA) have updated their guideline on prevention of future stroke in patients with a history of stroke or transient ischemic attack (TIA). Currently, the average annual rate of future stroke in these patients is at a historic low.

This is a result of new approaches and improvement of existing approaches to treating these patients. The following recommendations are new or substantially revised from the previous AHA/ASA guideline.

AMERICAN FAMILY PHYSICIAN Recommendations

Nutrition

Hypertension

A nutritional assessment for signs of over- or undernutrition is reasonable in patients with a history of stroke or TIA. Those with undernutrition should be referred for individualized nutritional counseling.

Routine vitamin supplementation is not recommended.

Blood pressure therapy should be initiated in previously untreated patients with stroke or TIA if, after the first few days, blood pressure is 140 mm Hg systolic or greater, or 90 mm Hg diastolic or greater. Resumption of treatment is recommended for previously treated patients with known hypertension in the first several days after stroke or TIA. The target blood pressure is unclear and should be individualized. However, it is reasonable to keep blood pressure below 140 mm Hg systolic and 90 mm Hg diastolic. In patients with a recent lacunar stroke, a target of less than 130 mm Hg may be reasonable.

Dyslipidemia Statin therapy with intensive lipid-lowering effects is recommended in patients with ischemic stroke or TIA thought to be of atherosclerotic origin who have a lowdensity lipoprotein cholesterol level of 100 mg per dL (2.59 mmol per L) or greater with or without evidence of other arteriosclerotic cardiovascular disease.

Statin therapy is also recommended in those who have a low-density lipoprotein cholesterol level of less than 100 mg per dL and no evidence of other arteriosclerotic cardiovascular disease.

Glucose Disorders All patients should probably be screened for diabetes mellitus after stroke or TIA using fasting plasma glucose, A1C, or oral glucose tolerance testing.

Decisions about the type and timing of testing should be based on clinical judgment. Acute illness may temporarily affect plasma glucose measurements.

In general, an A1C measurement may be more accurate than other screening tests immediately after the event.

Obesity Patients should receive obesity screening and body mass index measurement after a stroke or TIA. Despite the beneficial effects of weight loss on cardiovascular risk factors, the usefulness of weight loss after stroke or TIA in patients who are obese is unclear.

Physical Inactivity Referral to a comprehensive, behavior oriented program to increase physical activity is probably recommended for patients who are willing and able to participate in increased activity.

It is reasonable to counsel patients with stroke or TIA to reduce their sodium intake to less than 2.4 g per day (less than 1.5 g per day is even more effective at reducing blood pressure) and to follow a Mediterranean-style diet (emphasizes vegetables, fruits, and whole grains includes low-fat dairy products, poultry, fish, legumes, olive oil, and nuts) as opposed to a low-fat diet.

Sleep Apnea Because the prevalence of sleep apnea is high in patients with ischemic stroke or TIA and treatment of sleep apnea improves outcomes in the general population, a sleep assessment may be considered after stroke or TIA. If sleep apnea is present, treatment with continuous positive airway pressure may be considered.

Antiplatelet Therapy Aspirin plus clopidogrel may be initiated within 24 hours of a minor stroke or TIA, and continued for 90 days. In patients with stroke or TIA, atrial fibrillation, and coronary artery disease, the benefit of adding antiplatelet therapy to vitamin K antagonist therapy to reduce the risk of ischemic cardiovascular and cerebrovascular events is unclear; however, it may be warranted in cases of coronary artery stenting.

Other Other topics that were added or revised include carotid disease, intracranial atherosclerosis, atrial fibrillation, myocardial infarction and thrombus, cardiomyopathy, valvular heart disease, prosthetic heart valves, aortic arch atheroma, patent foramen ovale, homocysteinemia, hypercoagulation, antiphospholipid antibodies, sickle cell disease, pregnancy, and breastfeeding.

Source: Adapted from Am Fam Physician. 2015;91(2):136-137.

AHA/ASA RELEASE GUIDELINE ON STROKE PREVENTION IN WOMEN Stroke is the third leading cause of death in women, and its impact is becoming increasingly higher in women compared with men. The 2010 National Health Interview Survey showed that more than onehalf of the 6 million adults with stroke were women.

Another study showed that between 2006 and 2010,

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AMERICAN FAMILY PHYSICIAN the prevalence of stroke survivors did not significantly change for women, whereas it declined for men.

Although risk factors such as age, history of cardiovascular disease, obesity, unhealthy diet, physical inactivity, smoking, and metabolic syndrome increase the risk of stroke in men and women, risk factors that are stronger or more prevalent in women are migraine with aura, atrial fibrillation, diabetes mellitus, and hypertension. Additionally, there are sex-specific risk factors that affect only women such as pregnancy, preeclampsia, gestational diabetes, and use of oral contraceptives or postmenopausal hormones.

The American Heart Association and American Stroke Association (AHA/ASA) have released a guideline to help physicians identify women with increased risk of stroke and initiate appropriate preventive measures. The guideline includes recommendations on pregnancy and stroke; cerebral venous thrombosis; use of oral contraceptives; use of postmenopausal hormone therapy; migraine with aura; obesity, metabolic syndrome, and lifestyle; and atrial fibrillation.

Prevention Strategies Because women are underrepresented in clinical stroke prevention trials, it is unclear whether current evidencebased practices apply to women. Differences between men and women in the anatomy of the internal carotid arteries and in the composition of plaque may mean that there are different risks and benefits to treatment. Until further research is completed, the recommendations for prevention of stroke in women with symptomatic or asymptomatic carotid disease are the same as for men.

The following recommendations are based on data derived from multiple randomized clinical trials or meta-analyses.

Prophylactic carotid endarterectomy performed with less than 3% of morbidity and mortality can be useful in highly selected patients with asymptomatic carotid stenosis (at least 60% on angiography or at least 70% on validated Doppler ultrasonography). This procedure can be recommended in women with a recent (within past six months) transient ischemic attack or ischemic stroke and ipsilateral severe carotid stenosis (70% to 99%) if the estimated perioperative morbidity and mortality risk is less than 6%.

The following recommendations are based on data derived from a single randomized trial or nonrandomized studies. Depending on patient factors such as age and comorbidities, carotid endarterectomy can be recommended in women with a recent transient ischemic attack or ischemic stroke and ipsilateral moderate carotid stenosis (50% to 69%) if the estimated

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perioperative morbidity and mortality risk is less than 6%. If indicated, it is reasonable for the surgery to take place within two weeks in women with no contraindications to early revascularization. Aspirin therapy is reasonable in women with diabetes and no contraindications. It can also be useful in women 65 years and older if their blood pressure is controlled and the benefit for ischemic stroke and myocardial infarction prevention is likely to outweigh the risk of gastrointestinal bleeding and hemorrhagic stroke.

Aspirin may also be useful in women younger than 65 years. Clopidogrel can be substituted in women at high risk (i.e., 10-year predicted risk of cardiovascular disease is 10% or more) who cannot take aspirin.

The following recommendations are based on consensus opinion of experts, case studies, or standard of care.

Women with asymptomatic carotid stenosis should be screened for other treatable risk factors, and lifestyle modifications should be initiated. Because aspirin was used in all major trials that demonstrated effectiveness, it should be used in women undergoing carotid endarterectomy who do not have contraindications.

Preeclampsia Although stroke is uncommon in pregnancy, the risk is higher in young women who are pregnant compared with those who are not pregnant. The highest risk is in the third trimester and postpartum. Pregnancy-related hypertension is the leading cause of hemorrhagic stroke and ischemic stenosis in pregnancy and postpartum.

The following recommendations are based on data derived from multiple randomized clinical trials or metaanalyses. Women with chronic primary or secondary hypertension, or who had hypertension in a previous pregnancy should take low-dose aspirin from 12 weeks of gestation until delivery. To prevent preeclampsia, calcium supplementation should be considered for women with low intake of dietary calcium (less than 600 mg per day). Pregnant women with severe hypertension should be treated with safe and effective medications such as methyldopa, labetalol, and nifedipine. Maternal and fetal adverse effects should be considered when choosing a medication.

Source: Adapted from Am Fam Physician. 2015;91(5):330-331.

AAP RELEASES POLICY STATEMENT ON SCREENING FOR NONVIRAL SEXUALLY TRANSMITTED INFECTIONS IN ADOLESCENTS AND YOUNG ADULTS Many sexually transmitted infections (STIs) have a higher prevalence in the adolescent population. The objectives of screening for STIs include identifying

AMERICAN FAMILY PHYSICIAN persons with infection or possible infection, providing treatment, reducing transmission, avoiding or lessening consequences of the infection, and decreasing the prevalence of STIs. This policy statement from the American Academy of Pediatrics (AAP) provides recommendations on routine screening for nonviral STIs in adolescents and young adults (25 years and younger).

Recommendations Physicians should develop clinical processes to include STI risk assessment, screening, treatment, and prevention counseling when providing routine health care for sexually active adolescents. This should include providing staff with education and training related to procedures and other issues such as consent, confidentiality, and billing. Additionally, physicians should become proficient in screening for STIs with nucleic acid amplification testing. They should strive to reduce barriers to STI screening, including access to and stigma of screening, while being careful to avoid breaching confidentiality. Recommendations about specific STIs are outlined below.

Chlamydia Chlamydia trachomatis infection, which is the most common reportable communicable disease in the United States, has the highest rates in women 20 to 24 years of age and the second highest rates in female adolescents 15 to 19 years of age. Typically, chlamydia does not cause symptoms; however, if not treated, the infection can persist.

Chlamydia can cause cervicitis, urethritis, proctitis, and rarely, pharyngitis. Complications and sequelae of infection include adverse outcomes in pregnancy and for the infant, including neonatal infections, chronic pelvic pain, ectopic pregnancy, epididymitis, increased transmission of human immunodeficiency virus (HIV), pelvic inflammatory disease (PID), reactive arthritis, and tubal-factor infertility. Additionally, recurrent chlamydia is associated with increased reproductive sequelae.

All sexually active female adolescents and adults 25 years and younger should be screened every year for C. trachomatis infection. Sexually active adolescent males and young adult males who have sex with males should be screened ever year for rectal chlamydia if having receptive anal intercourse and urethral chlamydia if having insertive intercourse. Males who have sex with males who are high risk (e.g., multiple sex partners, sex combined with illicit drug use)

should be screened every three to six months. Annual screening should be considered in sexually active males in settings with a high prevalence of chlamydia (e.g., jail, high school clinics, national job training programs).

Additionally, because of their increased risk of infection, sex partners of persons with chlamydia (in the 60 days before diagnosis) should also be screened.

All adolescents found to have the infection should be screened again three months after treatment; this should be done whether or not the patient thinks his or her sex partner was treated. If it is not possible to perform screening again at three months, repeat screening should be performed when the patient next presents, in the year after treatment of the initial infection.

Gonorrhea Gonorrhea, the second most common reportable communicable disease in the United States, has the highest rates in women 20 to 24 years of age and the second highest rates in female adolescents 15 to 19 years of age. Many times, the infection does not cause symptoms. Neisseria gonorrhoeae infection can manifest as cervicitis, urethritis, proctitis, and pharyngitis, and rarely can lead to conjunctivitis. The upper genital tract can be affected by gonorrhea, causing PID and other problems (e.g., ectopic pregnancy, infertility, and chronic pelvic pain in females; epididymitis in males).

Additionally, gonorrhea infection is linked to increased transmission of HIV. In pregnant women, gonorrhea can cause chorioamnionitis, premature rupture of membranes, and preterm labor, and transmission perinatally can lead to ophthalmia neonatorum.

All sexually active female adolescents and adults younger than 25 years should be screened every year for N. gonorrhoeae infection. Sexually active adolescent and young adult males who have sex with males should be screened every year for pharyngeal gonorrhea if having receptive oral intercourse, rectal gonorrhea if having receptive anal intercourse, and urethral gonorrhea if having insertive intercourse. Males who have sex with males who are high risk (e.g., multiple sex partners, sex combined with illicit drug use) should be screened every three to six months. Annual screening should be considered in other sexually active young adult males based on individual and population-based risk factors; local epidemiology should be used to decide if gonorrhea screening is appropriate in a particular patient population.

Because reinfection is common, sex partners of persons with gonorrhea (in the 60 days before diagnosis) should also be screened. All adolescents found to have

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AMERICAN FAMILY PHYSICIAN gonorrhea should be screened again three months after treatment; this should be done whether or not the patient thinks his or her sex partner was treated.

If it is not possible to perform screening again at three months, repeat screening should be performed when the patient next presents, in the year after treatment of the initial infection.

Trichomoniasis Based on population studies, Trichomonas vaginalis genital tract infection is thought to be the most common nonviral STI. Rates of T. vaginalis infection in adolescent females are 2.1% to 14.4%. T. vaginalis infection is also common in older women. It usually does not have symptoms; however, it can cause vaginitis, PID, and preterm labor in females, and urethritis, epididymitis, and prostatitis in males. Additionally, it may increase transmission of HIV. In asymptomatic adolescents, routine screening is not recommended. However, female adolescents and young women may be at higher risk of infection because of individual or population-based factors (e.g., new or multiple partners, a history of STIs, exchanging sex for money, injecting drugs); these patients may need more extensive evaluation, including screening for T. vaginalis infection. Rescreening females previously diagnosed with trichomoniasis should be considered three months after treatment; rescreening in males has not been discussed in the literature. If it is not possible to perform screening again at three months, repeat screening should be performed when the patient next presents, in the year after treatment of the initial infection.

Syphilis In recent years, rates of syphilis have significantly increased, particularly among males who have sex with males. If the infection is left untreated, serious complications can occur, including neurosyphilis and, in infants of pregnant women with syphilis, congenital syphilis, which causes a variety of multisystem problems, including intrauterine death. Routine screening in nonpregnant, heterosexual adolescents is not recommended. However, sexually active adolescent and young adult males who have sex with males should be screened every year; those who are high risk should be screened every three to six months. Additionally, screening can be considered in adolescents and young adults with higher risk behaviors. Local health departments can provide local prevalence rates and risks, which may affect screening decisions.

Source: Adapted from Am Fam Physician. 2015;91(9):652-654.

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ACP PROVIDES GUIDANCE ON NONSURGICAL TREATMENT OF URINARY INCONTINENCE IN WOMEN The prevalence of urinary incontinence (UI) ranges from 25% in females 14 to 21 years of age to 75% in women 75 years and older, although it may actually be higher than reported because some evidence has shown that one-half or more of women with UI do not tell their physicians about symptoms. There is an increased risk of UI with preg­nancy and with pelvic floor trauma from delivering vaginally, as well as in women who are menopausal or obese; who have a uri­ nary tract infection, functional or cognitive impairment, chronic cough, or constipation; or who have had a hysterectomy.

There are two categories of UI: stress, which is caused when the urethral sphincter does not work because of intra-abdominal pressure, and urgency, which is associated with the urgent need to urinate. Stress UI can cause urine to leak when laughing, coughing, or sneezing. Mixed UI is stress and urgency UI combined.

The American College of Physicians (ACP) has provided recommendations for nonsurgical treatment of UI in women. Treatment of UI is aimed at achieving, or at least improving, symptoms. It is deemed effective if it reduces the number of episodes by at least one-half.

Nonpharmacologic Therapy Nonpharmacologic therapy options for UI, which have been shown to be effective and have a lower risk of adverse effects, include lifestyle changes (weight loss and physical activity), bladder training, pelvic floor mus­cle training (PFMT), continence services, vaginal cones, and medical devices. There have not been enough data to compare vari­ous types of nonpharmacologic therapies or to compare nonpharmacologic with pharma­cologic therapies.

Lifestyle Changes In women with UI who are obese, weight loss and exercise are recommended, with moderate-quality evidence indicating improvement in symptoms.

Additionally, no associated harms were apparent with this intervention.

Bladder Training Bladder training, which is behavioral treat­ment that entails having women lengthen the time between urinating, is recommended in women with urgency UI, with low-quality evidence indicating improvement vs. no treatment.

AMERICAN FAMILY PHYSICIAN Pelvic Floor Muscle Training Based on high-quality evidence, PFMT con­sisting of educating women on the voluntary contraction of pelvic floor muscles should be first-line treatment for stress UI, and PFMT combined with bladder training is recom­mended for mixed UI. Studies have shown that, compared with no treatment, PFMT improved continence rates and quality of life in women with stress UI. It also was shown to have an effectiveness greater than five times that of no treatment for improving stress UI. Additionally, PFMT can be combined with biofeedback from vaginal electromyography, which allows patients to see when they are contracting their pelvic floor muscles cor­rectly; this also has been shown to improve stress UI. In women with mixed UI, PFMT plus bladder training led to continence and improved UI more often than no treatment.

Continence Services Continence services enlist the assistance of health care professionals who have knowledge and experience in diagnosing and managing UI; however, studies have shown that, compared with no treatment, it provided no statistically significant improvement in continence or UI. Vaginal Cones, Medical Devices, and Other Treatments Data are insufficient to make a conclusion about the effectiveness, compared with no treatment, of vaginal cones, pessaries, or intravaginal and intraurethral devices for treating stress UI, or of programs for behavioral changes, diets supplemented with soy, or acupuncture for mixed UI.

Pharmacologic Treatment Systemic pharmacologic therapy is not recommended in women with stress UI; however, based on high-quality evidence, it is recommended in women with urgency UI in whom bladder training has failed. Decisions regard­ ing medication should be based on tolerability, adverse effects, ease of use, and cost. Although it has some effec­tiveness, it should be noted that pharmacologic therapy has adverse effects, with evidence indicating that women may discontinue therapy as a result.

Medication options include antimuscarinics, beta3adrenoceptor agonists, duloxetine, and estrogen. Data are insuf­fi cient to conclude which medications are most effective and safe.

Stress UI There are not enough data on topical estrogen prepara­tions regarding the effectiveness for treating

stress UI; however, vaginal estrogen appears to improve continence and UI. Compared with placebo, transdermal formula­tions made stress UI worse and estradiol implants did not provide improvement.

Estrogen tablets and ovules improved UI compared with placebo, with tablets also increasing continence.

Intravaginal estriol combined with PFMT was more effective for attaining continence compared with estriol monotherapy, based on low-quality evidence. Highquality evidence showed that there was no statistically significant improvement in UI with duloxetine vs. placebo; however, based on low-quality evidence, it was shown to improve quality of life in women without severe UI or overactive bladder.

Urgency UI Antimuscarinics. Based on high-quality evidence and in comparison with placebo, darifenacin, fes­oterodine, and tolterodine improved UI; darifenacin improved quality of life; and oxybutynin, solifenacin, tolterodine, and trospium attained continence more often. Additionally, fesoterodine improved UI more than tolterodine.

Based on moderate-quality evidence and in compari­son with placebo, fesoterodine attained continence more often, and oxybutynin and propiverine (not available in the United States) improved UI. Additionally, fesotero­ dine attained continence more often than tolterodine.

Beta3-adrenoceptor Agonists. Based on moderate-quality evidence and in comparison with placebo, mirabegron improved UI and attained continence more often.

Other. There are not enough data to make conclusions about the effectiveness of resiniferatoxin or nimodipine as UI therapy.

Adverse Effects Among the different classes of medication, adverse effects tended to be similar. Common adverse effects of anti­muscarinics were dry mouth, constipation, and blurred vision. In addition, tolterodine also increased the likeli­hood that a patient would experience hallucinations. With regard to beta3-adrenoceptor agonists, patients taking mirabegron experienced more nasopharyngitis and gastrointestinal problems than those taking placebo. Although pharmacologic therapy can improve UI, and possibly can provide complete continence, patients may stop treatment because of adverse effects.

Source: Adapted from Am Fam Physician. 2015;91(11):801-802.

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AMERICAN FAMILY PHYSICIAN ACIP RELEASES 2015 CHILDHOOD IMMUNIZATION SCHEDULES The 2015 immunization schedule for children and the catch-up schedule from the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) have a few changes that are pertinent for family physicians. The sched­ules are available at http://www.aafp.org/patientcare/immunizations/schedules.html.

The most notable change involves the quadrivalent live attenuated influenza vaccine (LAIV). In June 2014, ACIP made a preferential recommendation for LAIV over inactivated influenza vaccine for children two to eight years of age. This was based on data showing that LAIV provided better protection against influenza for those children. The recommendation stated that LAIV was preferred only if immediately available. The emphasis is that any other influenza vaccine should be given instead of waiting for LAIV to arrive.

However, a review of the 2013-2014 vaccine efficacy data surprised everyone by showing that LAIV was less effec­tive than inactivated influenza vaccine against the H1N1 strain. Effectiveness against other strains of influenza was the same or better than inactivated influenza vaccine. The cause for this unexpected finding is unknown, but is under investigation. For now, the CDC has not changed any of its recommendations regarding influenza vaccination (http://www.cdc.gov/ flu/news/nasal-spray-effectiveness.htm). Updates are expected at the February 2015 ACIP meeting, and offices may want to delay preordering any 2015-2016 influenza vaccine until after that meeting.

The footnotes of the childhood vaccine schedule were extensively modified for the meningitis vaccine. The meningococcal vaccine is recommended for use in children at high risk of invasive meningococcal disease (i.e., infants with complement component deficiencies or functional or anatomic asplenia, including sickle cell disease; healthy infants who are part of an outbreak; or travelers in hyperendemic or epidemic areas). The vaccine should be given at two, four, six, and 12 months.

However, each of the three childhood meningococcal vaccines has different indications based on the child’s age and medical condition. The footnotes now delineate the recommendations by specific condition and vaccine, which should make it easier to decide which vaccine to use in which situation.

The CDC has published a comprehensive toolkit that can help guide you through safe storage and handling practices for your office (http://www.cdc.gov/vaccines/ recs/storage/toolkit/storage-handling-toolkit.pdf).

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There is a small but real association between febrile seizures and concurrent administration of influenza plus pneumococcal 13-valent conjugate vaccine and/or diphtheria and tetanus toxoids and acellular pertussis (DTaP). The number needed to vaccinate to produce one additional febrile seizure is approximately 2,200 children. Given the generally benign nature of febrile seizures and the benefits of the vaccines, ACIP has not recommended any change in practice at this time.

A free vaccination schedule app for iOS and Android devices is available from the CDC at http://www.cdc. gov/vaccines/schedules/hcp/schedule-app.html.

Some new vaccines will likely be available in 2015.

A meningitis B vaccine was approved by the U.S. Food and Drug Administration in October 2014, and a second is expected be approved shortly. The nine-valent human papillomavirus vaccine may also be approved soon. ACIP will likely make recommendations for the appropriate use of these vaccines at the February 2015 meeting.

Source: Adapted from Am Fam Physician. 2015;91(4):265.

ECG, ECHOCARDIOGRAPHY, OR MPI FOR CARDIAC SCREENING: GUIDANCE FROM THE ACP In the United States, one in three deaths is from cardio­ vascular disease; coronary heart disease is the leading cause of death. Screening for coronary heart disease can be performed with resting or stress electrocardiography (ECG), stress echocardiography, or myocardial perfusion imaging (MPI). This guideline from the American Col­lege of Physicians (ACP) provides recommendations on cardiac screening using these modalities.

Recommendations and Practice Although the benefit of cardiac screening in adults at low-risk of coronary heart disease is questionable, it is often still performed. The American Heart Association, among other organizations, does not recommend performing ECG for cardiac screening in low-risk adults, and the U.S. Preventive Services Task Force specifically recommends against it. With regard to stress echocardiography and MPI, the American College of Cardiology Foundation and the American Heart Association recommend against using either to evaluate cardiovascular risk in adults at low risk without symptoms.

Despite this, a study of national data determined that the use of ECG for screening purposes at general physician office visits increased from 6.1% in 1999 to 11.3% in 2009, and a systematic review concluded

AMERICAN FAMILY PHYSICIAN that the rates of overuse were 9.2% for ECG and 3% to 52% for cardiac stress tests. Additionally, based on data from three studies, approximately 15% of MPI and stress echocardiography fail to meet criteria for appropriate use.

Orthopaedic Surgeons (AAOS) has provided guidance in determining the best options for treating an ACL injury.

Benefits and Harms

Based on Strong Evidence

Benefits of screening with imaging include detecting cor­onary heart disease that has not yet been diagnosed, and determining if a person has a higher risk of a cardiovas­cular event, such as myocardial infarction or arrhythmia.

Harms associated with stress tests include sudden death or an event in which a patient needs to be hospital­ ized; however, the risk is minimal, estimated at one per 10,000 exercise ECGs performed. Pharmacologic agents used to induce stress can have adverse effects, such as hypotension or myocardial ischemia, but the rates of serious effects appear to be low.

There are also harms stemming from false-positive results, such as anxiety and unnecessary treatments or follow-up tests, and from true-positive results, such as disease labeling and health insurance issues (e.g., increased cost). Downstream harms are also possible from follow-up tests and treatments.

High-value Care Recommendations Cardiac disease screening using resting or stress ECG, stress echocardiography, or stress MPI should not be performed in low-risk adults without symptoms.

Instead, the focus should be on decreasing each patient’s risk by addressing adjustable factors that increase the patient’s risk (e.g., smoking, diabetes mellitus, being overweight) and promoting exercise. Global risk calculators such as the Framingham Risk Score (http:// cvdrisk.nhlbi.nih.gov/calculator.asp), SCORE (www. heartscore.org/Pages/welcome.aspx), and PROCAM (www.myhealthywaist.org/evaluating-cmr/assessingcvd-risk-traditional-approaches/procam/page/5/index. html) can be used to help assess risk for heart disease.

Source: Adapted from Am Fam Physician. 2015;92(6):531.

MANAGEMENT OF ACL INJURIES: CLINICAL PRACTICE GUIDELINE FROM THE AAOS Anterior cruciate ligament (ACL) injuries, which are usually related to sports, have an incidence of approximately 252,000 yearly, with women two to eight times more likely to have an ACL injury vs. men. Persons who experience ACL injuries have an increased risk of arthritis. The American Academy of

Recommendations Diagnosis. Because of their effectiveness in diagnosing ACL injuries, a history (e.g., mech­anism of injury, presence of a popping sensa­tion, locking, or catching; weight-bearing ability; ability to return to play; previous knee injuries; area of pain) should be obtained and musculoskeletal examination of the lower extremities (e.g., distal perfusion and tibial/peroneal nerve function; joint line tenderness or obvious stepoff/deformity; effusion; varus and valgus laxity at 0 and 30 degrees of exten­sion; anteroposterior and rotational laxity) should be performed. The presence of a pop­ping sensation in combination with swelling is a significant predictor of an ACL injury, as are positive findings on the Lachman test.

Magnetic resonance imaging has a high sensitivity and specificity for confirming an ACL injury. It also can help determine if other conditions are present, such as a meniscal injury; however, the sensitivity and specificity for this use are lower.

Treatment. Physicians performing ACL reconstruction should use autograft or allograft tissue that is processed correctly. Studies have found that the clinical out­comes are similar between the two; however, how the allograft is prepared (e.g., procure­ment, processing, storage, implantation) may cause some differences. Physicians should use bone-patellar tendon-bone or hamstringtendon auto­grafts, and should use a single- or doublebundle approach when performing intra-articular ACL reconstruction. Results of stability testing, patient satisfaction, knee function scores, and rates of failure have been shown to be similar between these two types of grafts, and there is no statistically significant difference in outcomes, including postoperative pain and knee function scores, between the single- and double-bundle approaches. It should be noted that the rate of postoperative pain while kneeling has been shown to be greater in persons receiving the bone-patellar tendon-bone graft.

Based on Moderate Evidence Prevention. Neuromuscular training pro­ grams may reduce or prevent ACL injuries, with several studies supporting this training; one analysis suggests 109 athletes would need to participate to prevent one injury.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

45

AMERICAN FAMILY PHYSICIAN Treatment. Surgery can be appropriate in persons with an ACL tear who are 18 to 35 years of age and active, because it has been shown to decrease pathologic laxity, instances of instability, and additional inju­ries.

Reconstructive surgery should be per­ formed in the five months following injury; this is to protect the articular cartilage and menisci. Performing reconstruction within three to five months vs. after three to five months has been shown to improve stability, allow a higher level of activity and greater function, and reduce meniscus tears.

When performing an intra-articular ACL reconstruction, a tibial independent or trans­ tibial technique can be used for femoral tunnel placement; there appear to be no consis­tent differences between the techniques with regard to objective metrics, results reported by patients, or knee function scores. Because of the lack of evidence of benefit regarding function or laxity, routinely using functional knee braces (e.g., neoprene brace) after ACL reconstruction is not recommended.

Early accelerated (19 weeks) and non-accelerated (32 weeks) rehabilitation programs may be beneficial after ACL reconstruction, with studies showing that, two years after undergoing reconstruction, patients in both types of programs had similar outcomes (e.g., knee laxity, satisfaction, level of activity, function).

Based on Limited Evidence Prevention. Physicians may not recommend knee bracing as a preventive measure for ACL injuries, because risk of injury does not appear to be lower when bracing is used. Two studies of low and moderate strength found that the rate of injury was not reduced in football play­ers at high school and college levels.

Treatment. Limited evidence supports that rather than providing nonsurgical manage­ment, physicians may opt to perform recon­ struction because it decreases pathologic knee laxity. If a patient has a meniscus tear in addition to an ACL injury, physicians may repair the meniscus when performing reconstruction. Despite limited evidence, physicians may still perform ACL reconstruction in per­sons who are skeletally immature, because it appears to provide significant benefit vs. nonsurgical management with regard to stability, function, and activity.

Evidence is limited to support nonsurgical treatment for persons who are less active and have less laxity, or performing reconstruc­tion of an ACL tear combined with treat­ing medial collateral ligament tears without surgery. Additionally, having to reach a par­ticular functional milestone or waiting a certain amount of

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time after injury or sur­gery before returning to play or activity is not recommended.

Based on Consensus Opinion Diagnosis. When first assessing persons with a knee injury, anteroposterior and lateral knee radiography should be performed to determine if there are possible injuries that may necessitate emergency care (e.g., frac­ture, dislocation, neoplasm, foreign body); making a diagnosis early in these cases can be beneficial in reducing morbidity. However, if magnetic resonance imaging or computed tomography is an imaging option, other radi­ography may not be needed.

Treatment. Immediate treatment is rec­ ommended in persons with a torn ACL and a locked knee from a displaced meniscus tear, which can lead to fixed flexion contracture. Promptly unlocking the knee can help pre­vent this from occurring. If the meniscus is reduced earlier, then the tear may be more easily repaired.

Source: Adapted from Am Fam Physician. 2015;92(3):232-234.

ACIP RELEASES RECOMMENDATIONS FOR INFLUENZA VACCINATION, 2015-2016 The Centers for Disease Control and Preven­tion’s Advisory Committee on Immuniza­tion Practices (ACIP) has released its yearly recommendations for routine influenza vac­cination in the 2015-2016 season.

Updates this year include the antigenic composition of seasonal influenza vaccines available in the United States; information on influenza vaccines expected to be available this season; updated information for determining the number of doses required for children six months to eight years of age; and recommendations for the use of live attenuated influ­enza vaccine (LAIV) when both LAIV and inactivated influenza vaccine are available, including the removal of 2014-2015 preferential recommendation for LAIV in healthy children two to eight years of age.

Routine annual influenza vaccination is recommended for all persons six months and older who do not have contraindications. Vaccination should ideally occur before the onset of influenza activity in the community.

Clinicians should offer vaccination by October, if possible, and continue through the influenza season.

Children six months to eight years of age who require two doses should receive their first dose as soon as possible after vaccine becomes available, and the second dose no earlier than four weeks later.

For the 2015-2016 influenza season, U.S.-licensed trivalent influenza vaccines will include hemagglutinin

AMERICAN FAMILY PHYSICIAN derived from an A/California/7/2009 (H1N1)-like virus, an A/Switzerland/9715293/2013 (H3N2)-like virus, and a B/Phuket/3073/2013-like (Yamagata lineage) virus.

Quadrivalent vac­cines will contain these viruses plus a B/Brisbane/60/2008-like (Victoria lineage) virus.

Influenza vaccines expected to be avail­able this season are listed in Table 1. New vaccines and updated vaccine indications include the following: ÂÂ

The trivalent inactivated influenza vac­cine Afluria has been approved for intra­muscular administration via a needle-free jet injector in persons 18 to 64 years of age. Afluria is the only inactivated influenza vaccine that can be administered without a needle and syringe.

ÂÂ

The trivalent recombinant influenza vac­cine, Flublok, (for persons with egg allergy) is now indicated for all adults 18 years and older. It was previously approved only for persons 18 to 49 years of age.

ÂÂ

The quadrivalent intradermal inacti­vated influenza vaccine, Fluzone Intrader­mal, is now indicated for adults 18 to 64 years of age. This formulation is expected to replace the previously available trivalent intradermal inactivated vaccine.

Children six months to eight years of age require two doses of influenza vaccine dur­ing their first season of vaccination. Since the emergence of influenza A(H1N1)pdm09 (the 2009 H1N1 pandemic virus), recommendations for determining the number of doses needed have been based on whether a child previously received vaccine containing influ­enza A(H1N1) pdm09. Because this strain continues to circulate as the predominant H1N1 virus, and because of the inclusion of an A/California/7/2009(H1N1)-like virus in seasonal influenza vaccines available in the United States since the 2010-2011 season, separate consideration of receipt of vaccine doses containing this virus is no longer rec­ommended. Children six months to eight years of age who received at least two doses of trivalent or quadrivalent influenza vaccine before July 1, 2015, need only one dose this season. The two previous doses do not have to have been given during the same season or consecutive seasons.

LAIV and inactivated influenza vaccine have both been proven effective in children and adults. Although ACIP previously rec­ommended that LAIV be given to healthy children two to eight years of age, recent evidence has shown that LAIV is no more effective than inactivated influenza vaccine. Therefore, LAIV is no longer recommended over inactivated vaccine;

when both vac­cines are available in an age-appropriate formulation, either can be given.

Egg Allergy Severe allergic and anaphylactic reactions can occur in response to various components of influenza vaccine, but such reactions are rare.

All currently available influenza vac­cines except trivalent recombinant influenza vaccine and cell-culture–based inactivated influenza vaccine are prepared by propagation of virus in embryonated eggs.

For the 2015-2016 influenza season, ACIP recommends the following: ÂÂ

Persons with a history of egg allergy who have experienced only hives after exposure to egg should receive inactivated influenza vaccine or trivalent recombinant influenza vaccine.

Recombinant vaccine can be used in adults 18 years and older who have no contraindications.

However, inactivated vaccine may also be used if it is administered by a clinician who is familiar with the poten­ tial manifestations of egg allergy and if the patient can be observed for signs of a reac­tion for at least 30 minutes after vaccination.

ÂÂ

Persons with a history of symptoms such as angioedema, respiratory distress, light­headedness, or recurrent emesis after expo­sure to egg, or who required epinephrine or another emergency medical intervention, may receive recombinant influenza vaccine if they are at least 18 years of age and have no other contraindications. If recombinant vaccine is not available or the recipient is not within the indicated age range, inactivated influenza vaccine should be administered by a clinician experienced in the recognition and management of severe allergic reactions.

ÂÂ

Regardless of allergy history, all vac­cines should be administered in settings in which personnel and equipment for rapid recognition and treatment of anaphylaxis are available.

ÂÂ

Persons who can eat lightly cooked egg (e.g., scrambled egg) without reaction are unlikely to be allergic. Egg-allergic persons may tolerate egg in baked products (e.g., bread, cake). Tolerance to eggcontaining foods does not exclude the possibility of egg allergy. Egg allergy can be confirmed by a consistent medical history of adverse reac­tions to eggs and egg-containing foods, plus skin or blood testing for immunoglobulin E directed against egg proteins.

ÂÂ

In persons with no history of egg expo­sure who are suspected of being allergic on the basis of

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

47

AMERICAN FAMILY PHYSICIAN allergy testing, consultation with a clinician who has expertise in the man­agement of allergic conditions should be obtained before vaccination.

Alternatively, trivalent recombinant influenza vaccine can be administered if the patient is at least 18 years of age. ÂÂ

A history of severe allergic reaction to influenza vaccine is a contraindication to future receipt of the vaccine, regardless of the component suspected of causing the reaction.

Note: For complete article visit: www.aafp.org/afp.

Source: Adapted from Am Fam Physician. 2015;92(8):732-740.

EARLY PEANUT INTRODUCTION AND PREVENTION OF PEANUT ALLERGY IN HIGH-RISK INFANTS: CONSENSUS COMMUNICATION In westernized countries, 1% to 3% of chil­dren have a peanut allergy, with almost 100,000 new cases each year in the United States and United Kingdom. This consen­ sus communication focuses on new data that support introducing peanuts early in infants, and it aims to assist with deci­ sions about introduction; it can be used for guidance while formal guidelines are being developed. The consensus communication is from a variety of organizations, including the American Academy of Allergy, Asthma & Immunology; American Academy of Pediat­rics; American College of Allergy, Asthma & Immunology; Australasian Society of Clinical Immunology and Allergy; Canadian Soci­ety of Allergy and Clinical Immunology; European Academy of Allergy and Clinical Immunology; Israel Association of Allergy and Clinical Immunology; Japanese Society for Allergology; Society for Pediatric Derma­tology; and World Allergy Organization.

Although previous guidelines suggest that there is no need to wait to introduce peanuts until after four to six months of age, they also did not specifically recommend intro­ducing peanuts in high-risk infants between four and six months of age, and certain guidelines state that some high-risk infants should have consultation with an expert before introduction. Recent data suggest that early introduction is safe and effective in selected patients.

LEAP Trial The LEAP (learning early about peanut allergy) trial, which is the first prospective randomized study regarding early peanut introduction, evaluated 640 infants at high risk living in the United Kingdom.

Infants were considered high risk if they did not have a history of egg tolerance, but did have a wheal

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diameter of at least 6 mm on a skin prick test when exposed to raw hen’s egg white; had a wheal diameter of at least 3 mm when exposed to pasteurized hen’s egg white, as well as associated allergy symptoms; had severe eczema requiring topical corticoste­roids or calcineurin inhibitors that lasted at least 12 of 30 days twice in infants younger than six months or 12 of 30 days twice in the past six months in children older than six months; or scored at least a 40 on the modi­fied SCORAD (scoring atopic dermatitis) evaluation.

The study included infants four to 11 months of age who were randomized to avoid products containing peanuts until five years of age or to eat products con­ taining peanuts at least three times per week.

Approximately 17% of infants not consuming peanuts had a peanut allergy by five years of age compared with about 3% of infants consuming peanuts (absolute risk reduction = 14%; number needed to treat = 7.1; relative risk reduction = 80%). The risks associated with introducing pea­nuts early in life was low, with only seven children in the group that consumed pea­nuts having reactions during the baseline food challenge, indicating that introduc­ing peanuts early is a safe and reasonable approach. It should be noted that infants with a lower risk were not evaluated in the LEAP trial; therefore, data on early peanut introduction in general or low-risk popula­tions are lacking.

Interim Guidance In infants at high risk who live in countries with a prevalence of peanut allergies, prod­ucts containing peanuts should be intro­duced at four to 11 months of age; waiting any longer can result in an increased risk of allergy. Infants in the LEAP trial who were in the peanut consumption group ate a median of 7.7 g of peanut protein each week in first two years; examples of foods consumed include smooth peanut butter mixed with milk or fruit, Bamba snacks, peanut soup, and ground peanuts mixed with other foods. The LEAP trial did not assess consumption of a different amount of peanut protein, length of treatment needed, or possible risks of dis­continuing or intermittently eating peanut products.

Consultation with an allergist or expert in managing allergies may be beneficial in infants who have an atopic disease early in life or egg allergies in the first four to six months; these specialists can assist with diagnosis and determine how appropriate early peanut introduction would be. Skin prick testing, an observed peanut challenge, or both may be evaluation options in this population.

Source: Adapted from Am Fam Physician. 2016;93(1):61-62.

2016

Every citizen of India should have the right to accessible, affordable, quality and safe heart care irrespective of his/her economical background

Sameer Malik Heart Care Foundation Fund An Initiative of Heart Care Foundation of India

E-219, Greater Kailash, Part I, New Delhi - 110048 E-mail: heartcarefoundationfund@gmail.com Helpline Number: +91 - 9958771177

“No one should die of heart disease just because he/she cannot afford it” About Sameer Malik Heart Care Foundation Fund

Who is Eligible?

“Sameer Malik Heart Care Foundation Fund” it is an initiative of the Heart Care Foundation of India created with an objective to cater to the heart care needs of people.

Objectives Assist heart patients belonging to economically weaker sections of the society in getting affordable and quality treatment.

Raise awareness about the fundamental right of individuals to medical treatment irrespective of their religion or economical background.

Sensitize the central and state government about the need for a National Cardiovascular Disease Control Program.

Encourage and involve key stakeholders such as other NGOs, private institutions and individual to help reduce the number of deaths due to heart disease in the country.

To promote heart care research in India.

All heart patients who need pacemakers, valve replacement, bypass surgery, surgery for congenital heart diseases, etc. are eligible to apply for assistance from the Fund. The Application form can be downloaded from the website of the Fund. http://heartcarefoundationfund.heartcarefoundation. org and submitted in the HCFI Fund office.

Important Notes The patient must be a citizen of India with valid Voter ID Card/ Aadhaar Card/Driving License.

The patient must be needy and underprivileged, to be assessed

by Fund Committee.

The HCFI Fund reserves the right to accept/reject any application for financial assistance without assigning any reasons thereof.

The review of applications may take 4-6 weeks.

All applications are judged on merit by a Medical Advisory Board who meet every Tuesday and decide on the acceptance/rejection of applications.

The HCFI Fund is not responsible for failure of treatment/death of patient during or after the treatment has been rendered to the patient at designated hospitals.

To promote and train hands-only CPR.

Activities of the Fund Financial Assistance

The HCFI Fund reserves the right to advise/direct the beneficiary to the designated hospital for the treatment.

Financial assistance is given to eligible non emergent heart patients.

Apart from its own resources, the fund raises money through donations, aid from individuals, organizations, professional bodies, associations and other philanthropic organizations, etc.

The financial assistance granted will be given directly to the treating hospital/medical center.

After the sanction of grant, the fund members facilitate the patient in getting his/her heart intervention done at state of art heart hospitals in Delhi NCR like Medanta – The Medicity, National Heart Institute, All India Institute of Medical Sciences (AIIMS), RML Hospital, GB Pant Hospital, Jaipur Golden Hospital, etc. The money is transferred directly to the concerned hospital where surgery is to be done.

Drug Subsidy

The HCFI Fund has the right to print/publish/webcast/web post details of the patient including photos, and other details. (Under taking needs to be given to the HCFI Fund to publish the medical details so that more people can be benefitted).

The HCFI Fund does not provide assistance for any emergent heart interventions.

Check List of Documents to be Submitted with Application Form Passport size photo of the patient and the family A copy of medical records Identity proof with proof of residence Income proof (preferably given by SDM)

The HCFI Fund has tied up with Helpline Pharmacy in Delhi to facilitate

BPL Card (If Card holder)

patients with medicines at highly discounted rates (up to 50%) post surgery.

Details of financial assistance taken/applied from other sources (Prime Minister’s Relief Fund, National Illness Assistance Fund Ministry of Health Govt of India, Rotary Relief Fund, Delhi Arogya Kosh, Delhi Arogya Nidhi), etc., if anyone.

The HCFI Fund has also tied up for providing up to 50% discount on imaging (CT, MR, CT angiography, etc.)

Free Diagnostic Facility

Free Education and Employment Facility

The Fund has installed the latest State-of-the-Art 3 D Color Doppler EPIQ 7C Philips at E – 219, Greater Kailash, Part 1, New Delhi.

HCFI has tied up with a leading educational institution and an export house in Delhi NCR to adopt and to provide free education and employment opportunities to needy heart patients post surgery. Girls and women will be preferred.

This machine is used to screen children and adult patients for any heart disease.

Laboratory Subsidy HCFI has also tied up with leading laboratories in Delhi to give up to 50% discounts on all pathological lab tests.

About Heart Care Foundation of India

Help Us to Save Lives The Foundation seeks support, donations and contributions from individuals, organizations and establishments both private and governmental in its endeavor to reduce the number of deaths due to heart disease in the country. All donations made towards the Heart Care Foundation Fund are exempted from tax under Section 80 G of the IT Act (1961) within India. The Fund is also eligible for overseas donations under FCRA Registration (Reg. No 231650979). The objectives and activities of the trust are charitable within the meaning of 2 (15) of the IT Act 1961.

Heart Care Foundation of India was founded in 1986 as a National Charitable Trust with the basic objective of creating awareness about all aspects of health for people from all walks of life incorporating all pathies using low-cost infotainment modules under one roof.

HCFI is the only NGO in the country on whose community-based health awareness events, the Government of India has released two commemorative national stamps (Rs 1 in 1991 on Run For The Heart and Rs 6.50 in 1993 on Heart Care Festival- First Perfect Health Mela). In February 2012, Government of Rajasthan also released one Cancellation stamp for organizing the first mega health camp at Ajmer.

Objectives Preventive Health Care Education Perfect Health Mela Providing Financial Support for Heart Care Interventions Reversal of Sudden Cardiac Death Through CPR-10 Training Workshops Research in Heart Care

Donate Now...

Heart Care Foundation Blood Donation Camps The Heart Care Foundation organizes regular blood donation camps. The blood collected is used for patients undergoing heart surgeries in various institutions across Delhi.

Committee Members

Chief Patron

President

Raghu Kataria

Dr KK Aggarwal

Entrepreneur

Padma Shri, Dr BC Roy National & DST National Science Communication Awardee

Governing Council Members Sumi Malik Vivek Kumar Karna Chopra Dr Veena Aggarwal Veena Jaju Naina Aggarwal Nilesh Aggarwal H M Bangur

Advisors Mukul Rohtagi Ashok Chakradhar

Executive Council Members Deep Malik Geeta Anand Dr Uday Kakroo Harish Malik Aarti Upadhyay Raj Kumar Daga Shalin Kataria Anisha Kataria Vishnu Sureka

This Fund is dedicated to the memory of Sameer Malik who was an unfortunate victim of sudden cardiac death at a young age.

Rishab Soni

HCFI has associated with Shree Cement Ltd. for newspaper and outdoor publicity campaign HCFI also provides Free ambulance services for adopted heart patients HCFI has also tied up with Manav Ashray to provide free/highly subsidized accommodation to heart patients & their families visiting Delhi for treatment.

http://heartcarefoundationfund.heartcarefoundation.org

SANGHI MEDICAL CENTRE (P) Ltd. World Class Diagnostic Center

Patient Services Offered

Fully Computerized Automated Laboratory

Radiology & Imaging Facilities

Other Facilities

PFT (Pulmonary Function Test)

Corporate Office ADDRESS Sanghi Medical Centre Pvt. Ltd. S-51, Greater Kailash – I, New Delhi – 110048 Tel.: +91 11 29232010, +91 11 29234400

Audiometry

Cardiology Facilities Laboratory

AMERICAN FAMILY PHYSICIAN ACP RELEASES BEST PRACTICE ADVICE ON SCREENING FOR CERVICAL CANCER Screening for cervical cancer has likely con­tributed to decreased incidence and mor­tality rates of the disease over the past several decades. However, the medical cost of screening is substantial. New evidence-based guidelines aim to minimize the harms of overscreening while maximizing benefit. Based on the best available evidence, the American College of Physicians (ACP) has released best practice advice on cervical can­ cer screening in average-risk, asymptomatic women 21 years or older. This advice is targeted to all clinicians, and refers to screen­ing for cervical precancerous and cancerous lesions detected on cytology and other tests for high-risk types of human papilloma­virus (HPV).

This advice is supported by the American Congress of Obstetricians and Gynecologists and endorsed by the American Society for Clinical Pathology.

Best Practice Advice ACP’s best practice advice focuses on increas­ing the age at which to begin screening, increasing the screening interval, and discon­tinuing screening in lowrisk women.

(1) Clinicians should not screen average-risk women younger than 21 years. This applies regardless of sexual history. Cytologic abnor­malities are common in this age group, but clinically important cervical lesions are rare. If screened, many women younger than 21 years will have colposcopy and biopsy, with some treated for lesions with a high likeli­hood of regression.

(2) Clinicians should begin screening average-risk women at 21 years of age once every three years with cytology (cytologic test­ing without HPV tests). HPV testing is not recommended in this age group because of the high prevalence of HPV infection.

(3) Clinicians should not screen average-risk women with cytology more often than once every three years.

Annual screening is no longer recommended because of increased rates of false-positive results with minimal effect on subsequent cancer. The average time for a high-grade precancerous lesion to progress to cancer is 10 years. The three-year interval allows sufficient time for identifica­tion and treatment.

(4) Clinicians may screen using a combina­tion of cytologic and HPV testing once every five years in average-risk women 30 years or older who prefer longer screening intervals. This strategy, known as cotesting, is an alternative to cytology alone. The rationale for this approach is that women with normal cytologic results and no evidence of high-risk HPV are at low risk of cervical cancer; therefore, the screening interval may be safely extended to five years.

(5) Clinicians should not test for HPV in average-risk women younger than 30 years. HPV testing alone or in combination with cytology is not recommended for primary screening in this population. The U.S. Pre­ventive Services Task Force qualifies this as a grade D recommendation, because there are likely no net benefits or the harms outweigh them.

(6) Clinicians should discontinue screening average-risk women older than 65 years after three consecutive negative cytology results, or two consecutive negative cytology plus HPV test results within 10 years, if the last one was performed within the previous five years.

Cer­ vical cancer is uncommon in older women who have had normal previous screening results, although the chance of false-positive results with consequent invasive interven­tions continues.

(7) Clinicians should not screen average-risk women of any age after hysterectomy with removal of the cervix. After surgical removal of the cervix, the risk of cervical cancer is zero, making screening in these patients extremely low-value.

Talking Points with Patients When discussing cervical cancer screening with patients, clinicians should explain that beginning screening too early can lead to testing and treating lesions that may resolve on their own. Screening more often than every three years increases the chance of false-positive test results and invasive pro­cedures while offering little benefit. In low-risk women older than 65 years, continuing cervical cancer screening provides little to no benefit with the potential for invasive procedures.

After hysterectomy with removal of the cervix, patients can be reassured that there is no risk of cervical cancer.

Source: Adapted from Am Fam Physician. 2015;92(12):1107-1110.

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

53

DERMATOLOGY

Efficacy and Tolerability of an Oatmeal Moisturizer Containing Colloidal Oatmeal for Dry Skin Conditions: A Post-marketing Study VARSHA NARAYANAN*, ANIL GANJOO†, GANESH KADHE‡

ABSTRACT Background: Skin dryness is a common condition that represents significant change in the outermost layer of the epidermis of the skin. Oatmeal moisturizer therapy plays an important role in treating various skin diseases. Methodology/Principal findings: The study included a total of 528 patients aged 2-65 years with atopic dermatitis/xerosis, eczema, acne, psoriasis and other types of skin infections. The patients were treated with oatmeal moisturizer (Nourish Oat) for a duration of 8 weeks.

All the patients were evaluated with modified Kligman grading scale, before and after the end of therapy. There was a significant improvement (p < 0.05) with an increase in the mean difference in dryness scores from baseline to the end of each treatment interval (2 weeks- 0.88, 4 weeks- 1.43, 6 weeks- 1.77 and 8 weeks- 1.93). The mean differences in itching scores from baseline to the end of treatment were 0.09 after 2 weeks (p < 0.05), 1.66 after 4 weeks (p < 0.05), 0.09 after 6 weeks (p < 0.22) and 1.66 after 8 weeks (p < 0.05). Overall, 53% and 59% patients had reduced dryness >60% and reduced itching, respectively after 4 weeks of treatment period and 89% and 93% patients had reduced dryness >80% and reduced itching, respectively at the end of 8 weeks. No serious skin reactions were reported. Conclusion: Nourish Oat shows good tolerability, efficacy and demonstrates significant anti-itching and moisturizing properties against varieties of dry skin conditions in the patients of all age groups.

However, long-term studies can better clarify the role of oatmeal moisturizer in dry skin conditions.

Keywords: Xerosis, atopic dermatitis, pruritus, dryness, itching

D

ryness of the skin, also called xerosis is a common condition which represents significant change in the stratum corneum (outermost layer of the epidermis) of the skin.1,2 The consequence of the dry skin includes impairment in barrier function, inflammation of the skin and loss of suppleness that leads to the cracking of skin. It is multifactorial and may be acquired, constitutional and genetic in origin.1 Adverse events (AEs) such as chances of occurrence of dermatitis or discomfort on application (with emollients),3,4 thinning of the skin (anti-inflammatory agents/corticosteroids)5 and skin irritation and burning

*Head, Medical Affairs, Wockhardt Ltd., Mumbai, Maharashtra †Senior Consultant, Dermatovenereologist and Laser Surgeon, Delhi ‡Additional Vice President - Medical, Wockhardt Ltd., Mumbai, Maharashtra Address for correspondence Dr Varsha Narayanan Head, Medical Affairs, Wockhardt Ltd., Wockhardt Towers, Bandra Kurla Complex, Bandra (East), Mumbai - 400 051, Maharashtra E-mail: VNarayanan@wockhardt.com

(calcineurin-inhibitors)6 have been reported. Menthol, topical doxepin, topical naltrexone and topical retinoids may also cause allergic contact dermatitis and in greater concentration can cause burning and erythema of the skin.7,8 Soothing effect of colloidal oatmeal and its skin protecting properties make it an effective option in treating skin infections including atopic dermatitis and pruritus.9 The US Food and Drug Administration (FDA) in 1989 accepted that oatmeal extract is a category 1 (safe and effective) ingredient for skin products.10 The safety and efficacy of oatmeal moisturizers has been proven previously in numerous clinical studies in infants, children and individuals of all age groups.11,12 The aim of the present study was to evaluate the post-marketing efficacy and tolerability of oatmeal moisturizer containing colloidal oatmeal (Nourish Oat) in patients with atopic dermatitis/xerosis, eczema, acne, psoriasis and other types of dry skin conditions through a feedback post-marketing survey.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

55

DERMATOLOGY MATERIAL AND METHODS

Study Population Subjects (male or female) aged 2-65 years with atopic dermatitis/xerosis, eczema, acne, psoriasis and other types of skin infections; and willing to give an informed consent were enrolled in the study. Subjects with an allergy to any of the product ingredients, having any uncontrolled medical illness such as diabetes mellitus, hypertension, liver disease or history of alcoholism, human immunodeficiency virus (HIV), hepatitis or any other serious medical illness were excluded. Pregnant women or nursing mothers were also excluded from the study.

Study Design The study was an open-labeled, feedback, phase IV (post-marketing) trial conducted on 528 subjects for a duration of 8 weeks. All the patients were advised to apply the oatmeal moisturizer once- or twicedaily, depending on the severity of the condition for a period of 8 weeks. All the subjects were observed and examined for their vital signs and symptoms before and after using the moisturizer. Skin hydration, sebum levels and transepidermal water loss, constitutive loss of water from the skin surface were assessed before and after the treatment.

The primary outcome variables in the study were the improvements in dryness and itching in the patient.

The improvement in patientsâ&#x20AC;&#x2122; symptoms and evaluation of challenge patch test reactions were assessed with modified Kligman grading scale. The scores in the scale are in range from 0 to 3 for dryness (0- healthy skin with no evidence of dryness even on scratching; 1- mild dryness on scratching; 2- moderate dryness, small dry flakes or visible whitening of dermatoglyphic triangles without scratching and 3- severe well-defined xerosis with the dermatoglyphic triangles uplifted and redness are readily apparent) and itching (0- no itching of the skin; 1- mild interference of disease with the quality, work and social life of an individual; 2- moderate interference of itching and 3- severe interference of itching). The secondary outcome variable included global assessment by the patient and the investigator.

Safety/tolerability was assessed on the basis of AEs experienced by the patients during or after the end of treatment period.

at baseline and at the end of 8 weeks. The difference in mean scores at baseline and at the end of 8 weeks was compared for itching and dryness. A p-value <0.05 was deemed significant. SPSS version 19.0 (IBM Corporation, United States) software was used for statistical analysis.

RESULTS A total of 528 subjects with various types of skin infections were enrolled in the study (Fig. 1). The patients were diagnosed provisionally on the basis of previous exposure to dry heat, air-conditioned exposures, substance use, their present medication, systematic complaints and the family history of skin diseases. Of these, 206 (39%) patients applied the oatmeal moisturizer alone while, 322 (61%) patients applied the oatmeal moisturizer with a co-prescription.

Efficacy All the patients showed an improvement in their symptoms at the end of treatment. The overall Kligman score for dryness for the patients was 2 at baseline that reduced to 1.4 after 2 weeks, 0.9 after 4 weeks, 0.5 after 6 weeks and 0.3 at the end of 8 weeks. There was a significant improvement (p < 0.05) with an increase in the mean difference in scores from baseline to the end of each treatment interval (2 weeks- 0.88, 4 weeks- 1.43, 6 weeks- 1.77 and 8 weeks- 1.93). Similarly, itching was reduced in all the patients at the end of the therapy; the overall score of the patients are presented in Figure 2.

The mean differences in scores from baseline to the end of treatment were significant (p < 0.05) after each treatment interval and are shown in Table 1.

The average patient satisfaction scores for reduced dryness were 47.9% after 2 weeks, 72.1% after 4 weeks,

Others (23%) Psoriasis (9%)

Atopic dermatitis (46%)

Acne (7%) Eczema (15%)

Statistical Analysis Descriptive statistics were used to summarize the data.

Paired t-test was used to compare the average scores

56

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

Figure 1. Provisionally diagnosed patients with various types of skin infections.

DERMATOLOGY 88.6% after 6 weeks and 94.5% at the end of 8 weeks (Fig. 3). The mean differences in scores from baseline to the end of treatment were 0.09 after 2 weeks (p < 0.05), 1.66 after 4 weeks (p < 0.05), 0.09 after 6 weeks (p < 0.22) and 1.66 after 8 weeks (p < 0.05). Overall, 53% patients had reduced dryness >60% after 4 weeks of treatment

period and 89% patients had reduced dryness >80% at the end of 8 weeks. Similarly, 59% patients had reduced itching >60% after 4 weeks of treatment period and 93% had reduced itching >80% at the end of 8 weeks.

The patient satisfaction score for all the symptoms was achieved for 70.2% patients at the end of 8 weeks.

Table 1. Difference in Scores from Baseline Parameters

Statistical parameters

Treatment duration 2 weeks

4 weeks

6 weeks

8 weeks

N

434

432

431

430

Mean ± SD

0.88 ± 0.79

1.43 ± 0.83

1.77 ± 0.89

1.93 ± 0.81

P value

0.00

0.00

0.00

0.00

N

397

396

395

394

Mean ± SD

0.92 ± 0.85

1.43 ± 0.88

1.77 ± 0.83

1.84 ± 0.88

P value

0.00

0.00

0.00

0.00

Dryness

Itching

Patient satisfaction scores

N

430

252

212

109

Mean ± SD

-0.96 ± 1.60

-0.52 ± 1.69

0.09 ± 1.80

1.66 ± 1.24

P value

0.00

0.00

0.22*

0.00

Total score

N

369

368

367

366

Mean ± SD

1.65 ± 1.46

2.67 ± 1.58

3.29 ± 1.57

3.46 ± 1.56

P value

0.00

0.00

0.00

0.00

N = Number of patients,*nonsignificant.

Baseline

2 weeks

4 weeks

4

6 weeks

8 weeks

3.7

100

0.5 0

Patient scores

Patient scores

2.5

2.5

1

89

90

3

1.5

2 weeks

2

1.8 1.4 0.9 0.6 0.4 Dryness

1.2 0.7 0.4 0.3 Itching

4 weeks

6 weeks

8 weeks

110

3.5

2

120

1.5

80

50

76

72

70 60

96 91

95

54

48

91

95

75 51

40 30

0.9 0.7

20 10 0

Total score

Figure 2. Improvement in patients symptoms along with the treatment period.

a. Dryness

b. Itching

Total score (a + b)

Figure 3. Parametric satisfaction scores of patients.

Table 2. Adverse Events Observed in Patients During the Study Duration

Number of patients Stickiness (%)

Irritation/burning (%)

Redness (%)

Odor (%)

2 weeks

29 (5.5)

29 (5.5)

25 (4.7)

29 (5.5)

4 weeks

21 (4.0)

14 (2.7)

11 (2.1)

10 (2.0)

6 weeks

18 (3.4)

9 (1.7)

10 (2.0)

11 (2.1)

8 weeks

18 (3.4)

7 (1.3)

10 (2.0)

4 (0.8)

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

57

DERMATOLOGY Safety There were no serious or life-threatening AEs observed in the study. Common and mild AEs included stickiness, irritation/burning, redness and odor (Table 2). Overall, 29 patients reported stickiness from the moisturizer after 2 weeks and the number of patients reporting stickiness was reduced to 18 at the end of treatment.

Similarly, a total of 29 patients reported odor after 2 weeks and only 4 patients reported odor at the end of treatment.

DISCUSSION The results of this open labeled, phase IV (post-marketing) feedback trial show that the oatmeal moisturizer is welltolerated and efficacious in the treatment of patients with numerous dry skin conditions. The improvement in patients scores were observed after application of oatmeal moisturizer for all the symptoms of skin infection such as atopic dermatitis, xerosis, eczema, acne, psoriasis, etc. Itching is reported as the primary symptom of numerous dermatological diseases such as lichen simplex, lichen planus, atopic dermatitis, etc.12,13 In response to this, scratching provides an instant relief by stimulating mechanical nociceptors, nonetheless it again exacerbates the condition by encouraging further lesions in the skin.14 Numerous topical medications are used but universally no accepted therapy is available.15 The colloidal oatmeal is prepared by removing the hulls from beans, which contain groat or kernel in it.

According to the US pharmacopeia, the colloidal oatmeal is defined as the powder obtained after grinding and processing of whole oat grain.16 Oat comprises of flavonoids, phospholipids, sterols which exhibit moisturizing effect and emollient activity. Flavonoids (phenolic compounds) have anti-inflammatory, antioxidant and antipruritic properties and reduce the formation of free radicals from lipids.17 They also inhibit the synthesis of prostaglandins (a mediator of itching) via anti-inflammatory and lenitive actions.18 One of the phenolic compounds, avenanthramides present in the oats exhibit antioxidant activity in various cell types. They inhibit the intracellular adhesion molecule-1 (ICAM-1), vascular adhesion molecule-1 (VCAM-1) and E-selectin that decrease the level of cytosolic phospholipase A2 in keratinocytes. This leads to a reduction in the secretion of pro-inflammatory cytokines (tumor necrosis factor [TNF]-α, interleukin [IL]-8, monocyte chemoattractant protein [MCP]-1 and histamine) via, nuclear factor kappa B (NFKβ) pathway in keratinocytes.17

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

The oatmeal exhibits anti-inflammatory transforming growth factor β1 (TGFβ1) via keratinocytes, which inhibits the production of ILs.19 It is reported that the activity of arachidonic acid, cystolic phospholipase and importantly TNF-α gets decreased with the oatmeal extract. After its inhibition, histamine and pro-inflammatory cytokines are released and inhibit the TNF-α induced NFKβ luciferase activity, which hinders systemic inflammation.20 Additionally, the soothing effect of oatmeal and its skin shielding properties make it an efficient option for treating numerous types of skin diseases.7 Moreover, oatmeal possesses insoluble proteins (having buffering properties) that help in maintaining pH of the skin.21 Oats are rich in lipids and majority of them are unsaturated fatty acids (having antioxidant property), which prevent the oxidation of lipids. The activity of antioxidation is stimulated by phenolic esters, especially glyceryl esters, which moisturize the skin by their humectant hydration action.10,22 In addition to these, linoleic acid, proteins and carbohydrates present in oats show multifaceted properties in skin conditioning, cell regeneration, stimulating and anti-inflammatory activities. The oatmeal moisturizer has shown encouraging results in the past for numerous types of skin conditions associated dry skin and itching.23,24 A study by Reynertson and colleagues demonstrated the benefits of colloidal oatmeal skin protectant lotion in 29 healthy female subjects with bilateral mild-tomoderate itching due to dry skin on their lower legs.

After treatment, it was observed that the colloidal oatmeal extract reduced pro-inflammatory cytokines in vitro and remission in all the clinical signs such as skin dryness, scaling, roughness and itch intensity was observed.23 Another study by Vié and colleagues demonstrated modulating effects of oatmeal extracts in the sodium lauryl sulfate skin irritancy model. Overall, 12 subjects were pretreated with oatmeal extracts for 2 hours with one side left untreated. The application of 1% sodium lauryl sulfate with oatmeal extract was applied for 24 hours. The results displayed a significant (p < 0.05) reduction in skin irritation in the model.25 Matheson conducted an assessor blind clinical trial in 35 patients with itching due to sustained burn injuries.

After application of a product containing 5% colloidal oatmeal twice-daily for 10 months, the author reported a significant reduction in itching and significantly less antihistamine request than those using the oil containing liquid paraffin (p < 0.001). Overall, the patients using liquid paraffin reported daily mean itch of at least twice as much intensity as compared to those using colloidal oatmeal.26

DERMATOLOGY Criquet and colleagues demonstrated the safety and efficacy of colloidal oatmeal products by conducting 12 independent studies in two countries (10 studies in US and 2 studies in Romania). Of 2,291 subjects, low level reactions were reported in 1.0% of subjects during the induction phase of repeat insult patch testing; only one subject developed low level reaction during challenge phase in repeat insult patch testing. The study summarized that the oatmeal containing products possess low irritant and low allergenic sensitization potential. The colloidal oatmeal cosmetic care products were also highly efficacious. Skin hydration, appearance of squamae and skin roughness were significantly more improved than on the control area at all time points for those using the oatmeal product, including at 2 weeks after cessation of application as compared with the baseline.27 The studies conducted among infants, children and adults (with atopic dermatitis) containing colloidal oatmeal products assure its safety and tolerability.28 Nollent et al conducted 12-week open, multicentric study in Greece, Portugal and Italy among 99 subjects of ages 6 months to adulthood with atopic dermatitis.

Of 99 subjects, 71 completed the study. After treatment with moisturizer containing oatmeal extracts, a significant (p < 0.05) improvement in skin condition parameters was observed. Overall, 100% improvement was observed by the patients in skin hydration, 75% improvement in redness, 68% improvement in scaling, 65% improvement in dryness and 64% improvement in itching. Interestingly, it was also observed that 63% population after the therapy used fewer corticosteroids in their daily life.12 Kyriakos in the year 2012 presented a preliminary safety data of oatmeal in children aged 2 months to 16 years at European Society for Pediatric Dermatology Congress, Istanbul. Overall, 1607 patients were enrolled in the study with mild-to-moderate eczema with or without the use of topical steroids. The evaluation of the scores were assessed with Investigator Global Assessment (IGA), self-assessment and by quality-oflife questionnaires. After 8-week treatment period with oatmeal moisturizing cream, a significant improvement in IGA scores was observed (p < 0.01). It was observed that 78% of patients felt less need for use of medication after second visit. Overall, 98% of patients reported a good tolerability profile of the moisturizing cream containing oatmeal.12 Some of the previous studies suggested that the persistent use of oatmeal containing products might lead to oat sensitization specifically in children under 2 years of age but the data has been contrasting. In a study of 302 children with atopic dermatitis, atopy patch tests (APT) and skin prick tests (SPT) to oat proteins were positive in 14.6% and

19.2% of cases, respectively. The children less than 2 years of age were more affected as compared with the older age group. The authors recommended not using oatmeal products before the age of 2 years in predisposed children.29 However, in a double-blind, randomized patch study of 65 children aged 6 months to 2 years, no immediate urticarial or allergic reactions were observed in children after application of 0.007% colloidal oats. The authors concluded that colloidal oats could be used as an adjunct in the management of mild atopic dermatitis in children under 2 years of age.30 In another study, the authors reported a low frequency (2.9%) of oat sensitivity in 202 atopic children who were oat cream users that was comparable with 2.1% of those who had never used oat cream.18 Criquet et al also reported a low allergenic potential on repeat insult patch testing in a series of studies in patients (18-69 years) using colloidal oatmeal containing skin care products. During a 3-year period, 4,45,820 consumers using the oatmeal skin care products did not have any allergic reaction.27 In the present study, we tested the efficacy and tolerability of oatmeal moisturizer containing colloidal oatmeal and observed a significant reduction in the symptoms of patients.

The AEs were few and mild. None of the patients developed persistent erythema or sensitization to the product. Further, our study included a heterogeneous group of patients ranging from 2 months to 65 years; but none of them reported any untoward reaction.

However, our study has certain shortcomings. This was a feedback survey based on baseline and end of treatment session observations. However, like other feedback surveys it tends to exclude other explanations for the effect observed. Further, no test group was included in the study and the study was of short duration (i.e., 8 weeks). Future well-designed long-term follow-up studies can further clarify the role of oatmeal moisturizer in patients with dry skin conditions.

CONCLUSION Summarizing, the oatmeal moisturizer shows good tolerability, efficacy and demonstrates significant antiitching and moisturizing properties against varieties of skin infections in the patients of all age groups. â&#x20AC;&#x153;Oatmeal nourishâ&#x20AC;? moisturizer might therefore be considered as a competent application for the treatment of patients with atopic dermatitis/xerosis, eczema, acne, psoriasis and other types of dry skin conditions.

Acknowledgment The author acknowledges Knowledge Isotopes (www. knowledgeisotopes.com) for writing this article and subsequently revising it by addressing author comments.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

59

DERMATOLOGY REFERENCES 1. Siddappa K. Dry skin conditions, eczema and emollients in their management. Indian J Dermatol Venereol Leprol. 2003;69(2):69-75.

2. Del Rosso JQ. Repair and maintenance of the epidermal barrier in patients diagnosed with atopic dermatitis: an evaluation of the components of a body wash-moisturizer skin care regimen directed at management of atopic skin.

J Clin Aesthet Dermatol. 2011;4(6):45-55.

3. Todd G, Manjra AI, Sinclair W, Green RJ, Levin ME. Non-pharmacological treatment modalities for atopic dermatitis. South Afr Med J. 2014;104(10):713.

4. Lawton S. Effective use of emollients in infants and young people. Nurs Stand. 2004;19(7):44-50; quiz 52, 54.

5. Korting HC, Unholzer A, Schäfer-Korting M, Tausch I, Gassmueller J, Nietsch KH. Different skin thinning potential of equipotent medium-strength glucocorticoids.

Skin Pharmacol Appl Skin Physiol. 2002;15(2):85-91.

6. Pariser D. Topical corticosteroids and topical calcineurin inhibitors in the treatment of atopic dermatitis: focus on percutaneous absorption. Am J Ther. 2009;16(3):264-73.

7. Hong J, Buddenkotte J, Berger TG, Steinhoff M. Management of itch in atopic dermatitis. Semin Cutan Med Surg. 2011;30(2):71-86.

8. Chularojanamontri L, Tuchinda P, Kulthanan K, Pongparit K. Moisturizers for Acne: What are their Constituents?

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9. Correa MCM, Nebus J. Management of patients with atopic dermatitis: the role of emollient therapy. Dermatol Res Pract. 2012;2012:836931.

10. Kurtz ES, Wallo W. Colloidal oatmeal: history, chemistry and clinical properties. J Drugs Dermatol. 2007;6(2): 167-70.

11. Tucker R. What evidence is there for moisturisers? 2011.

Available from: http://www.pharmaceutical-journal. com/files/rps-pjonline/pdf/pj20110416_cpd.pdf [Accessed 6 January, 2016].

12. Wahlgren CF. Itch and atopic dermatitis: clinical and experimental studies. Acta Derm Venereol Suppl (Stockh). 1991;165:1-53.

13. Hägermark O. Peripheral and central mediators of itch.

Skin Pharmacol. 1992;5(1):1-8.

14. Nilsson HJ, Schouenborg J. Differential inhibitory effect on human nociceptive skin senses induced by local stimulation of thin cutaneous fibers. Pain.

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15. Patel T, Yosipovitch G. Therapy of pruritus. Expert Opin Pharmacother. 2010;11(10):1673-82.

16. U.S. Pharmacopeia. Colloidal Oatmeal. Available from: http://www.pharmacopeia.cn/v29240/usp29nf24s0_ m20023.html [Accessed 21 January, 2016].

17. Sur R, Nigam A, Grote D, Liebel F, Southall MD. Avenanthramides, polyphenols from oats, exhibit

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anti-inflammatory and anti-itch activity. Arch Dermatol Res. 2008;300(10):569-74.

18. Rancé F, Dargassies J, Dupuy P, Schmitt AM, Guérin L, Dutau G. Faut-il contre-indiquer l’utilisation des émollients à base d’avoine chez l’enfant atopique? Revue Française d’Allergologie et d’Immunologie Clinique.

2001;41(5):477-83.

19. Dawid-Pać R. Medicinal plants used in treatment of inflammatory skin diseases. Postepy Dermatol Alergol.

2013;30(3):170-7.

20. Pazyar N, Yaghoobi R, Kazerouni A, Feily A. Oatmeal in dermatology: a brief review. Indian J Dermatol Venereol Leprol. 2012;78(2):142-5.

21. Pacifico A, De Angelis L, Fargnoli MC, De Felice C, Chimenti S, Peris K. Clinical trial on aveeno skin relief moisturizing lotion in patients with itching accompanied by skin lesions and xerosis. J Appl Res. 2005;5(2):325-30.

22. Meyer J, Marshall B, Gacula M Jr, Rheins L. Evaluation of additive effects of hydrolyzed jojoba (Simmondsia chinensis) esters and glycerol: a preliminary study.

J Cosmet Dermatol. 2008;7(4):268-74.

23. Reynertson KA, Garay M, Nebus J, Chon S, Kaur S, Mahmood K, et al. Anti-inflammatory activities of colloidal oatmeal (Avena sativa) contribute to the effectiveness of oats in treatment of itch associated with dry, irritated skin. J Drugs Dermatol. 2015;14(1):43-8.

24. Fowler JF Jr. Colloidal oatmeal formulations and the treatment of atopic dermatitis. J Drugs Dermatol.

2014;13(10):1180-3; quiz 1184-5.

25. Vié K, Cours-Darne S, Vienne MP, Boyer F, Fabre B, Dupuy P. Modulating effects of oatmeal extracts in the sodium lauryl sulfate skin irritancy model. Skin Pharmacol Appl Skin Physiol. 2002;15(2):120-4.

26. Matheson JD, Clayton J, Muller MJ. The reduction of itch during burn wound healing. J Burn Care Rehabil.

2001;22(1):76-81; discussion 75.

27. Criquet M, Roure R, Dayan L, Nollent V, Bertin C. Safety and efficacy of personal care products containing colloidal oatmeal. Clin Cosmet Investig Dermatol. 2012;5:183-93.

28. Fowler JF, Nebus J, Wallo W, Eichenfield LF. Colloidal oatmeal formulations as adjunct treatments in atopic dermatitis. J Drugs Dermatol. 2012;11(7):804-7.

29. Boussault P, Léauté-Labrèze C, Saubusse E, Maurice-Tison S, Perromat M, Roul S, et al. Oat sensitization in children with atopic dermatitis: prevalence, risks and associated factors. Allergy. 2007;62(11):1251-6.

30. Pigatto P, Bigardi A, Caputo R, Angelini G, Foti C, Grandolfo M, et al. An evaluation of the allergic contact dermatitis potential of colloidal grain suspensions. Am J Contact Dermat. 1997;8(4):207-9.

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Asian Journal of Diabetology

—

Emerging role of Cardiac MRI in Ischemic and Non-ischemic Cardiomyopathy

—

Acute Renal Failure and Silent Myocardial Infarction Following Multiple Honey Bee Stings

—

Superficial Brachial Artery: Its Embryological and Clinical Significance

—

Glucose Tolerance in Nondiabetic Patients after First Attack of Acute Myocardial Infarction and its Outcome

—

A Case of Left Atrial Myxoma Presenting as Severe Pulmonary Hypertension

—

Double-Chambered Right Ventricle with Transient 2:1 Atrioventricular Block: A Rare Presentation

—

Cornary Artery Air Embolism

Volume 17, Number 5

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January-March 2015

Volume 1, Number 1

Asian Journal of OBS & Gynae Practice Asian Journal of Paediatric Practice

Volume 18, Number 3

Dr Swati Y Bhave

Dr KK Aggarwal

Editor

Group Editor-in-Chief

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DERMATOLOGY

Biotinyl-GHK and Hair Growth PHILIPPE MONDON

ABSTRACT Androgenetic alopecia represents the commonest type of baldness and is characterized by progressive hair loss. It is linked with stepwise miniaturization of the hair follicle, occurring as a result of alteration in the hair cycle dynamics, eventually leading to vellus transformation of terminal hair follicle. Data suggest a role of androgens and the interaction between the dermal papillae and hair follicle in miniaturization of hair follicles. Overt deficiency of biotin, a member of the B complex group of vitamins, has been linked with hair loss. With the aim of enhancing the anchorage of the hair sheath and dermis, a peptide sequence enriched with pro-matricial activities: the peptide, Glycyl-Hystidyl-Lysine, a member of the Matrikines® series, was selected and bound to vitamin H (biotin). A new entity was thus created: Biotinyl-GHK, with the expectation of a dual matricial and metabolic action.

A new product has been launched in which three active substances have been combined - oleanolic acid to inhibit 5α-reductase, apigenin to enhance blood perfusion and Biotinyl-GHK for enhanced anchoring of the hair with strengthened growth. In vitro and in vivo studies have shown that the complex shows hair loss and improves the health of hair follicles.

Keywords: Androgenetic alopecia, biotin, Matrikines®, Biotinyl-GHK, oleanolic acid, apigenin

A

ndrogenetic alopecia (AGA), i.e., alopecia induced by androgens in genetically predisposed individuals, has significant psychological effects on affected patients.1 AGA represents the commonest type of baldness and is characterized by progressive hair loss. AGA has been shown to affect all races. In India, a population-based study of 1,005 subjects exhibited a 58% prevalence of AGA in males aged 30-50 years.1 AGA is linked with stepwise miniaturization of the hair follicle, occurring as a result of alteration in the hair cycle dynamics, eventually leading to vellus transformation of terminal hair follicle.1

ÂÂ

The catagen phase is characterized by a process of involution, where apoptosis occurs in most of the follicular keratinocytes. Besides this, termination of pigment production and condensation of dermal papillae occurs in this phase. This results in an upward movement of dermal papillae.1

ÂÂ

In the telogen phase, the hair shaft is seen maturing into vellus hair. The hair eventually fall off due to combing and washing and this is followed by the anagen phase again.1

WHAT CAUSES HAIR LOSS IN AGA? ÂÂ

In AGA, the span of the anagen phase is decreased while that of telogen phase is prolonged. As a result, the maximum length that the new anagen hair attains becomes shorter than that of its predecessor, resulting in miniaturization, yielding a bald appearance.1

ÂÂ

Data suggest a role of androgens and the interaction between the dermal papillae and hair follicle in miniaturization of hair follicles.1

ÂÂ

Follicles on the scalp show a shift from long growth (anagen) and short rest (telogen) cycles, to long rest and short growth cycles. This is associated with miniaturization of the follicles. These changes are attributed to androgens and genetic-inheritance.2

ÂÂ

The concentrations of dihydrotestosterone (DHT) and 5α-reductase and androgen receptors are increased in alopecia.1

NORMAL HAIR CYCLE Active growth phase “Anagen” - lasts from 2 to 6-7 years Stage of regression “Catagen” - lasts 1-2 weeks Resting phase “Telogen” - lasts from 5 to 6 weeks to about 100 days.

Sederma R&D Director Address for correspondence Dr Philippe Mondon 29 Rue du Chemin Vert 78610 Le Perray-en-Yvelines, France

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

63

DERMATOLOGY ÂÂ

ÂÂ

The premature termination of anagen associated with premature entry into catagen occurs due to decreased expression of anagen maintaining factors, including growth factors - insulin-like growth factor-1 (IGF-1), basic fibroblast growth factor (bFGF) and vascular endothelial growth factor (VEGF).1 Increased expression of cytokines (transforming growth factor ([TGF]-β1, interleukin [IL]-1α and tumor necrosis factor [TNF]-α) has been reported to promote apoptosis.1

BIOTIN AND HAIR Vitamin H, also known as biotin, is a member of the B complex group of vitamins. B vitamins have a role in the conversion of carbohydrates into glucose to produce energy. The B vitamins also help in fat and protein metabolism. B complex vitamins are needed for healthy skin, hair, eyes and liver.3 Biotin is a watersoluble vitamin and serves as an essential coenzyme for some important enzymes.4 Overt biotin deficiency has been linked with hair loss.5 Biotin supplements have been seen to improve thin, splitting or brittle toe and fingernails, as well as hair.3 Biotin, in association with zinc and topical clobetasol propionate, has can fight alopecia in both children and adults.3

investigate for selective localization of the product around the pilial zone.

Skin explants (with hair follicles) were incubated in the presence of 60 ppm peptide for 18 hours. These were compared with control explants exposed to peptide-free excipient. After 18 hours, an 8-mm biopsy was removed from the center of each well and immediately frozen in liquid nitrogen. 15 μm thick sections were made using a freezing microtome (cryostat), then dried and fixed. Biotinyl-GHK was detected by immunolabeling coupled with streptavidin peroxidase.

The sections demonstrated clear peri-pilial localization of peptide Biotinyl-GHK (Fig. 1 A-D).

BIOTINYL-GHK FOR MANAGING HAIR LOSS With the aim of enhancing the anchorage of the hair sheath and dermis, a peptide sequence enriched with pro-matricial activities: the peptide, Glycyl-HystidylLysine, a member of the Matrikines® series, was selected and bound to vitamin H (biotin). A new entity was thus created: Biotinyl-GHK, with the expectation of a dual matricial and metabolic action. A new product has been launched in which three active substances have been combined - oleanolic acid to inhibit 5α-reductase, apigenin to enhance blood perfusion and Biotinyl-GHK for enhanced anchoring of the hair with strengthened growth.

Figure 1A. No labeling around the hair shaft (magnification 20X).

In vitro and in vivo studies have been conducted to test the efficacy of Biotinyl-GHK in hair growth.

In vitro Studies Study on Cultured Hair Follicle Explants The study was conducted on human skin explants (abdominal plasty) cultured in phosphate buffered saline (PBS) medium in a moist chamber at 21°C. Following incubation of the explants with the peptide, immunohistochemical study of sections was done to

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

Figure 1B. Clear localization of Biotinyl-GHK around 2 adjacent hair shafts (magnification 20X).

DERMATOLOGY A fraction of the follicles was frozen to carry out more advanced immunohistochemical studies. Growth was monitored using a digital camera with images taken on Days 0, 3, 5, 7, 11 and 14.

Conclusion: Under exposure to 2 ppm peptide, 58% more growth was noted as compared to that of the control and the growth was similar to that observed in the presence of 2 ppm Minoxidil® (Fig. 2). With 5 ppm Biotinyl-GHK, the growth was 121% more than that of the control.

Anti-aging Activity on the Root Sheath Figure 1C. Peripheral concentric zone of the hair is strongly labeled by Biotinyl-GHK.

Researchers used mitotic marker Ki67 to evidence cell growth activity. Freezing microtome sections were made on Day 0 and Day 14 and were exposed to peroxidase-bound anti-Ki67 antibody. On the sections, the dividing cells were stained dark brown. A count was conducted on the lower section of the root sheath of the hair shaft. The cells showing Ki67 marker were counted (zone 1) (Fig. 3).

140

Hair shaft growth from Day 0 to Day 14 (%) +121%

120 100 80 +58%

60

Figure 1D. Longitudinal section, specific localization of Biotinyl-GHK with good distribution along the length of the hair and no labeling of the surrounding tissue.

Conclusion: Biotinyl-GHK is a substantive peptide that exhibits specific localization around the hair follicle.

+58%

40 Control

Positive control Minoxidil® (2 ppm)

Biotinyl-GHK Biotinyl-GHK (2 ppm) (5 ppm)

Figure 2. Hair shaft growth in the different groups at Day 14.

Anti-aging Study on Cultured Hair Follicles The excess hair follicles prepared in the context of a micrograft transplantation session were collected for culturing. The hair follicles were individually incubated at 37°C under an air plus CO2 (5%) atmosphere for 14 days. The explants were divided into the following groups: ÂÂ

Control group in the culture medium alone

ÂÂ

Positive control group (positive reference product)

ÂÂ

Test group exposed to peptide Biotinyl-GHK.

The culture media were changed every 2 days. General morphology was observed on Day 0 and Day 14.

Zone 3 Zone 2 Zone 1

Ki67 mitosis count zone

Figure 3. Cell count showing Ki67 marker in zone 1.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

65

DERMATOLOGY For the control bulb, a decrease in mitotic keratinocytes was noted on Day 14 of culture, indicating cell aging.

Minoxidil® maintained proliferative activity. The same was noted with 0.3 μM Biotinyl-GHK (2 ppm) and approximately 1 μM (5 ppm) Biotinyl-GHK. The effect obtained with Biotinyl-GHK was superior as it was attained at concentrations 10- to 30-fold lower than Minoxidil® concentration, 10 μM (2 ppm).

Stimulation of the Adhesion Proteins of the Root Sheath and Dermal Papilla The quality of the dermoepidermal junction depends on the formation of a dense basal lamina rich in laminin 5 and collagen IV. This is where the keratinocytes of the first basement layer rest and adhere to.

Morphological observation after 14 days of culturing revealed that in the control follicles, the dermoepidermal junction on the outer sheath side was flattened and had lost its basal lamina. However, when the hair follicle was incubated with Biotinyl-GHK for 14 days, the basal lamina persisted and was clearly drawn showing its sinusoidal character.

The freezing microtome sections of the Day 0 and Day 14 samples were exposed to fluorescent antibodies specific to laminin 5 and collagen IV. In the control follicle, the laminin 5 band lost thickness after 14 days.

Following exposure to 2 ppm (10 μM) Minoxidil®, the follicle showed a laminin 5 band that remained thick and strip-like after 14 days. Likewise, after exposure to 2 ppm (0.3 μM) Biotinyl-GHK, laminin 5 remained strongly present at papilla level and in the outer root sheath after 14 days.

In the control follicles, the collagen IV band, very thick at T0, destructured and lost density at T14 days.

Exposure to 2 ppm (10 μM) Minoxidil® induced a loss of collagen IV density in the dermal papilla and in the root sheath after 14 days. Interestingly, in the presence of Biotinyl-GHK, collagen IV remained strongly present in the dermal papilla and was very thick and structured at root sheath level after 14 days.

Conclusion: The results clearly revealed the protective and reparative effects of peptide Biotinyl-GHK on the constituents of the root sheath and dermal papilla, collagen IV and laminin 5. On hair follicle explants cultured over 14 days, the effects observed were more marked than those induced by Minoxidil® at BiotinylGHK concentrations that were 30-fold lower.

Biotinyl-GHK seems to have very marked antiaging activity on hair follicle keratinocytes (14-day culture) with maintenance of a viable root sheath

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

(mitoses, Ki67) and improved structuring by adhesion proteins (collagen IV and laminin 5) responsible for anchorage in the dermis.

Gene activations by a complex consisting of 3 active substances: peptide Biotinyl-GHK, oleanolic acid and apigenin The DNA array study included a panel of 600 genes selected for their interest with respect to cell function.

This study was conducted on reconstituted human epidermis samples incubated in the presence of the complex. Incubation was conducted for 18 hours. The mRNA present in the cells was reverse transcribed to yield DNA and amplified (reverse transcription polymerase chain reaction [RT-PCR] method) to obtain a legible signal versus the control cultures.

Markers of cell proliferation including proliferating cell nuclear antigen (PCNA), steroid receptor coactivator and cytokeratins 10, 14 and 16 (proliferation and differentiation) were markedly up-regulated, but also associated with protein HSP27 (164%), suggesting pro-differentiation activity. The differentiation was associated with an increase in several adhesion proteins, including desmogleins, desmocollins, laminin-binding protein, vimentin, integrin α and β.

Gene down-regulation involved decreased expression of the interferon receptor, associated with an increase in the interferon antagonist, both making a strong antiinflammatory contribution.

To be specific, the genes involved in matrix remodeling and angiogenesis were temporarily down-regulated, while the cell proliferation pathways were intensified by a decrease in the factors that exerted a negative impact on those pathways: CRABP 1/2 (cytoplasmic retinoic acid-binding proteins) and vitamin D3 receptor (transcription factor for cell proliferation and differentiation).

Overall conclusion of the in vitro studies ÂÂ

High anti-aging activity with Ki67, enhanced general morphology (root sheath and papilla), antioxidant cellular enzymes and PCNA markers of proliferation activated.

ÂÂ

High de novo synthesis of proteins of the adhesion complex (collagen IV, laminin 5, vimentin, desmogleins and desmocollins).

ÂÂ

Marked stimulation of cell metabolism (mitochondrial enzymes) and growth activation (hair shaft and cytokeratins 10, 14 and 16).

This is consistent with the profile of a product promoting hair morphogenesis and strengthening the anchorage of the root sheath in the dermis.

DERMATOLOGY

A 4-month study was designed wherein videotrichogram method was employed to establish and monitor the time course of the ratio of the proportion of hairs in the anagen phase and the proportion in the telogen phase (A/T parameter). Thirty-five male subjects of Caucasian origin, 18 to 50 years of age, presenting with more than 20% of their hair in the telogen phase were included.

Exclusion criteria included: ÂÂ

Gray hair on the vertex

ÂÂ

Diseases of the scalp

ÂÂ

Intake of corticosteroids, immunosuppressants or retinoids in the 6 months or anti-inflammatories in the week preceding the study

ÂÂ

Local application of Minoxidil® or any local ‘antihair loss’ treatment, applied topically or taken orally, or trophic treatment of the hair in the last 3 months

ÂÂ

Topical or oral treatment of the scalp (antiseborrheic, antidandruff daily friction in the 4 weeks preceding the study)

ÂÂ

Change in dietary or exercise habits during the study

ÂÂ

Immoderate use of alcohol or tobacco.

The product - complex consisting of 3 active substances: peptide Biotinyl-GHK, oleanolic acid and apigenin or placebo was applied twice-daily to the scalp using gentle massage. The complex was formulated as a 3% dilute alcohol lotion with the appearance of a colorless liquid. Compliance and safety was assessed after 4, 8 and 12 weeks of treatment. A physical examination of the scalp was conducted at time points T0 and T4 months.

Safety was assessed by subject interview.

Image acquisition at T0 and after 4 months was conducted on the shaved hair zone (about 1 cm2/200 hairs, on average), after marking. The length and growth rate of the hair and the proportion of hair in the anagen phase and proportion in the telogen phase were monitored. At T0 and at the end of the study, 24 hairs were sampled from the border of the alopecic zone using tweezers. Six subjects in the treatment group and 6 in the placebo group underwent sampling. The hairs were fixed in Bouin’s fluid (12 hairs) or frozen immediately (12 hairs) prior to shipment to BIO-EC for analysis. In all, 35 subjects were included in the study. Of these, 18 were allocated to the complex group

After 4 months of treatment with the complex, a marked improvement was observed in the proportion of anagen phase hairs, significantly superior compared to T0 (+10%, p < 0.05). The placebo was inactive.

A comparison with data published for Finasteride® by oral administration revealed that the complex under investigation also has a remarkable activity (Fig. 4).

In the complex group, 67% of the subjects presented with an improvement in A/T ratio and, for 3 subjects out of the 12 improved, the A/T increase was 31.2%, 33.5% and 46.3%, respectively. In contrast, in the placebo group, there was a trend toward a decrease in anagen hairs (Fig. 5). The mean hair growth rate for the 17 subjects showed no significant difference, baseline versus end of study. However, a trend toward improvement was shown by 8 volunteers, who presented with an increase

Variation of A/T ratio compared to T0 (%)

Four-month Placebo-controlled Clinical Trial

(37 ± 2 years) and 17 to the placebo group (38 ± 1 year).

The complex was very well-tolerated by all volunteers over the 4 months of use.

40 Finasteride® 11 months

30

20 Complex under investigation 4 months

10

Finasteride® 5 months

0

Figure 4. Comparison of activity of complex under investigation with oral Finasteride®.

Variation of A/T ratio (Complex under investigation after 4 months)

In vivo Studies

1.4 1.2 1 0.8 0.6 0.4 0.2 0 -0.2 -0.4 -0.6

18 Subjects

Figure 5. In patients treated with complex under investigation, 67% showed improvement in A/T ratio while in the placebo group, there was a trend toward a decrease in anagen hair.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

67

DERMATOLOGY

Figure 6A. Placebo T4 months (bulb).

Figure 6B. Complex T4 months (bulb).

Figure 6C. Placebo T4 months (root sheath).

Figure 6D. Complex T4 months (root sheath).

in growth rate, in the complex-treated group. Therefore, the complex seems to be a powerful moderator of hair loss on account of its hair anchoring action in the skin.

of the hair. On the inner root sheath side, anchoring zones with the hair shaft were observed. These two zones were not very structured in the placebo group.

Additionally, greater laminin 5 fluorescence of the root sheath was observed for the telogen bulbs in the complex group. Collagen IV labeling of the telogen bulb was also more marked in this group.

Morphological Changes in the Hair After 4 Months The complex-treated group showed much more highly structured hair bulbs in comparison with placebo (Fig. 6 A and B). The complex-treated hair showed root sheaths with well-differentiated cell bases, clearly anchored with respect to the inner hair shaft and also with a very good quality outer interface (anchoring in the dermis) (Fig. 6 C and D).

In a given subject, complex treatment was associated with marked improvement in the bulb zone of telogen hair, T0 versus T4 months. The root sheath of anagen hairs also improved, with thickening and clearly defined cell bases. The root sheath was of high quality with a perfectly structured basal lamina ensuring optimum dermal-epidermal adhesion on the outer side

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

Conclusion: The results of the 4-month clinical trial covering a complete telogen phase revealed a significant increase in the A/T ratio comparable to oral Finastéride® treatment in the complex-treated group.

OVERALL CONCLUSION ÂÂ

The tested complex, consisting of 3 active substances, is a potent anti-hair loss complex that targets the 3 phenomena responsible for hair loss: zz

5α-reductase, which converts testosterone to DHT

DERMATOLOGY

ÂÂ

ÂÂ

ÂÂ

zz

Inadequate blood perfusion

zz

Failing anchorage of the hair in the dermal papilla.

ÂÂ

The 3 active substances act together: Peptide Biotinyl-GHK, a Matrikine®, acts on the anchoring of the hair on account of its adhesion proteins; apigenin, a citrus extract flavonoid with a vasodilatory effect; oleanolic acid, extracted from olive tree leaves, inhibits the production of DHT via 5α-reductase.

In vitro data revealed: The substantiveness of the product regarding the hair shaft and its selective localization; improvement in hair morphology with a living root sheath well-structured by adhesion proteins - vimentin, desmogleins, desmocollins, laminin 5 and collagen IV; potent activity on keratinocytic multiplication and hair morphogenesis.

In vivo, out of 18 volunteers in the complex group, 67% showed significant improvement in the mean A/T ratio, in the same range reported for Finasteride® after a treatment of 5 months by oral administration. Certain subjects showed an improvement >30% or even 46%, after complex treatment for 4 months.

The bulb of telogen hair, root sheath and laminin 5 and collagen IV densities were considerably improved in the complex group, in comparison with the placebo group.

The complex thus seems to act by promoting enhanced anchorage of telogen hair in the dermis through regeneration of the root sheath. The complex thus slows hair loss and improves the health of hair follicles.

REFERENCES 1. Kaliyadan F, Nambiar A, Vijayaraghavan S. Androgenetic alopecia: an update. Indian J Dermatol Venereol Leprol. 2013;79(5):613-25.

2. Ellis JA, Sinclair R, Harrap SB. Androgenetic alopecia: pathogenesis and potential for therapy. Expert Rev Mol Med. 2002;4(22):1-11.

3. Vitamin H (Biotin). Available from: http://umm.edu/ health/medical/altmed/supplement/vitamin-h-biotin.

Accessed on Feb 21, 2016.

4. Glynis A. A double-blind, placebo-controlled study evaluating the efficacy of an oral supplement in women with self-perceived thinning hair. J Clin Aesthet Dermatol.

2012;5(11):28-34.

http://lpi.oregonstate.edu/mic/ 5. Available from: vitamins/biotin. Accessed on Feb 21, 2016.

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

69

DRUGS

Efficacy and Safety of Fixed-dose Combination of Cefpodoxime 200 mg plus Clavulanic Acid 125 mg versus Cefpodoxime 200 mg in Lower Respiratory Tract Infections DEEPAK TALWAR*, SANDEEP R SABOO†, RN SARKAR‡, J SALVE#, MANU HC¥, SWATI BISWAS$

ABSTRACT Objective: To evaluate the efficacy and safety of fixed-dose combination (FDC) of cefpodoxime plus clavulanic acid versus cefpodoxime in lower respiratory tract infections (LRTIs). Material and methods: In this randomized, open label, prospective, two-arm, multicentric study, adult patients with LRTI were randomized to receive either FDC cefpodoxime 200 mg plus clavulanic acid 125 mg or cefpodoxime 200 mg twice-daily orally for 7 days. The primary endpoint was comparative reduction in symptom severity while overall assessment of efficacy, tolerability and safety of treatment were the secondary endpoints. Results: Seventyeight patients were enrolled in each arm of which four and three patients in cefpodoxime plus clavulanate and cefpodoxime group dropped out, respectively. Clinical response with FDC was significantly superior compared to cefpodoxime (p < 0.0001).

At the end of treatment, 94.52% patients on cefpodoxime plus clavulanic acid were cured compared to 72.2% of patients on plain cefpodoxime. As per the global assessment of efficacy by investigator as well as patient, cefpodoxime plus clavulanate (n = 73) was significantly superior to cefpodoxime (p < 0.0001), while global assessment of tolerability evaluated by investigator (p = 0.312) or patient (p = 0.596) was similar. Incidence of adverse events was lower with FDC compared to cefpodoxime (6.41% vs. 12.82%), but not statistically significant. All adverse events were mild in nature. Incidence of diarrhea was more with cefpodoxime (Day 3 - 3.85%, Day 5 - 7.69%, Day 7 - 3.85%) compared to FDC (Day 3 - 1.28%, Day 5 - 0%, Day 7 - 0%).

Conclusion: Cefpodoxime 200 mg plus clavulanic acid 125 mg FDC may be favored over cefpodoxime 200 mg in LRTI because of better clinical response and lower incidence of adverse events.

Keywords: Efficacy, safety, cefpodoxime plus clavulanic acid, LRTI, tolerability

L

ower respiratory tract infections (LRTIs) are commonly seen in clinical practice accounting for about 6% of all general practitioner consultations.1 An acute LRTI usually presents with cough as the main symptom, with other symptoms such as sputum

*Pulmonologist Senior Consultant and Chairman - Metro Respiratory Center Metro Hospital and Multispeciality Institute, Noida, Uttar Pradesh †Pulmonologist ‡Professor Dept. of Medicine, Calcutta Medical College, Kolkata, West Bengal #Physician

Risk Care Hospital, Thane, Maharashtra ¥Medical Advisor Abbott Healthcare Pvt. Ltd., Mumbai, Maharashtra $Chief Manager Medical Services, Abbott Healthcare Pvt. Ltd., Mumbai, Maharashtra Address for correspondence Medical Services Abbott Healthcare Pvt. Ltd.,1st Floor, DMart Building, Mulund - Goregaon Link Road, Mulund (West), Mumbai - 400 080, Maharashtra

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Indian Journal of Clinical Practice, Vol. 7, No. 1, June 2016

production, dyspnea, wheeze or chest pain.2 In many cases with LRTI, either pathogen is not identified or multiple organisms may be found.2 Treatment of community-acquired LRTI is often empirical3 and hence, an agent covering broad range of pathogens is suitable for the treatment of such cases.

The rising incidence of resistance has complicated the empirical treatment of respiratory tract infections.4 With continuous usage of antibiotics, β-lactamases have emerged as one of the important causes of antibiotic resistance.5 Cefpodoxime is a third-generation cephalosporin with broad-spectrum of antibacterial activity covering both Gram-negative and Gram-positive bacteria. Due to wide coverage, it is a good option for empirical use in different community-acquired infections.6 It has been used widely in the treatment of respiratory infections.7 With rising resistance among microorganisms, attempts

DRUGS have been made to improve efficacy of antibiotics by innovative approaches. Clavulanic acid is a novel, effective and irreversible inhibitor of β-lactamases of the Richmond types II, III, IV and V.8 In India, cefpodoxime plus clavulanic acid combination is commercialized and available as cefpodoxime proxetil 200 mg plus potassium clavulanate 125 mg. The efficacy of this combination has been proved in the management of LRTI in a comparative study, versus cefuroxime axetil.9 However, there are no head-to-head comparative studies of cefpodoxime proxetil 200 mg plus potassium clavulanate 125 mg FDC versus cefpodoxime proxetil 200 mg in Indian patients with LRTIs.

or worsening of baseline clinical signs and symptoms”.

The secondary endpoints were overall assessment of efficacy, tolerability and safety of treatment by investigator and patient. Overall assessment of efficacy of treatment was rated on a five-point scale as follows: 1 = excellent, 2 = very good, 3 = good, 4 = satisfactory and 5 = poor; while the overall response for tolerability was rated on a three-point scale as follows: 1 = good (side effects mild or not observed), 2 = moderate (side effects of moderate intensity) and 3 = poor (side effects severe or discontinuation).

The objective of the study was to evaluate the efficacy and safety of FDC of cefpodoxime 200 mg plus clavulanic acid 125 mg versus cefpodoxime 200 mg in the treatment of patients with LRTIs.

Safety was graded as “excellent = no adverse event reported”, “good = mild adverse event(s) which subsided with or without medication” and “fair = moderate-to-severe adverse event(s) which subsided with or without medication and did not necessitate stoppage of study medication” and “poor = severe or serious adverse event(s) which necessitated stoppage of study medication”.

MATERIAL AND METHODS

Statistical Analysis

In this randomized, open label, prospective, two-arm, comparative, multicentric study, adult patients >18 years with clinical signs and symptoms of LRTIs without any abnormality on chest X-ray were included, if they were willing to sign written informed consent and comply with the protocol requirements. The patients with upper respiratory tract infection (URTI), or with a known allergy to any of ingredients of study products, cephalosporin group of antibiotics or penicillin were excluded from the study. Moreover, pregnant and lactating females, patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with cefpodoxime and/or clavulanic acid were also excluded from the study.

Data describing quantitative measures was expressed as mean ± standard deviation (SD) or standard error (SE) with range. Qualitative variables were presented as counts and percentage. Summary statistics (n, mean, SD, range) was presented for continuous variables, and counts and percentages were presented for categorical variables. Analysis of covariance (ANCOVA) with center as factor and baseline as covariate was used for all continuous variables.

OBJECTIVE

The enrolled patients were randomized to receive either cefpodoxime 200 mg plus clavulanic acid 125 mg FDC tablet or cefpodoxime 200 mg tablet. Both products were given twice-daily for 7 days. The primary endpoint of the study was to compare the reduction in severity of symptoms (fever, cough, dyspnea, wheezing, rhonchi and chest pain) from baseline to the end of treatment.

The investigator graded all symptoms except fever on four-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). The fever was recorded as patient’s actual temperature. The clinical response at the end of treatment was recorded as “cure - disappearance of clinical signs and symptoms within the treatment period”, “improved - subsiding signs and symptoms but with incomplete resolution” or “failure - unchanged

A repeated measure analysis of variance (ANOVA) with Kruskal-Wallis was used to assess efficacy variables over the course of study. The change in grade of global improvement or clinical success rate from baseline value till the end of study treatment (Day 7) was checked for statistical significant by using Chisquare test. The decrease in severity of all symptoms except fever from baseline to the end of treatment was analyzed using Chi-square test. Improvement in ‘fever’ was analyzed using ANOVA test. The overall assessment of efficacy and safety of treatment was also analyzed by Chi-square test. All p values were reported based on two-sided and all the statistical tests were interpreted at 5% level of significance level.

RESULTS A total of 78 patients were enrolled in each arm. The baseline characteristics of patients are presented in Table 1, while the flow diagram and number of patients completing study are shown in Figure 1.

Indian Journal of Clinical Practice, Vol. 7, No. 1, June 2016

71

DRUGS Table 1. Baseline Characteristics Male n (%)

CC (n = 78)

CP (n = 78)

43 (55.13%)

36 (46.15%)

P value

Female n (%)

35 (44.87%)

42 (53.85%)

Age (years) mean (±SD)

39.82 ± 14.35

41.17 ± 15.0

0.574

Height (cm) mean (±SD)

160.69 ± 7.88

160.65 ± 7.22

0.978

Weight (kg) mean (±SD)

59.46 ± 11.37

59.04 ± 11.14

0.816

CC = Cefpodoxime plus clavulanate; CP = Cefpodoxime proxetil.

Cure Randomized (n = 156)

Drop outs (n = 4) No. of cases analyzed for efficacy (n = 74)

Analysis

Allocated to cefpodoxime (n = 78)

Four and three patients in cefpodoxime plus clavulanate and cefpodoxime group, respectively dropped out. Data of 78 patients in each group was analyzed for safety assessment, while efficacy was assessed based on data from 74 and 75 patients in cefpodoxime plus clavulanate and cefpodoxime group, respectively (Fig. 1).

The presenting symptoms of the patients included cough, wheezing, expectoration, fever, chest pain and breathlessness. There was no difference in the vital parameters (respiratory rate, blood pressure and temperature) between two groups at baseline (p > 0.05 for all).

In terms of clinical response at the end of therapy, cefpodoxime plus clavulanate was significantly superior compared to cefpodoxime (p < 0.0001). With combination of cefpodoxime plus clavulanate all the patients were either cured or improved while with cefpodoxime therapy, 5.56% failed to achieve cure or improvement (Fig. 2).

Temperature was reduced in both groups compared to baseline (Fig. 3). The percentage reduction in temperature was similar in cefpodoxime plus

Indian Journal of Clinical Practice, Vol. 7, No. 1, June 2016

80 70

72.22

60 50 40 30

22.22

20 10

Drop outs (n = 3) No. of cases analyzed for efficacy (n = 75)

Figure 1. Flow diagram.

72

Clinical response (% of patients)

Allocation

94.52

90

0

5.56

5.48 Cefpodoxime + Clavulanate (n = 73)

Cefpodoxime (n = 72)

Figure 2. Clinical response at the end of the therapy.

Cefpodoxime + Clavulanate (n = 74)

101 100.47 100 Fever (mean °F)

Allocated to cefpodoxime plus clavulanate (n = 78)

Failure

Improved

100

Cefpodoxime (n = 75)

99.96 99.40

99.65 98.99 98.90

99

98.42 98.48

98

97 Baseline

Day 3

Day 5

Day 7

Figure 3. Temperature reduction.

Table 2. Reduction in Pulse Rate CC (n = 78)

CP (n = 78)

P value

Baseline

99.26 ± 7.83

97.77 ± 6.47

0.198

Day 3

92.99 ± 6.19

94.17 ± 5.58

0.219

Day 5

88.52 ± 6.22

89.49 ± 5.21

0.309

Day 7

83.78 ± 5.85

84.49 ± 6.03

0.470

DRUGS as patient, cefpodoxime plus clavulanate (n = 73) was significantly superior to cefpodoxime alone (n = 75) (Tables 4 and 5; p < 0.0001).

clavulanate versus cefpodoxime at Day 3 (p = 0.350), Day 5 (p = 0.314) and Day 7 (p = 0.309).

With reduction in temperature, corresponding reduction in pulse rate was also seen without significant difference between two groups (Table 2).

Both the study drugs were well-tolerated. Global assessment of tolerability as evaluated by investigator (p = 0.312) or patient (p = 0.596) was similar in both groups (Table 6). The incidence of adverse event with cefpodoxime plus clavulanate (n = 78) was 6.41%. All the adverse events were mild in nature.

Cough, dyspnea, wheezing, rhonchi and chest pain was reduced in both groups compared to baseline.

The percentage reduction in cough and wheezing at Day 3, Day 5 and Day 7 (p > 0.05; Table 3) was more in cefpodoxime plus clavulanate group compared with cefpodoxime proxetil, although not statistically significant.

Diarrhea was reported by more patients in cefpodoxime group (Day 3 - 3.85%, Day 5 - 7.69%, Day 7 - 3.85%) compared to those receiving cefpodoxime plus clavulanate (Day 3 - 1.28%, Day 5 - 0%, Day 7 - 0%).

No serious adverse events were reported by any patient during the study. As per the global assessment of safety, cefpodoxime plus clavulanate was significantly better compared to cefpodoxime alone (Fig. 4; p = 0.044).

After treatment for 7 days, no difference was seen in

Similarly, the percentage reduction in rhonchi at Day 5 and Day 7, dyspnea at Day 3 and Day 5 and chest pain at Day 5 was more in cefpodoxime plus clavulanate group compared with cefpodoxime proxetil, but not statistically significant (p > 0.05; Table 3). As per the global assessment of efficacy by investigator as well Table 3. Percentage Reduction in Symptoms Day 3

Day 5

Day 7

CC (n = 74)

CP (n = 75)

P value

CC (n = 74)

CP (n = 75)

P value

CC (n = 74)

CP (n = 75)

P value

Cough

-29.32%

-23.36%

0.784

-59.08%

-47.58%

0.471

-84.29%

-67.78%

0.217

Dyspnea

-30.37%

-18.96%

0.239

-70.99%

-60.17%

0.606

-99.02%

99.03%

0.608

Wheezing

-27.12%

-20.20%

0.398

-61.22%

-58.96%

0.785

-98.08%

-90.54%

0.715

Rhonchi

-24.15%

-27.53%

0.175

-59.61%

-49.44%

0.897

-98.00%

-88.71%

0.401

Chest pain

-38.17%

-46.27%

0.324

-92.46%

-88.66%

0.892

-98.45%

-100%

0.911

Table 4. Global Assessment of Efficacy by Investigator (% of Patients) CC (n = 73)

CP (n = 75)

Excellent

89.04%

46.67%

Very good

5.48%

Good

Table 5. Global Assessment of Efficacy by Patient (% of Patients) CC (n = 73)

CP (n = 75)

Excellent

84.93%

42.67%

25.33%

Very good

8.22%

25.33%

5.48%

9.33%

Good

2.74%

12.00%

Satisfactory

0

13.33%

Satisfactory

2.74%

5.33%

Poor

0

5.33%

Poor

1.37%

14.67%

Table 6. Global Assessment of Tolerability (% of Patients) Investigator Good Moderate Poor

CC (n = 73)

CP (n = 74)

98.63%

100%

0

0

1.37%

0

Patient P value 0.312

CC (n = 73)

CP (n = 76)

97.26%

97.37%

1.37%

0

1.37%

2.63%

P value 0.596

Indian Journal of Clinical Practice, Vol. 7, No. 1, June 2016

73

DRUGS

Excellent Safety assessment at end of therapy (% of patients)

100 90

Good 95.89

86.67

The secondary evaluation parameter, of global assessment of efficacy as evaluated by investigator as well as patient showed that cefpodoxime plus clavulanate was significantly better than cefpodoxime (p < 0.0001), which is in line with one of primary endpoints (i.e., clinical response).

80 70 60 50 40 30 20 10 0

13.33 4.11 Cefpodoxime (n = 75)

Cefpodoxime + Clavulanate (n = 73)

Figure 4. Global assessment of safety (% of patients).

the systolic or diastolic blood pressure between two groups (p > 0.05).

DISCUSSION Cefpodoxime proxetil at a dosage equivalent to 200 mg of cefpodoxime twice-daily for 5-10 days is commonly used treatment for LRTIs.10 Cefpodoxime proxetil 200 mg and potassium clavulanate 125 mg FDC has been shown to provide significantly better clinical cure and improvement in symptoms of LRTI compared to cefuroxime axetil 500 mg.9 In this study, we evaluated whether addition of clavulanate provides any benefit over cefpodoxime alone.

The patients receiving cefpodoxime plus clavulanate showed significantly better clinical response compared to cefpodoxime (p < 0.0001) with no failure in any case. Analysis of 10 clinical trials with cefpodoxime in respiratory infection has shown satisfactory clinical response in 95.4% patients.11 Our results are in concurrence with these results. In our study, 94.44% patients were considered to be cured or improved with cefpodoxime proxetil therapy. Failure was seen in 5.56% patients receiving cefpodoxime therapy.

We observed that all patients were either cured or improved with cefpodoxime plus clavulanate combination, indicating combination of cefpodoxime plus clavulanic acid provides better clinical response compared to cefpodoxime proxetil. Clavulanic acid acts synergistically with cephalosporins to inhibit β-lactamase-producing Staphylococcus aureus and Enterobacteriaceae.8 This might be the reason for improved efficacy in our study; however, it needs to be confirmed by performing bacteriological/culture tests.

74

Subjective responses or small sample size may be the reasons for differences in the results of clinical response and percentage reduction in symptom severity.

Indian Journal of Clinical Practice, Vol. 7, No. 1, June 2016

Global assessment of tolerability as evaluated by investigator or patient did not show any significant difference between the two groups. The safety of combination of cefpodoxime plus clavulanate and cefpodoxime is very well-demonstrated in the study.

None of the patients in this study developed serious adverse event or required study drug discontinuation.

Cefpodoxime proxetil is generally well-tolerated. With therapeutic doses, mild-to-moderate gastrointestinal adverse events are reported in 4-15% patients.6 Our observations were also similar to these results.

The incidence of adverse event with cefpodoxime in this study was 12.82% with most of the adverse events involving gastrointestinal tract. Overall, the incidence of adverse event was less in patients receiving cefpodoxime plus clavulanic acid compared to cefpodoxime (6.41% vs. 12.82%). Gastrointestinal (abdominal colic, nausea, diarrhea, dyspepsia) adverse events were common in both the groups. Diarrhea was reported by more patients receiving cefpodoxime compared to cefpodoxime plus clavulanate. A total of seven patients dropped out from the study (lost to follow-up). There was no drop out because of the adverse events or lack of efficacy. This demonstrates the good tolerability and efficacy of cefpodoxime and cefpodoxime plus clavulanate in the treatment of LRTIs. Our study has some limitations. Firstly, the evaluation in this study was done only based on symptomatic improvement. Effect of both agents on bacteriological cure would provide better results and add value to the study findings. Secondly, the design of the study was open label. We recommend double-blind study assessing symptomatic improvement along with effect on the culture to confirm our findings.

CONCLUSION Fixed-dose combination of cefpodoxime 200 mg plus clavulanic acid 125 mg and cefpodoxime 200 mg alone are effective and well-tolerated in the treatment of LRTIs. The FDC of cefpodoxime 200 mg plus clavulanic acid 125 mg may be favored over cefpodoxime 200 mg

DRUGS in LRTIs because of better clinical response and less incidence of side effects.

Acknowledgment

5. Singh RE, Raghukumar KG, Veena M, Vishwanath G, Rao PNS, Murlimanju BV. ESBL production: resistance pattern in Escherichia coli and Klebsiella pneumoniae, a study by NCCLS method. RJPBCS. 2012;3(1):559-65.

The authors of this study wish to thank all the participant investigators of this study and Dr Anant Patil for assistance in writing the manuscript.

6. Frampton JE, Brogden RN, Langtry HD, Buckley MM. Cefpodoxime proxetil. A review of its antibacterial activity, pharmacokinetic properties and therapeutic potential. Drugs. 1992;44(5):889-917.

REFERENCES

7. Todd WM. Cefpodoxime proxetil: a comprehensive review. Int J Antimicrob Agents. 1994;4(1):37-62.

1. Anderson H, Esmail A, Hollowell J, Littlejohns P, Strachen D. Epidemiologically based needs assessment: lower respiratory disease. DHA Project Research Prograrnme. 1993:6-12.

2. Woodhead M, Blasi F, Ewig S, Garau J, Huchon G, Ieven M, et al; Joint Task Force of the European Respiratory Society and European Society for Clinical Microbiology and Infectious Diseases. Guidelines for the management of adult lower respiratory tract infections - full version.

Clin Microbiol Infect. 2011;17 Suppl 6:E1-59.

3. Okesola AO, Ige OM. Trends in bacterial pathogens of lower respiratory tract infections. Indian J Chest Dis Allied Sci. 2008;50(3):269-72.

8. Neu HC, Fu KP. Clavulanic acid, a novel inhibitor of beta-lactamases. Antimicrob Agents Chemother.

1978;14(5):650-5.

9. Awad NT. Efficacy and safety of fixed dose combination of cefpodoxime proxetil and potassium clavulanate (Cefchamp) in comparison with cefuroxime axetil in patients with lower respiratory tract infections. Indian Medical Gazette. April 2012:127-32.

10. Geddes AM. Cefpodoxime proxetil in the treatment of lower respiratory tract infections. Drugs. 1991;42 Suppl 3: 34-40.

11. Safran C. Cefpodoxime proxetil: dosage, efficacy and tolerance in adults suffering from respiratory tract infections.

4. Guthrie R. Community-acquired lower respiratory tract infections: etiology and treatment. Chest. 2001;120(6):2021-34.

J Antimicrob Chemother. 1990;26 Suppl E:93-101.

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75

ORTHOPEDICS

Role of Medial Open-wedge Osteotomy Fixed with Angle Stable Locking Plate Device System in Variable Degrees of Osteoarthritis Knee: A Case Series A SWAROOP*, SACHIN AVASTHI†, VINEET KUMAR‡, SANJAY KUMAR#, VIKAS GAHLOT$

ABSTRACT Osteoarthritis (OA) is primarily a noninflammatory disorder of movable joints characterized by an imbalance between the synthesis and degradation of articular cartilage leading to classic pathologic changes of wearing away and destruction of cartilage. The gradual wear and tear of knee joint leads to progressive shift of mechanical weight-bearing axis to medial compartment. High tibial osteotomy is a well-established procedure for OA knee. It gradually evolved from lateral closing wedge osteotomy to medial opening osteotomy. A prospective study was conducted between 2007 and 2011 on 74 patients having predominantly unicompartmental involvement of knee joint. The aim was to evaluate the role of medial open-wedge osteotomy fixed with angle stable locking plate device system in variable degrees of OA knee.

Keywords: Osteoarthritis, unicompartmental knee osteoarthritis, medial open-wedge osteotomy, angle stable locking plate device system

O

steoarthritis (OA) is the most common form of arthritis. American College of Rheumatology defines OA as a “heterogeneous group of conditions that lead to joint symptoms and signs which are associated with defective integrity of articular cartilage, in addition to related changes in the underlying bone at the joint margin”.1 Most recent consensus definition of OA is “Osteoarthritis diseases are a result of both mechanical and biological events that destabilize the normal coupling of degradation and synthesis of articular cartilage chondrocytes and extracellular matrix”.2 OA is primarily a noninflammatory disorder of movable joints characterized by an imbalance between the synthesis and degradation of articular

*Professor Dept. of Orthopedics, GSVM Medical College, Kanpur, Uttar Pradesh †Associate Professor Dept. of Emergency Medicine, RMLIMS, Lucknow, Uttar Pradesh ‡Assistant Professor Dept. of Orthopedics, KGMU, Lucknow, Uttar Pradesh #Associate Professor $Senior Resident Dept. of Orthopedics, GSVM Medical College, Kanpur, Uttar Pradesh Address for correspondence Dr Sachin Avasthi Dept. of Emergency Medicine Dr RMLIMS, Vibhuti Khand, Gomtinagar, Lucknow, Uttar Pradesh E-mail: sachinavasthi4778@gmail.com

76

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

cartilage leading to classic pathologic changes of wearing away and destruction of cartilage.3 The gradual wear and tear of knee joint leads to progressive shift of mechanical weight-bearing axis to medial compartment. This further increases the degeneration by mechanical loading of damaged chondrocytes. OA affects nearly 21 million people in the United States, accounting for 25% of visits to primary care physicians, and half of all nonsteroidal anti-inflammatory drugs (NSAIDs) prescriptions. It is estimated that about 80% of the population was having radiographic evidence of OA by the age of 65 years, although only about 60% of these were symptomatic.4 Epidemiological profile of this disease in India is not clear but it is estimated that more than 30-40% of our population suffer from OA beyond the age of 50 years.5 Though the pathology of OA is well-defined, the etiological factors are not fully characterized.

Multiple secondary causes are considered to be responsible for the increased wear and tear but the etiology of primary OA is yet not understood definitively. Risk factors have been defined for incident OA. Body weight as risk factor has been proved by multiple studies.6-12 Age is a well-known risk factor associated with OA knee. Aged cartilage has altered chondrocyte function and material properties. It responds differently to cytokines and

ORTHOPEDICS growth factors. In addition, joint protective neural and mechanical factors may become impaired with age such as proprioception, varus-valgus laxity and muscle strength.13,14 Gender may influence knee OA via multiple routes including hormonal influences on cartilage metabolism, gender variation in injury risk and gender differences in mechanical environment of knee e.g., varus-valgus laxity,13 strength relative to body weight.14 Age-related decrease in bone mineral density predisposes to trabecular microfractures leading to increased stress on damaged chondrocytes.

This increases the predisposition of postmenopausal women towards varus OA knee.15 Biomechanical factors responsible for varus deformity have been well-established and mechanical loading of the medial compartment was found to be responsible for early loss of medial joint space.16,17 Multiple studies have been performed since Coventry gave the idea of osteotomy at upper end of tibia.18-22 Many studies comparing the results of closing wedge and opening wedge osteotomy have been done showing long-term results but the results have been variable in all the studies.19-38 MATERIAL AND METHODS The study was conducted between 2007 and 2011. All the patients having predominantly unicompartmental involvement of knee joint were enrolled. All the patients were subjected to clinical and radiological examination of the knee joint. Clinical scoring of the knee joint was done using visual analog scale (VAS) score, Western Ontario and McMaster Universities Arthritis Index (WOMAC) score and Knee Society Scoring system (KSS). Radiographic grading of the knee was done using Kellgren-Lawrence grading system. Systemic examination was done using hematological parameters such as total leukocyte count (TLC), differential leukocyte count (DLC), erythrocyte sedimentation rate (ESR), rheumatoid factor (RA), C-reactive protein and blood sugar - fasting and postprandial. These parameters were used to rule out known secondary causes of arthritis knee. We enrolled primary OA knee cases with predominantly unicompartmental involvement.

Preoperative templating was used to calculate the angle of correction and the desired width of wedge graft was also calculated using standard method.

After preoperative examination and anesthetic evaluation, all the patients were subjected to medial opening wedge osteotomy using arthroplasty midline/ paramedian incision. Osteotomy was performed

using bone saw taking meticulous care for not damaging the lateral cortex. Osteotomy was opened using multiple osteotomes and opening jig as per standard methodology. Peroperative correction was checked under image intensifier and eyeballing of the acquired valgus angle. When the desired correction was achieved, the osteotomy was fixed using angle stable locking plate device system after putting the adequate sized wedge-shaped tricortical bone graft taken from iliac crest and filling the rest of the gap by cancellous bone chips. Closure was done in layers of dissection.

Postoperatively, nonweight-bearing physiotherapy in the form of range of motion exercises was started as soon as the pain permitted (usually third postoperative day). Nonweight-bearing walking was started using a walker support after subsidence of pain. Stitches were removed on the 10th postoperative day. Follow-up was done at 6 weeks, 3 months, 6 months and 6-monthly interval thereafter. Clinical and radiological parameters were assessed in all the follow-ups. Loss of angle of correction was also calculated in all the follow-ups.

Statistical analysis was done at 2-year follow-up.

OBSERVATIONS AND RESULTS A total of 74 patients were enrolled, out of which 34 (45.94%) were males and 40 (54.05%) were females.

The mean age of all the patients was 57.16 ± 8.7 years ranging from 40 to 79 years. The mean duration of symptoms prior to surgery was 4.44 ± 5.05 years.

Mean preoperative varus deformity was 5.21 ± 1.37°.

Maximum patients operated were Kellgren-Lawrence Grade III - 49 (66.21%) followed by Grade II - 11 (14.86%) and Grade IV were 14 (18.91%). We did not find any patient of Grade I OA knee as most of our patients present late to the clinic. Mean hospital stay for the surgery came out to be 5.01 ± 1.04 days. Average blood loss during surgery was 47.31 ± 7.69 mL of blood (Table 1). Mean time of start of range of movement Table 1. Demographic Profile of the Patients Total number of patients Male Female Mean age Mean duration of symptoms KL Grade Ι KL Grade ΙΙ KL Grade ΙΙΙ KL Grade ΙV Mean hospital stay

74 34 (45.94%) 40 (54.01%) 57.16 ± 8.7 years 4.44 ± 5.05 years 0 (0.00%) 11 (14.86%) 49 (66.21%) 14 (18.91%) 5.01 ± 1.04 days

KL = Kellgren-Lawrence.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

77

ORTHOPEDICS exercises was 3.60 ± 0.85 days after surgery, while mean time of start of partial weight-bearing exercises was 4.72 ± 0.92 days. Full weight-bearing was started at mean time of 32.36 ± 2.44 days after surgery.

Mean time of radiological union was found to be 6.17 ± 0.81 weeks after surgery. The change in angle of deformity was also calculated. Mean pre-op varus angle was 5.21 ± 1.37°. Mean post-op valgus angle obtained was 6.36 ± 1.11°, which reduced to 5.97 ± 0.97° of valgus at 2-year follow-up. The mean loss of correction in the valgus angle obtained was 0.39 ± 0.77° (p > 0.05) (Table 2). Mean size of wedge graft used was 12.4 ± 1.4 mm.

Mean preoperative WOMAC pain score was 17.05 ± 1.92, which improved to 2.93 ± 0.74 at 2-year follow-up with the p value being 0.0001. Mean WOMAC activity of daily living score at pre-op was 55.13 ± 7.82, which changed to 23.20 ± 3.59 with p value being 0.0001.

Mean WOMAC stiffness score at pre-op was 5.59 ± 1.41, which improved to 1.51 ± 0.55 with the p value being 0.0001. Total WOMAC improved from 77.78 ± 9.91 to 28.93 ± 4.36 with p value being 0.0001 (Table 3).

Mean preoperative VAS score was 8.09 ± 0.84, which changed to 2.89 ± 0.71 at 2-year follow-up with p value being 0.0001.

Mean Knee score subcomponent of KSS was 46.10 ± 6.99 at preoperative period, while it was 87.55 ± 5.88 at 2-year follow-up with p value being 0.0001. Mean

function subcomponent of KSS was 49.70 ± 9.23 preoperatvely, which changed to 95.79 ± 5.49 at 2-year follow-up with p value being 0.0001. Total KSS changed from preoperative 95.81 ± 11.49 to 183.35 ± 10.26 at 2-year with p value being 0.0001. Overall, the results were graded as excellent in 72 patients (97.29%) and good in 2 patients (2.70%). None of the patients have showed fair or poor results.

Total range of movement changed from 113.98° ± 11.31° to 116.64° ± 11.07° at 2-year follow-up with p value being 0.0001.

Knee stability was evaluated in all the patients. None of the knees showed anterior/posterior instability, while 16 knees showed laxity on varus strain showing laxity of lateral collateral ligament. This laxity improved in all the cases postoperatively as assessed independently by two surgeons postoperatively.

Complications were also noted in a few patients. Two of the patients showed superficial infection, which healed to conservative management in the form of antibiotic supplementation. One patient developed deep infection, which resolved after implant removal.

Postoperative swelling in the knee joint was noted in 6 patients, which resolved gradually over a period of 2-3 weeks in 4 patients; however, 2 patients needed intra-articular steroid application for the same. Limb swelling developed in 5 patients but none of them showed signs of deep-vein thrombosis.

Table 2. Angle of Correction Angle

Pre-op varus angle

Post-op valgus angle

Valgus angle at 2-year

Loss of valgus angle at 2-year

5.21 ± 1.37°

6.36 ± 1.11°

5.97 ± 0.97°

0.39 ± 0.77°

Table 3. Change of Various Scoring Systems in Preoperative and Postoperative Period Score

Subscore

Pre-op

Post-op (at 2 years)

P value

WOMAC

Pain

17.05 ± 1.92

2.93 ± 0.74

0.0001

Activity of daily living

55.13 ± 7.82

23.20 ± 3.59

0.0001

Stiffness

5.59 ± 1.41

1.51 ± 0.55

0.0001

Total

77.78 ± 9.91

28.93 ± 4.36

0.0001

8.09 ± 0.84

2.89 ± 0.71

0.0001

Knee score

46.10 ± 6.99

87.55 ± 5.88

0.0001

Function score

49.70 ± 9.23

95.79 ± 5.49

0.0001

Total

95.79 ± 11.49

183.35 ± 10.26

0.0001

113.98° ± 11.31°

116.64° ± 11.07°

0.0001

VAS Knee Society Score

Range of movement

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

ORTHOPEDICS DISCUSSION High tibial osteotomy is a well-established procedure for OA knee. It gradually evolved from lateral closing wedge osteotomy to medial opening osteotomy over a period of 20 years. Recent studies have shown variable results of medial open-wedge osteotomy fixed with locking plates. Our data is based on a short-term prospective study on Indian patients suffering from variable degree of OA. The impact of success of this surgery is more in our subcontinent because of high cost of total knee replacement and poor population, which cannot afford such a costly treatment.

We found that the mean age of patients needing this surgery was 57.16 ± 8.7 years. However, the data from the population study shows that OA knee starts at an age as early as 40 years.39 This shows that the awareness for the treatment option is delayed due to socioeconomic reasons in India, which is leading to more advanced stage OA at the time of presentation of patients. The mean duration of symptom was 4.44 ± 5.06 years at the time of presentation of the patient in a tertiary grade hospital.

Females have outnumbered males in incidence of cases.

This is comparable with the data of Sharma et al,39 which also shows that the disease is more prevalent in females than males. Decreased bone mineral density in postmenopausal females leading to microfractures of tibial condyle produces more stress on cartilage. This leads to female predisposition of OA knee.15 Maximum number of patients are presenting for treatment at radiological Kellgren-Lawrence Grade III. This is different from western population where the patients are presenting at an earlier stage.

We performed osteotomy from all the described approaches but finally we were satisfied after certain modifications in the described technique. In this approach, we made an oblique incision starting from 1 cm distal to tibial tuberosity running obliquely at approximately 60° towards knee joint. This approach enables for more oblique osteotomy leading to less stress on proximal tibia and increased surface area of union. More oblique surface leads to neutralization of rotational forces, which work after correction of deformity and might lead to failure of surgery later on.

We have invariably used autologous bone graft in all the patients. This was done to ensure bone union in all the cases and early start of weight-bearing. In this aspect, we would also like to add that this decision of bone grafting was taken as our patients are illiterate and interpreted the suggestion in different ways.

To ensure union in all adverse conditions, we did precautionary bone grafting in all the cases. We used tricortical iliac crest autograft for filling the osteotomy site. In postoperative period, patients complained of pain at the donor site, which responded to conservative management in all the patients within a week. Some authors have also used fibular graft to fill the osteotomy site,40 but we found a uniform and confirmed healing pattern in all the cases after usage of tricortical iliac crest graft with no long-term disability and complications.

Average blood loss in surgery was calculated to be 47.31 ± 7.69 mL. This was mainly because of our surgical process of deflation of tournique for checking of any active bleeder after completion of fixation of osteotomy site.

Patellar height did not change in any of the patients as we started early physiotherapy. Our finding is supported by other observers who have consented that patellar tendon contraction after surgery can lead to change in patellar height, but it can be avoided by early start of range of motion exercise.24,27,41 However, early attempt of acute flexion required for social habitus might also have played the role.

We started physiotherapy as soon as the pain permitted for the same. The mean time of start was 3.60 ± 0.85 days. The younger patients cooperated better than the older patients. This observation is supported by Hoell27 who have stated age as a important factor in cooperation towards physiotherapy.

Radiological union was achieved in all the patients.

Mean postoperative valgus angle was 6.36 ± 1.11°, which reduced to 5.97 ± 0.97° at 2-year follow-up.

However, the loss of correction was insignificant (p > 0.05).

Overall success of surgery can be attributed to maintenance of femorotibial angle as quoted by Koshino.40 In our view, the usage of angle stable locking plate device system has made a revolution in maintenance of this angle leading to successful outcome.

We used WOMAC, VAS and KSS for assessment at follow-up. Usage of three scoring systems enabled us to evaluate almost all forms of routine activities requiring movement of knee joint. We found a uniform pattern of significant improvement in all the systems with p value being 0.0001. All the previous studies have also shown significant improvement in knee scores irrespective of type of osteotomy and method of fixation.22-28,34-38,40-42 Corrected postoperative femorotibial angle leading to shift of weight-bearing axis

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

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ORTHOPEDICS can be a cause of improvement in functional capacities.

We found that postoperative range of movement improved significantly at 2-year follow-up (p = 0.0001).

Proper alignment of knee and improved strength of posteromedial structures can lead to improvement in range of movement. Increased opening of medial joint space on weight-bearing, decreased swelling and better rotation on lateral femoral condyle might also have played the role.

Very few complications were noted. One deep infection was noted, which responded to conservative management after plate removal. Reactive swelling was noted in 6 patients, which responded to conservative methods in 4 patients and 2 required intra-articular steroid injection for complete relief. We did not find any incidence of deep-vein thrombosis probably due to early start of active physiotherapy.

CONCLUSION We concluded that high tibial osteotomy is not only an excellent option for early knee OA cases but it is also useful in relatively advanced predominantly unicompartmental cases as well. Proper selection of patients, preoperative planning and proper execution of surgery is a critical step for successful outcome.

Economically challenged patients who cannot afford joint replacement can be managed at a much less cost. Indian subcontinent patients will be highly benefitted because of high number of such poor class population. We believe that indications for high tibial osteotomy should be redefined. Age should not be a limiting factor. Physical activity, muscle strength and subjectivity of clinical signs and symptomatology should be considered before taking the decision of high tibial osteotomy.

REFERENCES 1. McAlindon T, Dieppe P. Osteoarthritis: definitions and criteria. Ann Rheum Dis. 1989;48(7):531-2.

2. Kuettner KE, Goldberg VM. Introduction. In: Kuettner KE, Goldberg VM (Eds.). Osteoarthritic Disorders.

Rosemont (IL): American Academy of Orthopaedic Surgeons; 1995. p. xxi-xxv.

3. Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986;29(8):1039-49.

4. Green GA. Understanding NSAIDs: from aspirin to COX-2. Clin Cornerstone. 2001;3(5):50-60.

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5. Statistics by country. Available at: www.wrongdiagnosis. com 6. Felson DT, Anderson JJ, Naimark A, Walker AM, Meenan RF. Obesity and knee osteoarthritis. The Framingham Study. Ann Intern Med. 1988;109(1):18-24.

7. Felson DT, Zhang Y, Anthony JM, Naimark A, Anderson JJ. Weight loss reduces the risk for symptomatic knee osteoarthritis in women. The Framingham Study. Ann Intern Med. 1992;116(7):535-9.

8. Felson DT, Weissman B, radiographic Framingham 728-33.

Zhang Y, Hannan MT, Naimark A, Aliabadi P, et al. Risk factors for incident knee osteoarthritis in the elderly: the Study. Arthritis Rheum. 1997;40(4):

9. Hart DJ, Doyle DV, Spector TD. Incidence and risk factors for radiographic knee osteoarthritis in middleaged women: the Chingford Study. Arthritis Rheum.

1999;42(1):17-24.

10. Hart DJ, Doyle DV, Spector TD. Association between metabolic factors and knee osteoarthritis in women: the Chingford Study. J Rheumatol. 1995;22(6):1118-23.

11. Davis MA, Neuhaus JM, Ettinger WH, Mueller WH. Body fat distribution and osteoarthritis. Am J Epidemiol.

1990;132(4):701-7.

12. Davis MA, Ettinger WH, Neuhaus JM. The role of metabolic factors and blood pressure in the association of obesity with osteoarthritis of the knee. J Rheumatol.

1988;15(12):1827-32.

13. Sharma L, Lou C, Felson DT, Dunlop DD, KirwanMellis G, Hayes KW, et al. Laxity in healthy and osteoarthritic knees. Arthritis Rheum. 1999;42(5): 861-70.

14. Slemenda C, Heilman DK, Brandt KD, Katz BP, Mazzuca SA, Braunstein EM, et al. Reduced quadriceps strength relative to body weight: a risk factor for knee osteoarthritis in women? Arthritis Rheum.

1998;41(11):1951-9.

15. Terauchi M, Shirakura K, Katayama M, Higuchi H, Takagishi K. The influence of osteoporosis on varus osteoarthritis of the knee. J Bone Joint Surg Br. 1998;80(3):432-6.

16. Brouwer RW, Bierma-Zeinstra SM, van Koeveringe AJ, Verhaar JA. Patellar height and the inclination of the tibial plateau after high tibial osteotomy. The open versus the closed-wedge technique. J Bone Joint Surg Br. 2005;87(9):1227-32.

17. Shaw JA, Moulton MJ. High tibial osteotomy: an operation based on a spurious mechanical concept. A theoretic treatise. Am J Orthop (Belle Mead NJ). 1996;25(6):429-36.

18. Coventry MB. Osteotomy of the upper portion of the tibia for degenerative arthritis of the knee. A preliminary report. J Bone Joint Surg Am. 1965;47:984-90.

19. Coventry MB. Osteotomy about the knee for degenerative and rheumatoid arthritis. J Bone Joint Surg Am. 1973;55(1):23-48.

ORTHOPEDICS 20. Coventry MB. Upper tibial osteotomy for gonarthrosis.

The evolution of the operation in the last 18 years and long term results. Orthop Clin North Am. 1979;10(1):191-210.

21. Coventry MB. Proximal tibial osteotomy. Orthop Rev. 1988;17(5):456-8.

32. Gaasbeek RD, Nicolaas L, Rijnberg WJ, van Loon CJ, van Kampen A. Correction accuracy and collateral laxity in open versus closed wedge high tibial osteotomy.

A one-year randomised controlled study. Int Orthop.

2010;34(2):201-7.

22. Coventry MB, Ilstrup DM, Wallrichs SL. Proximal tibial osteotomy. A critical long-term study of eighty-seven cases. J Bone Joint Surg Am. 1993;75(2):196-201.

33. Rudan JF, Simurda MA. High tibial osteotomy.

A prospective clinical and roentgenographic review.

Clin Orthop Relat Res. 1990;(255):251-6.

23. Adili A, Bhandari M, Giffin R, Whately C, Kwok DC. Valgus high tibial osteotomy. Comparison between an Ilizarov and a Coventry wedge technique for the treatment of medial compartment osteoarthritis of the knee. Knee Surg Sports Traumatol Arthrosc. 2002;10(3):169-76.

24. Billings A, Scott DF, Camargo MP, Hofmann AA. High tibial osteotomy with a calibrated osteotomy guide, rigid internal fixation, and early motion. Long-term follow-up.

J Bone Joint Surg Am. 2000;82(1):70-9.

25. Brouwer RW, Bierma-Zeinstra SM, van Raaij TM, Verhaar JA. Osteotomy for medial compartment arthritis of the knee using a closing wedge or an opening wedge controlled by a Puddu plate. A one-year randomised, controlled study. J Bone Joint Surg Br. 2006;88(11):1454-9.

26. Hernigou P, Medevielle D, Debeyre J, Goutallier D. Proximal tibial osteotomy for osteoarthritis with varus deformity. A ten to thirteen-year follow-up study. J Bone Joint Surg Am. 1987;69(3):332-54.

27. Hoell S, Suttmoeller J, Stoll V, Fuchs S, Gosheger G. The high tibial osteotomy, open versus closed wedge, a comparison of methods in 108 patients. Arch Orthop Trauma Surg. 2005;125(9):638-43.

28. Ivarsson I, Myrnerts R, Gillquist J. High tibial osteotomy for medial osteoarthritis of the knee. A 5 to 7 and 11 year follow-up. J Bone Joint Surg Br. 1990;72(2):238-44.

29. Kesmezacar H, Erginer R, Ogut T, Seyahi A, Babacan M, Tenekecioglu Y. Evaluation of patellar height and measurement methods after valgus high tibial osteotomy.

Knee Surg Sports Traumatol Arthrosc. 2005;13(7):539-44 30. Magyar G, Toksvig-Larsen S, Lindstrand A. Changes in osseous correction after proximal tibial osteotomy: radiostereometry of closed- and open-wedge osteotomy in 33 patients. Acta Orthop Scand. 1999;70(5):473-7.

34. Takeuchi R, Aratake M, Bito H, Saito I, Kumagai K, Ishikawa H, et al. Simultaneous bilateral opening-wedge high tibial osteotomy with early full weight-bearing exercise. Knee Surg Sports Traumatol Arthrosc.

2008;16(11):1030-7.

35. Takeuchi R, Ishikawa H, Aratake M, Bito H, Saito I, Kumagai K, et al. Medial opening wedge high tibial osteotomy with early full weight bearing. Arthroscopy.

2009;25(1):46-53.

36. Munzinger U, Frey P, Huber M, Miehlke W. 03262: Long term results after high tibial osteotomy for the treatment of varus gonarthrosis. Orthopaedic Proceedings. March 1, 2004.

37. Wu LD, Hahne HJ, Hassenpflug T. A long-term followup study of high tibial osteotomy for medial compartment osteoarthrosis. Chin J Traumatol. 2004;7(6):348-53.

38. Zhou YX, Yao L, Kang Q, Xu H, Dou BX, Huang DY. Long term follow up of patients with knee osteoarthritis after high tibial osteotomy. Zhonghua Yi Xue Za Zhi. 2003;83(22):1949-51.

39. Sharma MK, Swami HM, Bhatia V, Verma A, Bhatia SPS, Kaur G. An epidemiological study of correlates of osteoarthritis in geriatric population of UT Chandigarh. Indian J Commun Med. 2007;32(1):77-8.

40. Koshino T, Murase T, Saito T. Medial opening-wedge high tibial osteotomy with use of porous hydroxyapatite to treat medial compartment osteoarthritis of the knee.

J Bone Joint Surg Am. 2003;85-A(1):78-85.

41. Backstein D, Meisami B, Gross AE. Patella baja after the modified Coventry-Maquet high tibial osteotomy. J Knee Surg. 2003;16(4):203-8

42.

31. Pfahler M, Lutz C, Anetzberger H, Maier M, Hausdorf J, Pellengahr C, et al. Long-term results of high tibial osteotomy for medial osteoarthritis of the knee. Acta Chir Belg. 2003;103(6):603-6.

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Hui C, Salmon LJ, Kok A, Williams HA, Hockers N, van der Tempel WM, et al. Long-term survival of high tibial osteotomy for medial compartment osteoarthritis of the knee. Am J Sports Med. 2011;39(1):64-70.

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CONFERENCE PROCEEDINGS

60th Annual Conference of the Indian Orthopaedic Association (IOACON 2015) TREATMENT OF THE NEGLECTED AND Cx OF PROXIMAL HUMERUS FRACTURE Dr M Shantharam Shetty, Mangalore ÂÂ

Neglected or failures of treated proximal humeral fractures are a challenge to treat.

ÂÂ

It is better to prevent the failures and complications than to treat it by the proper understanding of the anatomy and biomechanics and the implant to be used.

ÂÂ

Age has an important part to play in planning treatment, for the dictum is ‘younger the patient preserve the head, if older, replace it’.

ÂÂ

All AVNs in this fracture are not symptomatic.

ÂÂ

When you choose arthroplasty, hemi or anatomical or reverse, definitive indications have to be followed as enumerated, especially the rotator cuff integrity.

ÂÂ

Rehabilitation and physiotherapy has an important role to play for what is important is function and painless movement.

SHOULD BIOMECHANICS AND CLINICAL GAIT ANALYSIS BE PRE-REQUISITE TO SURGICAL INTERVENTION? Dr Rami J Abboud, UK ÂÂ

In order to effectively treat any part of the human musculoskeletal system, it is important to fully understand its biomechanics and yet biomechanics is still not part of any undergraduate medical or vocational curriculum worldwide (Curr Orthop.

2002;16:165-79).

ÂÂ

Rules Always try to find the primary cause of the

problem.

Never treat its secondary symptoms without

knowing the primary cause of the problem.

Try not to ignore any details, no matter how

irrelevant you might think they are!

TIPS & TRICKS: PLATING OF C3 FRACTURE DISTAL RADIUS Dr PP Kotwal, New Delhi

DOUBLE-BUNDLE ANATOMIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: DO OR DO NOT RESTORE THE ACL VOLUME

ÂÂ

Plating for C3 fractures is a good option.

ÂÂ

It is technically demanding.

Dr Rajat Jangir, Jaipur

ÂÂ

Identify fracture anatomy correctly.

ÂÂ

The concept of anatomic ACL reconstruction centers on restoration of a patient’s own native ACL.

ÂÂ

K wires, external fixators are useful adjuncts in selected cases.

ÂÂ

Previous studies are suggestive that smaller the ACL volume, more is the chance of ACL injury.

ÂÂ

MRI study by Chaudhari et al shows there are anthropometric differences between the knees of subjects with ACL injury and those without an ACL injury, suggesting that ACL volume may play a direct role in ACL injury.

ÂÂ

ÂÂ

ÂÂ

82

POSTEROLATERAL CORNER INJURIES Dr SC Kaushik, Gorakhpur ÂÂ

Posterolateral corner is the most misunderstood “dark side of knee” (Andrews 1988).

ÂÂ

Considering this fact ACL reconstruction may aim towards the restoration of ACL volume to that of the patient native ACL.

Success of cruciate ligament reconstruction depends on posterolateral corner integrity.

ÂÂ

The mean graft volume is 172.41 mm3 higher than the contralateral normal side after anatomic double bundle ACL reconstruction.

Failure to address the posterolateral corner injury has been recognized as the main cause of longterm failures of ACL or PCL reconstruction.

ÂÂ

Complexity of anatomy of structures included in posterolateral corner is partly due to the phylogenic history of fibular distal migration from its femoral articulation.

Anatomic double-bundle ACL is able to restore the graft volume to that of the native ACL or higher.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

CONFERENCE PROCEEDINGS ÂÂ

ÂÂ

ÂÂ

ÂÂ

ÂÂ

It has been reported that FCL, popliteus tendon and PFL are the main posterolateral static stabilizers based on selective sectioning and biomechanical testing.

Most recent literature resolves this seemingly complex issue into: LCL injury, popliteus/ popliteofibular ligament complex injury.

Current surgical options are aimed at repair or reconstruction of these structures.

Mullar’s technique: Repaired ligament is near to midline. Due to short lever arm it is less powerful.

In sagittal plane, it is near parallel to PCL so it provides less rotatory stability.

Larson’s technique: Needs less soft tissue surgery, biplanar in sagittal view, anatomically near the normal, provides better stability, but the donor site is the other limb.

KOHLMAN MODIFICATION OF VASCULARIZED MUSCLE PEDICLE GRAFT PROCEDURE FOR NONUNION OF SCAPHOID FRACTURE Dr Padmanabha MK, Dr PK Raju, Bangalore Ten percent of the scaphoid fractures treated nonoperatively may end up in non-union, progress to carpal collapse and eventually radiocarpal osteoarthritis.

ÂÂ

Non-union is more common in proximal pole fractures, due to compromised vascularity.

ÂÂ

Failure of conventional bone grafting is due to avascularity. Vascularized bone grafts can preserve the normal anatomy of the carpus, which maximizes anatomic motion and decreases the risk of degenerative change and collapse.

ÂÂ

84

Dr Ramesh K Sen, Chandigarh ÂÂ

Manifestations of neglected pelvic fractures are non-union or a malunion.

ÂÂ

Indications of surgical reconstruction in pelvic fractures failing to unite in 6 months of injury (J Bone Joint Surg Br. 2003;85(1):21-30): Disabling pelvic pain inadequately controlled by

Clancy’s technique: Strong biceps muscle shifted anteriorly, so it limits the ROM at knee and needs a long protocol of physiotherapy to get working ROM. In sagittal plane, it is near parallel to PCL so it provides less rotatory stability.

Key Points ÂÂ Posterolateral corner repair/reconstruction important in restoring rotational stability. ÂÂ It is best done at the same time as ACL or PCL reconstruction. ÂÂ Pivot shift or reverse pivot shift are indicators of posterolateral corner deficiency respectively with ACL or PCL rupture.

ÂÂ

NEGLECTED PELVIC FRACTURES

The Kohlman modification of vascularized muscle pedicle graft procedure is recommended for patients with old non-union (>1 year) or proximal pole fractures.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

simple analgesics and pain management

Instability, assessed by using an image intensifier Pain was an indication of surgery when it

correlated with non-union or specific deformity (not when it correlated with a lumbosacral plexopathy and dysesthetic pain or a lower back problem).

ÂÂ

It is possible to correct most deformities (J Orthop Traumatol Rehabil. 2014;7:43-7) but surgery is complex, takes long time, greater blood loss and there is a higher complication rate.

THORACOLUMBAR FRACTURE: SURGEONS DILEMMA! Dr Vishal Kundnani, Mumbai Absolute indications of surgery are incomplete/ progressive neurodeficit and structural compression.

Principles of management ÂÂ

Whom to Operate? Indications

ÂÂ

When to Operate? Urgency

ÂÂ

How to Operate? Anterior/Posterior/Combined

Thoracolumbar trauma is growing. Dilemmas are mounting, but answers are present. Knowledge of classification systems is a must and decision-making must follow principles.

TKR IN VALGUS KNEE Dr M Amjad Hossain, Bangladesh ÂÂ

Lateral femoral condyle hypoplasia.

ÂÂ

Conservative bone cuts.

ÂÂ

Parallel to epicondylar axis.

ÂÂ

Release of ITB and capsule.

ÂÂ

Medial laxity and a valgus tibial bow.

ÂÂ

Protect peroneal nerve.

Valgus deformed knee is really a problem that makes the patients suffer in their daily activities and is challenging for the surgeon also.

CONFERENCE PROCEEDINGS ACUTE MANAGEMENT OF PROXIMAL HUMERUS FRACTURES

What have I Learned? ÂÂ Important basic research questions start at the bedside. ÂÂ The best studies result in more questions than answers. ÂÂ In the case of blood supply: Maintenance is critical, interventions that affect blood vessel formation are promising.

Dr Robert Dunbar, USA ÂÂ

Young patients with unstable fractures get fixation: Hemiarthroplasty doesn’t offer enough function, reduction is key to stability and outcome, technical aspects important, most get ORIF with locked plate.

ÂÂ

Older patients operative indications poorly understood: Non-op tx for the best and the worst fractures? More severe fx or osteopenia makes ORIF less desirable, hemiarthroplasty offers a single operation with decent pain relief at the price of functional limitations.

ÂÂ

We don’t know as much as we think we know.

ÂÂ

Non-ops can do fairly well if managed correctly… we could try harder.

ÂÂ

New technologies often don’t turn out to be panaceas.

ÂÂ

Technical aspects of plating and arthroplasty make or break the outcome.

BLOOD SUPPLY AND FRACTURE REPAIR: BEDSIDE TO BENCH

ACETABULAR FRACTURES: ACUTE AND DEFINITIVE MANAGEMENT Dr Michael J Gardner, USA ÂÂ

Initial patient assessment: ACLS, patient history, mechanism of injury, hemodynamic stability, dislocation, physical examination, soft tissue status, open wounds, detailed neurological exam.

ÂÂ

Emergent care of: Displacement at GSN (superior gluteal), associated injuries (intracranial, urologic, thoracoabdominal).

ÂÂ

Indications for urgent intervention: Dislocation, subluxation, retained intra-articular fragment, progressive neurological deficit, open fracture.

ÂÂ

Factors that influence decision-making: Is this an operative injury? When to operate? How to approach the fracture? Reduction/Fixation techniques; After treatment.

ÂÂ

Operative indications: Loss of congruence, >2 mm displacement, roof arc <45o, dynamic instability, intra-articular fragment.

ÂÂ

Most displaced acetabular fractures will require reduction and fixation.

ÂÂ

Subluxation/hip stability is the main indication for ORIF. Location and displacement are also considerations.

Dr Theodore Miclau, USA ÂÂ

ÂÂ

ÂÂ

There are about 5.6 million fractures per year in the United States.

Price associated with limb trauma: $325 billion/year societal cost, $26 billion lost work, 51% of workers do not return to work at 6 months, 5-10% of fractures go onto non-union.

History of internal fixation: AO 1958, anatomical reduction, stable internal fixation, preservation of blood supply, early active pain-free motion.

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

85

CONFERENCE PROCEEDINGS

62nd Annual Conference of Cardiological Society of India (CSI 2016) benefits and mortality associated with CABG vs PTCA.

ISCHEMIA AND VIABILITY DRIVEN REVASCULARIZATION: IS IT THE ANSWER? Dr Praveen Chandra, Gurgaon ÂÂ

ÂÂ

ÂÂ

Tools used to make decisions are symptoms, clinical presentation, biomarkers; angiography is the gold standard.

Newer tools: To assess intermediate lesions (FFR, IVUS), to assess viability and inducible ischemia (PET CT, SPECT), to assess risk (EURO and STS score for CABG, SYNTAX score for PTCA) and patient preference (socioeconomic status, availability of healthcare facility).

Cardiologists and cardiac surgeons have for long differed on optimum treatment of multivessel disease.

ÂÂ

Simply treating all patients with MVD disease with either CABG or PCI makes little sense; a tailored approach is recommended.

ÂÂ

In ARTS and SYNTAX, the decision for revascularization of a particular lesion was based upon angiography (stenosis >50%).

ÂÂ

In patients with similar degree of anatomic disease, the most important predictor of outcome is the presence and extent of inducible ischemia (Beller.

Circulation. 2000).

ÂÂ

Revascularization is warranted for functionally significant stenoses only (DEFER study Circulation.

June 2001).

ÂÂ

FAME concluded that routine measurement of FFR during DES-stenting in patients with MVD is superior to current angiography-guided treatment and improves outcomes of PCI.

ÂÂ

In MVD, coronary pressure measurement is an excellent tool to identify the culprit lesion/s by FFR <0.75, which can group patients into two according to the functional extent of disease.

ÂÂ

Angiography should not be the only tool to decide on revascularization; also FFR for physiology and PET scan to look at viability before planning revascularization.

ÂÂ

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“Heart team approach” to optimize revascularization decision-making; family explained risks and

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

ACUTE RHEUMATIC FEVER: TREATMENT CONTROVERSIES Prof Dr Geetha Subramanian, Varanasi ÂÂ

Identify people with RHD early in the natural history of their illness when most cases are asymptomatic.

ÂÂ

Preventive measures can be instituted at a time when they are likely to have the greatest effect.

ÂÂ

Secondary prophylaxis delivered to people with mild RHD results in the vast majority having no detectable disease 5-10 years later.

ÂÂ

There is no conclusive evidence to indicate that the use of corticosteroids in patients with acute rheumatic fever will prevent heart disease in the long-term.

ÂÂ

There should be vigilance in the application of the clinical manifestations and use of arthralgia and monoarthritis as major criteria and low-grade fever as minor in high risk settings.

ÂÂ

Appropriate role of noninvasive cardiac imaging, namely, echocardiography combined with Doppler flow assessment.

ÂÂ

Large scale follow-up cohort studies of young patient population and controls to solve controversies.

HF WITH REDUCED EJECTION FRACTION IN 2015: AN INDIAN VIEWPOINT Dr Amal Kumar Banerjee, Kolkata ÂÂ

HF in India has reached epidemic proportions.

ÂÂ

Early identification of the risk factors and initiation of appropriate therapy at early stages prevents development of HF.

ÂÂ

Clinical diagnosis and diagnostic imaging, echocardiogram in particular identifies patients with HF.

ÂÂ

The optimum utilization of the available drugs, general measures and surgical procedures appropriate to the condition improves the outcome of these patients.

CONFERENCE PROCEEDINGS DES: EVIDENCE-BASED USAGE

ÂÂ

Interestingly, the effect estimates of air pollution on CV complications are higher than lung disorders and even on all-cause mortality.

ÂÂ

Air pollution accounts for over a million premature deaths every year (WHO).

ÂÂ

Even brief exposures to air pollution have been associated with increases in CV mortality.

ÂÂ

Air pollution should be viewed as one of several major modifiable risk factors in the prevention and management of CVD.

ÂÂ

Efforts to reduce exposure to air pollution should be intensified.

ÂÂ

Health professionals have an important role to play in supporting educational and policy initiatives as well as counseling their patients.

Dr Asok Venkataraman, UK ÂÂ

Modern second generation DES allow us to achieve remarkable success in all comers.

ÂÂ

Main complications of DES: Stent thrombosis (1% acute/subacute, 0.4%/year for late/very late) and restenosis (around 5%).

ÂÂ

Intravascular imaging during PCI and stenting appears to be helpful. Next generations of metal DES and bioabsorbable DES are undergoing testing.

ÂÂ

ÂÂ

Novel way of testing of newer devices needs to be developed to show superiority over current state of art therapies.

Aggressive risk factor reduction in patients undergoing stenting looks set to reduce further need for revascularization.

TAVR VS SAVR: PRESENT SCENARIO Dr Brian Pinto, Mumbai ÂÂ

TAVR is increasing in popularity and in ease of procedure.

ÂÂ

From inoperable to extreme risk and then to intermediate risk, the procedure is comparable or even better than SAVR in the short-and mediumterm.

ÂÂ

Procedure is now totally done by a puncture technique in more than 90% of patients and under LA with sedation.

ÂÂ

The stroke rate and incidence of paravalvular leak has come down dramatically.

ÂÂ

The new devices are partially or totally retrievable improving significantly the ease of implantation.

ÂÂ

Valve-in-valve and bicuspid AV are becoming indications.

ÂÂ

Very soon low risk patients will also enter the domain of TAVR.

STUCK ROTA BURR Dr Viveka Kumar, New Delhi ÂÂ

Co-axial alignment of guide catheter and guidewire has to be verified before ablation.

ÂÂ

Positioning of guide catheter is important for ease of advancement of burr.

ÂÂ

Start with relatively small burr size with higher speed of rotation.

ÂÂ

Do not exert excessive forward force during burr advancement; avoid significant deceleration of rotational speed (>5,000 rpm) in order to avoid entrapment.

ÂÂ

Prevent burr from jumping into the artery when the burr is activated at coronary ostium, thereby avoiding burr entrapment in proximal lesion.

DEDICATED BIFURCATION STENTS Dr Dharmendra Jain, Varanasi ÂÂ

Bifurcation PCI is still a difficult call for the interventionist despite advancements in the instrumentation, technical skill and the imaging modalities. With major cardiac events related to the side-branch (SB) compromise, the concept and practice of dedicated bifurcation stents seems exciting.

ÂÂ

Coronary bifurcations vary not only in basal anatomy (plaque burden, plaque location, angle, branch diameter and site) but also in dynamic anatomical changes during treatment (plaque shift, dissection and carina modification).

ÂÂ

Bifurcation PCI has moved past an important milestone in accepting single stent strategy being the best for most of the bifurcations. The adoption

ENVIRONMENTAL POLLUTION AND HEART Dr Vitull K Gupta, Bathinda ÂÂ

Globally, environmental pollution is emerging as one of the greatest problems and is increasing with every passing year.

ÂÂ

Besides lungs, air pollution can affect CV health, particularly in people already at risk.

ÂÂ

Several review articles including two AHA scientific statements conclude that air pollution poses a risk to the heart.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

87

CONFERENCE PROCEEDINGS of two stent strategy may be considered in the case of a large SB with ostial lesion, dissection of SB, significant pinching with decreased flow, etc. ÂÂ

In order to clarify the best bifurcation PCI approach between ‘provisional’ T-stenting of implanting only one-DES (1 DES) in the main-branch (MB) vs a two-DES approach with routine stenting of both bifurcation branches (MB and SB), a number of studies and RCTs have been performed.

ÂÂ

The dedicated bifurcation stents opens out a new array of highly innovative technology into the cath lab, which requires skillful expertise to handle given the complexities in the design and technique.

It is definitively a step forwards, but long-term large volume clinical trials are warranted before reaching a solid conclusion.

ÂÂ

Given the dynamicity and the individual variations in the coronary bifurcation anatomy, it is logical to think whether the dedicated stents do really dedicate themselves to all patients.

IS REVASCULARIZATION MAINSTAY THERAPY FOR CHRONIC STABLE ANGINA? Dr VK Bahl, New Delhi ÂÂ

The term “Stable Angina” includes a range of patient and disease characteristics: Patients with single vessel to left main disease and patients with symptoms to patients with no angina (silent ischemia).

function and presence and reduction of baseline ischemia that predict survival that is free of MI. ÂÂ

Meta-analysis of 7 studies, n = 2449, medical therapy vs CABG showed that CABG offered a survival advantage over medical therapy for patients with left main or 3-vessel CAD with 4% absolute reduction in long-term mortality with CABG at follow-up at 10 years (Yusuf et al. Lancet.

1994).

ÂÂ

MASS II: MVD, CABG vs medical therapy; those treated with CABG had less chances of subsequent MI, additional revascularization or death at 10 years follow-up (Hueb et al. Circulation. 2010).

ÂÂ

Katritis et al in NEJM 2007 showed no reduction in death/MI with PTCA vs medical therapy.

ÂÂ

When revascularizing in patients with stable angina, consider: Heart Team Approach, patient preference after honest discussion, angina symptoms, ischemia, LV function, compliance to drugs, PTCA feasibility, CABG risk.

AN APPROACH TO A PATIENT WITH SICK SINUS SYNDROME Dr Ulhas M Pandurangi, Chennai ÂÂ

A common yet unrecognized cause of fatigability and dyspnea in the elderly.

ÂÂ

Search for culprit medications leading to sinus node dysfunction may avoid implantation of pacemaker.

ÂÂ

Not only are the symptoms of “stable angina” diverse, but also is the prognosis.

ÂÂ

Relief of angina is not the only goal when we revascularize a patient of stable angina, the goals are also to prevent MI and death and improve prognosis.

ÂÂ

Every SSS patient needs to undergo investigations to rule out atrial tachyarrhythmia, specifically atrial fibrillation and stroke prevention measures should be considered.

ÂÂ

Symptoms control does not predict improved prognosis. It is the anatomical severity of CAD, LV

ÂÂ

DDDR mode of pacemaker is better than AAIR mode. VDDR mode should not be considered.

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Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

CONFERENCE PROCEEDINGS

India Live 2016 PRASUGREL AND TICAGRELOR: HAS THE TIME COME TO MOVE ON FROM CLOPIDOGREL? Dr Marc Cohen, USA ÂÂ

Clopidogrel has a lot of discrepancies.

ÂÂ

PLATO trial: In ACS patients with or without STsegment elevation, treatment with ticagrelor as compared with clopidogrel significantly reduced the rate of death from vascular causes, MI or stroke without an increase in the rate of overall major bleeding but with an increase in the rate of non– procedure-related bleeding.

ÂÂ

Ticagrelor does not require hepatic metabolism for activation. Ticagrelor is immediately active.

ÂÂ

DISPERSE trial: Ticagrelor was generally welltolerated and exhibited more rapid, potent and sustained inhibition of ADP-induced platelet aggregation compared with clopidogrel in patients with atherosclerosis taking aspirin. Ticagrelor increased bleeding and dyspnea, possibly in a dosedependent manner, compared with clopidogrel.

These adverse effects, however, were mostly minor or mild-to-moderate in nature.

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Ticagrelor has uniform and intense platelet inhibition among diabetic patients, as compared with prasugrel.

TRITON-TIMI 38: In patients with ACS with scheduled PCI, prasugrel therapy was associated with significantly reduced rates of ischemic events, including stent thrombosis, but with an increased risk of major bleeding, including fatal bleeding.

Ticagrelor has been noted to have highly significant benefit in terms of CV and all-cause mortality, in comparison with clopidogrel.

BIVALIRUDIN: DO RESULTS JUSTIFY ABANDONING CHEAP HEPARIN? Prof Imad Sheiban, Italy ÂÂ

IV heparin is the standard anticoagulant.

ÂÂ

Bivalirudin has been shown to have superior safety, compared with heparin.

ÂÂ

Increased glycoprotein IIb/IIIa inhibitors (GPI) use leads to increased bleeding, which has been observed for both bivalirudin and heparin.

ÂÂ

The HORIZONS-AMI trial evaluated whether, in patients with STEMI undergoing PCI, the reduction in cardiac mortality in those taking bivalirudin compared with unfractionated heparin plus a GPI (UFH + GPI) can be fully attributed to reduced bleeding. The study concluded that bivalirudin reduces cardiac mortality in patients with STEMI undergoing primary PCI, an effect that can only partly be attributed to prevention of bleeding.

ÂÂ

The BRIGHT trial revealed that among patients with AMI undergoing primary PCI, the use of bivalirudin with a median 3-hour post-procedure PCI-dose infusion led to a decrease in net adverse clinical events compared with both heparin alone and heparin plus tirofiban.

ÂÂ

However, in the HEAT-PPCI trial, the major adverse ischemic events (MACE) outcomes were in favor of heparin.

ÂÂ

UFH is an effective and safe alternative to bivalirudin if low-dose of UFH with provisional use of GPI is used.

ÂÂ

Safety can be enhanced by tailoring care for each patient according to bleeding risk.

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There are increased chances of stent thrombosis with bivalirudin.

COMPLEX CORONARY CONCLAVE: CALCIFIED LESIONS AND ROTABLATION ANGIOPLASTY Dr Binoy John, Chennai ÂÂ

Calcified lesions form 10% to 15% of lesions associated with coronary angiograms.

ÂÂ

These are more commonly seen in the elderly patients.

ÂÂ

Often these are associated with severe triple vessel disease and these patients are candidates for bypass surgery.

ÂÂ

Many of these elderly patients, however, may have comorbidities like COPD and renal impairment, which places them at higher risk for CABG and hence angioplasty would be the default procedure of choice.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

89

CONFERENCE PROCEEDINGS ÂÂ

Rotablation-angioplasty, thus becomes the only alternative solution to handle these calcified lesions. This procedure; however, needs experience and expertise as the complications associated are numerous and life-threatening.

ÂÂ

Most of the calcified lesions can be managed with the 1.5 and 1.75 burrs to achieve a good immediate and long-term angioplasty result.

ÂÂ

Perforation and cardiac-tamponade, slow-flow, no-flow and acute myocardial infarction are the commoner causes of morbidity and mortality, besides the technical intricacies and challenges.

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The stand-by use of intra-aortic balloon pump, temporary pacemaker implantation are often necessary to ensure a safe procedure.

The use of imaging modalities like OCT and IVUS can be used wisely to differentiate between adventitial and luminal calcium and thus make a judicious selection of cases which truly benefit from rotablation-angioplasty, rather than an indiscriminate use.

Cost is however the major deterrent associated with this useful technique.

DURATION OF ANTIPLATELET THERAPY-EXTENDED DURATION IS UNNECESSARY FOR MOST PATIENTS Dr S Ramakrishnan, New Delhi ÂÂ

There is no difference in short-term vs. long-term DAPT after DES.

ÂÂ

DAPT trial shows lower rate of MACE, stent thrombosis and MI with 12-30 months of DAPT.

ÂÂ

It has been shown that longer DAPT leads to more bleeding and eventually more deaths.

Every patient can’t be given long-term DAPT. We have to individualize.

IMAGING: HOW IT HELPS TO MANAGE IN COMPLEX SITUATIONS? Dr G Sengottuvelu, Chennai ÂÂ

Intracoronary imaging has been steadily increasing in Indian cathlabs and more interventionalists are interested to learn the technique.

ÂÂ

Compared to angiography-guided PCI, average stent size selected and the final in-stent MSA seem to be higher when IVUS is used.

ÂÂ

IVUS can visualize the vessel size and optimize stenting. IVUS is optimal for PCI guidance (LM) and has abundant literature.

90

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

ÂÂ

OCT is best for lumen analysis and may have a potential to delineate underlying pathophysiology of thrombotic event, which may allow us tailor made therapy including intervention without stent.

ÂÂ

Both IVUS and/or OCT can be used for post-PCI optimization. Both can be used in some cases to get additional information.

ROLE OF CARDIAC ASSIST DEVICES IN HIGH RISK PCI Prof Dr Sandeep Mishra, New Delhi ÂÂ

Cardiac assists devices can be useful safety techniques in high risk PCI.

ÂÂ

It is important to use right device at right time.

ÂÂ

In high risk PCI, ischemic protection is better than mere hemodynamic support.

ÂÂ

Impella device gives best combination of ischemic protection, hemodynamic support, ease of insertion and safety.

LOWER STENT THROMBOSIS, MI RISKS WITH NEWER DES Dr VV Radhakrishnan, Kerala Compared to early-generation drug-eluting stents (DES), new-generation DES carry lower long-term risks of stent thrombosis and myocardial infarction (MI) in patients receiving percutaneous coronary intervention (PCI).

At 3 years, new-generation DES were associated with reduced risks of MI and definite stent thrombosis compared with early-generation DES, but the rate of MACE (all-cause death, MI and TVR) did not differ between the groups. When looking only at events associated with ACS, the risks of MACE, TVR and the composite of death and MI were lower with newgeneration DES. Several previously published clinical trials and metaanalyses have shown newer DES to have better safety profiles than the earlier generation, but the current study is one of the largest and longest to confirm this finding in everyday clinical practice. With the first-generation DES, there was definitely more stent thrombosis than we saw with bare-metal stents and even though the excess was very slight it was still a safety concern.

I think, it is now clear that the new-generation DES are as safe as BMS and are associated with a lower risk for repeat procedures.

The use of BMS in the United States is now limited to patients perceived to be poor candidates for several

CONFERENCE PROCEEDINGS months of dual antiplatelet therapy, however, that even in this population, use of new-generation DES is increasing. The bottom line is these second-generation DES really are an advance in PCI.

ÂÂ

The condition for which they were originally hospitalized may hinder reperfusion

ÂÂ

Lack of data on who in this subgroup may benefit from reperfusion.

IHJ GOES TO THE WINDY CITY: “FACTEUR D’IMPACT” SESSION DURING ACC CHICAGO, 2ND APRIL 2016

Recognition of STEMI, the process of obtaining and interpreting an ECG, and the decision about treatment all tend to be delayed for in-hospital onset. The larger databases explicitly exclude inpatient STEMI and tend to focus on outpatient quality measurements such as door-to-balloon time. Because improvements have been made in that category, he continued, the cardiology community should apply the same methodology to inpatient-onset STEMI, starting with data collection.

Prof Sundeep Mishra, Hony. Editor, Indian Heart Journal We wish to facilitate our unsung heroes who took their time out, to review the manuscripts, worked with the authors to improve it, who scrutinized it in “private” before it went out there for anyone to see and criticize.

We have instituted a host of Reviewer Appreciation Awards to recognize and facilitate them. We have planned our IHJ Session on the sidelines of ACC 2016 in Chicago, on 2nd April, 2016, 6-10 pm.

On behalf of my Editorial Board, I am pleased to invite you to this historic evening with us. Many of the World’s “Who’s Who” of Cardiology are likely to be present there and I promise you that we will have a wonderful and fruitful evening together. Please RSVP

by March 15th as seats are limited.

IN-HOSPITAL STEMI DEADLIER, MORE EXPENSIVE THAN OUT-OF-HOSPITAL STEMI Dr Sreekala, Kerala Patients who have an ST-segment elevation myocardial infarction (STEMI) while already hospitalized are 3 times more likely to die during their stay than those who have a STEMI outside of the hospital, according to a retrospective, multicenter study published in the Journal of the American Medical Association.

Patients with inpatient occurrence of STEMI were older (71.5 vs. 64.9 years; p < 0.001) and more often female and had more comorbidities than those with outpatientonset STEMI. But they were less likely to have diabetes without complications. The mortality increase could be partially due to a lack of invasive procedures, because “data from outpatient-onset STEMI show that reperfusion in general and primary PCI in particular improves outcomes.”

There are 4 major reasons to possibly explain the reduced use of such procedures seen here: ÂÂ

Patients with in-hospital STEMI are more often female and older than those with outpatient STEMI

ÂÂ

They tend to have more comorbidities, including lung and kidney disease

ISCHEMIA-BASED TREATMENT DOES NOT ALTER MORTALITY IN POST REVASCULARIZATION PATIENTS Dr Kamal Sharma, Ahmedabad Patients with previous revascularization showing silent ischemia on myocardial perfusion imaging do not need a repeat procedure, as medical therapy results in similar mortality rates.

The revascularization of asymptomatic post revascularization patients does not improve survival.

The utility of current appropriate use criteria that recommend post revascularization stress testing more than 5 years after CABG but reflect uncertainty for such testing within that time frame for CABG patients and within any time after PCI. A remarkable finding in the current report is that, despite selection bias, unadjusted and adjusted outcomes were not. Although the population from the current study is asymptomatic, the results are supportive of those from the COURAGE trial, which showed no additional benefit from PCI over medical therapy alone in stable CAD patients.

The current study reinforces the fact that it’s a slippery slope with patients who are asymptomatic; one has to be very careful and selective about who you subject to revascularization. We shouldn’t revascularize someone with no or minimal or even mild or moderate ischemia.

However, if one has severe ischemia, I would personally feel revascularization was justified. “It’s a little disappointing that in this group of patients with prior revascularization who had demonstrable ischemia, there was no further improvement in outcomes compared with medical therapy alone.” Overall the results reinforce existing appropriate-use criteria.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

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Highlights of 2015-2016 1.

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Current Guidelines for Cardiac Pacemaker Implantation

20.

Importance of Pharmacoeconomic Evaluation: Current Scenario in India

Ann Mary Paul, Anil Antony, Sruthi Nu, Hyfa Hameed, Vimal Mathew

21.

Rifampicin and Streptomycin-induced Exfoliative Dermatitis: A Rare Case Report

Praveen B Gautam, HN Chaudhary, Santosh Kumar Singh, Gaurav Murti

Kamal Kumar, Shivanjali Kumar, Ranjana Kumar Understanding Evolution of Resistant Strains in Recent Decades and Approach Towards Antibiotic Therapy Neethu Poulose, Anil Antony, Sreelakshmi Sreedhar, Anil Babu Carmi Syndrome with a Favorable Outcome: A Case Report Sindhu Desabandhu, Aditya Kumar Bubna, Mahalakshmi Veeraraghavan, Sudha Rangarajan Management of Diabetic End-stage Renal Disease: Role of Hemodialysis H Sudarshan Ballal A Short-term Comparative Prospective Observational Evaluation of Ramipril versus Telmisartan in Hypertensive Patients with Type 2 Diabetes Mellitus Pankaj Kumar, AK Kapoor, HK Singh, Malini Kulshrestha Hepatic Dysfunction in Dengue Fever: A Retrospective Study from Tertiary Referral Hospital in Rajasthan Monika Maheshwari, Sanjiv Maheshwari, Mukesh Cortical Vein Thrombosis: A Rare Manifestation of Tubercular Meningitis Anjum Mirza Chughtai, Muhammad Uwais Ashraf, MR Ajmal Headache with Visual Hallucinations: Lessons Learnt Debaprasad Chakrabarti, Anindya Sundar Trivedi, Amrit Kr Bhattacharyya A Randomized Comparative Study of Intramuscular Camylofin Dihydrochloride and Intravenous Drotaverine Hydrochloride on Cervical Dilatation in Labor

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Binu P Pregnancy with Anemia and Severe Thrombocytopenia: Case Series Kavita Agarwal

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Stereotactic Radiosurgery and Fractionated Stereotactic Radiotherapy in Patients with Single Brain Metastasis Meena J Shah, Rakesh K Vyas Pediatric Syrup Caps: How Safe? Contamination and Pediatric Dosing Concerns with Syrup Caps–CAPCONS Study Varsha Narayanan, Ganesh Kadhe, Aparna Jairam Clinical Expression of Graves’ Disease in Children: Case Report Jwal B Doctor, Bharat J Kumar Nonpuerperal Breast Abscesses in South Nigeria Afeyodion Akhator Increasing Trend of CHD in Underweight Patients of Rural Areas Due to Excess of Tobacco Chewing and Other Stress-related Risk Factors

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OP Patidar Ambulatory Blood Pressure Monitoring Kamal Kumar, Shivanjali Kumar, Ranjana Kumar Patient Safety: An Overview…

Sunil Kumar Saggar Evaluation of Hand Hygiene Practice: Role in Prevention of Infection

35.

36.

Deepak Arora, MK Mahajan

19.

Awareness Regarding Emergency Contraceptives Amongst Women of Reproductive Age Group in a Rural Tertiary Care Teaching Hospital

Jyoti R Patil, VM Motghare, SL Padwal, VS Deshmukh, SC Jaykare, HN Pise

37.

Acalculous Cholecystitis in Dengue: Is it Rare?

CR Jothi, R Umarani, K Baburaj Generalized Fatigue, Amenorrhea Due to Snake Bite?

Sreenivasa Rao Sudulagunta, Mahesh Babu Sodalagunta, Hadi Khorram, Mona Sepehrar To Study the Safety and Efficacy of Intravenous Iron Sucrose in Anemic Antenatal Women Khushpreet Kaur, Parneet Kaur, Arvinder Kaur, Isha Gupta The Effect of Myo-inositol Supplementation on Insulin Resistance and Ovulation in PCOD Patients Sangeeta Shah Tuberculosis in Children Akoijam Mamata Devi, Ritu Yadav Chronic Alcoholism with Very High HDL Cholesterol: An Unusual Risk Factor for Hypertension Pradeep Nigam, Ankur Gupta, Praveen Kumar Baghel, Mahendra Kumar Jain, Dharmendra Jain Emergency PCI Using Ticagrelor as a Reversible Antiplatelet Agent in the Treatment of STEMI in High-risk Patient: A Case Report Pasupati Rajoria, Yang Ke Ping, Zhang Yunfeng, Xu Chenghong, Yang Hua, Yang Jiawei Seroprevalence of Hepatitis B Surface Antigen in a Tertiary Care Hospital Shashi Chopra, Kailash Chand, Mahajan, Jaspal Kaur, Sheevani, Yadwinder Singh Another Feather to the Tale: Pseudo-vesicular Pityriasis Rosea Shaurya Rohatgi, Saurabh Jindal, Shahnaz Khan The Drug Regulatory Scenario in India KK Aggarwal, Prachi Garg To Study the Carotid Intima-media Thickness in Patients of Fatty Liver Disease Sandeep Aharwar Asymptomatic Hypercortisolism Manish N Mehta, Hemang K Acharya, Ajay C Tanna, Jemima Bhaskar, Suchitra Garhwal Cerebroprotein Hydrolysate in Traumatic Brain Injury: A Retrospective Study Ashutosh Agarwal, Sudeep Bharadwaj, Arun Tungaria, Shaifali Tungaria, Abhishek Dadhich A Rare Case of Ovarian Pregnancy Following Intracytoplasmic Sperm Injection and Embryo Transfer Ritu Punhani, Kundavi Shankar, Thankam Rama Varma Clinicopathological Study of Ovarian Tumors in a Referral Tertiary Hospital in West Bengal Tamal Kumar Mandal, Barunoday Chakraborty Primary Hyperparathyroidism in Pregnancy: A Case Report Vinita Singh, Mousumi Das Ghosh, Sunita Murmu, Monimala Murmu, Suman Kumari

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A One Year Prospective Study of Obstetrical Emergencies at a Tertiary Care Referral Hospital Parneet Kaur, Khushpreet Kaur, Gurdip Kaur, Surya Malik Use of Fetal Pillow During Cesarean Section in Deeply Engaged Head: A Comparative Study with Patwardhan’s Technique Sannyasi Charan Barman, Barunoday Chakraborty, Sanjoy Saha, Ramkrishna Sahana, Swarupananda Maity, Debilina Roy Paget’s Disease of Bone in Indian Patients: Two Case Reports Bhavana Venkata Nagabhushana Rao, BVS Raman Letterer-Siwe Disease Presenting as a Retroauricular Swelling: A Diagnostic Dilemma Rishav Raj, Braja Kishore Behera Right Atrial Mass Monika Maheshwari, Swapnil Continuous Spinal Anesthesia in Geriatric Orthopedic Surgeries Sudivya Sharma, Susheela Taxak, Nikita Jain Satisfaction Levels and Recommendation Intentions of Healthcare Consumers: An Exploratory Study Based on Multispecialty Hospitals in North India Vishal Kamra, Harjot Singh, Kalyan Kumar De A Survey of Public Awareness About Voluntary Body Donation Shalini Chaudhary, Sarvesh, APS Batra The Rise in Incidence of the Enterococcus: Beyond Vancomycin Resistance: A Review

59.

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Evaluation of Hand Hygiene Practice: Role in Prevention of Infection Deepak Arora, MK Mahajan Desquamative Gingivitis: A Clinician’s Nightmare Swapan Kumar Purkait, Utpal Mukhopadhyay, Sumanta Kumar Koley, Maitreyi Guha Study of the Clinico-Epidemiological Pattern and the Precipitating Factors in 100 Melasma Patients in an Urban Town Pradip Kumar Das, Debjit Panja Tonsil Schwannoma Presenting as a Tonsillar Cyst: A Rare Case Saurabh Varshney, Ravi Meher Spectrum of Lesions of Liver in Autopsy in India: One Year Study Amar Ranjan, Divya Sethi Dengue Myopericarditis: A Rare Complication of Dengue Fever Pooja Shashidharan, Manish Pangi Interstitial Brachytherapy Using Martinez Universal Perineal Interstitial Template in Locally Advanced Gynecological Malignancies Meena J Shah, Rakesh K Vyas Managing Iron Deficiency: New Approaches

Payal Preet, Harinder Singh, Vijay K Sehgal, Vishal Chopra

56.

What Gravity, Genetics and Smoking, Together can Achieve Somendra Mohan Sharma

Priyanka Mandve, Vijay M Motghare Clinical Efficacy of Bioactive Glass-containing Dentifrice: A 3-month Controlled Study Meera H Gohil, Sharmila Verma, Geeta Singh Bhaduria Erythroderma Secondary to Herbal Medicine KH Basavaraj, Archana Meka Netherton Syndrome: A Report of Two Cases BK Brar, Neerja Puri, BB Mahajan, Gurmet Sethi

62.

Nimesulide-induced Angioedema: A Case Report

Tushar B Nishandar, Anand S Kale, Harshal N Pise, Swapnil P Chube

63.

Revisiting Antacids: Co-therapy with Proton Pump Inhibitors in Gastroesophageal Reflux Disease

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Philip Abraham Thrombocytosis: Reactionary versus Primary?

Nandini Swamy, Chaitra G, Prashanth, Siva Subramaniyam, Vivek Tirlapur Poncet Disease: A Case Report of Polyarthropathy Debaprasad Chakrabarti, Abhijit Datta, Amrit Kr Bhattacharyya Isaacs’ Syndrome (Neuromyotonia): A Case Report Ibraheem Khan, GN Saxena, Swati Srivastava, Surendra Yadav, Kamlesh Sharma A Randomized Comparative Study of Intramuscular Camylofin Dihydrochloride and Intravenous Drotaverine Hydrochloride on Cervical Dilatation in Labor

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Rajani Uday, Binu P A Rare Case of Primary Ovarian Ectopic Pregnancy After Interval Tubal Ligation

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Dipangkar Hazarika To Evaluate the Compliance with ICS/NCCP Guidelines in the Management of Community-acquired Pneumonia in a North Indian Tertiary Care Hospital

A Study of Effect of Oral Iron Therapy on Cognitive Function in Irondeficient Adolescent Girls

Deepak Arora, Narinder Kaur

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Tamal Kumar Mandal, Pratima Gorain, Debjani Deb, Kanak Lata Resveratrol in Gynecology Alka Gahlot A 28 Weeks Pregnancy with Huge Ovarian Cyst: A Rare Case Report Monica Verma, Laxmi Maru, Devyani Tiwari Role of Zinc in Growth and Immunity in Children Shweta Pathak An Atypical Presentation of Obsessive Compulsive Disorder with Repeated Somersaults Nitisha Verma, Shilpa Adarkar, Deoraj Sinha, Ravindra M Kamath A Case of Cardiac Tamponade Due to Hypothyroidism Mallikarjunreddy M, Venugopal K, Bharath Raj MY, Manjunath Ganiger, Kadappa Jaligidad, Mahesh Sreenivas Prasad Study of Hair Dye Poisoning: A Complete Profile KB Yadavendra Reddy, P Vijayanarasimha Reddy, P Kiran Kumar, M Asha, B Visalakshi Study of Healthcare-associated Infections PH Mishra, Pallavi Banerjee, Heema Gosain Extended-spectrum β-lactamase and AmpC-producing Klebsiella pneumoniae: A Therapeutic Challenge

57.

Correlation of Retinopathy and TMT Positivity in Patients of Diabetes Mellitus

77.

S Gupta, PK Baghel, H Gupta, S Lakhtakiya, MK Jain, Dharmendra Jain

Sheevani, Shashi Chopra, Gomty Mahajan, Jaspal Kaur, Yadwinder Singh Chouhan Effect of Various Surface Treatment on the Push-out Bond Strength of Glass Fiber Posts Bonded to Human Root Dentin: An in vitro Study AVK Narene, P Shankar, A Karthick

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Helicobacter pylori Infection can Cause Chronic Urticaria Pradip Kumar Das A Hospital-based Study of Prevalence of Gestational Diabetes Mellitus

97.

Atish Singla, Parneet Kaur, Khushpreet Kaur, Arvinder Kaur, Preetkanwal Sibia

98.

Role of β-blockers in Prevention of Hepatopulmonary Syndrome in Chronic Liver Disease: An Observation

99.

Ashish Gautam, Prabhat Agrawal, Ashwini Nigam A Case Report of Oculopharyngeal Muscular Dystrophy KB Gurumurthy, SG Jayaraj, Jobin V Joseph Henoch-Schönlein Purpura with Upper Gastrointestinal Hemorrhage in an Adult BV Nagabhushana Rao, BVS Raman Cerebral Palsy Sudivya Sharma An Operated Case of Vaginocutaneous Fistula: A Rare Case Namrata Tiwari Mishra, Shiksha Tiwari, Anupam Tiwari, Mahesh Tiwari Addition of Simple Laboratory Test to Reduce Overtreatment of Pelvic Inflammatory Disease by Syndromic Approach Kavita Agarwal, Rekha Bharti, Achla Batra, Aruna Batra Viral Infections in Pregnancy V Padma

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Rapunzel Syndrome in a 6-year-old Child: A Case Report Shivanand Reddy KV, Ramesh H Understanding the Basics of a Coronary Angiogram Kamal Kumar, Shivanjali Kumar, Omer Mustafa Hasan, Ranjana Kumar, Mriganka Mehra

Bhavana Venkata Nagabhushana Rao, Ch VNGR Ramanujam

101. Prescribing Pattern of Antihypertensive Drugs in a Tertiary Care Teaching Hospital in Lucknow Region

Vijay K Yadav, Shyam Sunder Keshari, Krishna Pandey

102. Study of Prevalence of Severe Acute Malnutrition in Children Under 5 Years in Chatra Area of Serampore Municipality Under the State of West Bengal

Pradip Kumar Das

103. Clinical Survey with Dermatologists on Benefits and Safety of Minoxidil 10%

Sujeet N Charugulla, Amisha Ahuja

104. Diabetic Ketoacidosis: Clinical Characteristics and Precipitating Factors in a Tertiary Care Hospital, Bareilly, Uttar Pradesh

Amit Varshney, Rohit Singh, Tanvi Sood, P Nigam

105. Thyroid, Obesity and Thyromimetic Compounds

Tuberculosis of the Female Genital Tract in Patients Attending an Infertility Clinic and its Effect on Pregnancy Outcome in in vitro Fertilization and Embryo Transfer Alka Gahlot, ML Swarankar, Ravikant Soni Lactation-induced Osteoporotic Vertebrae Fracture: A Rare Clinical Entity Monika Maheshwari Comparative Evaluation of Cost-effectiveness Between Ramipril 2 Diabetes Mellitus

90.

Meena J Shah

100. Cutaneous Larva Migrans

Pankaj Kumar, AK Kapoor, HK Singh, Malini Kulshrestha Hyperlactatemia in Critically Ill: A Review Subhranshu Sekhar Kar Posology of Antidiabetic Drugs and Insulins: A Review of Standard Textbooks Garima Bhutani, Sanjay Kalra Hypothyroidism in Metabolic Syndrome Darshana Makwana, Jignesh Tank, Deepak Kumar Study of Prevalence of Hypothyroidism and Effect of Treatment with L-thyroxine in Patients of Chronic Kidney Disease NS Sengar, Nipun Gupta, Nandita Prabhat Volkmann’s Ischemic Contracture: A Late Complication of Snakebite Lubna Zafar, Shahna Ali, Anjum Parvez Retrospective Study of Inpatients Admitted Following Medical Abortion Veena Vidyasagar Colposcopic and Pap Smear Evaluation and Therapeutic Role of Cryotherapy in Cervical Erosion Rachana Agarwal, Ajay Halder, Urvashi Verma, Mohita Agarwal, Saroj Singh

Pragati Kapoor, Pankaj Kumar, AK Kapoor

106. Detection of Pulmonary Nocardiosis Mimicking Tuberculosis: Role of Sputum Microscopy

Shashi Chopra, Shaveta Dhiman, Gomty Mahajan, Silky Mahajan

107. Self-injected “Harpic” Poisoning: A Case Report

Mantu Jain, Ritesh Runu, Manish Kumar, Santosh Kumar

108. Can Snake Bite Present as Jaundice - It Can!

versus Telmisartan in Cases of Hypertension Associated with Type

Short (Single Dose) versus Long-course Radiotherapy for Palliation of Painful Bone Metastases

Manish N Mehta, Hemanth K Acharya, AC Tanna, Jemima Bhaskar, Pratik M Vora

109. Enlarged Ovaries Following IVF/ICSI as an Etiology of Obstructive Uropathy Resulting in Acute Renal Failure: A Case Report

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Pratibha Vishwakarma, Priya Mohan, Kundavi Shankar, Thangam R Varma Neurocysticercosis - A Cause of Convulsions During Pregnancy: A Case Report Jaya Kundan Gedam, Minal Bhalerao Malignant Peripheral Nerve Sheath Tumor Arising in a Neurofibroma: A Case Report Monica Kumbhat M, Leena Dennis Joseph, Archana B, Arulappan Chromosome 3p Duplication: A Rare Chromosomal Anomaly Braja Kishore Behera, Rishav Raj, Sailabala Shaw, Mitali Mahapatra Vital Nutritional Requirements in the Growing Years Shweta Pathak Gender Differences in Prognosis of Systolic Heart Failure in Patients Undergoing Bypass Surgery PS Gandhi, RK Goyal, AR Jain, SB Mallya, VM Gupta, DS Shah, BR Trivedi, NA Shastri, CB Mehta, KA Jain, NS Bhavsar, UJ Shah Prevalence of Inducible Clindamycin Resistance among Staphylococci in an Urban Tertiary Care Hospital of Jalandhar, Punjab Sheevani, Jaspal Kaur, Kailash Chand, Gomty Mahajan, Shashi Chopra

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Recommendation Patterns by Various Practitioners in the Treatment of Colicky Abdominal Pain in India

Mukesh Gabhane, Lisa Braganza, Srirupa Das, Vishal Vaidya Diclofenac: Dose and Formulation Based Protocol in Pain Management HR Jhunjhunwala, Rajiva Gupta, MS Ghosh, Vikas Agashe, GPV Subbaiah, GVS Moorthy, AK Jain, JC Chowdhury, Vikas Gupta, Venkatramana Nagire, Amit Thavkar, Apurva Gawai

BV Nagabhushana Rao, BVS Raman, Sailesh Modi, M Umamaheswara Rao

Bharat J Parmar, Jwal Doctor

Praveen Kumar, Kalpana Chandra

Mamta Rani, Parneet Kaur, Khushpreet Kaur, Gurdip Kaur, Satinder Pal Kaur

Avishek Bhadra, Pallab Kumar Mistri, Bandana Biswas, Shilpa Kumari, Sudip Mukherjee

Manab Narayan Baruah

139. Clinicopathologic Study of Goiters in Warri, Nigeria

R Varmora, V Siddhpura, N Gupta, BK Amin

Shakeel Ahmad Khan, Muhammad Uwais Ashraf, Juwairia Ashraf

Shyamala G, Sunil Kumar N, Swathi BS, Mahesh Menon, Hemantha Kumar

Rekha Rani, Shikha Singh, Saroj Singh, Urvashi Verma, Ruchika Garg, Rachana Agrawal, Latica

Shaveta Jain, Roopa Malik, Smiti Nanda, Nitin Jain

145. Pelvic Hematoma Mimicking Ovarian Malignancy

Shreyasi Bid, Sambhu Nath Bandyopadhyay, Chandan Sasmal

146. Programmed Labor and Its Effect on Labor Outcome

Shweta Singh, Taru Gupta, Sangeeta Gupta

Ruchika Garg, Urvashi Verma, Soniya Dhiman, Mohita Agrawal, Meenal Jain

147. Mental Health in Children: An Overview

P Thulasi, Shanthi M

Kshama Vishwakarma, P Shukla, K Yadav

S Santheev, Lubna Zafar, Anjum Parvez, HS Khan

144. Intraperitoneal Bladder Injury During Tubectomy: A Conservative Approach

Manish N Mehta, Hemang K Acharya, Ajay C Tanna, Jemima Bhaskar, Dhaval P Ajmera

131. Secondary Abdominal Pregnancy Following Rupture of Rudimentary Horn: A Rare Case Report

Javed Sayyed, Deepti Sharma, SR Meena, Sanket Singh, Pallavi Vij, Mukesh Verma

143. Prophylactic Preoperative Use of Rectal Misoprostol versus Intravenous Oxytocin Infusion During Cesarean Section to Reduce Intraoperative and Postoperative Blood Loss

130. Bilateral Pregnancy Luteoma: A Case Report

Afeyodion Akhator, CP Oside, E Ijomone

142. Erythema Nodosum in Tuberculosis: Contemporaries or Causation

Prabhu Kasture, Shailaja Kale, Priya Palimkar

129. Omental Herniation: A Complication of Drain Site: A Case Report

Bhaghya Prasad, K Harikrishnan, Anjaly S, Maria C Kuriakose, Naresh Kumar V

141. Prevalence of Microalbuminuria in Patients of HIV/AIDS and Its Correlation with CD4 Cell Count and the Duration of Ιllness

128. An Interesting Case of a Patient Presenting with Green Urine Secondary to Thinner Poisoning

Amitabha Sarkar, Sandip Ghosh

138. Amitriptyline-induced Edema: A Case Report

127. A Retropharyngeal Abscess: Lest We Forget

Sneha Vadhvana, Manish N Mehta, Aniket Bhardwaj

137. Filling and Refilling: The Melancholy of Malaria Since Independence in India

Sudivya Sharma, Pradnya Sawant

126. The Etiology and Outcome of Patients with Fever Attending Civil Hospital, Ahmedabad, India

125. An Open Label, Prospective, Multicentric, Post-marketing Surveillance Study to Evaluate the Lipid-lowering Efficacy and Safety of Rosuvastatin in Indian Patients with Dyslipidemia

SA Ayisha, KM Sudha

140. To Study the Correlation Between SAAG and Platelet Count/Spleen Size Ratio for Prediction of Esophageal Varices in CLD Patients

124. An Approach to Diagnosis of Skeletal Dysplasias in Children

Mehul Shah, Shreya Shah, Pramod Upadhyay

136. A Case of Brucellosis Presented as Pericarditis: Rare Presentation

123. Constriction Band Syndrome

135. A Randomized Open Label Comparative Clinical Study of a Synbiotic Against a Probiotic in the Treatment of Acute Diarrhea in Children

Clinical Pearls: Iron-deficiency Anemia

122. Complete Hydatidiform Mole Coexisting with a Live Fetus in Twin Pregnancy: A Case Report

Meena J Shah, Rakesh K Vyas

134. Wooden Sticks as Object of Ocular Injury: Anti-infective Profile

Amebiasis Mimics Malignancy in the Transverse Colon and Transpires in Liver Abscess

121. A Study to Evaluate Safety and Efficacy of Postpartum Intrauterine Contraceptive Device Insertion

Parmjit Kaur, Ruby Bhatia, Nidhi Kailey, Himani Kundoo, Aman Dev

133. A Simple Inexpensive Surface Applicator for High Dose Rate Intraluminal Brachytherapy of Anal Cancer

120. Clinico-hematological Profile of Kala-azar in Nonendemic Area: A Case Series

132. Evaluation of Risk Factors and Prevalence of Gestational Diabetes Mellitus in a Tertiary Care Center: An Observational Study

Krishan Kumar, Rajeev Dogra, Brij Lata Kotia

148. Oral Tertiary Syphilis: A Case Report

Deepa MS, Anita Balan, S Sunil, Bifi Joy

■■■■

http://ebook.ijcpgroup.com/Indian-Journal-of-Clinical-Practice-may-2016.aspx

LIGHTER READING

HUMOR

Masterpiece One day a girl came home crying to her mom.

The mom asked what was wrong. The girl responded, “I’m not a creation, God made men first! I’m nothing!”

Then the mom said, “Oh baby that’s not true, God may have made men first, but there’s always a rough draft before the masterpiece.”

The Physician Writing Out a Prescription The physician writing out a prescription for his hypertensive cardiac patient: “Diazepam 5 mg (tranquilizer) TDS”. The patient’s wife asks, “Doctor, when are these medicines to be given?”

Doctor: “These are to be taken by you. He needs rest”.

Threatening Letters The fellow stormed into the postmaster’s office in a fury. “I’ve been getting threatening letters in the mail for months and I want them stopped.”

“Of course,” said the postmaster.

“Sending threatening letters through the mail is a federal offense. Do you know who’s sending them?” “Yes,” shouted the man. “It’s those idiots down at the Internal Revenue Service.”

Mind Trivia There are three houses one is red one is blue band one is white. If the red house is to the left of the house in the middle and the blue house is to the right to the house in the middle where is the white house?

Ans: In Washington DC !

If an electric train is going 150 miles per hour north and the wind is blowing the same south, which way does the smoke blow?

Ans: It is an electric train there is no smoke!

QUOTES

LAUGH-A-WHILE

Lighter Side of Medicine

“High achievers spot rich opportunities swiftly, make big decisions quickly and move into action immediately. Follow these principles and you can make your dreams come true.” ―Robert H. Schuller “The best and most beautiful things in the world cannot be seen or even touched – they must be felt with the heart.” ―Helen Keller

Dr. Good and Dr. Bad SITUATION: A patient with COPD needed oxygen.

Nobel Prize A man is driving down a country road, when he spots a farmer standing in the middle of a huge field of grass. He pulls the car over to the side of the road and notices that the farmer is just standing there, doing nothing, looking at nothing.

Use binasal cannula

Use Venturi mask

The farmer replies, “I’m trying to win a Nobel Prize.” “How?” asks the man, puzzled.

“Well I heard they give the Nobel Prize to people who are outstanding in their field.”

96

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

© IJCP Academy

The man gets out of the car, walks all the way out to the farmer and asks him, “Ah excuse me mister, but what are you doing?”

LESSON: Venturi mask helps to wash out carbon dioxide.

Information for Authors Manuscripts should be prepared in accordance with the ‘Uniform requirements for manuscripts submitted to biomedical journals’ compiled by the International Committee of Medical Journal Editors (Ann. Intern. Med. 1992;96: 766-767).

Indian Journal of Clinical Practice strongly disapproves of the submission of the same articles simultaneously to different journals for consideration as well as duplicate publication and will decline to accept fresh manuscripts submitted by authors who have done so.

The boxed checklist will help authors in preparing their manuscript according to our requirements. Improperly prepared manuscripts may be returned to the author without review. The checklist should accompany each manuscript.

Authors may provide on the checklist, the names and addresses of experts from Asia and from other parts of the World who, in the authors’ opinion, are best qualified to review the paper.

Covering letter –

– –

The covering letter should explain if there is any deviation from the standard IMRAD format (Introduction, Methods, Results and Discussion) and should outline the importance of the paper.

Principal/Senior author must sign the covering letter indicating full responsibility for the paper submitted, preferably with signatures of all the authors.

Articles must be accompanied by a declaration by all authors stating that the article has not been published in any other Journal/Book. Authors should mentioned complete designation and departments, etc. on the manuscript.

Manuscript – Three complete sets of the manuscript should be submitted and preferably with a CD; typed double spaced throughout (including references, tables and legends to figures).

–

The manuscript should be arranged as follow: Covering letter, Checklist, Title page, Abstract, Keywords (for indexing, if required), Introduction, Methods, Results, Discussion, References, Tables, Legends to Figures and Figures.

–

All pages should be numbered consecutively beginning with the title page.

Note: Please keep a copy of your manuscript as we are not responsible for its loss in the mail. Manuscripts will not be returned to authors.

Title page Should contain the title, short title, names of all the authors (without degrees or diplomas), names and full location of the departments and institutions where the work was performed,

name of the corresponding authors, acknowledgment of financial support and abbreviations used.

– The title should be of no more than 80 characters and should represent the major theme of the manuscript.

A subtitle can be added if necessary.

– A short title of not more than 50 characters (including inter-word spaces) for use as a running head should be included.

– The name, telephone and fax numbers, e-mail and postal addresses of the author to whom communications are to be sent should be typed in the lower right corner of the title page.

– A list of abbreviations used in the paper should be included. In general, the use of abbreviations is discouraged unless they are essential for improving the readability of the text.

Summary – The summary of not more than 200 words. It must convey the essential features of the paper.

– It should not contain abbreviations, footnotes or references.

Introduction – The introduction should state why the study was carried out and what were its specific aims/objectives.

Methods – These should be described in sufficient detail to permit evaluation and duplication of the work by others.

– Ethical guidelines followed by the investigations should be described.

Statistics The following information should be given: – The statistical universe i.e., the population from which the sample for the study is selected.

– Method of selecting the sample (cases, subjects, etc. from the statistical universe).

– Method of allocating the subjects into different groups.

– Statistical methods used for presentation and analysis of data i.e., in terms of mean and standard deviation values or percentages and statistical tests such as Student’s ‘t’ test, Chi-square test and analysis of variance or non-parametric tests and multivariate techniques.

–

Confidence intervals for the measurements should be provided wherever appropriate.

Results – These should be concise and include only the tables and figures necessary to enhance the understanding of the text.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

97

Discussion –

This should consist of a review of the literature and relate the major findings of the article to other publications on the subject. The particular relevance of the results to healthcare in India should be stressed, e.g., practicality and cost.

References These should conform to the Vancouver style. References should be numbered in the order in which they appear in the texts and these numbers should be inserted above the lines on each occasion the author is cited (Sinha12 confirmed other reports13,14...). References cited only in tables or in legends to figures should be numbered in the text of the particular table or illustration. Include among the references papers accepted but not yet published; designate the journal and add ‘in press’ (in parentheses). Information from manuscripts submitted but not yet accepted should be cited in the text as ‘unpublished observations’ (in parentheses).

At the end of the article the full list of references should include the names of all authors if there are fewer than seven or if there are more, the first six followed by et al., the full title of the journal article or book chapters; the title of journals abbreviated according to the style of the Index Medicus and the first and final page numbers of the article or chapter. The authors should check that the references are accurate. If they are not this may result in the rejection of an otherwise adequate contribution.

Examples of common forms of references are: Articles Paintal AS. Impulses in vagal afferent fibres from specific pulmonary deflation receptors. The response of those receptors to phenylguanide, potato S-hydroxytryptamine and their role in respiratory and cardiovascular reflexes.

Q. J. Expt. Physiol. 1955;40:89-111.

Figures – Two complete sets of glossy prints of high quality should be submitted. The labelling must be clear and neat.

– All photomicrographs should indicate the magnification of the print.

– Special features should be indicated by arrows or letters which contrast with the background.

– The back of each illustration should bear the first author’s last name, figure number and an arrow indicating the top. This should be written lightly in pencil only. Please do not use a hard pencil, ball point or felt pen.

– Color illustrations will be accepted if they make a contribution to the understanding of the article.

–

Do not use clips/staples on photographs and artwork.

–

Illustrations must be drawn neatly by an artist and photographs must be sent on glossy paper. No captions should be written directly on the photographs or illustration. Legends to all photographs and illustrations should be typed on a separate sheet of paper. All illustrations and figures must be referred to in the text and abbreviated as “Fig.”.

Please complete the following checklist and attach to the manuscript: 1. Classification (e.g. original article, review, selected summary, etc.)_______________________________ 2. Total number of pages ________________________ 3. Number of tables ____________________________ 4. Number of figures ___________________________

Books

5. Special requests _____________________________

Stansfield AG. Lymph Node Biopsy Interpretation Churchill Livingstone, New York 1985.

6. Suggestions for reviewers (name and postal address)

Articles in Books

2.____________ 2.________________

Strong MS. Recurrent respiratory papillomatosis. In: Scott Brown’s Otolaryngology. Paediatric Otolaryngology Evans JNG (Ed.), Butterworths, London 1987;6:466-470.

3.____________ 3.________________

4.____________ 4.________________

Tables –

These should be typed double spaced on separate sheets with the table number (in Roman Arabic numerals) and title above the table and explanatory notes below the table.

Legends – These should be typed double spaces on a separate sheet and figure numbers (in Arabic numerals) corresponding with the order in which the figures are presented in the text.

–

98

The legend must include enough information to permit interpretation of the figure without reference to the text.

Indian Journal of Clinical Practice, Vol. 27, No. 1, June 2016

Indian 1.____________Foreign 1.________________

7. All authors’ signatures________________________ 8.

Corresponding author’s name, current postal and e-mail address and telephone and fax numbers __________________________________________

Online Submission Also e-Issue @ www.ijcpgroup.com For Editorial Correspondence

Dr KK Aggarwal

Group Editor-in-Chief Indian Journal of Clinical Practice E-219, Greater Kailash, Part-1 New Delhi - 110 048. Tel: 40587513 E-mail: editorial@ijcp.com Website: www.ijcpgroup.com

R.N.I. No. 50798/1990 Date of Publication 13th of Same Month Date of Posting 13-14 Same Month

POSTAL REGISTRATION NO. DL (S)-01/3200/2015-2017 Posted in N.D. PSO New Delhi

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