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Volume 27, Number 11

April 2017, Pages 1001â&#x20AC;&#x201C;1100

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yy American Family Physician yy Dermatology yy Drugs yy Endocrinology yy Internal Medicine yy Oncology yy Orthopedics yy Psychiatry

an i c i ys ians

yy Surgery yy Pictorial CME

Phly Physic y l mi ami

yy Conference Proceedings

Fademy of F n ica Aca

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yy Around the Globe

ingurnal of th t a or d Jo

yy Lighter Reading

rp-reviewe o c In eer AP

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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 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

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.

Volume 27, Number 11, April 2017 FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

1005 Write Drug Names in Capital Letters to Avoid Prescription Errors

KK Aggarwal

AMERICAN FAMILY PHYSICIAN

1008 Pulmonary Hypertension: Diagnosis and Treatment

Beth Dunlap, George Weyer

1016 Practice Guidelines 1018 Photo Quiz DERMATOLOGY

1023 To Study the Prevalence of Metabolic Syndrome and Dyslipidemia in Patients of Xanthelasma Palpebrarum at a Tertiary Care Hospital

Swati Gondane, Ashok Meherda, Rajkumar Kothiwala

DRUGS

1028 An Open-label, Single-arm, Single-center, Clinical Study to Evaluate Safety and Efficacy of Heparin Sodium Topical Solution (1,000 IU/mL) in Prevention of Infusion-associated Superficial Thrombophlebitis

Prakash Kurmi

ENDOCRINOLOGY

1033 Guidelines for the Management of Diabetes at the End of Life

Mukesh Mehra, Mriganka Mehra

INTERNAL MEDICINE

1038 Isolated Rectus Sheath Hematoma Mimicking a Desmoid Tumor: A Rare Presentation of Dengue Fever

Anjum Mirza Chughtai, Muhammad Uwais Ashraf, MR Ajmal

ONCOLOGY

1042 Transformation of Mature Teratoma into Adenocarcinoma in an 18-year-old Boy

Mukur Dipi Ray, Amar Ranjan, Sachidanandjee Bharti

ORTHOPEDICS

1045 An Open-label Prospective Study to Evaluate the Efficacy, Safety and Tolerability of KenacortÂ® Injection (Triamcinolone Acetonide) in the Treatment of Patients with Osteoarthritis, Rheumatoid Arthritis, Frozen Shoulder and Tennis Elbow

Anil Kumar H, Neeraj Bindal, Atul K Agarwal, Manu HC

PSYCHIATRY

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

1053 Burnout Syndrome: A Disease of Modern Era

Parinita C Hazarika, Smaranika Choudhury, Arun Kumar Gupta

1062 Global Pathway, Current Condition and Challenges in the Management of Autism in Children

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

Sathish Amirthalingam

SURGERY

1072 Blunt Abdominal Trauma: “Pandora’s Box Revisited” A Prospective Study

The copyright for all the editorial material contained in this journal, in the form of layout, content including images and design, is held by IJCP Publications Ltd. No part of this publication may be published in any form whatsoever without the prior written permission of the publisher.

Venkatesh Subbiah, Benita Florence, Somasundaram S

PICTORIAL CME

1080 Pseudocardiomegaly

Editorial Policies

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.

Bhavana Venkata Nagabhushana Rao, BVS Raman

CONFERENCE PROCEEDINGS

1082 69th Annual National Conference of Indian Psychiatric Society (ANCIPS 2017) 1086 72nd Annual Conference of the Association of Physicians of India (APICON 2017) MEDILAW

1090 A Doctor, Like Any Other Professional, can Take Leave if Felt Necessary by Him AROUND THE GLOBE

1092 News and Views LIGHTER READING

1096 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

Dr KK Aggarwal

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

Write Drug Names in Capital Letters to Avoid Prescription Errors

octors are known to have poor handwriting and they also use abbreviations in their prescriptions. As a result, quite often, prescriptions may be unreadable and it is often said that only chemists could decipher a doctor’s prescription. This is an area that needs to be addressed by doctors as illegible prescriptions may be misread and wrongly dispensed, often with disastrous consequences. A report ‘Preventing Medication Errors’ from the Institute of Medicine (IOM) published in 2006 said, “In hospitals, errors are common during every step of the medication process—procuring the drug, prescribing it, dispensing it, administering it and monitoring its impact—but they occur most frequently during the prescribing and administering stages.” Beneficence and nonmaleficence along with patient autonomy and justice constitute the four guiding tenets of medical ethics. Patients come to us when they are sick and as clinicians, we are trained to use our skills and knowledge to diagnose and treat them. This is the principle of beneficence ‘do good’ complemented by that of 'nonmaleficence' i.e., to do no harm. The fiduciary nature of the doctor-patient relationship places an ethical obligation on the doctor to always put the interests of the patient first. To reduce prescription errors, the Medical Council of India (MCI) has issued guidelines that require doctors to write in capital letters to that the writing is legible. In September 2016, MCI revised its code of ethics notified as Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations,

2016 – Part I. This revision required doctors to write the generic names of drugs and in capital letters so that the drugs prescribed could be easily read and dispensed. The notification read as follows: In Chapter 1-B-Duties and responsibilities of the Physician in general, Clause – 1.5 under the heading–Use of Generic names of drugs, the following shall be substituted: “Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs.” Indian Medical Association (IMA) welcomes the new MCI gazette notification asking doctors to prescribe generic medicine in capital letters but clarifies it further. “Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs”. Here are some examples of common prescription errors and how to avoid them. ÂÂ

Always spell the drug: Always spell the drug if you are giving telephonic instructions. Sound-alike drugs can cause confusion. E.g., the patient received Isoprin IV in place of Isoptin and nearly died. E.g., Amlopress AT/80 mg; a hypertensive called up his family physician who asked him to take amlopress AT but the patient took amlopress 80 mg. After sometime he developed dizziness, flushing, palpitation, nausea and abdominal pain.

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

Never write ‘U’ to abbreviate the word ‘units’: Do not write ‘U’ for units when writing prescription. Always write the complete word ‘units’. It may be mistaken as zero. E.g., never write 4U insulin. The patient may be given 40 units of insulin when the doctor meant 4 U (4 units).

ÂÂ

Never write the numeric after a decimal point: The use of a trailing zero after a decimal point when writing prescription may lead to medication errors. E.g., do not write 5.0 mg. There are chances that the patient may get 50 mg; 5.0 mistaken as 50 mg if the decimal point is not seen.

ÂÂ

Always write the numeric 0 before the decimal point: Always add a leading zero when writing dose of a drug, which is less than one. Lack of a leading zero may lead to a decimal point being missed. For example, never write .25 mg; instead write 0.25 mg. Otherwise there are chances the patient may take 25 mg in the first instance itself.

ÂÂ

8-2-8 mistake: The time interval should be written more clearly as 8 am 2 pm 8 pm. Or, the patient may consider it to be the number of tablets to be taken 8 in the morning, 2 in the afternoon and again 8 at night.

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AMERICAN FAMILY PHYSICIAN

Pulmonary Hypertension: Diagnosis and Treatment BETH DUNLAP, GEORGE WEYER

ABSTRACT Pulmonary hypertension is a common, complex group of disorders that result from different pathophysiologic mechanisms but are all defined by a mean pulmonary arterial pressure of 25 mm Hg or greater. Patients often initially present to family physicians; however, because the symptoms are typically nonspecific or easily attributable to comorbid conditions, diagnosis can be challenging and requires a stepwise evaluation. There is limited evidence to support screening of asymptomatic individuals. Echocardiography is recommended as the initial step in the evaluation of patients with suspected pulmonary hypertension. A definitive diagnosis cannot be made on echocardiographic abnormalities alone, and some patients require invasive evaluation by right heart catheterization. For certain categories of pulmonary hypertension, particularly pulmonary arterial hypertension, treatment options are rapidly evolving, and early diagnosis and prompt referral to an expert center are critical to ensure the best prognosis. There are no directed therapies for many other categories of pulmonary hypertension; therefore, family physicians have a central role in managing contributing comorbidities. Other important considerations for patients with pulmonary hypertension include influenza and pneumonia immunizations, contraception counseling, preoperative assessment, and mental health.

Keywords: Pulmonary hypertension, stepwise evaluation, echocardiography, right heart catheterization, influenza and pneumonia immunizations

ulmonary hypertension is a heterogeneous group of disorders characterized by a mean pulmonary arterial pressure of 25 mm Hg or greater at rest during right heart catheterization.1-4 Patients with pulmonary hypertension may initially present to family physicians, but symptoms such as dyspnea on exertion and fatigue are nonspecific and may be attributed to comorbid conditions.5 Pulmonary hypertension is categorized on the basis of pathophysiology, hemodynamics, and therapeutic options. In 2013, the classification scheme was updated to recognize five groups of pulmonary hypertension6 (Table 13,4,6). Although pulmonary arterial hypertension (group 1) has benefited the most from progress with targeted therapy, this diagnosis is rare and may not be encountered by many family physicians.7 However, in certain populations, such as persons with systemic sclerosis, pulmonary arterial hypertension is more

BETH DUNLAP, MD, is a family physician at Erie Family Health Center, Waukegan, Ill.; an assistant professor of family medicine at Northwestern University, Chicago, Ill.; and the associate program director for the Northwestern McGaw Family Medicine Residency at Lake Forest, Grayslake, Ill. GEORGE WEYER, MD, is an assistant professor of medicine at the University of Chicago and also practices within the University of Chicago Primary Care Group. Source: Adapted from Am Fam Physician. 2016;94(6):463-469.

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common.8 Treatment is rapidly evolving and usually administered in expert centers. The American College of Chest Physicians published treatment guidelines in 2014.1 Family physicians most often encounter pulmonary hypertension in patients with chronic disease such as heart failure, obstructive lung disease, and thromboembolism. Pulmonary hypertension is most prevalent in those with left heart disease (group 2).9 In systolic or diastolic left heart failure, prevalence estimates range from 25% to 83%.10 Pulmonary hypertension is also common in patients with lung disease and/or hypoxia (group 3). In patients with chronic obstructive pulmonary disease (COPD), the prevalence of pulmonary hypertension increases with COPD severity. It is found in 20% of patients who have been hospitalized and in more than 50% of patients with end-stage disease.11 After an acute pulmonary embolism, one study found a 3.8% incidence of chronic thromboembolic pulmonary hypertension (group 4) after two years.12 Group 5 is multifactorial in etiology and best characterized in the setting of sickle cell disease, where it is an independent predictor of mortality.13,14 The prevalence of pulmonary hypertension increases with age. A population-based study in Minnesota estimated that the total prevalence could reach 10% to 20% in the general population.15

AMERICAN FAMILY PHYSICIAN Table 1. Clinical Classification of Pulmonary Hypertension Classification

Targeted treatment available?

Group 1*: Pulmonary arterial hypertension

Yes

Including idiopathic, heritable, and HIV-associated; systemic sclerosis and other connective tissue disease; congenital heart disease; schistosomiasis; drug- and toxin-induced Group 2: Pulmonary hypertension due to left heart disease

Including systolic and diastolic dysfunction and valvular heart disease Group 3: Pulmonary hypertension due to lung diseases and/or hypoxia

Including chronic obstructive pulmonary disease, sleep-disordered breathing, and interstitial lung disease Group 4: Chronic thromboembolic pulmonary hypertension

Yes

Group 5: Multifactorial pulmonary hypertension

Including metabolic, systemic, and hematologic disorders (sickle cell disease), and others HIV = Human immunodeficiency virus. *Also includes 1’ (pulmonary venoocclusive disease and/or pulmonary capillary hemangiomatosis) and 1” (persistent pulmonary hypertension of the newborn). Information from references 3, 4, and 6.

There is limited evidence to guide screening for pulmonary hypertension in asymptomatic individuals, even in high-risk groups, which leads to significant delays in diagnosis. A multicenter retrospective study of patients with idiopathic pulmonary arterial hypertension found a mean time from symptom onset to diagnosis of 47 (± 34) months encompassing 5.3 (± 3.8) primary care visits and evaluation by 3.0 (± 2.1) subspecialists.16 Registries from the United Kingdom and Ireland show that in patients older than 50 years, the median duration of symptoms at diagnosis was 24 months vs. 12 months for patients younger than 50 years. This likely reflects the challenges of diagnosis in patients with comorbidities.5 Reducing this delay allows initiation of therapy before right heart failure develops.1 Independent of classification, pulmonary hypertension can cause progressive, disabling symptoms, as well as increases in morbidity and mortality. For example, pulmonary hypertension status in patients who also have COPD may be more predictive of mortality than pulmonary function markers, such as forced expiratory volume in one second or diffusing capacity.11 Patients with pulmonary arterial hypertension have a 36% five-year mortality rate.17 PATHOPHYSIOLOGY The mechanisms that increase pulmonary pressures can act primarily on the pulmonary arterial bed or venous bed, either alone or in combination.3,18 Pulmonary arterial hypertension is characterized by progressive narrowing of distal pulmonary arteries

attributed to a variety of pathologic insults, such as arterial vasoconstriction, medial hypertrophy, intimal proliferation, and fibrosis.19 There are some genetic associations, such as BMPR2, but these are insufficient to explain the pathogenesis without other contributing factors.20 Pulmonary hypertension due to left heart disease is primarily a pulmonary venous process and likely results from passive pulmonary venous congestion with vasoconstriction and venous remodeling.3,9 In pulmonary hypertension due to lung disease and/or hypoxia, increases in pulmonary arterial pressures may arise from destruction of the alveolar capillary bed or chronic hypoxic vasoconstriction.3 Chronic thromboembolic pulmonary hypertension develops following thrombotic macrovascular obstruction with subsequent vasoconstriction and remodeling of the pulmonary arterial bed.19 Regardless of the mechanism, persistently increased pulmonary arterial pressure strains the thin-walled right ventricle. Adapted to the low-pressure pulmonary circulation, the right ventricle is unable to sustain cardiac output with these pressures.3 Ultimately, right ventricular failure is the most common cause of death in patients with pulmonary hypertension.21 SCREENING AND DIAGNOSTIC EVALUATION There are no data to support screening of asymptomatic individuals for pulmonary hypertension, even in high-risk groups such as those with a family history of pulmonary arterial hypertension without known BMPR2 mutations.3,22 For patients with systemic sclerosis and related diseases, expert opinion suggests

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AMERICAN FAMILY PHYSICIAN annual screening with laboratory testing (including brain natriuretic peptide), electrocardiography, and pulmonary function testing, followed by echocardiography.3,8 Expert consensus recommends annual echocardiography in patients with sickle cell disease and those with known BMPR2 mutations.3,14 Recognizing pulmonary hypertension in patients presenting with new signs or symptoms can be difficult because many symptoms are common and associated with an extensive differential diagnosis (Table 21-3,22). Pulmonary hypertension should be considered in patients with chronic illness and symptoms that are disproportionate to the underlying disease or poorly responsive to treatment. A stepwise approach can minimize the risks and costs of unnecessary testing (Figure 1). Physicians should initially consider the history, clinical findings, and targeted noninvasive testing, particularly echocardiography. Patients presenting with signs of advanced pulmonary hypertension (right heart failure or syncope) should be promptly evaluated with echocardiography. Some patients require right heart catheterization, which is important for classification and subsequent treatment options.1 However, not all patients with evidence of pulmonary hypertension on noninvasive testing need catheterization. For example, those with mildly increased systolic pulmonary arterial pressure (i.e., less than 35 mm Hg) and an established precipitating diagnosis often do not need catheterization. Echocardiography is the initial noninvasive diagnostic test, according to national guidelines.1-3,22 It is readily available and provides information about abnormalities in undiagnosed patients. An estimated systolic pulmonary arterial pressure of 35 to 40 mm Hg or greater on echocardiography is suggestive of pulmonary hypertension.1,21,22 Echocardiography also assesses right heart function, which is needed for diagnosis and monitoring disease progression.21 A meta-analysis calculated the accuracy of echocardiography vs. right heart catheterization for diagnosing pulmonary hypertension and found a sensitivity of 83% (95% confidence interval [CI], 73 to 90), a specificity of 72% (95% CI, 53 to 85), and an odds ratio of 13 (95% CI, 5 to 31).23 Elevated systolic pulmonary arterial pressure occurs in other conditions (Table 321-23), and echocardiography and right heart catheterization results can be disparate. In an observational U.S. cohort study, approximately 60% of echocardiography

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Table 2. Findings Suggestive of Pulmonary Hypertension History Angina Dyspnea on exertion Exercise intolerance Fatigue History of medical illness associated with pulmonary hypertension Syncope or presyncope Physical examination Abnormal pulse oximetry, elevated jugular venous pressure, ascites, lower extremity edema, right ventricular heave, tricuspid regurgitation murmur (increased pulmonic component of S2) Signs of right heart failure Office-based diagnostic tests Chest radiography: right ventricular enlargement, engorged pulmonary arteries Electrocardiography: right ventricular enlargement, right bundle branch block, right ventricular strain pattern, S1Q3T3 pattern Laboratory studies: elevated brain natriuretic peptide level

estimates of systolic pulmonary arterial pressure had a difference of more than 10 mm Hg vs. catheterization.24 On meta-analysis, the correlation between systolic pulmonary arterial pressure on echocardiography compared with heart catheterization was 0.70 (95% CI, 0.67 to 0.73).23 Additional testing, including right heart catheterization, depends on the differential and the treatment response.3 For example, if chronic thromboembolic pulmonary hypertension is suspected, a ventilation-perfusion scan is part of the initial evaluation, but in a patient with underlying chronic lung disease, pulmonary function tests should be performed.3,25 Subspecialty consultation may be useful, particularly for patients with symptoms that progress despite treatment of comorbidities.3 TREATMENT The diagnostic classification of pulmonary hypertension determines the treatment options. Evidence supporting targeted treatment is available only for pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension.1,22 For the other classes, there are no data on treatment effectiveness, and for some therapies, there is evidence of harm. For example, in the Choosing Wisely campaign, treatment with advanced vasoactive agents is recommended only for the management of pulmonary arterial hypertension.26

AMERICAN FAMILY PHYSICIAN Evaluation of Suspected Pulmonary Hypertension in Primary Care Signs and symptoms suggestive of pulmonary hypertension (Table 2)

Office-based diagnostic tests: chest radiography, electrocardiography, complete blood count, comprehensive metabolic panel, brain natriuretic peptide, others as clinically indicated* (if high suspicion, go to A )

Alternative diagnosis clearly supported? Yes

Symptoms respond as expected to treatment of alternative diagnosis? Yes

No A Perform echocardiography

Manage alternative diagnosis as appropriate

Systolic pulmonary arterial pressure ≥ 35 to 40 mm Hg or other sign†?

Yes

After reconsideration of alternative diagnoses, does suspicion for pulmonary hypertension remain high?

No Manage alternative diagnosis as appropriate

Is a common cause of elevated systolic pulmonary arterial pressure apparent (Table 3)? Additional targeted testing may be considered‡

Yes Repeat echocardiography or expert referral

Yes

Suspected group 1 or 4 pulmonary hypertension

Symptoms improve after optimizing treatment of the underlying illness per guidelines?

Yes§

No Expert referral/right heart catheterization

Monitor for clinical worsening; consider follow-up echocardiography

Figure 1. Suggested algorithm for the evaluation of suspected pulmonary hypertension in primary care. *Human immunodeficiency virus or rheumatologic evaluation. †Other signs suggestive of pulmonary hypertension include right ventricular or right atrial enlargement, right ventricular hypertrophy, high-velocity regurgitant jet, or flattening of the interventricular septum. ‡Pulmonary function test, sleep study, ambulatory pulse oximetry, chest computed tomography, or other testing based on clinical suspicion. §Consistent with, but not diagnostic of, group 2, 3, or 5 pulmonary hypertension.

Pulmonary Arterial Hypertension Drug development has focused on the treatment of patients with pulmonary arterial hypertension. Studies are limited by short follow-up periods and a lack of patient-centered outcomes.1,22 Patients should have a right heart catheterization and subspecialty referral before initiation of vasodilator or other targeted therapies.1-3 Patients without symptoms or evidence of functional impairment (using a six-minute walk test) should generally be monitored without therapy.1 After symptoms develop, patients with acute vasoreactivity

on right heart catheterization should begin a trial of calcium channel blockers.1 Patients with a mean pulmonary arterial pressure decrease of more than 10 mm Hg to less than 40 mm Hg and with an unchanged or increased cardiac output when challenged are considered vasoreactive.3 Other treatments may include an endothelin receptor antagonist (bosentan), a phosphodiesterase type 5 inhibitor (sildenafil), or a soluble guanylate cyclase stimulator (riociguat).1 Further treatment may include parenteral or inhaled prostanoids, such as epoprostenol, and newer oral prostacyclin agents, such as selexipag and treprostinil.1,27

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AMERICAN FAMILY PHYSICIAN Table 3. Common Causes of Elevated Systolic Pulmonary Arterial Pressure* Chronic lung disease and sleep disorders (including chronic obstructive pulmonary disease and obstructive sleep apnea) High cardiac output states (e.g., anemia, hyperthyroidism) Hypertension Left heart disease, including heart failure with preserved or reduced ejection fraction Obesity Volume overload, particularly in heart failure or in the setting of dialysis and chronic kidney disease *Other than increased vascular resistance. Information from references 21 through 23.

Pulmonary Hypertension Due to Left Heart Disease The focus for these patients is optimizing the underlying heart disease and controlling comorbidities.3,9,10 This includes management of hypertension and heart failure, and addressing significant valvular disease when present. Control of fluid volume and diuretic therapy are essential, particularly in patients with a history of volume overload or right heart failure.10 Vasodilators are not recommended for the treatment of pulmonary hypertension due to left heart disease.10,26

Pulmonary Hypertension Due to Lung Disease The treatment of pulmonary hypertension due to lung disease should focus on managing the underlying lung disease and optimizing treatment of other comorbidities.3,11 Lung disease should be treated according to the best available evidence.28,29 Patients with COPD and arterial oxygen pressures less than 60 mm Hg should receive supplemental oxygen, which may improve mortality by lowering pulmonary arterial pressures.11,29 Patients should be screened for obstructive sleep apnea and treated when necessary.2,30 Patients with hypoxic lung disease may benefit from supplemental oxygen to maintain saturation greater than 90%.11 The use of vasodilators in chronic lung disease may worsen ventilation-perfusion mismatching.11,26 Patients with chronic lung disease and severe pulmonary hypertension should consult with a subspecialist.11

Chronic Thromboembolic Pulmonary Hypertension A pulmonary endarterectomy performed at a center of excellence can be curative and is first-line therapy in patients with chronic thromboembolic pulmonary

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hypertension who are surgical candidates. Patients who are not surgical candidates can be considered for targeted medical therapies also used to treat pulmonary arterial hypertension. Regardless of the treatment, these patients should receive lifelong anticoagulation therapy in the absence of contraindications.25

Multifactorial Pulmonary Hypertension There are limited data on the treatment of pulmonary hypertension for most of the etiologies in this group. In patients with sickle cell disease, guidelines recommend initiating hydroxyurea in patients with elevated mortality risk. Chronic transfusion therapy is a second-line option. The use of therapies targeted at pulmonary arterial hypertension is strongly discouraged.14 OTHER CONSIDERATIONS

Immunization Patients with pulmonary hypertension should have seasonal influenza vaccination. Age-based recommendations for pneumococcal vaccination should be followed, including use of the 23-valent pneumococcal polysaccharide vaccine for adults younger than 65 years.1,31,32

Perioperative Assessment Pulmonary hypertension is associated with increased morbidity and mortality during the perioperative period.1,33 The perioperative assessment should include an assessment of functional status, care goals, and alternatives to surgery.33 Echocardiography assessing right ventricular function can help determine surgical risk.33 Surgical management of patients with severe pulmonary hypertension should be performed with subspecialty consultation.1,33

Contraception There is an elevated risk of pregnancy complications in women with pulmonary hypertension and particularly pulmonary arterial hypertension. Current guidelines discourage pregnancy and recommend contraception counseling with emphasis on prescribing a long-acting, highly effective method of contraception.34

Mental Health and Patient Education An ethnographic study of patients with pulmonary hypertension found that many described uncertainty surrounding their prognosis and expressed feelings

AMERICAN FAMILY PHYSICIAN of isolation.35 Patients may benefit from resources available through the Pulmonary Hypertension Association (http://www.phassociation.org). REFERENCES 1. Taichman DB, Ornelas J, Chung L, et al. Pharmacologic therapy for pulmonary arterial hypertension in adults: CHEST guideline and expert panel report. Chest. 2014;146(2):449-475. 2. Galiè N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Eur Heart J. 2016;37(1):67-119. 3. McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/ AHA 2009 expert consensus document on pulmonary hypertension: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association: developed in collaboration with the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association [published correction appears in Circulation. 2009;120(2):e13]. Circulation.2009;119(16):2250-2294. 4. Hoeper MM, Bogaard HJ, Condliffe R, et al. Definitions and diagnosis of pulmonary hypertension. J Am Coll Cardiol. 2013;62(25 suppl):D42-D50. 5. Hoeper MM, Simon R, Gibbs J. The changing landscape of pulmonary arterial hypertension and implications for patient care. Eur Respir Rev. 2014;23(134):450-457. 6. Simonneau G, Gatzoulis MA, Adatia I, et al. Updated clinical classification of pulmonary hypertension [published correction appears in J Am Coll Cardiol. 2014; 63(7):746]. J Am Coll Cardiol. 2013;62(25 suppl): D34-D41. 7. George MG, Schieb LJ, Ayala C, Talwalkar A, Levant S. Pulmonary hypertension surveillance: United States, 2001 to 2010. Chest. 2014;146(2):476-495. 8. Coghlan JG, Denton CP, Grünig E, et al.; DETECT study group. Evidence-based detection of pulmonary arterial hypertension in systemic sclerosis: the DETECT study. Ann Rheum Dis. 2014;73(7):1340-1349. 9. Guazzi M, Borlaug BA. Pulmonary hypertension due to left heart disease. Circulation. 2012;126(8):975-990. 10. Vachiéry JL, Adir Y, Barberà JA, et al. Pulmonary hypertension due to left heart diseases. J Am Coll Cardiol. 2013;62(25 suppl):D100-D108.

after pulmonary embolism. N Engl J Med. 2004;350(22): 2257-2264. 13. Gladwin MT, Vichinsky E. Pulmonary complications of sickle cell disease. N Engl J Med. 2008; 359(21):2254-2265. 14. Klings ES, Machado RF, Barst RJ, et al. An official American Thoracic Society clinical practice guideline: diagnosis, risk stratification, and management of pulmonary hypertension of sickle cell disease. Am J Respir Crit Care Med. 2014;189(6):727-740. 15. Lam CS, Borlaug BA, Kane GC, Enders FT, Rodeheffer RJ, Redfield MM. Age-associated increases in pulmonary artery systolic pressure in the general population. Circulation. 2009;119(20):2663-2670. 16. Strange G, Gabbay E, Kermeen F, et al. Time from symptoms to definitive diagnosis of idiopathic pulmonary arterial hypertension: the delay study. Pulm Circ. 2013; 3(1):89-94. 17. Thenappan T, Shah SJ, Rich S, Tian L, Archer SL, GombergMaitland M. Survival in pulmonary arterial hypertension: a reappraisal of the NIH risk stratification equation. Eur Respir J. 2010;35(5):1079-1087. 18. Tuder RM, Archer SL, Dorfmüller P, et al. Relevant issues in the pathology and pathobiology of pulmonary hypertension. J Am Coll Cardiol. 2013; 62(25 suppl):D4-D12. 19. Humbert M. Pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension: pathophysiology. Eur Respir Rev. 2010;19(115):59-63. 20. Yuan JX, Rubin LJ. Pathogenesis of pulmonary arterial hypertension: the need for multiple hits. Circulation. 2005;111(5):534-538. 21. Vonk Noordegraaf A, Galiè N. The role of the right ventricle in pulmonary arterial hypertension. Eur Respir Rev. 2011;20(122):243-253. 22. Agency for Healthcare Research and Quality. Pulmonary arterial hypertension: screening, management, and treatment: executive summary. April 25, 2013. http://effectivehealthcare.ahrq.gov/ index.cfm/searchfor-guides-reviews-and-reports /?productid=1479&pageaction=displayproduct. Accessed August 18, 2015. 23. Janda S, Shahidi N, Gin K, Swiston J. Diagnostic accuracy of echocardiography for pulmonary hypertension: a systematic review and meta-analysis [published correction appears in Heart. 2011;97(13):1112].Heart. 2011;97(8): 612-622.

11. Seeger W, Adir Y, Barberà JA, et al. Pulmonary hypertension in chronic lung diseases. J Am Coll Cardiol. 2013;62(25 suppl):D109-D116.

24. Farber HW, Foreman AJ, Miller DP, McGoon MD. REVEAL registry: correlation of right heart catheterization and echocardiography in patients with pulmonary arterial hypertension. Congest Heart Fail. 2011;17(2):56-64.

12. Pengo V, Lensing AW, Prins MH, et al.; Thromboembolic Pulmonary Hypertension Study Group. Incidence of chronic thromboembolic pulmonary hypertension

25. Kim NH, Delcroix M, Jenkins DP, et al. Chronic thromboembolic pulmonary hypertension. J Am Coll Cardiol. 2013;62(25 suppl):D92-D99.

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AMERICAN FAMILY PHYSICIAN 26. Halpern SD, Becker D, Curtis JR, et al. An official American Thoracic Society/American Association of Critical-Care Nurses/American College of Chest Physicians/Society of Critical Care Medicine policy statement: the Choosing Wisely® top 5 list in critical care medicine. Am J Respir Crit Care Med. 2014;190(7):818-826. 27. Simonneau G, Torbicki A, Hoeper MM, et al. Selexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension. Eur Respir J. 2012;40(4):874-880. 28. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for diagnosis, management, and prevention of COPD—2016. http://goldcopd.org/globalstrategy-diagnosis-management-prevention-copd-2016/. Accessed June 10, 2016. 29. Vestbo J, Hurd SS, Agustí AG, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013;187(4): 347-365.

31. Kim DK, Bridges CB, Harriman KH. Advisory Committee on Immunization Practices recommended immunization schedule for adults aged 19 years or older—United States, 2016. MMWR Morb Mortal Wkly Rep. 2016;65(4):88-90. 32. Tomczyk S, Bennett NM, Stoecker C, et al.; Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2014;63(37):822-825. 33. Klinger JR, Frantz RP, eds. Diagnosis and Management of Pulmonary Hypertension. New York, NY: Humana Press; 2015:437-464. 34. Olsson KM, Jais X. Birth control and pregnancy management in pulmonary hypertension. Semin Respir Crit Care Med. 2013;34(5):681-688. 35. Kingman M, Hinzmann B, Sweet O, Vachiéry JL. Living with pulmonary hypertension: unique insights from an international ethnographic study. BMJ Open. 2014;4(5):e004735.

30. Arias MA, García-Río F, Alonso-Fernández A, Martínez I, Villamor J. Pulmonary hypertension in obstructive sleep 36. Stringham R, Shah NR. Pulmonary arterial hypertension: apnoea: effects of continuous positive airway pressure: an update on diagnosis and treatment. Am Fam Physician. a randomized, controlled cross-over study. Eur Heart J. 2006;27(9):1106-1113. 2010;82(4):370-377. ■■■■

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AMERICAN FAMILY PHYSICIAN

Practice Guidelines AAFP RELEASES POSITION PAPER ON PRECONCEPTION CARE Preconception care is defined as personalized care for men and women that is focused on reducing maternal and fetal morbidity and mortality, increasing chances of conception, and preventing unintended pregnancies. Family physicians have the opportunity to discuss risk factors that negatively impact maternal and infant health such as being overweight, smoking, hypertension, and diabetes mellitus. There are multiple barriers to providing comprehensive preconception care. Usually, preconception is focused on patients planning a pregnancy. Because one-half of U.S. pregnancies are reported as unintended, the timing of addressing preconception is a challenge. Most women recognize the need for counseling before conception to achieve optimal health outcomes, but the majority reported that they did not receive any counseling, and most physicians did not provide or recommend counseling to their patients of reproductive age. The American Academy of Family Physicians (AAFP) has released a position paper providing evidencebased recommendations that address reproductive health care.

Preconception Interventions for Women A womanâ&#x20AC;&#x2122;s reproductive plan should be discussed at each visit because her plans may change depending on life circumstances. These discussions should include risks due to age, maternal or paternal conditions, and obstetric and family history. Women who wish to prevent pregnancy should be offered contraceptive methods approved by the U.S. Food and Drug Administration, an assessment to identify safe methods, counseling to help choose a contraceptive method, and prompt delivery of the contraceptive method selected. Shared decision making and tailored information should focus on patient preferences. Routine counseling about emergency contraception should also be available when needed.

Source: Adapted from Am Fam Physician. 2016;94(6):508-510.

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Overall health and management of chronic conditions are essential for proper preconception care. Women of reproductive age should take a daily supplement of 400 to 800 mcg of folic acid, starting before conception and continuing through 12 weeks of pregnancy, and consume a balanced diet of folate-rich foods to reduce the risk of neural tube defects. Obesity, chronic hypertension, diabetes, and lifestyle risks (e.g., use of alcohol, tobacco, illicit substances) can lead to pregnancy complications and should be addressed, as well as counseling on medication use. Many commonly prescribed medications are considered unsafe in pregnancy and it may be necessary to switch to safer medications before conception. A mental health assessment should be included in preconception care because mood and anxiety disorders are highly prevalent in women of reproductive age, with a high prevalence of relapse of a previously diagnosed mental health disorder or a new-onset disorder in pregnancy. Treatment for these disorders during pregnancy should be individualized. Immunization status should be evaluated annually in all women of reproductive age. Table 1 shows general recommendations preconception interventions for women.

for

Preconception Interventions for Men The Centers for Disease Control and Prevention and the U.S. Department of Health and Human Services have recognized the need for improvements in meeting menâ&#x20AC;&#x2122;s reproductive health needs. The objective of preconception interventions for men is to ensure positive outcomes of their reproductive and sexual behaviors, while minimizing negative consequences of unhealthy lifestyle choices. Men should be counseled on contraception, overcoming fertility issues, ensuring a healthy pregnancy for his partner, and ensuring optimal postpartum outcomes for his partner and child (Table 2). Fertility and Conception Studies have identified several factors that affect sperm quality, quantity, concentration, and motility. Health concerns such as diabetes, erectile dysfunction, and testicular conditions may affect fertility. Certain medications can alter the hypothalamic-pituitarygonadal axis, contribute to reduced male libido

AMERICAN FAMILY PHYSICIAN and erectile dysfunction, and have toxic effects on sperm. Tobacco, alcohol, and drug use can affect spermatogenesis. Other factors that can affect sperm quality and production are stress, obesity, genetic disorders, and exposure to certain hazardous materials. Effects on Maternal and Fetal Outcomes A man’s lifestyle factors can directly impact his partner’s pregnancy (e.g., tobacco smoking, sexually transmitted infections). Secondhand smoke can lead to low birth weight, intrauterine growth restriction, and preterm birth, as well as increase the risk of sudden infant death

syndrome. Paternal involvement during pregnancy can have a positive effect on health outcomes for himself, his partner, and child. During wellness visits, physicians have the opportunity to discuss issues such as intimate partner violence and coercive relationships, and to promote consensual sexual relationships. A link between paternal genetics and age and conditions such as autism and schizophrenia has been found. Screening for genetic conditions should be discussed and offered if needed. Note: For complete article visit: www.aafp.org/afp.

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Photo Quiz BILATERAL PRURITIC AURICULAR PAPULES AND PLAQUES

was otherwise unremarkable. A punch biopsy of the plaque was performed.

A 59-year-old woman presented with several years of persistent and worsening bilateral pruritic auricular lesions. The rash was limited to the ears, and the patient did not have a history of a similar rash on other areas of her body. She reported rubbing and scratching her ears often. A trial of ketoconazole shampoo and triamcinolone cream was ineffective.

Question

Examination revealed cobblestoned, slightly keratotic, brown papules and plaques on the concave surfaces of both ears (Figures 1 and 2). The physical examination

Figure 1.

Based on the patientâ&#x20AC;&#x2122;s history and physical examination findings, which one of the following is the most likely diagnosis? A. Amyloidosis. B. Colloid milium. C. Flat warts. D. Intertriginous granular parakeratosis.

Figure 2.

SEE THE FOLLOWING PAGE FOR DISCUSSION

Source: Adapted from Am Fam Physician. 2016;94(6):486-489.

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AMERICAN FAMILY PHYSICIAN Summary Table Condition

Characteristics

Area affected

Demographic affected

Amyloidosis

Highly pruritic, pigmented papules and plaques

Shins, upper back, auricular concha; other sites of chronic scratching

Adults

Colloid milium

Dome-shaped, translucent to yellow-brown papules

Sun-exposed areas

Middle-aged, fair-skinned individuals

Flat warts (verrucae plana)

Flat, flesh-colored papules

Face, dorsal hands, and shins are most common

Usually children

Intertriginous granular parakeratosis

Pruritic, brownish-red, keratotic papules that can coalesce into plaques

The axillae are most common, but Adult form almost always occurs in any intertriginous site can be affected women; childhood form in diaper area affects boys and girls equally

Discussion The answer is A: amyloidosis. Amyloid deposition in the skin can occur with systemic disease such as multiple myeloma, in which amyloid is derived from immunoglobulin light chains. It can also occur without systemic disease in primary localized cutaneous variants of amyloidosis in which amyloid is derived from epidermal keratin. Auricular amyloidosis, also known as amyloidosis of the auricular concha or collagenous papules of the ear, is a variant of primary localized cutaneous amyloidosis.1,2 Patients present with papules or plaques limited to the auricular concha. Lichen amyloidosis is another form that presents on the front of the shins and extensor aspect of the forearms.3 The calves, ankles, dorsal feet, thighs, and trunk may also be affected.4 The punch biopsy revealed pale homogenous eosinophilic globules in the papillary dermis (Figure 3), which is characteristic of amyloid deposition. The Congo red stain was reactive. Chronic irritation to the skin has been proposed as the etiology of the amyloid deposition in primary localized cutaneous amyloidosis.5 The chronic damage to the epidermis is thought to induce apoptosis of keratinocytes, leading to amyloid deposition high in the papillary dermis.6 Histochemically, the amyloid stains selectively with Congo red, leading to the characteristic apple-green birefringence under polarized light.1 Colloid milium is a rare disorder in which dome-shaped, translucent to yellow-brown papules develop in sunexposed areas of the skin. It is thought to be related to photo-induced damage to dermal elastic fibers. On histopathology, nodules composed of homogenous eosinophilic colloid material are seen in the papillary dermis with a staining profile similar to amyloidosis.7 Flat warts, or verrucae plana, appear as flat, fleshcolored papules. The warts are caused by human papillomavirus types 2, 3, and 10. The presentation can

Figure 3. Punch biopsy showing pale homogenous eosinophilic globules in the papillary dermis, which is characteristic of amyloid deposition.

vary from a few solitary papules to numerous confluent papules. Histologic examination reveals hyperkeratosis with cytoplasmic vacuolation of the keratinocytes in the upper part of the stratum spinosum.8 Intertriginous granular parakeratosis presents as pruritic, brownish-red, keratotic papules that can coalesce into plaques in intertriginous sites, such as the axillae. It is thought to be caused by a keratinization disorder. The histopathology is characterized by parakeratosis with retention of basophilic granules within the areas of parakeratosis.9 REFERENCES 1. Mahalingam M, Steinberg-Benjes L, Goldberg LJ. Primary amyloidosis of the auricular concha â&#x20AC;&#x201C; a case report and review. J Cutan Pathol. 2000;27:564. 2. Mahalingam M, Palko M, Steinberg-Benjes L, Goldberg LJ. Amyloidosis of the auricular concha: an uncommon variant of localized cutaneous amyloidosis. Am J Dermatopathol. 2002;24(5):447-448.

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AMERICAN FAMILY PHYSICIAN 3. Salim T, Shenoi SD, Balachandran C, Mehta VR. Lichen amyloidosus: a study of clinical, histopathologic and immunofluorescence findings in 30 cases. Indian J Dermatol Venereol Leprol. 2005;71(3):166-169. 4. Brownstein MH, Helwig EB. The cutaneous amyloidoses. I. Localized forms. Arch Dermatol. 1970;102(1):8-19. 5. MacSween RM, Saihan EM. Nylon cloth macular amyloidosis. Clin Exp Dermatol. 1997;22(1):28-29.

7. Pourrabbani S, Marra DE, Iwasaki J, Fincher EF, Ronald LM. Colloid milium: a review and update. J Drugs Dermatol. 2007;6(3):293-296. 8. Prose NS, Von Knebel-Doeberitz C, Miller S, Miller PB, Meilman E. Widespread flat warts associated with human papillomavirus type 5: a cutaneous manifestation of human immunodeficiency virus infection. J Am Acad Dermatol. 1990;23(5 pt 2):978-981.

9. Ding CY, Liu H, Khachemoune A. Granular parakeratosis: 6. Weyers W, Weyers I, Bonczkowitz M, Diaz-Cascajo C, a comprehensive review and a critical reappraisal. Am J Schill WB. Lichen amyloidosus: a consequence of Clin Dermatol. 2015;16(6):495-500. scratching. J Am Acad Dermatol. 1999;37(6):923-928. ■■■■

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DERMATOLOGY

To Study the Prevalence of Metabolic Syndrome and Dyslipidemia in Patients of Xanthelasma Palpebrarum at a Tertiary Care Hospital SWATI GONDANE*, ASHOK MEHERDA†, RAJKUMAR KOTHIWALA‡

ABSTRACT Background: Xanthelasma palpebrarum (XP) are yellow plaques that occur most commonly near the inner canthus of the eyelid, more often on the upper lid than the lower lid and are often associated with dyslipidemia, metabolic syndrome, cardiovascular disease, diabetes, obesity, etc. Aim: This study was planned to address the issue of prevalence of dyslipidemia and metabolic syndrome in xanthelasma patients attending dermatology clinic at a tertiary care hospital, Ajmer. Material and methods: A total of 73 patients were detected to be having xanthelasma and constituted the study group. The control group constituted 73 apparently normal individuals. Each patient underwent detailed history and examination. Body mass index (BMI), waist circumference, arterial blood pressures, fasting plasma glucose (FPG), serum lipids and liver enzyme levels were estimated in cases and controls. Results: The most prevalent age group was 40-50 years. Females outnumbered males. Dyslipidemia was present in 63% and metabolic syndrome in 45.2% of cases. The mean levels of FPG, BMI, waist circumference in XP patients were significantly higher in patients than those in controls. Conclusions: A significant number of cases of XP are found to be associated with metabolic syndrome, central obesity, hypertension, diabetes mellitus and dyslipidemia which are the major risk factors for coronary artery diseases. Efforts should be made to rule out the same in xanthelasma subjects.

Keywords: Xanthelasma, dyslipidemia, metabolic syndrome

anthelasma palpebrarum (XP) (Greek; xanthos: yellow and elasma: beaten metal plate) are yellow plaques that occur commonly near the inner canthus of the eyelid, more often on the upper lid.1 Xanthelasma can be soft, semisolid or calcareous, and are frequently symmetrical with all four-eyelid involvement. They have a tendency to progress, coalesce and become permanent. Xanthelasma represent areas of macrophage-containing lipids, primarily cholesterol esters, but the exact pathogenesis is not known.2 Xanthelasma are composed of xanthoma cells which are foamy histiocytes laden with intracellular fat deposits primarily within the upper reticular dermis. Most studies have found increased concentrations of

*3rd Year Resident †Professor and Head ‡Associate Professor Dept. of Dermatology, Venereology and Leprology JLN Medical College, Ajmer, Rajasthan Address for correspondence Dr Swati Gondane 784, Ahuja Nagar, Jariptka, Nagpur - 40014, Maharashtra E-mail: swati.gondane2004@gmail.com

plasma total cholesterol or low-density lipoprotein (LDL) cholesterol in people with xanthelasma. It has been known to be associated with atherosclerosis, coronary artery disease (CAD), insulin resistance, diabetes mellitus (DM), hypertension, stroke, dyslipidemia, obesity and hyperuricemia. However, it is still controversial whether such lesions are a marker for cardiovascular or metabolic disease or not. A study was planned to address the issue of prevalence of metabolic syndrome and dyslipidemia in xanthelasma patients attending dermatology clinic at our center. MATERIAL AND METHODS This study was conducted in the Dept. of Dermatology at JLN Medical College, Ajmer, Rajasthan from January 2013 to July 2014. Seventy-three clinically diagnosed cases of XP were selected after informed consent and these constituted the study group. Control group was age- and gender-matched apparently healthy participants with no xanthelasma, randomly selected from the outpatient clinic. Exclusion criteria were patients taking any drugs that could alter lipid level or blood glucose level, patient

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DERMATOLOGY having concomitant disorder(s) that could affect the outcome of the study. Each patient underwent detailed history and physical examination including height, weight, waist and hip circumference. Body mass index (BMI) was calculated for the participants in both groups and obesity was defined by BMI 30 or greater. All blood pressure (BP) measurements were taken with standard calibrated mercury manometers in the right arm of each individual in a sitting position after a rest of 5 minutes. Fasting blood samples were collected after 14-hour fasting. All cases underwent lipid profile study (total cholesterol [TC], LDL cholesterol, highdensity lipoprotein [HDL] cholesterol, very low-density lipoprotein [VLDL], triglycerides [TGs]) on empty stomach. Dyslipidemia: Abnormal lipid levels were diagnosed according to the National Cholesterol Education Program-Adult Treatment Panel III (NCEP-ATP III) guidelines. Metabolic syndrome: According to the third report of the NCEP-ATP III, adults to be diagnosed with metabolic syndrome must have three or more of the following: ÂÂ

Waist circumference >102 cm (40.2 in) in men and >88 cm (35.6 in) in women

ÂÂ

Serum TGs ≥150 mg/dL

ÂÂ

BP ≥130/85 mmHg

ÂÂ

HDL cholesterol <40 <50 mg/dL in women

ÂÂ

Fasting plasma glucose (FPG) >6.1 mmol/L (≥100 mg/dL).

TC levels were increased in 46 cases (63.01%) as compared to 20 controls (27.4%). Similarly, LDL cholesterol and TG levels were also increased in 52 cases (71.2%) as compared to 29 controls (39.72%) and in 29 cases (39.7%) as compared to 17 (23.3%) controls, respectively. HDL levels were decreased in 34 cases (46.6%) as compared to 22 controls (30.1%). VLDL cholesterol was increased in 29 cases (39.7%) and 17 controls (23.3%). Mean values of TC, LDL cholesterol and TG levels were increased compared to control group with significant p value. Mean value of HDL cholesterol was found to be decreased compared to control group with significant p value; however, p value was not found to be significant in mean value of VLDL cholesterol compared to controls (Table 1). Nearly, 18 (24.66%) patients and 8 (11%) controls were diagnosed with DM according to the American Diabetes Association (ADA) criteria and this difference was statistically significant (p = 0.0305). Table 1. Relationship Between Various Cholesterol Fractions and XP in Cases and Controls

mg/dL

men

and

Data were statistically described in terms of mean (standard deviation), frequency (number of cases) and percentages when appropriate. Comparison of quantitative variables between the study groups was carried out using the Student’s t-test and Chi-squared test, respectively. Statistical analysis was carried out using graphpad software. RESULTS The total number of cases of xanthelasma and controls was 73. The youngest case with XP was 30 years, while the eldest was 73 years. Mean age of the cases being 51.18 and that of controls 52.01 with a ‛t’ value of 0.4829 and p value of 0.6299 making the two groups statistically comparable. Prevalence was the highest in the age group of 40-50 years (33%). Prevalence was higher in females (82.2%) as compared to males (17.8%). Most of the cases (93.15%) were Hindus, while 6.85%

1024

were Muslims. While xanthelasma was found mostly bilaterally (56 cases; 76.72%), unilateral presentation was found in 17 cases (23.28%). In 9 cases (12.32%), it was present on all four eyelids. Family history of XP was obtained in 8 cases (10.95%) in our study.

Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

Mean

t value

P value*

Cases

212.6

(34.8)

4.9843

Control

181.8

(39.6)

<0.0001 Highly significant

Cases

137.3

(23.52)

3.4434

Control

124.3

3 (21.92)

P = 0.0008 Highly significant

Cases

41.33

(7.87)

2.288

Control

44.35

(8.09)

P = 0.0236 Significant

Cases

152.29

(70.09)

2.1352

Control

132.27

(38.74)

P = 0.0344 Significant

Cases

30.10

(15.89)

0.9445

Control

27.8

(12.18)

P = 0.3465 Not significant

LDL

HDL

VLDL

XP = Xanthelasma palpebrarum; TC = Total cholesterol; LDL = Low-density lipoprotein; HDL = High-density lipoprotein; TG = Triglyceride; VLDL = Very low-density lipoprotein; SD = Standard deviation. *P < 0.05 is considered to be statistically significant.

DERMATOLOGY Table 2. Comparision Between Various Metabolic Syndrome in XP Patients and Controls No. of the patients

P value*

↑ 48 (65.8%) N 25 (34.2%)

P = 0.0298 Significant

WC Cases Control

↑ 35 (48%)

N 38 (52%)

↑ 22 (30%)

N 51 (70%)

BP Cases Control

↑ 14 (19.2%) N 59 (80.8%)

P = 1.245 Not significant

HDL Cases

↓44 (60.3%)

N 29 (39.7%)

Control

↓31 (42.5%)

N 42 (57.5%)

Cases

↑29 (39.7%)

N 44 (60.3%)

Control

↑17 (23.3%)

N 56 (76.7%)

P = 0.0314 Significant

TG P = 0.0325 Significant

MS Cases Control

P 33 (45.2%) A 40 (54.8%)

P = 0.0002 P 12 (16.4%) A 61 (83.6%) Highly significant

XP = Xanthelasma palpebrarum; WC = Waist circumference; BP = Blood pressure; HDL = High-density lipoprotein; TG = Triglyceride; MS = Metabolic syndrome; ↑ = Increased; ↓ = Decreased; N = Normal; P = Disease present; A = Disease absent. *P < 0.05 is considered to be statistically significant calculated from Chi-squared test.

Metabolic syndrome was present in 45.2% (33 cases) in XP patients as compared to 16.4% (12 cases) in control group with significant p value (p = 0.0002). Individual components of metabolic syndrome like hypertriglyceridemia, decreased HDL cholesterol, impaired FPG and waist circumference were also more prevalent in cases than in controls (Table 2). However, systolic and diastolic BP were noted higher (22 cases, 30%) as compared to controls (14 cases, 19.2%) but p value was not found to be statistically significant (p = 1.245). Mean value for BMI in case group (27.71) was higher than control group (26.50) with significant p value (p = 0.0268). DISCUSSION Xanthelasma is fairly prevalent in our population. However, people tend to complain only for esthetic reasons. Most of our cases were not aware of the significance of these deposits. Age distribution was wide ranging from 21 to 73 years. We found the peak incidence between 40 and 60 years. This was similar as that reported by Gangopadadhya et al3 and Jain et al2 in their studies from Delhi. They found the majority

of patients in the age group of 31-50 years. XP was found more in females (82.2%) as compared to males (17.8%). This was in concurrence with the study done by Gangopadadhya et al, Jain et al, Epstein et al and Pedace et al.2-5 But Chhetri et al6 showed a male preponderance in his study. Jain et al, Chhetri and Reddy et al found a positive family history in 8.9% and 9.8% patients, respectively.2,6,7 Family history of XP was noted in our cases was 10.95% similar to 10% cases found positive family history by Vacca et al.8 Jain et al reported that 91% of patients had multiple lesions and 72.7% had both lids involvement. Two or more eyelids involvement was observed in 87.9% of the cases.2 Chhetri et al reported bilateral lesions in 39% cases, two eyelids involvement in 53.2% cases and one eyelid involvement in 7.8% cases.6 Ribera et al reported that 11.3% patients had only one eyelid involvement, 42.6% in two eyelids, 12.2% in three eyelids and 33.9% in four eyelids.9 In our study, 56 cases (76.72%) had bilateral lesions and 17 cases (23.28%) had unilateral lesions. Single lesions were present in 14 cases (19.18%) and multiple lesions were present in 59 cases (80.82%). We found associations with hypertension, dyslipidemia, metabolic syndrome and diabetes in a sizeable percentage of our patients. Increased TC value in xanthelasma patients have been observed by Gangopadadhya et al, Pedace et al, Epstein et al and Kahn et al.3-5,10 We also found similar results with TC levels increased in 46 cases (63%) as compared to 20 controls (27.4%) with p < 0.0001, making it highly significant. Increase LDL cholesterol levels have been observed by various authers.3,9,11-13 Except for study done by Vermeer et al,14 where it was found to be normal. This was in concurrence with our study showing increased LDL cholesterol levels in 52 cases (71.2%) as compared to 29 controls (39.72%), which was more significant in comparison to other studies and was statistically significant with p value of 0.001. Gangopadadhya et al,3 Bates et al15 and Ribera et al9 observed a significant decrease in HDL cholesterol levels. Similar results were shown in our study, which observed that decrease in HDL cholesterol in 34 cases (46.6%) as compared to 22 control (30.1%) with a significant p value of 0.0411. We found TGs were increased in 29 cases (39.7%) and 17 controls (23.2%) with a significant p value of 0.0325 as observed by many authors,2,3,6,10,16 although there were no comparison with controls by some authors. These findings were not similar to study done by

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DERMATOLOGY Ribera et al in which 5.21% cases and 6.66% controls showed hypertriglyceridemia.9 Watanabe et al reported that VLDL levels were significantly above the control levels (p = 0.001) in cases.11 Sharma et al and Jain et al observed a significant increase in VLDL levels in patients with xanthelasma as compared to controls (p < 0.01, p = 0.001).2,17 In our study, VLDL cholesterol were increased in 15 cases (20.5%) and 11 controls (15%) but difference was not found to be statistically significant (p = 0.3869). Jain et al2 found that 42.4% of patients had associated systemic diseases like hypertension, CAD, DM and cholelithiasis. Chhetri6 and Gangopadadhya3 reported cardiovascular disease (CVD) and hypertension in patients of XP in their studies. From western countries incidence of DM associated with XP was reported to be 6-34.2%.8,9 Clinical study done by Dey et al had observed prevalence of DM 18.03% in XP.18 In our study, 18 cases (24.66%) had DM as compared to 8 (11%) controls with significant p value (p = 0.0305). Various studies have observed that subjects with DM, hypertension, metabolic syndrome and dyslipidemia have increased risk of CVDs.19-21 We found metabolic syndrome was present in 45.2% (33 cases) in XP patients as compared to 16.4% (12 cases) in control group with significant p value (p = 0.0002). Individual components of metabolic syndrome like hypertriglyceridemia, decreased HDL cholesterol, impaired FPG, BMI and waist circumference were also observed more prevalent in cases than in controls. Whether or not xanthelasma alone can predict risk of CAD is still not clear, although studies have shown that it can. Christoffersen et al22 recently reported that xanthelasma can predict the risk of myocardial infarction, ischemic heart disease, severe atherosclerosis and death in the general population, independently of the well-known cardiovascular risk factors.18 At the end of this study, it was observed that there is a significant elevation in lipid profile in xanthelasma patients as compared to controls, thereby making lipid profile study mandatory for all patients. We also found significant association of DM and metabolic syndrome in xanthelasma patients as compared to controls. The presence of xanthelasma merits identification and treatment in order to prevent metabolic syndrome, which is gaining epidemic proportions in our country.

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REFERENCES 1. Dwivedi S, Jhamb R. Cutaneous markers of coronary artery disease. World J Cardiol. 2010;2(9):262-9. 2. Jain A, Goyal P, Nigam PK, Gurbaksh H, Sharma RC. Xanthelasma palpebrarum-clinical and biochemical profile in a tertiary care hospital of Delhi. Indian J Clin Biochem. 2007;22(2):151-3. 3. Gangopadadhya DN, Dey SK, Chanda M, Pal D, Chaudhuri S. Serum lipid profile in xanthelasma. Indian J Dermatol. 1998;43(2):53-7. 4. Epstein NN, Rosenman RH, Gofman JW. Serum lipoproteins and cholesterol metabolism in xanthelasma. AMA Arch Derm Syphilol. 1952;65(1):70-81. 5. Pedace FJ, Winkelmann RK. Xanthelasma palpebrarum. JAMA. 1965;193:893-4. 6. Chhetri MK, Chowdhury ND, De B. Xanthelasma palpebrarum: an analysis of 141 cases. J Assoc Physicians India. 1967;15(9):405-12. 7. Reddy BS, Singh G, Pandey SS, Tiwari D. Clinical and lipid profile studies in xanthelasma palpebrarum. Indian J Dermatol Venereol Leprol. 1983;49(3):127-131. 8. Vacca JB, Knight WA Jr, Broun GO Sr. Clinical observations regarding xanthelasma. Ann Intern Med. 1959;51:1019-31. 9. Ribera M, Pintó X, Argimon JM, Fiol C, Pujol R, Ferrándiz C. Lipid metabolism and apolipoprotein E phenotypes in patients with xanthelasma. Am J Med. 1995;99(5):485-90. 10. Kahán A, Kahán IL, Timár V. Lipid anomalies in cases of xanthelasma. Am J Ophthalmol. 1967;63(2):320-5. 11. Watanabe A, Yoshimura A, Wakasugi T, Tatami R, Ueda K, Ueda R, et al. Serum lipids, lipoprotein lipids and coronary heart disease in patients with xanthelasma palpebrarum. Atherosclerosis. 1981;38(3-4):283-90. 12. Segal P, Insull W Jr, Chambless LE, Stinnett S, LaRosa JC, Weissfeld L, et al. The association of dyslipoproteinemia with corneal arcus and xanthelasma. The Lipid Research Clinics Program Prevalence Study. Circulation. 1986; 73(1 Pt 2):I108-18. 13. Gómez JA, Gónzalez MJ, de Moragas JM, Serrat J, Gónzalez-Sastre F, Pérez M. Apolipoprotein E phenotypes, lipoprotein composition, and xanthelasmas. Arch Dermatol. 1988;124(8):1230-4. 14. Vermeer BJ, Mateysen AA, van Gent CM, van Sabben RM, Emeis JJ. The lipid composition and localization of free and esterified cholesterol in different types of xanthomas. J Invest Dermatol. 1982;78(4):305-8. 15. Bates MC, Warren SG. Xanthelasma: clinical indicator of decreased levels of high-density lipoprotein cholesterol. South Med J. 1989;82(5):570-4. 16. Ozdöl S, Sahin S, Tokgözoğlu L. Xanthelasma palpebrarum and its relation to atherosclerotic risk factors and lipoprotein (a). Int J Dermatol. 2008;47(8):785-9. 17. Sharma SB, Dwivedi S, Prabhu KM, Kumar N, Baruah MC. Preliminary studies on serum lipids, apolipoprotein-B and

DERMATOLOGY oxidative stress in xanthelasma. Indian J Clin Biochem. 1999;14(2):245-8.

disease in acute coronary syndrome. Arq Bras Cardiol. 2008;90(1):24-30.

18. Dey A, Aggarwal R, Dwivedi S. Cardiovascular profile of xanthelasma palpebrarum. Biomed Res Int. 2013;2013:932863.

21. Fallow GD, Singh J. The prevalence, type and severity of cardiovascular disease in diabetic and non-diabetic patients: a matched-paired retrospective analysis using coronary angiography as the diagnostic tool. Mol Cell Biochem. 2004;261(1-2):263-9.

19. Mishra TK, Das S, Patnaik UK, Routray SN, Behera M. Relationship of metabolic syndrome with quantum of coronary artery disease in Indian patients with chronic stable angina. Metab Syndr Relat Disord. 2004;2(3): 187-91.

22. Christoffersen M, Frikke-Schmidt R, Schnohr P, Jensen GB, Nordestgaard BG, Tybjærg-Hansen A. Xanthelasmata, arcus corneae, and ischaemic vascular disease and death in general population: prospective cohort study. BMJ. 20. Penalva RA, Huoya Mde O, Correia LC, Feitosa GS, Ladeia AM. Lipid profile and intensity of atherosclerosis 2011;343:d5497. ■■■■

Black Tattoos with Papulonodular Reactions are Markers of Sarcoidosis, Says Study A study of 92 tattoo reactions from a hospital material published February 7, 2017 in the journal Dermatology concluded that black tattoos with papulonodular reactions should be seen as markers of sarcoidosis. Of the 92 reactions with a papulonodular pattern, 27 (29%) reactions in 19 patients were diagnosed as cutaneous or systemic sarcoidosis, supported by histology, while 65 (71%) were diagnosed as nonsarcoidosis due to histology and no clinical sarcoid manifestations. "Rush phenomenon" with concomitant reaction in many other black tattoos, triggered by a recent tattoo with a papulonodular reaction, was observed in 70% in the sarcoidosis group and 28% in the nonsarcoidosis group.

Difference in Chronic Actinic Dermatitis in Patients with Lighter versus Darker Skin Type A retrospective evaluation of patients with chronic actinic dermatitis published March 22, 2017 in JAMA Dermatology has found that patients with darker skin types present at a younger age and are more frequently female compared with patients with a lighter skin type. Reactions to photopatch testing are also common in patients with chronic actinic dermatitis. Clinicians be aware of chronic actinic dermatitis in younger women with darker skin types.

Patients with Severe Psoriasis at Increased Cardiovascular Risk A study reported in the Australasian College of Dermatologists, February 27, 2017 has observed that patients with severe psoriasis smoked more heavily, were more likely to have diabetes or insulin resistance and had higher homocysteine and lower high-density lipoprotein cholesterol (HDL-C) levels than patients with mild psoriasis. In women, a higher waist circumference was observed.

Dupilumab Effectively Controls Symptoms of Moderate-to-severe Eczema One year results from the phase 3 randomized placebo-controlled CHRONOS trial of dupilumab presented March 4, 2017 at the American Academy of Dermatology Annual Meeting, which concluded yesterday in Orlando, Florida show that dupilumab can be used along with topical corticosteroids to safely control the symptoms of moderate-to-severe eczema such as itch over the long-term.

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DRUGS

An Open-label, Single-arm, Single-center, Clinical Study to Evaluate Safety and Efficacy of Heparin Sodium Topical Solution (1,000 IU/mL) in Prevention of Infusion-associated Superficial Thrombophlebitis PRAKASH KURMI

ABSTRACT Intravenous (IV) cannulation, to administer drugs, fluids, blood products and nutritional solutions, constitutes one of the most commonly carried out invasive procedures of hospital-based management. However, the use of IV cannula is often associated with the development of superficial thrombophlebitis. Topical heparin application at the site of cannulation is frequently done to prevent thrombophlebitis. Initiating prophylactic topical heparin, before thrombophlebitis sets in, i.e., from Day 1 of IV cannula insertion, can be more effective in preventing or delaying thrombophlebitis. The present study was undertaken to investigate the safety and efficacy of topical heparin sodium solution 1,000 IU/mL (Thrombotroy QPS, Troikaa Pharmaceuticals Limited) in preventing infusion-associated superficial thrombophlebitis when applied on the skin over the cannulated vein. Treatment with investigational product, heparin sodium topical solution (1,000 IU/mL) in a dose of 6 to 8 drops was applied on the skin over the cannulated vein immediately on cannulation and then applied approximately every 8 hours for the treatment period of 48 hours (total 7 doses). It was seen that topical heparin sodium solution (1,000 IU/mL) was safe and effective in preventing and/or delaying infusion-associated superficial thrombophlebitis when applied on the skin over the cannulated vein three times a day over a period of 48 hours after cannulation.

Keywords: Intravenous cannulation, topical heparin solution, infusion-associated superficial thrombophlebitis

ntravenous (IV) cannulation is an essential component of medical practice in the current times. It assists in the administration of drugs, fluids, blood products and nutritional solutions and constitutes one of the most commonly carried out invasive procedures in hospital-based management. However, maintaining a single indwelling IV cannula for long duration is associated with the development of superficial thrombophlebitis.1,2 In a study by Saini et al, conducted in an Indian tertiary care hospital, phlebitis associated with peripheral IV cannula was experienced by 29.8% of patients.2

prophylactic topical heparin, before thrombophlebitis sets in, i.e., from Day 1 of IV cannula insertion, can be more effective in preventing or delaying thrombophlebitis.1 Bhandari et al evaluated effects of topical anticoagulant ointment on post-infusion thrombophlebitis in 169 (84 test, 85 control) pediatric patients. Topical anticoagulant ointment decreased the incidence of thrombophlebitis if the duration of infusion was <12 hours and where the polythene cannula and latex rubber tubing set were used for infusion.3

Superficial thrombophlebitis is managed with topical heparin application for 7 days. Heparin prevents coagulation rather than lysing a formed clot. Initiating

Further, existing clinical evidence suggests that improving penetration of topical products can provide higher concentration and hence effectively manage superficial thrombophlebitis.

Shivam Medical Hospital C-4, Satyanarayan Society, Jashodanagar Cross Road, Gor No Kuvo Maninagar, Ahmedabad - 380 008, Gujarat E-mail: dr_prakashkurmi@yahoo.co.in

Based on these findings, a study was designed to determine the efficacy and safety of a topical Quick Penetrating Solution of heparin sodium 1,000 IU/mL (Thrombotroy QPS, Troikaa Pharmaceuticals Limited) in preventing infusion-associated superficial thrombophlebitis.

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Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

DRUGS OBJECTIVES The aim of the present study was to investigate the safety and efficacy of topical heparin sodium solution 1,000 IU/mL (Thrombotroy QPS, Troikaa Pharmaceuticals Limited) in preventing infusionassociated superficial thrombophlebitis when applied on the skin over the cannulated vein three times a day over a period of 48 hours after cannulation. The endpoints assessed included: ÂÂ

Occurrence of infusion-associated thrombophlebitis

superficial

ÂÂ

Delay in the development of infusion-associated superficial thrombophlebitis

ÂÂ

Occurrence of application site reactions.

DESIGN AND METHODOLOGY An open-label, single-arm clinical study was designed that enrolled 50 patients undergoing IV cannulation, planned to remain in situ for at least 48 hours indoor period. The investigational product was applied on the skin over the cannulated vein site every 8 hours for the treatment period of 48 hours (total 7 doses). Patients were monitored every 8 ± 1 hours from the time of cannulation for infusion phlebitis grade as per visual infusion phlebitis scale (Table 1)4 and application site reaction, if any. Patients with infusion phlebitis Grade II or above as per visual infusion phlebitis scale were to be discontinued from the study. The investigating doctor took informed written consent from all patients before enrollment using the Patient Information Sheet and Informed Consent Form. The study was conducted as per Table 1. Visual Infusion Phlebitis Score

the requirement of Indian Good Clinical Practice (GCP) guidelines. Study period was a maximum of 3 days: ÂÂ

Screening, enrollment and start of treatment (Day 1, cannulation)

ÂÂ

Monitoring for efficacy and safety (every 8 ± 1 hours from the time of cannulation)

ÂÂ

End of treatment (Day 3).

Treatment with investigational product was initiated immediately on cannulation and was applied approximately every 8 hours for the treatment period of 48 hours (total 7 doses). The investigator documented the observations on the case report forms (CRF). Concomitant medication taken for concomitant disease was also recorded in the CRF. The following medications were not permitted during the study treatment: ÂÂ

Anticoagulants systemically

locally

(in

the

cannula)

ÂÂ

Nonsteroidal anti-inflammatory drugs (NSAIDs) locally at IV site.

Inclusion Criteria Patients meeting the following criteria were included in the study: ÂÂ

Either gender, 18-65 years of age, undergoing elective surgery.

ÂÂ

Undergoing peripheral vein cannulation planned to remain in situ for at least 48 hours of indoor period.

ÂÂ

Willing and able to comply with study requirements (application of IP and study visit schedule, as indicated by written informed consent provided by the patient).

ÂÂ

If female of childbearing potential: Nonpregnant (supported by negative urine pregnancy test at screening), nonlactating and willing to maintain reliable birth control throughout the study.

IV site appears healthy

One of the following signs is evident: Slight pain near IV site or slight redness near IV site

Two of the following signs are evident: Pain at IV site, erythema, swelling

Exclusion Criteria

All of the following signs are found: Pain along path of cannula, erythema, induration

Patients meeting any of the following criteria were excluded from the study:

All of the following signs are evident and are extensive: Pain along path of cannula, erythema, induration, palpable venous cord

All of the following signs are evident and are extensive: Pain along path of cannula, erythema, induration, palpable venous cord, pyrexia

ÂÂ

Undergoing re-cannulation due to phlebitis at earlier cannulation site.

ÂÂ

Unconscious or comatose patients.

ÂÂ

History of hypersensitivity reaction to heparin or heparin-induced thrombocytopenia.

ÂÂ

Signs of systemic infection, bacteremia.

Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

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DRUGS ÂÂ

Planned administration of any of the following during study period:

the skin over the cannulated vein approximately every 8 hours for a period of 48 hours (total 7 doses).

Anticoagulants locally (in the cannula) or systemically

NSAIDs locally at IV site.

The following information was to be recorded for each adverse effect in the adverse events (AE) form provided in the CRF:

ÂÂ

Having participated in any clinical trial within last 30 days at the time of screening.

ÂÂ

Any disorder or condition that, in the opinion of investigator, would prohibit study participation or affect study outcome.

ÂÂ

Date of onset/reporting (if available)

ÂÂ

Date of resolution (if available)

ÂÂ

Severity - mild, moderate or severe

ÂÂ

Treatment, if any provided for the AE

ÂÂ

Outcome of AE (resolved, resolved with sequelae, ongoing, unknown or fatal)

ÂÂ

Is it expected or unexpected

ÂÂ

Is it serious (any effect that results in death, hospitalization/prolongation of hospitalization, congenital malformation, permanent disability or incapacity) or not.

Efficacy and Safety Measures

ÂÂ

0 + 1 hours: Within 1 hour of cannulation

ÂÂ

8 ± 1 hours: Between 7 to 9 hours of cannulation

ÂÂ

16 ± 1 hours: Between 15 to 17 hours of cannulation

ÂÂ

24 ± 1 hours: Between 23 to 25 hours of cannulation

ÂÂ

32 ± 1 hours: Between 31 to 33 hours of cannulation

ÂÂ

40 ± 1 hours: Between 39 to 41 hours of cannulation

ÂÂ

48 ± 1 hours: Between 47 to 49 hours of cannulation.

The patients were periodically monitored by an evaluator every 8 ± 1 hours (as per time points mentioned above) from cannulation for any application site reaction. The primary efficacy endpoints included: ÂÂ

Proportion of patients with infusion phlebitis (Grade II and above) during 48 hours of treatment period.

ÂÂ

Mean time to reach infusion phlebitis Grade II (or above) in hours: Depending on the time point when patient is first found to have phlebitis Grade II or above, mean time to reach phlebitis Grade II will be calculated in hours. For patients not reaching Grade II by 48 hours, it will be 48 hours.

The secondary efficacy endpoints included: ÂÂ

Incidence of first signs of phlebitis (Grade I).

ÂÂ

Mean time to reach infusion phlebitis Grade I (or above) in hours.

Treatment All enrolled patients were cannulated on back of the hand with IV cannula no. 18. The investigational product was heparin sodium topical solution (1,000 IU/mL). The dosage was 6 to 8 drops applied on

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Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

RESULTS Out of the enrolled patients, 11 were beyond the age limit mentioned in study design. Hence, data from those patients were not included in statistical analysis.

Efficacy Three out of 39 evaluated patients experienced Grade II phlebitis during the study period. As per the study plan, patients with phlebitis Grade II or above were discontinued from the study. It took a mean time of 46.36 hours to reach Grade II phlebitis after application of heparin sodium topical solution (1,000 IU/mL) every 8 hours. The proportion of patients with Grade II phlebitis is depicted in Figure 1.

Proportion of patients with Grade II phlebitis

Enrolled patients were periodically monitored every 8 ± 1 hours from the time of cannulation for infusion phlebitis grade as per visual infusion phlebitis scale on the following time points:

0.06 0.05

0.05 0.04

0.03

0.03 0.02 0.01 0

0.00 0

0.00 8

0.00 16

0.00 24

0.00 48

Time (hour)

Figure 1. Proportion of patients with Grade II phlebitis.

DRUGS All of the 39 patients experienced Grade I and/or Grade II phlebitis at some point of time during the study period. It took a mean time of 43.49 hours to reach the Grade I phlebitis after application of heparin sodium topical solution (1,000 IU/mL) every 8 hours. Figure 2 depicts the proportion of patients with Grade I phlebitis.

There was no site specific reaction observed for any patient during the study period.

Pain All of the 39 patients experienced pain at some point of time during the study period. Pain intensity was â&#x20AC;&#x2DC;slightâ&#x20AC;&#x2122; at each incidence. The incidences of pain were observed to be in correlation with phlebitis. The proportion of patients with slight pain is depicted in Figure 3. 0.70

Three patients out of 39 experienced swelling during the study period. The incidences of swelling were observed in correlation with Grade II phlebitis. The proportion of patients with induration is shown in Figure 5.

Palpable Venous Chord and Pyrexia Palpable venous chord and pyrexia were not observed in any patient at any time point during study period.

0.64

0.60 0.50 0.40

0.36

0.30 0.20 0.10 0.00 0

0.00 8

0.00 16

0.03

0.00

0.06 Proportion of patients with erythema

Proportion of patients with Grade I phlebitis

Three patients out of 39 experienced erythema during the study period. The incidences of erythema were observed in correlation with Grade II phlebitis. The proportion of patients with erythema is depicted in Figure 4.

Induration

Safety

0.00

Erythema

0.00

0.05

0.05 0.04

0.03

0.03 0.02 0.01 0.00

0.00 0

0.00 8

0.00 16

Time (hour)

Figure 2. Proportion of patients with Grade I phlebitis.

0.64

0.60 0.50 0.40

0.36

0.30 0.20 0.08

0.10 0.00

0.00 0

0.00 8

0.00 16

0.00 24 Time (hour)

0.00 40

Figure 3. Proportion of patients with slight pain.

24 Time (hour)

0.00 48

Figure 4. Proportion of patients with erythema.

0.00 48

0.06 Proportion of patients with induration

Proportion of patients with pain

0.70

0.00

0.05

0.05 0.04

0.03

0.03 0.02 0.01 0.00

0.00 0

0.00 8

0.00 16

0.00 24 Time (hour)

0.00 48

Figure 5. Proportion of patients with induration.

Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

1031

DRUGS DISCUSSION Intravenous cannulation, to administer drugs, fluids, blood products and nutritional solutions, is a significant part of hospital-based management. The use of IV cannula is often associated with the development of superficial thrombophlebitis. Topical heparin application at the site of cannulation is frequently done to prevent thrombophlebitis. The present study assessed the safety and efficacy of topical heparin sodium solution (1,000 IU/mL) in preventing infusion-associated superficial thrombophlebitis when applied on the skin over the cannulated vein three times a day over a period of 48 hours after cannulation. Three out of 39 evaluated patients experienced Grade II phlebitis. It took a mean time of 46.36 hours to reach Grade II phlebitis after application of heparin sodium topical solution (1,000 IU/mL) every 8 hours. Patients with phlebitis Grade II or above were discontinued from the study. All patients experienced Grade I and/or Grade II phlebitis at some point of time during the study period. It took a mean time of 43.49 hours to reach the Grade I phlebitis. There was no site specific reaction observed for any patient during the study period. Patients experienced only slight pain at some point of time during the study period. Only 3 out of 39 patients experienced erythema during the study period. The incidences of

erythema were observed in correlation with Grade II phlebitis. Additionally, 3 out of 39 patients experienced swelling during the study period. The incidences of swelling were also observed in correlation with Grade II phlebitis. None of the patients reported palpable venous chord and pyrexia at any time point during study period. Topical heparin sodium solution 1,000 IU/mL (Thrombotroy QPS, Troikaa Pharmaceuticals Limited) was thus found to be safe and effective in preventing and/or delaying infusion-associated superficial thrombophlebitis when applied on the skin over the cannulated vein three times a day over a period of 48 hours after cannulation. REFERENCES 1. Arun Babu T, Sharmila V. Prophylactic topical heparin can prevent or postpone intravenous cannula induced superficial thrombophlebitis. Med Hypotheses. 2010;74(5):857-8. 2. Saini R, Agnihotri M, Gupta A, Walia I. Epidemiology of infiltration and phlebitis. Nurs Midwif Res J. 2011;7(1): 22-33. 3. Bhandari B, Joshi T, Tak SK. Anti-coagulant ointment in the prevention of post-infusion thrombophlebitis in children. Indian J Pediatr. 1979;46(8):289-94.

4. Available from: http://www.vipscore.net/wp-content/ uploads/2012/04/002-IV3000-A4-score-and-vein-card.pdf. Accessed on February 28, 2017. ■■■■

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Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

ENDOCRINOLOGY

Guidelines for the Management of Diabetes at the End of Life MUKESH MEHRA*, MRIGANKA MEHRA

ABSTRACT End of life diabetes care calls for greater support and compassionate care toward the patients and their families till the end stage. In such cases; however, we are faced with a lack of structured and well-organized guidelines regarding the same. In this article, we reviewed the Guidelines for Quality Care for Diabetics at the End of Life, as well as the Management Goals and Targets to be met in care of the terminally ill diabetic.

Keywords: End of life diabetes care, terminally ill diabetic

DEFINITION OF END OF LIFE CARE Helps all those with advanced, progressive, incurable illness to live as well as possible until they die. It enables the supportive and palliative care needs of both patient and family to be identified and met throughout the last phase of life and into bereavement. It includes management of pain and other symptoms and provision of psychological, social, spiritual and practical support.1 INTRODUCTION End of life diabetes care should provide terminal patients comfort till the end stage and enable them to die with their pride intact. It also includes giving assistance and support to near and dear ones in coping with this difficult experience. Despite the greater need for standard care and guidance in this area, it is often not structured and organized. The stresses of other associated complaints and illnesses like malignancy, hypertension, stroke, respiratory diseases, steroids therapy and recurrent infections may pose challenge for care providers. This combined with the lack of trained specialists and staff, as well as lack of knowledge in end of life care leads to a failure to

*Associate Director Dept. of Medicine Max Superspeciality Hospital, Patparganj, New Delhi Address for correspondence Dr Mukesh Mehra B-27, Surajmal Vihar, Delhi - 110 092 E-mail: drmukeshmehra@rediffmail.com

deliver regulated, individualized and standardized quality care to the terminally ill diabetics.2,3 PURPOSES OF THESE GUIDELINES The guidelines are always a helpful tool for healthcare professionals and other care providers who have duty of managing these diabetic patients. The main purposes of these guidelines are: ÂÂ

Maintaining quality of standards for care towards end of life.

ÂÂ

Protocols about the priority areas in diabetes care at the end of life that offer responsive, proper and sympathetic care.

ÂÂ

Well-defined tasks and duties of healthcare professionals, care providers and of the patients in terminal stage diabetes care.

ÂÂ

Updating, training standards of care.2

and

educating

for

high

GUIDELINES FOR QUALITY CARE FOR DIABETICS AT THE END OF LIFE3,4 ÂÂ

Safe, well-planned and free from adverse effects treatment of diabetes.

ÂÂ

Avoiding diabetes related complications and situations requiring hospitalization like symptomatic hypoglycemia, diabetic ketoacidosis, infections and gross hyperglycemia.

ÂÂ

Avoidance of bedsores and peripheral vascular complications like gangrene in bed-ridden old diabetics.

Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

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ENDOCRINOLOGY ÂÂ

Efforts to avoid dehydration and starvation by ensuring adequate caloric intake along with balanced diet.

ÂÂ

Provide adequate support according to disease and it’s staging; provide symptomatic relief when needed.

ÂÂ

Support the patient in their diabetes selfmanagement in dignified manner and provide moral support till the end stage.

ÂÂ

Efforts to make end stage as painless and asymptomatic as possible.

MANAGEMENT GOALS AND TARGETS

Blood Sugar Levels No definitive evidence in support of blood sugar or glycosylated hemoglobin (HbA1c) levels to target at this stage of life. The ideal range will vary as per the stage of illness, patients eating and nutritional status, the frequency of hypoglycemia and ongoing treatment.

ÂÂ

Patients may have side effects from aspirin, gastrointestinal complaints with inadequate food intake or simultaneous steroid and drugs used for other comorbidities, may need a proton-pump inhibitor or similar alternatives.

ÂÂ

Oral hypoglycemic agents and the blood glucose targets should be rescheduled. Weight loss, physical inactivity, poor diet may need reduced doses of ongoing drugs or use of short-acting therapies like insulin (Tables 1 and 2).5,6

Disease at an Advance Stage Life-expectancy for Months Only ÂÂ

Advised to keep drug therapy to symptomatic control.

ÂÂ

Try to shift from combination of drugs and insulinto-insulin alone, as per requirement.

ÂÂ

At this stage, involvement of care providers become significant; switch from multiple or twice-daily to once-daily insulin.

ÂÂ

Start long-acting, once-daily insulin such as insulin glargine or insulin degludec at the reduced doses i.e., 75% of total twice-daily isophane or pre-mixed insulin.

As per available literature and practicality, the recommended targets are: ÂÂ

No sugar level <6 mmol/L

ÂÂ

No sugar level >15 mmol/L.

Patients may need reassurance and reasoning to agree on these new-targeted values.

Anticipated Stages and Related Guidelines We anticipate four stages within the end of life situation for antidiabetes therapies and other related pharmacotherapies: ÂÂ

Patient stable with expected survival for year or more

ÂÂ

Patient unstable and disease is in advanced stage and life expectancy is for few months

ÂÂ

Worsening condition and expected survival for weeks only

ÂÂ

Ending days terminal condition and survival for days only.

Patients Reasonably Stable with More Than a Year Life-expectancy ÂÂ

ÂÂ

The usage of cardiac drugs (e.g., β blockers, aspirin, statins, angiotensin-converting enzyme [ACE] inhibitors, calcium channel blockers, angiotensinreceptor blockers) should be re-evaluated in view of the diagnosis and the associated other diseases. Dosage modification, discontinuation of some of the ongoing drugs.

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Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

Patients with Weeks Life-expectancy ÂÂ

Patient is in critical stage, all of the previously recommended modifications are followed but time left for newer, modified or shifting therapies is very little.

ÂÂ

Intensive support required for everything like dose modification as general condition, physical activity and food intake changing rapidly. Controlling blood sugar is also challenging at this emotionally sensitive stage for patients, relatives and attending team.

ÂÂ

Approach should be balanced; do not give up as the presence of care provider is assuring and supportive.

Patients with Final Days/Terminal Care Days of Life-expectancy ÂÂ

During terminal days of life, diabetes drugs already minimal or stopped, few changes may be needed.

ÂÂ

If the time is arrived when patient is bed ridden, sensorium altered, is unable to eat or swallow, taking only sips of liquids or on nasogastric tube feeding, use of local guidelines and available protocols should be followed if available.

ÂÂ

Reassure relatives that diabetes is being managed differently and with best available protocol.

ÂÂ

Always use short-acting drugs or insulin to virtually rule out chances of hypoglycemia.

ENDOCRINOLOGY Table 1. Medicines Management - Noninsulin Therapies5,6 Metformin (Standard Metformin or Glucophage SR®)

Sulfonylureas (gliclazide/ glipizide/ glimepiride)

Pioglitazone

Gliptins

GLP-1 analogs (exenatide or liraglutide, lixisenatide and bydureon)

Sodium glucose co-transporter 2 agents (SGLT2) dapagliflozin (Forxiga)

Review dose according to changing renal function

Review if dietary intake is reduced and/or there is significant weight loss

The risk-benefit ratio for pioglitazone in patients with terminal disease requires review and should be only prescribed if benefits can clearly be identified

Review doses in accordance with individual licenses if renal function deteriorates

Review if eating patterns change or significant weight loss occurs

Starting dose is 10 mg daily, unless there is severe liver failure, then start at 5 mg

Withdraw if creatinine >150 mmol/L or eGFR <30 mL/l/1.73 m2

Review dose if renal function deteriorates and consider a switch to tolbutamide

Some gliptins can be used for all stages of renal disease

Withdraw if abdominal pain or pancreatitis develops

Withdraw if eGFR <60 mL/l/1.73 m2

Review if gastrointestinal disease is present or symptoms of nausea, heartburn, diarrhea or flatulence are making patients miserable with discomfort

Review dose if liver function deteriorates as hypoglycemia may occur

Should not be used in patients with or at risk of bladder tumor or heart failure

Combination with sulfonylureas increases the risk of hypoglycemia

Limited evidence for use in people over 75 years of age

Table 2. Insulin Therapies (Type 1 and Type 2 Diabetes)5,6 yy Doses may need to change with changes in renal function

yy Equipment for insulin delivery may need to be reassessed if physical capabilities alter, vision is poor, or carers become involved in giving insulin

yy Hypoglycemia risk will need to be reassessed with changes in eating patterns

yy Evening isophane (insulatard/humulin i or insuman basal) in combination with day time or al hypoglycemic drugs may be a good first-line treatment choice

yy A change of insulin regimen may be needed to yy The simplest regimen should be chosen if switching to insulin only, both once- or match changes in activity levels twice-daily injection can be considered

OTHER COMMON PROBLEMS THAT MAY NEED CONSIDERATION

Diet ÂÂ

Adequate nutrition in any form that is possible as per the stage of the disease and comorbidities. Patients on enteral feeding and food supplements for nutrition may affect blood glucose, and will need treatment modification to reduce the risk of challenging hyperglycemia.

Steroids ÂÂ Steroids are used to give relief in various comorbid conditions and their symptoms. ÂÂ Steroids can cause increased blood sugar levels, may need treatment adjustment. Fungal infections may require immediate medication. Weight Loss ÂÂ If patient is losing weight, reduce insulin dose, modify oral drugs, statins and other ongoing medications.

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ENDOCRINOLOGY Renal Failure ÂÂ Reduce the dose of insulin, modify oral hypoglycemic agents and avoid nephrotoxic drugs.

REFERENCES

Liver Dysfunction

2. Diabetes and End of Life Care. Association of British

ÂÂ

Risk of hypoglycemia may be increased; doses of medications like insulin, sulfonylureas should be reassessed. Thiazolidinedione should be stopped as they may cause hepatic failure.

Hypoglycemia ÂÂ

1. Commissioning End of Life - National Council for Palliative Care. 2006. Clinical Diabetologist’s Position Statement; 2010. 3. Mitchell GK. How well do general practitioners deliver palliative care? A systematic review. Palliat Med. 2002;16(6):457-64. 4. Roach MS. The Human Act of Caring: A Blueprint for the

Early detection and avoid this side effect of treatment. Careful planning of insulin doses and glucose targets. Extra careful when patient is anorexic.

Sick Day Management ÂÂ Careful monitoring and treatment modification in both type 1 and 2 diabetes to lessen the metabolic dysfunctions and other complications.

Health Professions (Rev Ed.). Ottawa: Canadian Hospital Association Press; 1992. 5. End of Life Care Strategy - promoting high quality care for all adults at the end of life. Department of Health, July 16, 2008. 6. End of Life Diabetes Care Commissioned by Diabetes UK Clinical Care Recommendations Endorsed By: Diabetes Second Edition, October 2013.

■■■■

Lifestyle + Drug Therapy may Achieve Short-term Remission of Type 2 Diabetes A short course of intensive lifestyle and drug therapy achieves on-treatment normoglycemia, promotes sustained weight loss and may also achieve prolonged, drug-free diabetes remission, according to results from a pilot trial published online March 15, 2017 in the Journal of Clinical Endocrinology and Metabolism. Fifty percent of patients in the 8-week intensive metabolic intervention group achieved normoglycemia on therapy; these percentages were 70.4% in the 16-week group and 3.6% in controls.

Metabolically Healthy Obese Also at Higher Risk of Ischemic Heart Disease According to a 10-year follow-up of the Inter 99 study reported online March 7, 2017 in the Journal of Clinical Endocrinology and Metabolism, obesity is associated with a higher incidence of ischemic heart disease (IHD) regardless of metabolic status. Metabolically healthy obese men were at an increased risk of IHD compared to metabolically healthy normal weight men.

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INTERNAL MEDICINE

Isolated Rectus Sheath Hematoma Mimicking a Desmoid Tumor: A Rare Presentation of Dengue Fever ANJUM MIRZA CHUGHTAI*, MUHAMMAD UWAIS ASHRAF*, MR AJMAL†

ABSTRACT Recently, many new presentations have been described in association with dengue fever. These newer manifestations may cause delay in diagnosis and management of dengue fever due to lack of suspicion. Rectus sheath hematoma (RSH) can be rare manifestation of dengue fever. It is more common in female patients and usually responds well to conservative management. Clinically, it is difficult to differentiate a RSH from abdominal wall tumors. In the case, we describe here, RSH was confused with a desmoid tumor and the two could not be differentiated even on CT scan, so a biopsy was done.

Keywords: Rectus sheath hematoma, lower abdominal wall, dengue fever, computed tomography, platelet transfusion

ectus sheath hematoma (RSH) is an uncommon condition, which can present as a rare cause of acute abdominal pain. RSH is an accumulation of blood in rectus abdominis sheath. It can occur as a result of damage to epigastric arteries or may result due to a direct tear of rectus muscle. A physician needs to be cautious about this condition as it may mimic acute abdomen, which may warrant immediate surgical intervention. The etiologies may include trauma, anticoagulant therapy, abdominal operations, subcutaneous drug injections, trocar site injury, hematological diseases and blood dyscrasias, hypertension, exercise, pregnancy, etc. RSH usually occurs in lower abdominal wall and usually does not cross the midline.1 We report a probable case of dengue fever which presented with a mass in the abdomen and was diagnosed by clinical examination and confirmed by ultrasound and computed tomography (CT). The patient recovered uneventfully after bed rest, intravenous fluid replacement, platelet transfusion and supportive therapy.

*Assistant Professor †Chairman Dept. of Medicine JN Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh Address for correspondence Dr Muhammad Uwais Ashraf Assistant Professor Dept. of Medicine JN Medical College, Aligarh Muslim University, Aligarh - 202 002, Uttar Pradesh E-mail: uwaisashraf@gmail.com

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CASE REPORT A 55-year-old female, known case of bronchial asthma on bronchodilators, came to OPD with complaints of pain in the lower abdomen. There was history of fever a few days back. The patient also noticed a lump in the lower abdomen. She was a regular visitor to the OPD and during her last visit a week back, she was thoroughly examined and there was no lump at that time. The lump was restricted to the lower abdomen. She had no history of diarrhea or constipation or distension of abdomen. There was no history of vomiting. There was no history of bleeding per vaginum or any history suggestive of intestinal obstruction. On examination, her pulse rate was 96/min, regular, blood pressure was 100/60 mmHg, temperature was 98.6°F. Per abdomen examination revealed minimal ecchymotic patches in the lower abdomen and lump in the lower abdomen, of the size of 7 × 7 cm with mild tenderness in the lump. The lump was freely mobile with a relaxed abdomen; however, it got fixed when the patient was asked to contract the abdominal muscles. It was an acute onset lump, as the patient had been examined in the OPD, 1 week prior to her recent presentation and no abdominal lump had been found at that time. The basic investigations like complete blood count, renal function tests, liver function tests, etc. were ordered and the patient was immediately referred to the surgeons for any urgent surgical intervention. Meanwhile, the investigation reports ordered by the physician came and revealed hemoglobin - 10.0 g/dL,

INTERNAL MEDICINE total leukocyte count (TLC) - 4,500, differential leukocyte count (DLC) - P60L40, platelets - 35,000 only. Since the patient had presented in an endemic area, at the peak season of dengue fever, a dengue serology was ordered, which revealed an immunoglobulin G (IgG) positive status for dengue. An ultrasonography (USG) of the abdomen was done, which revealed a lump of the size of 11 × 4.5 cm. The patient was referred back to us, and was re-examined. There were significant ecchymotic patches over the abdomen (Fig. 1), the size of lump had also increased. The general condition of the patient had dipped; however, she was maintaining vitals. Interestingly, there was no bleeding from any other site. Repeat investigations revealed a platelet count of 65,000, hematocrit was 35%, bleeding time, clotting time, prothrombin time, activated partial thromboplastin time were normal, dengue serology revealed IgG positive status. However, to ascertain what exactly the lump was, a contrast-enhanced computed tomography (CECT) abdomen was planned. Patient was put on conservative management. Platelet concentrate was transfused. CECT abdomen revealed, a well-defined, circumscribed, heterogeneously enhancing, soft tissue density lesion, with few areas of hypodensities within the lesion, involving the rectus sheath on the left side causing splaying of the left rectus abdominis muscle in the paramedian region on left lower abdominal quadrants, with no evidence of calcification (Fig. 2 a and b). The size of the lesion was 6.15 × 7.11 × 11 cm. There was no evidence of any regional lymphadenopathy. Based on these findings, the radiologists made an impression of a desmoid tumor. Since, the diagnosis of dengue was already in doubt as the patient had only

Figure 1. Lump in the lower abdomen with extensive ecchymoses over the abdomen.

Figure 2 a and b. CT abdomen showing a well-defined, circumscribed, heterogeneously enhancing, soft tissue lesion 6.15 × 7.11 × 11 cm, with few areas of hypodensities within the lesion, involving the rectus sheath on the left side with no evidence of calcification.

an IgG positive status with NS1 antigen and IgM being negative, and there was no evidence of bleeding from any other site as occurs in dengue, it was thought that the patient had basically developed a desmoid tumor and the ecchymotic patches could be due to bleeding within the fascial planes. Based on this assumption, the patient was again referred to the surgeons, who took a biopsy of the mass. However, the patient was continued on conservative management and no surgical intervention was carried out. The patient’s condition started improving and as the biopsy report was awaited, the patient was discharged on personal request, with instructions to report to the OPD with the biopsy report. The patient reported back to the OPD and it was found that lump had regressed and only minimal ecchymotic patches were left (Fig. 3). The size of the lump on repeat ultrasound was 6.6 × 3.1 × 6.6 cm. Report of biopsy specimen revealed only red blood cells. So, the lump, which was being thought to be a desmoid tumor, was actually a hematoma only; this could be secondary to thrombocytopenia due to probable dengue fever.

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INTERNAL MEDICINE intra-abdominal injections, etc.4 Clinical presentation is abdominal pain, mass in the abdomen, vomiting, abdominal cramps, etc.3 Diagnosis can be confirmed by USG, CT scan and magnetic resonance imaging (MRI). USG is cost-effective with no danger of radiation. However, it is a known fact that on ultrasound, these RSH may be confused with abdominal wall tumors as occurred in our patient.5 CT scan of the abdomen is superior to ultrasound as it can give the extent and the site of the hematoma.

Figure 3. Showing regression in the size of lump with minimal ecchymotic patches left.

Complete resorption of the hematoma usually occurs in around 3 months.6 The mainstay of treatment is conservative management in patients who are hemodynamically stable and in whom the hematoma is nonexpanding.

DISCUSSION

CONCLUSION

We present here a rare case in which, RSH, secondary to probable dengue, presented as a desmoid tumor on CT scan of the abdomen. Although the initial work-up of the patient had pointed towards this diagnosis, due to concomitant thrombocytopenia and IgG positive status, but the CT findings complicated the issue. However, the diagnosis of dengue was only probable. But, as the biopsy report confirmed the mass to be a hematoma, we can say that we were dealing with a case of dengue as, according to the World Health Organization (WHO) guidelines, our patient was fitting into the diagnosis of dengue fever with warning signs. The diagnosis of probable dengue can be made if the patient is a resident of/traveler to endemic area with any two of the following:

We have reported an interesting case here, which is not a straight forward case of dengue fever with thrombocytopenia. Important finding was an acute onset of abdominal lump in the presence of documented thrombocytopenia. On biopsy, this came out to be a hematoma and the patient responded well to conservative treatment. In our clinical set up, we have to remember that these acute febrile illnesses like dengue, malaria, Leptospirosis, etc. can have a myriad of presentations and making a correct diagnosis boosts the confidence of both the patient and the treating physician and unwanted procedures may be timely avoided as in this case, there was no role of surgical intervention, which was avoided due to prompt and correct diagnosis.

ÂÂ

Aches and pains: headache, myalgia, arthralgia, retro-orbital pain

ÂÂ

Rash

ÂÂ

Hemorrhagic manifestations: tourniquet test

ÂÂ

Nausea/vomiting

ÂÂ

Leukopenia

ÂÂ

Any warning signs.

petechiae,

+ve

Although, a single titer of IgG was positive in our patient, we need to demonstrate an increasing titer. Another important point for diagnosis is the occurrence in the same place or time, other cases of confirmed dengue. RSH is rarely seen in association with dengue fever as a cause of acute abdominal pain. Very few case reports exist in literature.2 RSH occurs more commonly in females, probably due to the fact that women have smaller muscle mass.3 Causes of RSH include trauma, anticoagulant therapy, excessive coughing,

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REFERENCES 1. Naschitz JE, Tsikonov I, Yeshurun D. Hematoma of the rectus abdominis muscle and sheath. Am J Gastroenterol. 1996;91(3):621. 2. Sharma A, Bhatia S, Singh RP, Malik G. Dengue Fever with rectus sheath hematoma: a case report. J Family Med Prim Care. 2014;3(2):159-60. 3. Luhmann A, Williams EV. Rectus sheath hematoma: a series of unfortunate events. World J Surg. 2006;30(11):2050-5. 4. Linhares MM, Lopes Filho GJ, Bruna PC, Ricca AB, Sato NY, Sacalabrini M. Spontaneous hematoma of the rectus abdominis sheath: a review of 177 cases with report of 7 personal cases. Int Surg. 1999;84(3):251-7. 5. Casey RG, Mahmoud M, Carroll K, Hurley M. Rectus sheath haematoma: an unusual diagnosis. Ir Med J. 2000;93(3):90-2. 6. Costello J, Wright J. Rectus sheath haematoma: ‘a diagnostic dilemma ?’. Emerg Med J. 2005;22(7):523-4.

ONCOLOGY

Transformation of Mature Teratoma into Adenocarcinoma in an 18-year-old Boy MUKUR DIPI RAY*, AMAR RANJAN†, SACHIDANANDJEE BHARTI‡

ABSTRACT An 18-year-old male presenting with testicular mass underwent orcheidectomy. On histopathological examination, mixed germ cell tumor was diagnosed. Tumor markers (AFP and β-hCG) were raised. Three cycles of chemotherapy with BEP regimen (bleomycin, etoposide and cisplatin) followed by radiotherapy of 51.2 Grays at 27 fractions given. Post-chemotherapy, physical examination revealed a mass in epigastrium; supported by computerized tomography (CT), retroperitoneal lymph node dissection was done. The mass turned out to be adenocarcinoma. This study proposes the presence of malignancy component in mature teratoma.

Keywords: Germ cell tumor, mature teratoma, adenocarcinoma

esticular cancer is 1% among all malignancies in male, age group being 15-35 years.1 Approximately, 95% of malignant tumors arising in the testis are germ-cell tumors (GCTs). GCT also occasionally arise in extragonadal primary sites, and their management follows that of testicular GCTs. More than 90% of patients with newly diagnosed GCTs are cured.2,3 Two most challenging aspects faced by a surgeon are the growing teratoma syndrome and malignant transformation of a mature component of teratoma. The present report shows synchronous presentation of mature teratoma with adenocarcinoma infiltrating duodenum. CASE REPORT

markers (alpha-fetoprotein [AFP] and beta-human chorionic gonadotropin [β-hCG]). Patient received 3 cycles of chemotherapy with BEP regimen (bleomycin, etoposide and cisplatin) followed by radiotherapy of 51.2 Grays at 27 fractions. After therapy, tumor markers were normalized, lactate dehydrogenase (LDH) remained marginally raised. Post-chemotherapy, physical examination of abdominal revealed a mass of size approximately 10 cm in diameter the epigastrium. Contrast-enhanced computerized tomography (CECT) scan of abdomen showed a 4 cm conglomerate mass in the aorto-caval location from lumbar vertebral level 2-4. Inferior vena cava (IVC) was compressed by the mass and 3rd part of duodenum was displaced (Fig. 1). In view of normalized tumor

An 18-year-old young male presented with right-sided testicular swelling for 1 year. Incision biopsy revealed immature teratoma. Histopathological examination (HPE) of orchidectomy specimen revealed mixed GCT with yolk sac, trophoblastic and teratomatous components. The diagnosis was supported by tumor

*Assistant Professor, Surgical Oncology †Assistant Professor, Lab. Oncology ‡Assistant Professor, Anesthesiology, Pain and Palliative Care Unit Dr BRAI-RCH, AIIMS, New Delhi Address for correspondence Dr Amar Ranjan Room No. 422, Lab. Oncology Unit Dr BRAI-RCH, AIIMS, Ansari Nagar, New Delhi - 110 029

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Figure 1. CT scan of upper abdomen showing a 4 cm conglomerate mass compressing IVC, displacing 3rd part of duodenum abutting abdominal aorta.

ONCOLOGY markers, nonseminomatous germ cell tumors (NSGCT) histology and the residual lymph node mass in the retroperitoneum, retroperitoneal lymph node dissection (RPLND) was done. Intraoperatively, a mass 6 cm in longest dimension was found in the aorto-caval junction. IVC and aorta were densely adhered to the mass, but could be separated. Duodenum was infiltrated completely from serosa to mucosa at the junction of second and third part, and an intraluminal proliferative growth was observed. All other solid organs were normal. En bloc resection of mass with the involved duodenum was done. Bowel continuity achieved by duodenoduodenostomy. Retroperitoneal dissection was completed. Right side scrotectomy with inguinal lymph node dissection was done because of the previous scrotal violation at the time of incisional biopsy. HPE of the resected mass revealed dysplastic glandular structures lined by pleomorphic cells infiltrating

duodenal wall in the sections taken from the part of the mass in the duodenum, suggesting adenocarcinoma in a mature teratoma. Sections from other parts of the mass showed mature components of all three germ layers e.g., colonic epithelium, smooth muscle, adipose tissue, cartilage and focal squamous epithelium (Fig. 2 a and b). After surgery, patient is only on supportive therapy and is on follow-up regularly without any complication approximately 4 months after the second surgery. DISCUSSION Development of an invasive malignancy in mature teratoma is rare. Limited studies are available on this topic. A teratoma may transform in any form of malignancy. It does not respond cisplatin base therapy. Surgical resection remained the main stay of therapy.4-6 But in our case after BEP regimen, patient is better till date. Comiter et al (1998) studied 21 patients diagnosed with teratoma with malignant transformation during 7 years period. These were usually metastatic at presentation, more aggressive and had high recurrence rate. Mediastinal one had the worst prognosis.4 Malagรณn et al (2007) studied 46 patients with GCT transforming into sarcoma involving either primary sites or their metastases. These portend aggressive behavior and behave like an independent tumor.5

Motzer et al (1998) studied 46 patients with GCT, transforming into different malignancies. Sarcoma was the commonest. Others were adenocarcinoma, neuroectodermal tumor, leukemia, etc. The associated chromosomal abnormality was i(12p).6 Game et al in 2001 reported two cases of mature teratoma arising 3 and 20 years after the initial resection, occurring after macro- or microscopically incomplete resection of a mature teratoma.7 Murphy et al in 1998 reported a 54-year-old male patient was found to have adenocarcinoma arising within a mature teratomatous retroperitoneal metastasis 15 years after treatment of a NSGCT. The tumor was successfully excised and he remained without evidence of disease.8

Figure 2 a and b. H&E section of intraduodenal mass showing dysplastic glandular structures lined by pleomorphic cells, 5X and 40X.

Management of GCT is well-established. In cases of NSGCT, all the patients with stage IIB onwards will undergo chemotherapy with BEP regimen followed by imaging and tumor marker assessment. If the markers are normalized and imaging does not show any mass, no further treatment is required.9

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ONCOLOGY If the CT shows any residual mass in the retroperitoneum or mediastinum, retroperitoneal lymph node dissection is advised. Further treatment is planned as per histopathology report, which can be divided in to 3 categories. One is only necrosis, which is present up to 50% of patients, second possibility is the presence of viable germ cell element (15%) and last situation is the possibility of teratoma component (35%).10 The matured cells in the teratoma do not respond to the chemotherapeutic agents and they present as residual mass. This study concludes that there is presence of invasive malignancy component in mature teratoma. REFERENCES 1. Fitzgerald JP, Ercole B, Parekh DJ. Management of postchemotherapy residual mass in patients with metastatic nonseminomatous germ cell tumors of the testis. Indian J Urol. 2010;26(1):98-101. 2. Scher H, Bosl G, Geller N, Cirrincione C, Whitmore W, Golbey R. Impact of symptomatic interval on prognosis of patients with stage III testicular cancer. Urology. 1983;21(6):559-61.

4. Comiter CV, Kibel AS, Richie JP, Nucci MR, Renshaw AA. Prognostic features of teratomas with malignant transformation: a clinicopathological study of 21 cases. J Urol. 1998;159(3):859-63. 5. Malagón HD, Valdez AM, Moran CA, Suster S. Germ cell tumors with sarcomatous components: a clinicopathologic and immunohistochemical study of 46 cases. Am J Surg Pathol. 2007;31(9):1356-62. 6. Motzer RJ, Amsterdam A, Prieto V, Sheinfeld J, Murty VV, Mazumdar M, et al. Teratoma with malignant transformation: diverse malignant histologies arising in men with germ cell tumors. J Urol. 1998;159(1):133-8. 7. Game X, Houlgatte A, Fournier R, Duhamel P, Baranger B, Khoury S. Dedifferentiation of mature teratomas secondary to testicular cancer: report of 2 cases. Prog Urol. 2001;11(1):73-6; discussion 76-7. 8. Murphy DP, Bancila E, Ciocca RG, Cummings KB, Weiss RE. Adenocarcinoma arising within a testicular metastasis. Urology. 1998;51(4):632-4. 9. Dennis AC, Mary CT. Manual of Surgical Oncology. 7th Edition, Chapter 12. Jonathan WP Jr. (Ed.). Lippincott Williams & Wilkins, a Wolters Kluwer Business, Philadelphia, US; pg. 361-2.

10. Lin CK, Liu HT. Evidence-based treatment for advanced 3. Bosl GJ, Vogelzang NJ, Goldman A, Fraley EE, Lange PH, germ cell tumor of the testis with a case illustration. Levitt SH, et al. Impact of delay in diagnosis on clinical stage of testicular cancer. Lancet. 1981;2(8253):970-3. J Chin Med Assoc. 2010;73(7):343-52. ■■■■

Updated Guideline on Brachytherapy in Prostate Cancer The American Society of Clinical Oncology (ASCO) and Cancer Care Ontario have issued a joint clinical practice guideline update on the use of brachytherapy for prostate cancer patients, published online March 27, in the Journal of Clinical Oncology. ÂÂ

In low-risk prostate cancer patients, who require or choose active treatment, low-dose rate brachytherapy (LDR) alone, external beam radiation therapy (EBRT) alone, and/or radical prostatectomy should be offered to eligible patients.

ÂÂ

For patients with intermediate-risk prostate cancer choosing EBRT with or without androgen-deprivation therapy, brachytherapy boost (LDR or high-dose rate [HDR]) should be offered to eligible patients.

ÂÂ

For patients with high-risk prostate cancer receiving EBRT and androgen-deprivation therapy, brachytherapy boost (LDR or HDR) should be offered to eligible patients.

Consider Hyperthyroidism in d/d of Persistent Arthralgia A case of a 53-year-old woman who presented with persistent arthralgia, hypercalcemia and extensive osteoporosis as the first manifestations of hyperthyroidism published in the February 2017 issue of the journal Molecular and Clinical Oncology suggests that hyperthyroidism should be considered in the differential diagnosis of patients with persistent arthralgia, even without typical symptoms.

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ORTHOPEDICS

An Open-label Prospective Study to Evaluate the Efficacy, Safety and Tolerability of Kenacort® Injection (Triamcinolone Acetonide) in the Treatment of Patients with Osteoarthritis, Rheumatoid Arthritis, Frozen Shoulder and Tennis Elbow ANIL KUMAR H*, NEERAJ BINDAL†, ATUL K AGARWAL‡, MANU HC#

ABSTRACT Background and objective: To assess the efficacy, safety and tolerability of "real time" use of Kenacort® (triamcinolone acetonide) 10 mg/40 mg injection in the treatment of osteoarthritis (OA), rheumatoid arthritis (RA), frozen shoulder (FS) and tennis elbow (TE). Methods: Two hundred fifty-two patients suffering from OA, RA, FS and TE were enrolled between June 2015 and January 2016, after meeting the eligibility criteria, in the 3-month follow-up study. Patients were assessed for severity of symptoms, including pain, stiffness, range of movement and swelling. The visual analog scale (VAS) 0-100 was used for pain assessment. Both patients and physicians were assessed for tolerability towards the medication at end of 3 months. Descriptive statistics was used to summarize the data. Results: Of 252 patients (OA: 136; RA: 32; FS: 67; TE: 17) enrolled, 249 (98.8%) completed the study. There was a statistically significant improvement in mean VAS score over 3 months of treatment in patients of all indications. There was an improvement in severity of pain, joint stiffness, swelling and limitation of range of movement from baseline to 3 months. No adverse drug reactions were reported in the study. The majority of physicians (89.3%) and patients (89%) rated the tolerability of Kenacort® injection as ‘good’. Conclusion: Kenacort® injection shows high efficacy, safety and tolerability in the treatment of patients with OA, RA, FS and TS.

Keywords: Intra-articular injection, steroids, triamcinolone acetonide, visual analog scale

usculoskeletal disorders (MSD) is a terminology used for a gamut of clinical conditions, from those of acute onset and short duration to lifelong disorders. The MSD is the second leading cause of patient disability, worldwide,1 imposing a huge healthcare burden on individuals, health systems and social care systems. Globally, the prevalence of MSDs ranges from 14% to as high as 42%,

with rate increasing with age.2 In India, the prevalence ranges between 12.8% and 14.1%.3 The increasing number of older people and the changes in lifestyle are expected to lead to a further increase in disease burden. Thus, there is an unmet need to appropriately manage MSD with an objective to reduce the severity of musculoskeletal pain, prevent disability and improve overall quality-of-life of an individual.

*Jayanagara Orthopedic Centre, Bangalore, Karnataka †All Orthopaedic Trauma Centre, New Delhi ‡SAS Health Care Hospital, Mumbai, Maharashtra #Abbott Healthcare Pvt Ltd, Mumbai, Maharashtra Address for correspondence Dr Manu HC Manager - Medical Services Abbott Healthcare Pvt. Ltd 18th Floor, Godrej BKC, Plot C-68, ‘G’ Block, Bandra Kurla Complex Near MCA Club, Bandra East, Mumbai - 400 051, Maharashtra E-mail: Manu.c@abbott.com

The MSDs affect muscles, bones, joints, tendons, ligaments, cartilage, nerves and blood vessels. Few of the factors which contribute to the risk of developing MSDs include physical or work-related factors (heavy physical work, awkward postures, exposure to low temperature, repetitive actions, prolonged sitting/ standing and prolonged vibration), psychosocial factors (high level of work stress, insufficient recovery/ rest time and mental strain), or individual factors (prior medical history, high body mass index, age,

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ORTHOPEDICS gender, smoking, sport or domestic activities and alcohol/tobacco consumption).4,5 Intra-articular injections of corticosteroids have been shown to be beneficial in the management of MSDs, lessening pain and inflammation, by reducing synovial blood flow, inflammatory response and by altering collagen synthesis.6-8 Kenacort® (triamcinolone acetonide [TA], 10 mg/40 mg injection) is a moderately potent synthetic glucocorticoid corticosteroid with favorable pharmacokinetic and dynamic profile.9 TA has been widely used in India (intra-articular or local) for the treatment of conditions such as osteoarthritis (OA), rheumatoid arthritis (RA), frozen shoulder (FS) and tennis elbow (TE)/lateral epicondylitis, since more than 25 years. Its advantage over the other corticosteroids lies in its ability to achieve equal anti-inflammatory effect with a lower dose.10-12 It down-regulates inflammatory cytokines, inhibits leukocyte migration and helps in the development of immune cells like natural killer cells, T and B cells. Moreover, TA is absorbed completely from the injection site and its levels are detectable in plasma for greater than 2 weeks. TA has very weak sodium-retaining effect and is probably the least electrolyte-retaining compound of the corticosteroid group.10,12 Further, triamcinolone has a plasma halflife of approximately 300 minutes and is classified as an intermediate acting glucocorticoid, whereas the acetonide salt has a longer duration of action and a higher lipid-water distribution coefficient.10-13 TA has minimal to zero mineralocorticoid action.14 The dosage requirements of TA are variable and are individualized based on the severity of the disease, the anticipated duration of steroid therapy and patient’s response. The effectiveness and low toxicity profile of TA make it a very good choice in clinical therapeutics when treatment with an intra-articular corticosteroid is necessary. However, data are scarce on "real time" use of TA (Kenacort®) in patients with OA, RA, FS and TE, in the Indian context. Hence the present study was conducted to assess the effectiveness, safety and tolerability of Kenacort® (10 mg/40 mg injection) in patients with OA, RA, FS and TE. In the present study, is limited only to four MSDs, OA, RA, FS and TE as these patients experience common symptoms of joint pain, joint stiffness after exercise/work, restricted range of movement, swelling and fatigue, and inflammation of bursa (bursitis) is involved. The data collected in this study will provide a comprehensive overview of the outcomes associated with Kenacort® injection and the factors influencing its use in the clinical management and treatment effectiveness in terms of symptom relief,

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duration of relief, frequency and duration of evaluation period. MATERIAL AND METHODS This 3-month, prospective, post-marketing observational study was conducted between June 2015 and January 2016 at 12 sites in India. Patients aged ≥18 years, who had received Kenacort® 10 mg/40 mg injection (via intradermal, intramuscular, intra-articular or other local route) as a part of their routine treatment for OA, RA, FS and TE and were willing to sign the patient authorization form were enrolled in the study. The study consisted of 6 suggested visits: a baseline visit and 5 follow-up visits (Week 1 [Visit 1], Week 2 [Visit 2], Month 1 [Visit 3], Month 2 [Visit 4] and Month 3 [Visit 5]) after the patient had taken Kenacort® injection. At every study visit, patients were assessed for pain (pain on movement, joint pain at rest, pain on passive movement, tenderness on examination, shoulder pain, pain on outside of the forearm, pain while lifting and pain while twisting), stiffness (stiffness of the joint, morning stiffness, duration of morning stiffness [in minutes]), range of movement (degree of movement and limitation of range of movement) and swelling (Figure 1). The severity of pain, joint stiffness, limitation of range of movement and swelling was rated as none,

Identify the patients as per IC/EC criteria Next Patient Willing to participate in the study Yes Sign patient authorization form

Enroll the patients (n = 252)

Evaluate the patients at the baseline conditions

Evaluate symptoms at each suggested follow-up visit: Visit 1, Visit 2, Visit 3, Visit 4, Visit 5

Statistical Analysis

Study Conclusions

Figure 1. Study design.

ORTHOPEDICS mild, moderate or severe. The morning stiffness was reported as ‘yes’ or ‘no’. The visual analog scale (VAS) was used to measure pain intensity at all study visits. The score of ‘0’ on the VAS scale indicated ‘no pain’ and the score of ‘100’ indicated ‘severe pain’. At the end of 3 months, both physician and patient assessed tolerability towards Kenacort® injection as ‘good’, ‘moderate’ and ‘poor’ (good = side effects of the medication as mild or not observed; moderate = side effects of moderate intensity; poor = side effects of severe intensity or discontinuation of medication). Any adverse drug reaction (local or systemic) reported during the study was expected to be considered for safety analyses. The study was conducted in conformity with the principles of the Declaration of Helsinki, International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines, Indian Council of Medical Research and Indian GCP guidelines after obtaining approval for the study from respective ethics committee.

Statistical Analyses The statistical analyses were done using SAS version 9.2. Approximately 252 patients were enrolled by assuming 15% dropout rate, 5% level of significance, 90% power, with the clinical relevant difference of 16 and a standard deviation (SD) of at most 35 for difference in VAS reading from baseline. The evaluable population (patients who received Kenacort® injection and had completed at least one post baseline/VAS score) was used for study analyses. Shift analysis was done to assess the change in pain symptoms, joint stiffness and limitation of range

of movement from baseline to 3 months. Descriptive statistics was used to summarize all study variables; continuous variables by mean and SD and categorical variables by frequencies and percentages. The paired t-test was used to capture significant changes in the duration of morning stiffness, range of movement and VAS from baseline to 3 months. Adverse drug reactions were to be coded using the Medical Dictionary for Regulatory Activities version 16.1. RESULTS A total of 252 patients (OA: 136 [54%]; RA: 32 [12.7%]; FS: 67 [26.6%]; TE: 17 [6.8%]) were enrolled in the study. Of these patients, 249 (98.8%) patients completed the study; the remaining 3 patients were either lost to follow-up (n = 2) or withdrew their consent (n = 1). Overall, 114 (45.2%) patients were males and 138 (54.8%) were females. Table 1 shows patient demographic and baseline characteristics per indication. About 94.8% (n = 239) of the patients received 40 mg dose and 5.2% (n = 13) patients received 10 mg dose of Kenacort® injection. The route of Kenacort® injection was intra-articular in 231 (91.7%) patients and intramuscular in 5 (2%) patients. Only 4 (1.6%) patients required additional Kenacort® injection during the study; all these 4 patients received intra-articular dose of 40 mg. More than 30% of the patients had a history of hypertension (45.9%) or diabetes mellitus (39.3%) and were on metformin (27.7%) or telmisartan (23%) prior to the enrollment in the study. Approximately 28% (n = 70) of the patients were on other medications prior

Table 1. Demographic and Baseline Characteristics Parameters

OA (n = 136)

RA (n = 32)

TE (n = 17)

FS (n = 67)

Age (year), mean ± SD

57.9 (12.57)

51.3 (14.87)

45.7 (11.05)

56.3 (11.27)

52 (38.2): 84 (61.8)

12 (37.5): 20 (62.5)

Gender, n (%); males: females Race, n (%); Asians

9 (52.9): 8 (47.1) 41 (61.2): 26 (38.8)

136 (100)

32 (100)

17 (100)

67 (100)

Height (cm), mean ± SD

161.9 (7.00)

163.4 (6.33)

162.5 (7.90)

163.3 (8.23)

Weight (kg), mean ± SD

69.4 (11.97)

65.0 (11.05)

67.5 (12.87)

68.9 (10.26)

Body mass index (kg/m2), mean ± SD

26.5 (4.55)

24.4 (4.04)

25.5 (3.60)

25.9 (3.77)

Patients having any family history, n (%)

5 (83.3)

1 (16.7)

Duration of indication in a family member (years), mean ± SD

3.9 ± 1.34

10 (.)

108.2 (48.17)

66.7 (51.07)

99.2 (97.46)

122.4 (52.34)

96 (71.6)

23 (71.9)

9 (52.9)

46 (68.7)

Duration of morning stiffness (min), mean ± SD

21.0 (22.41)

37.4 (35.80)

13.3 (8.66)

12.6 (4.91)

VAS score (0-100 scale), mean ± SD

75.5 (12.87)

79.4 (12.94)

73.8 (13.29)

77.4 (13.85)

Range of movement (°), mean ± SD Morning stiffness, n (%)

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ORTHOPEDICS

There was a statistically significant decline in the duration (min) of morning stiffness from baseline to all study visits (Weeks 1 and 2, Months 1 to 3) in patients with OA, RA and FS (except at Week 2 in FS patients) and from baseline to Visit 4 (2 months) and Visit 5 (3 months) in patients with TE (p < 0.05) (Fig. 2). There was a statistically significant improvement in the range of movement, starting from Week 1 in patients with OA, RA and FS; the range of movement increased from 108.2° at baseline to 128.6° after 3 months of Kenacort® injection in OA patients (p < 0.0001), 66.7° to 117.1° (p < 0.0001) in RA patients and from 122.4° at baseline to 174.3° at 3 months in FS patients (p < 0.0001). Though the range of movement increased from 99.2° at baseline to 122.5° at 3 months in TE patients, the change was not statistically significant (p = 0.56012) (Fig. 3). There was a statistically significant improvement in mean VAS score (decline in overall severity of pain) from baseline to all study visits, starting from Week 1, in patients with all the 4 indications. The VAS score reduced from 75.5 at baseline to 6.9 at 3 months in OA patients, 79.4 to 5.0 in RA patients, 77.4 to 8.8 in FS patients and from 73.8 at baseline to 6.8 at 3 months

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Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

Mean duration of morning stiffness (minutes)

37.4

35 30 25

18*

18.9*

13.3 12.6

10 5 0

13.3 12.5 11.6* 12.2 8.6* 7.8

12* 8.8* 9.5* 9.3* 8.3 7.1* 7.9* 5*

11* 7.5* 6.8* 5*

Baseline Week 1 Week 2 Month 1 Month 2 Month 3 Study visits

Figure 2. Duration of morning stiffness at baseline and over 3 months with Kenacort® injection. *P < 0.05.

Mean range of movement (degrees)

Majority of the patients had a normal physical examination at enrollment. There was an overall improvement in the severity of pain (pain on movement, joint pain at rest, pain on passive movement, tenderness on examination, shoulder pain, pain on outside of the forearm, pain while lifting and twisting), joint stiffness and limitation of range of movement from baseline to 3 months. The majority of patients had moderate-tosevere pain/joint stiffness at baseline; this severity of pain/joint stiffness declined steadily over the period of 3 months. In addition, the proportion of patients with no limitation of range of movement increased from 19.6% at baseline to 85.2% at 3 months. Indication-wise, the higher proportion of patients with OA, RA, FS and TE experienced no symptoms of pain, morning stiffness, joint stiffness, limitation of range of movement or swelling at 3 months, reflecting a marked improvement in all symptoms post-treatment with Kenacort® 10 mg/40 mg injection.

in TE patients (Fig. 4). No adverse drug reactions were reported in the study. The majority of physicians (89.3%) and patients (89.0%) rated the tolerability of Kenacort® injection as ‘good’. Approximately 10% of the physicians and 11% of the patients rated tolerability of Kenacort® injection as ‘moderate’ and none of the

200

174.3*

180 160 140 120 100 80 60

TE 154.6*

141.7* 146.8* 134.4* 127.9* 128.6* 124.6* 117.4* 119.4* 122.5 119.2 127.5 117.1* 108.2 95.8 99.2 111.3* 98.5* 105.4* 99.2 85.4* 66.7

122.4

40 20 0 Baseline Week 1 Week 2 Month 1 Month 2 Month 3 Study visits

Figure 3. Range of movement at baseline and over 3 months with Kenacort® injection. *P < 0.05.

Mean VAS score (0-100 scale)

to Kenacort® injection, (≥3 patients were on aceclofenac, diclofenac, etoricoxib, aceclofenac and paracetamol [for OA], on diclofenac sodium [for RA] and on aceclofenac, piroxicam and tramadol [for FS]). However, as these patients did not respond to above medications, they were switched over to Kenacort® treatment. During the period of 3 months, only 19 (7.5%) patients required concomitant medications where ≥5 patients were on aceclofenac (n = 6) and diclofenac (n = 5).

90 80 70 60 50 40

79.4 75.5

77.4 73.8 62.3* 60.1* 55.3* 57.1* 46.1* 41.5*

46.4* 44.1*

30 20 10 0

Baseline Week 1

Week 2

34.4* 27.1* 27.6* 24.5* 17.2* 13.2* 57 11.8* 8.8* 10* 6.9* 6.8* 5* Month 1 Month 2 Month 3

Study visits

Figure 4. Visual analog scale score at baseline and over 3 months with Kenacort® injection. *P < 0.05.

ORTHOPEDICS physicians or patients rated the tolerability of Kenacort® injection as ‘poor’. DISCUSSION Musculoskeletal conditions are the most common cause of severe long-term pain and physical disability, affecting patients’ social functioning and mental health, with an impact on the quality-of-life. The present prospective, 3-month post-marketing observational study was conducted with an objective to evaluate the efficacy, safety and tolerability of “real time” use of Kenacort® injection in the treatment of patients with OA, RA, FS and TE. Kenacort® injection (administered either intraarticularly, intramuscularly or locally) plays an important role in the management of MSDs. The intramuscular administration is indicated for systemic corticosteroid therapy in conditions like allergic disease, dermatoses, or generalized RA and other connective tissue disorders while intra-articular administration helps in injecting the drug directly into the tendon sheaths and helps in alleviating the pain by reducing synovial blood flow and lowering leukocyte migration and inflammatory process (by decreasing the production of IL-1, TNF-α and proteases). Intraarticular administration of corticosteroids has also been found to be effective in reducing the symptoms of swelling and pain in patients with OA, RA, FS and TE.15-25 According to the Osteoarthritis Research Society International (OARSI) evidence-based expert consensus guidelines, intra-articular injections with corticosteroids can be used in the treatment of hip or knee OA, and should be considered particularly when patients have moderate-to-severe pain not responding satisfactorily to oral analgesic/anti-inflammatory agents and in patients with symptomatic knee OA with effusions or other physical signs of local inflammation.26 In this study, intra-articular route was the most preferred route of Kenacort® injection (92% patients), as all 4 studied indications (OA, RA, FS and TE) were joint disorders and intra-articular route involves injection into the joint cavity. Doses of up to 10 mg TA for smaller areas and up to 40 mg for larger areas have been shown to be sufficient to alleviate symptoms. Though a single local injection of TA is sufficient, additional dosing is required for adequate relief of symptoms. The frequency of injection is guided by various factors such as underlying diseases, response to past injection, patient and/or physician preference.9 In the present study, 94.8% of the patients were on a 40 mg dose of Kenacort® and only 4 (1.6%)

patients had an additional requirement of Kenacort® injection, which was also administered intra-articularly. This low frequency of additional dosing indicates good efficacy of Kenacort® injection. Majority of patients were on nonsteroidal anti-inflammatory drugs (NSAIDs) prior to Kenacort® treatment; diclofenac and aceclofenac were the most common NSAIDs used by the patients. However, as there was no much effect with respect to pain and inflammation, patients had switched their treatment from NSAIDs to Kenacort® 10/40 mg injection. After initiating Kenacort® treatment, only 7.5% patients required concomitant medications; thereby highlighting good efficacy and safety aspect of Kenacort® 10 mg/40 mg injection. A total of 252 patients were enrolled in the study of which 136 patients were diagnosed with OA, 32 with RA, 67 with FS and 17 patients with TE. Though a gender difference amongst OA, RA and FS patients were noted at baseline, the proportion of males and females were comparable among TE cases. Out of 136 OA patients enrolled, 61.8% were females and 38.2% were males. Similar results were reported in other studies where higher incidence of OA was reported in females, especially around the time of menopause (i.e., approximately after the age of 50 years).27-29 Females again predominated males by ~1.7 times in RA cases (62.5% vs. 37.5%). The results were in concordance to earlier RA literature where there was a predominance of females over males. A significantly higher prevalence of RA in females was reported in low- and middleincome countries (0.75% vs. 0.16%, p < 0.0001) in an earlier published systematic review.30 Several other studies have also reported similar results.31,32 This higher proportion of females diagnosed with OA and RA compared with males may be attributed to their genetic factor, obesity or hormonal changes, with advancing age. However, in contrast to the earlier published studies which had reported a higher risk of FS in females than males,33,34 in our study, the proportion of males in FS cases was ~1.6 times higher than females (61.2% vs. 38.8%). Further, unlike earlier studies which reported a higher prevalence of TE among females,35,36 no gender-related difference was noted among TE patients (males: 52.9%; females: 47.1%). Major proportion of patients from all 4 indications reported a significant improvement in pain (VAS) score, joint stiffness, duration of morning stiffness, range of movement and swelling, post Kenacort® injection. In OA cases, 86.4%, 88.6%, 89.4% and 49.2% of the patients experienced no pain on movement, no joint pain at rest, no joint stiffness and no swelling, respectively. The

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ORTHOPEDICS duration of morning stiffness declined from 21 to 6.8 minutes, the range of movement increased from 108.2° to 128.6° and the pain (VAS) score decreased from 75.5 to 6.9, at 3 months post Kenacort® injection. Our results were comparable to the earlier published study where Chandanwale et al in 2008 compared the efficacy, safety and tolerability of TA injection with methylprednisolone acetate (MPA) injection for the treatment of knee OA. The results had shown a significant reduction in overall pain in knee joint from 75.02 to 19.60 (p < 0.0001); pain at rest in knee joint from 64.31 to 11.83 (p < 0.0001); pain in knee joint on movement from 64.31 to 11.83 (p < 0.0001) and an increase in the range of knee joint movement from 94.29° to 118.90° (p < 0.0001) after 3 months of treatment with TA injection.37 In cases of RA, 78.1%, 81.3%, 81.3% and 65.6% of the patients had no pain on movement, no joint pain at rest, no stiffness of joint and mild swelling, respectively. The duration of morning stiffness declined from 37.4 to 7.5 minutes, the range of movement increased from 66.7° to 117.1° and the pain score reduced from 79.4 to 5.0 at 3 months after Kenacort® injection. Similar results were reported in earlier studies where the efficacy, safety and tolerability of TA injection was compared with an MPA injection in the treatment of RA of metacarpophalangeal or interphalangeal joints. The results had shown a significant reduction in joint pain from 55.00 to 5.21 (p < 0.0001); joint pain at rest from 67.58 to 8.58 (p < 0.0001); joint pain on movement from 51.54 to 3.71 (p < 0.0001); increase in range of knee joint movement from 94.29° to 118.90° (p < 0.0001) and a reduction in the duration of morning stiffness from 65.42 to 7.10 min (p < 0.0001) after 3 months of treatment with TA injection.37 In FS cases, more than 70% of the patients had no pain on movement (76.1%), no joint pain at rest (77.6%), no pain on passive movement (71.6%), no shoulder pain (76.1%), no pain on outside of the forearm (82.1%), no pain while lifting (77.6%), no pain while twisting (79.1%), no stiffness of the joints (80.6%) and no limitation of range of movement (80.6%), at 3 months of treatment. Approximately 48% of the FS patients had no swelling at 3 months of treatment. The duration of morning stiffness declined from 12.6 to 11 minutes, the range of movement increased from 122.4° to 174.3 and the overall pain score reduced from 77.4 to 8.8, post 3 months of Kenacort® injection. Various studies have also reported the efficacy of TA in terms of reducing shoulder related disability and pain due to stiffness

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of the shoulder joint. In 1998, van der Windt et al reported a significant improvement in measures of pain and shoulder disability than physiotherapy alone, after treatment with TA 40 mg for 7 weeks.38 In 2005, Ryans et al conducted a randomized and placebocontrolled trial where the effectiveness of intra-articular triamcinolone 20 mg with and without physiotherapy was evaluated in the treatment of FS over the period of 6 weeks. Triamcinolone 20 mg with physiotherapy led to a significant improvement in shoulder-related disability and patient global assessment, while physiotherapy alone significantly improved the range of movement in external rotation 6 weeks after treatment.24 In 2007, Sakeni and Al-Nimer reported TA 40 mg to be effective in reducing the pain due to stiff shoulder in Iraqi patients with primary and secondary FS.39 In 2012, Khuhro et al recommended intra-articular injections of TA along with local anesthetic in the management of FS as it effectively improved pain scores and degree of shoulder movement.40 In cases of TE, higher proportion of patients reported no pain on movement/at rest/on passive movement or while lifting (82.4% patients), no joint stiffness or limitation of range of movement (82.4%), no pain on outside of the forearm or while twisting (70.6%), no shoulder pain (64.7%) and mild swelling (58.8%) at 3 months of treatment. The duration of morning stiffness declined from 13.3 to 5 minutes, the range of movement increased from 99.2° to 122.5° and the overall pain score reduced from 73.8 to 6.8 at 3 months after Kenacort® injection. In our study, the efficacy of Kenacort® injection was observed up to 3 months of treatment. However, few studies have reported shortterm (~1.5 months) efficacy of corticosteroids in TE patients. In 2002, Smidt et al evaluated the effectiveness of corticosteroid injections in TE patients and concluded that there was a statistically significant improvement in pain and grip strength after corticosteroid injection against placebo, local anesthetic and conservative treatments, when given for the duration of ≤6 weeks.41 In 2013, Olaussen and his team, in a systematic review, reported short-term (4-12 weeks) beneficial effect (pain reduction) of corticosteroid injection in TE patients.42 No adverse drug reactions were reported in this study, indicating good tolerability of Kenacort® injection. Both physicians and patients also rated the tolerability of Kenacort® injection as ‘good’. These results were consistent with earlier reported data.37,43 There were few limitations in our study. Firstly, the long-term effect of Kenacort® injection could not

ORTHOPEDICS be evaluated as this was a 3-month study. No direct comparison of Kenacort® injection with other steroids was done in this study. Further, the efficacy, safety and tolerability of additional doses of Kenacort® injection after initial dose at baseline visit were not evaluated in this study. Moreover, the benefits of different routes of Kenacort® injection were not compared with each other. CONCLUSION Kenacort® (TA) 10 mg/40 mg injection showed high efficacy, safety and tolerability in the treatment of patients with OA, RA, FS and TE. Its use was associated with significant improvement in the overall pain score and reduction in the severity of joint pain, joint stiffness, duration of morning stiffness, restriction in range of movement and swelling in patients of OA, RA, FS and TE. However, comparative studies with longer duration are warranted to further strengthen the results of the present study.

Acknowledgment The authors would like to thank all doctors and patients who participated in this study. The authors would also like to acknowledge site management and medical writing teams (JSS, India) for their efforts.

Disclosure This study was funded by Abbott Healthcare Pvt Ltd. Dr Manu C, Medical Advisor, has authored this manuscript in the capacity of employment with Abbott Healthcare Pvt Ltd. Dr Anil, Dr Neeraj and Dr Atul have received research funding from Abbott Healthcare Pvt. Ltd as investigators.

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6. Caldwell JR. Intra-articular corticosteroids. Guide to selection and indications for use. Drugs. 1996;52(4): 507-14. 7. Wei AS, Callaci JJ, Juknelis G, Marra G, Tonino P, Freedman KB, et al. The effect of corticosteroid on collagen expression in injured rotator cuff tendon. J Bone Joint Surg Am. 2006;88(6):1331-8. 8. Lavelle W, Lavelle ED, Lavelle L. Intra-articular injections. Med Clin North Am. 2007;91(2):241-50. 9. Kenacort-A40. New Zealand Data Sheet. Available at: http://www.medsafe.govt.nz/profs/datasheet/k/ KenacortA40inj.pdf. Accessed on April 27, 2016. 10. Martindale: The Extra Pharmacopoeia. London, England: The Pharmaceutical Press; 1977. pp. 432-3. 11. Gilman AG, Goodman LS, Gilman A (Eds.). The Pharmacological Basis of Therapeutics. New York: Macmillan Publishing Co., Inc.; 1980. pp. 1470-96. 12. Booth NH, McDonald LE (Eds.). Veterinary Pharmacology and Therapeutics. Ames, IA: The Iowa State University Press; 1982. pp. 553-70. 13. Osol A. Remington's Pharmaceutical Sciences. Easton, PA: EdMack Publishing Company; 1980. pp. 898-901. 14. Melby JC. Drug spotlight program: Systemic corticosteroid therapy: pharmacology and endocrinologic considerations. Ann Intern Med. 1974;81(4):505-12. 15. Hochberg MC, Altman RD, Brandt KD, Clark BM, Dieppe PA, Griffin MR, et al. Guidelines for the medical management of osteoarthritis. Part II. Osteoarthritis of the knee: American College of Rheumatology. Arthritis Rheum. 1995;38(11):1541-6. 16. Kirwan JR. Arthritis and rheumatism council low-dose glucocorticoid study group. The effect of glucocorticoids on joint destruction in rheumatoid arthritis. N Engl J Med. 1995;333(3):142-6. 17. Assendelft WJ, Hay EM, Adshead R, Bouter LM. Corticosteroid injections for lateral epicondylitis: a systematic overview. Br J Gen Pract. 1996;46(405):209-16. 18. Neustadt DH. Intra-articular therapy. In: Moskowitz RW, Howell DS, Altman RD, Budwalter JA, Goldberg VM (Eds.). Osteoarthritis Diagnosis and Medical/Surgical Management. Philadelphia: WB Saunders; 2001. pp. 393-411. 19. Van Everdingen AA, Jacobs JW, Siewertsz Van Reesema DR, Bijlsma JW. Low-dose prednisone therapy for patients with early active rheumatoid arthritis: clinical efficacy, disease-modifying properties, and side effects: a randomized, double-blind, placebo-controlled clinical trial. Ann Intern Med. 2002;136(1):1-12. 20. Carette S, Moffet H, Tardif J, Bessette L, Morin F, Frémont P, et al. Intraarticular corticosteroids, supervised physiotherapy, or a combination of the two in the treatment of adhesive capsulitis of the shoulder: a placebocontrolled trial. Arthritis Rheum. 2003;48(3):829-38. 21. Raynauld JP, Buckland-Wright C, Ward R, Choquette D, Haraoui B, Martel-Pelletier J, et al. Safety and efficacy of

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33. Kozin F. Two unique shoulder disorders. Adhesive capsulitis and reflex sympathetic dystrophy syndrome. Postgrad Med 1983;73(5):207-10.

22. Buchbinder R, Hoving JL, Green S, Hall S, Forbes A, Nash P. Short course prednisolone for adhesive capsulitis (frozen shoulder or stiff painful shoulder): a randomized, double blind, placebo controlled trial. Ann Rheum Dis. 2004;63(11):1460-9.

34. Neviaser RJ, Neviaser TI. The frozen shoulder: Diagnosis and management. Clin Orthop Relat Res. 1987;223:59-64.

23. Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005;55(512):224-8.

36. Wolf JM, Mountcastle S, Burks R, Sturdivant RX, Owens BD. Epidemiology of lateral and medial epicondylitis in a military population. Mil Med. 2010;175(5):3363-9.

24. Ryans I, Montgomery A, Galway R, Kernohan WG, McKane R. A randomized controlled trial of intraarticular triamcinolone and/or physiotherapy in shoulder capsulitis. Rheumatology(Oxford). 2005;44(4):529-35. 25. Lewis M, Hay EM, Paterson SM, Croft P. Local steroid injections for tennis elbow: does the pain get worse before it gets better? Results from a randomized controlled trial. Clin J Pain. 2005;21(4):330-4. 26. Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16(2):137-62. 27. Srikanth VK, Fryer JL, Zhai G, Winzenberg TM, Hosmer D, Jones G. A meta-analysis of sex differences in prevalence, incidence and severity of osteoarthritis. Osteoarthritis Cartilage. 2005;13(9):769-81. 28. Neogi T, Zhang Y. Epidemiology of osteoarthritis. Rheum Dis Clin North Am. 2013;39:1-19. 29. Johnson VL, Hunter DJ. The epidemiology of osteoarthritis. Best Pract Res Clin Rheumatol. 2014;28(1):5-15. 30. Rudan I, Sidhu S, Papana A, Meng SJ, Xin-Wei Y, Wang W, et al. Prevalence of rheumatoid arthritis in lowand middle-income countries: A systematic review and analysis. J Glob Health. 2015;5(1):010409. 31. Mitchell DM. Epidemiology. In: Utsinger PD, Zvaifler NJ, Ehrlich GE (Eds.). Rheumatoid Arthritis, Etiology, Diagnosis and Treatment. Philadelphia: Lippincott JB; 1985. pp. 133-50.

35. Stasinopoulos D, Stasinopoulou K, Johnson MI. An exercise programme for the management of lateral elbow tendinopathy. Br J Sports Med. 2005;39(12):944-7.

37. Chandanwale AS, Langade DG, Nawale S, Rao URK, Fatima F. An open comparative study to evaluate the efficacy, safety and tolerability of Kenacort® injection (triamcinolone acetonide) versus methyl prednisolone injection in the treatment of osteoarthritis of knee. Indian Medical Gazette. 2008a:187-93. 38. Van der Windt DA, Koes BW, Devillé W, Boeke AJ, de Jong BA, Bouter LM. Effectiveness of corticosteroid injections versus physiotherapy for treatment of painful stiff shoulder in primary care: randomized trial. BMJ. 1998;317(7168):1292-6. 39. Sakeni RA, Al-Nimer MS. Comparison between intraarticular triamcinolone acetonide and methylprednisolone acetate injections in treatment of frozen shoulder. Saudi Med J. 2007;28(5):707-12. 40. Khuhro BA, Memon GA, Shaikh AA, Sohal ZA, Tabasum R. Comparative efficacy of triamcinolone acetonide and methylprednisolone along with local anaesthetics in the management of frozen shoulder. Annals. 2012;18(1):95-9. 41. Smidt N, Assendelft WJ, van der Windt DA, Hay EM, Buchbinder R, Bouter LM. Corticosteroid injections for lateral epicondylitis: a systematic review. Pain. 2002; 96(1-2):23-40. 42. Olaussen M, Holmedal O, Lindbaek M, Brage S, Solvang H. Treating lateral epicondylitis with corticosteroid injections or non-electrotherapeutical physiotherapy: a systematic review. BMJ Open. 2013;3(10):e003564.

43. Chandanwale AS, Langade DG, Nawale S, Sinha SR. An open comparative study to evaluate the efficacy, safety and tolerability of triamcinolone acetonide (Kenacort®) versus 32. Tobón GJ, Youinou P, Saraux A. The environment, geomethyl prednisolone injection in the treatment of rheumatoid epidemiology, and autoimmune disease: rheumatoid arthritis of metacarpophalangeal or interphalangeal joints. arthritis. J Autoimmun. 2010;35(1):10-4. Indian Medical Gazette. 2008b:104-10. ■■■■

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PSYCHIATRY

Burnout Syndrome: A Disease of Modern Era PARINITA C HAZARIKA*, SMARANIKA CHOUDHURY†, ARUN KUMAR GUPTA‡

ABSTRACT Burnout syndrome (BOS) is recognized worldwide as a major challenge to workers’ health and the functioning of their organizations. It is a work-related constellation of symptoms that usually occurs in individuals without any prior history of psychological or psychiatric disorders. The trigger is the discrepancy between the expectations and ideals of the employee and the actual requirements of their position. It occurs most amongst professional people in the caring professions of medicine, nursing, social work, counseling and teaching whose work involves constant demands and intense interactions with people who have physical and emotional needs. According to the most common description at present, burnout syndrome is characterized by exhaustion, depersonalization and reduced satisfaction in performance. This article gives an overview of the current scenario for burnout syndrome. By examining diagnostic criteria and possible therapies, methods of prevention are discussed.

Keywords: Burnout syndrome, healthcare professionals, chronic stress, exhaustion, depersonalization

urnout is a global concern and work-related stress has the potential to negatively affect the individual’s psychological and physical health and therefore affects the organization’s effectiveness. Thus, it is recognized worldwide as a major challenge to workers’ health and the functioning of their organizations. In the last decade, several epidemiological studies have found a high prevalence of the professional stress syndrome of burnout in western and developing countries.1 Burnout is usually assessed in an occupational setting and most occupational groups, white-collar (civil servants), bluecollar (manual workers) and the ‘helping’ professions (healthcare workers, caregivers and teachers) may be affected.2,3 Nevertheless, burnout syndrome (BOS) occurs mainly among professionals whose work involves constant demands and intense interactions with people who have physical and emotional needs.

*Head of Department Dept. of Anesthesia Mrs Girdhari Lal Maternity Hospital, North MCD, New Delhi †Senior Resident Dept. of Anesthesiology and Critical Care Lady Hardinge Medical College and Shrimati Sucheta Kriplani Hospital, New Delhi ‡Consultant Dept. of Anesthesia and Critical Care Sharda Medical College, Greater Noida, Uttar Pradesh Address for correspondence Dr Parinita C Hazarika Add-570, Mandakini Enclave, Alaknanda, New Delhi - 110 019 E-mail: drparinitamalik@gmail.com

The term ‘burnout’ was coined in the USA a good 25 years ago. The psychoanalyst Freudenberger, for example, published one of the first scientific descriptions of the BOS as psychiatric and physical breakdown.4 In 1981, Maslach introduced a further reaching definition and an instrument for measuring burnout which is still the most frequently used today, the Maslach Burnout Inventory (MBI).5,6 BOS is a work-related constellation of symptoms that usually occurs in individuals without any prior history of psychological or psychiatric disorders. BOS is triggered by the discrepancy between the expectations and ideals of the employee and the actual requirements of their position. RISK FACTORS Negative job characteristics ÂÂ

Workload: overwork and heavy workload, boredom

ÂÂ

Work conflicts

ÂÂ

Diminished resources

ÂÂ

Lack of input or feedback

ÂÂ

Job insecurity

ÂÂ

Effort-reward imbalance

ÂÂ

Length of training and delayed gratification

Occupational factors ÂÂ Step hierarchy ÂÂ Understaffing ÂÂ High demands for employees

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PSYCHIATRY ÂÂ

Number of years in current profession and total number of years

Organizational factors ÂÂ

Continuing rapid organizational changes

Demographic variables ÂÂ

Younger adults

ÂÂ

Unmarried people/women caring for children

Personality traits ÂÂ

Low hardiness

ÂÂ

Poor self-esteem

Job attitudes ÂÂ

Unrealistically high expectations

ÂÂ

Financial issues (salary).

EPIDEMIOLOGY Burnout can occur in any occupation.7 However, it has been found to occur most amongst professional people in the caring professions of medicine, nursing, social work, counseling and teaching. When studied, the prevalence amongst healthcare workers approaches 25%.8

Phases Psychologists Herbert Freudenberger and Gail North have theorized that the burnout process can be divided into 12 phases, which are not necessarily followed sequentially. 1. The compulsion to prove oneself: Often found at the beginning is excessive ambition. The desire to prove oneself in the workplace turns into compulsion. 2. Working harder: In order to meet the expectations, they tend to focus solely on work, while they take on more work than they otherwise would. It may happen that they become obsessed with doing everything themselves to show that they are irreplaceable. 3. Neglecting their needs: Since, they have to devote everything to work, they now have no time and energy for anything else. 4. Displacement of conflicts: They become aware that what they are doing is not right, but they are unable to see the source of the problem. 5. Revision of values: While falling into a state of denial of basic physical needs, perceptions and

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value systems change. Work consumes all energy, leaving none for friends and hobbies. 6. Denial of emerging problems: People may become intolerant and dislike being social. They may be seen as aggressive and sarcastic. 7. Withdrawal: Minimal social contact turns into isolation. Even alcohol or drugs may be used as a release from obsessive working. 8. Obvious behavioral changes: Co-workers, family, friends and others in their immediate social circles cannot overlook the behavioral changes in these people. 9. Depersonalization: It is possible that they no longer see themselves or others as valuable. Their view of life narrows to only seeing the moment and life turns into a series of mechanical functions. 10. Inner emptiness. 11. Depression. 12. Burnout syndrome. They collapse physically and emotionally and need immediate medical attention. In extreme cases, suicidal ideation may occur. SIGNS AND SYMPTOMS Burnout is considered to have a range of symptoms. It is a state of chronic stress that leads to: ÂÂ

Physical and emotional exhaustion

ÂÂ

Cynicism and detachment

ÂÂ

Feelings of ineffectiveness accomplishment.

and

lack

However, burnout does not happen suddenly. Its nature is much more insidious, creeping up on us over time like a slow leak, which makes it much harder to recognize. Still, our bodies and minds do give us warnings, and if we know what to look for, we can recognize it before it is too late. WHAT ARE THE SIGNS OF BURNOUT? Each of the three areas described above is characterized by certain signs and symptoms (although there is overlap in some areas). These signs and symptoms exist along a continuum.

Signs of Physical and Emotional Exhaustion ÂÂ

Chronic fatigue

ÂÂ

Insomnia

PSYCHIATRY ÂÂ

Forget fulness/impaired attention

concentration

and

ÂÂ

Physical symptoms: Physical symptoms may include chest pain, heart palpitations, shortness of breath, gastrointestinal pain, dizziness, fainting and/or headaches.

ÂÂ

Increased illness

ÂÂ

Loss of appetite

ÂÂ

Anxiety

ÂÂ

Depression

ÂÂ

Anger.

Signs of Cynicism and Detachment ÂÂ

Loss of enjoyment.

ÂÂ

Pessimism: At first, this may present itself as negative self-talk and/or moving from a glass halffull to a glass half-empty attitude. At its worst, this may move beyond how we feel about ourselves and extend to trust issues with co-workers and family members and a feeling that we cannot count on anyone.

ÂÂ

Isolation: In the early stages, this may seem like mild resistance to socializing. In the latter stages, we may become angry when someone speaks to us, or we may come in early or leave late to avoid interactions. Detachment: Detachment is a general sense of feeling disconnected from others or from our environment. It can take the form of the isolative behaviors described above.

Signs of Ineffectiveness and Lack of Accomplishment ÂÂ Feelings of apathy and hopelessness: This is similar to what is described in the depression and pessimism sections of this article. ÂÂ Increased irritability. HOW IS BURNOUT DIAGNOSED? There are no well-researched methods to diagnose burnout yet. Various questionnaires can be used for self-assessment. The problem with these questionnaires is that there is no common definition of what burnout is. The most common questionnaire is the “Maslach Burnout Inventory” (MBI), which is available for different professional groups. This questionnaire was not developed for clinical practice; however, but rather for scientific research on burnout. The MBI is by far the most widely used, accepted, valid and

reliable measurement tool of stress and burnout. The 22 total items are broken up into the three themes with nine items relating to emotional exhaustion, five to depersonalization and eight to accomplishment. Each item is also rated on a frequency and intensity scale. The frequency scale ranges from zero (never) to six (everyday). The intensity scale ranges from one (never) to six (very-strong). Generally, symptoms said to be a result of burnout can also have other causes, for example mental or psychosomatic disorders like depression, anxiety disorders or chronic fatigue syndrome. So, it is important to look for possible causes and not to think of ‘burnout’ straight away. Otherwise there is a risk of using wrong or ineffective treatments. HOW TO RECOVER FROM (OR PREVENT) BURNOUT? The first and most important step in preventing or recovering from burnout is to recognize the problem and objectively survey the situation.

Stop (or at least Slow Down) If we are working 50 or more hours a week, cutting that number to the bare minimum helps. If possible, availing of sick days, working from home once a week and taking a vacation or a leave of absence will give ourselves the time needed to decompress, reflect and reconnect.

Communicate When in doubt, there is a need to seek counsel and support from family, friends and industry peers.

Set Boundaries and Expectations The days of the 9-to-5 jobs are gone and the boundaries between work and home are blurred to the point of nonexistence. We are expected to be available nearly all the time, and the problem is often exacerbated for freelancers or anyone who works primarily from a home office, where the only divide between being ‘at home’ and being ‘at work’ is a single door or a flight of stairs.

Sleep More Sleep gives our brains a chance to work out problems and process the information we have absorbed throughout the day. Even if we can function on 4 or 5 hours of sleep, how much better would we function on 7 or 8 hours?

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PSYCHIATRY Create a Daily Routine It is not unusual for creative types to do their best work at the same time every day. By this, it means that it is important to follow our own circadian rhythms. It is recommended that the most important work (or the work requiring the greatest focus) be done during that time when we are most energized and have the fewest distractions.

Make Time for Numero Uno Spending time with family, friends or your personal interests may provide the fulfilment, which we donâ&#x20AC;&#x2122;t get at work.

Examine Your Values, Goals and Measures of Success To know ourself. What are we passionate about? How do we evaluate ourself against expectations placed on us by managers and clients, and the work we are doing? Are these measures grounded in reality? Are our personal development goals being met by the type of work we are doing? Are we feeling too much pressure from unrealistic demands or those that go against our values? What frustrates us? Simply connecting with things that matter to us can provide perspective.

Focus Good work requires focus. Modern communication conveniences provide us a valuable social connection to the outside world, but they can also destroy our concentration and clarity.

Change Your Situation Changing departments, learning a new skill or simply focussing more on the things we are good at, can make us happy.

Rely on a Good Process If we already have a process that we think works on talking to our peers, reading up on the topic, seeing what processes others use, experimenting and finding out what works for us, we can scrutinize, clarify and simplify it as much as possible.

Regaining Your Balance When we are burned out, we know it. The process often begins with a look inward to learn what gives our life balance, such as family, friends, personal interests

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and hobbiesâ&#x20AC;&#x201D;the things that counterbalance our life on the web. If our waking hours are entirely consumed by our work, or if we are unfocused and inattentive to our own needs, burnout will be waiting at every turn of our life. RESEARCH The intensive care unit (ICU) is a highly stressful environment and may therefore be associated with a high rate of BOS in staff members.9,10 The cost of BOS includes decreased quality of care, absenteeism and high turnover rates and poor communication with families. A large multicenter study of the prevalence of severe BOS in ICU nursing staff members was conducted in France as measured by the MBI scale for human service professionals (Questionnaire Survey). Among 278 ICUs contacted for the study, 165 (59.4%) included 2,525 nursing staff members, of whom 2,392 returned questionnaires with complete MBI data. Of the 2,392 respondents (82% female), 80% were nurses, 15% nursing assistants and 5% head nurses. Severe BOS-related symptoms were identified in 790 (33%) respondents.11 Burnout is frequent among physicians with rates ranging from 25% to 60%, depending on the working conditions and medical speciality. Studies of burnout in practicing physicians have shown that burnout can develop at any stage in the career of a physician. In a study focused on internal medicine residents, 76% of respondents met a high level of BOS. Determinants of burnout consist of job characteristics, demographic variables (sex, age) and personality traits.12 Many aspects of professional practice have changed for both doctors and nurses and include lack of autonomy, decreased resources and the requirement of a high level of competence and technical support. Workload, stressful work environments like ICUs, severity of illness and conflicts with co-worker or with patients, may be risk factors for BOS. CONCLUSION In the light of social change and a transformation in the work situation, interest in the problem of burnout has grown over the past decade. There is a conspicuous discrepancy; however, between what is regarded as certain knowledge and what is published opinion. To date, there is no generally accepted definition of burnout, or binding diagnostic criteria. According to the most common description at present, BOS is

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

Automated Radiology & Imaging Facilities Fully Computerizetd Computerized Automated Laboratory

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

PSYCHIATRY characterized by exhaustion, depersonalization and reduced satisfaction in performance. Because of its etiopathogenesis, burnout is today mainly regarded as the result of chronic stress, which has not been successfully dealt with. This paper gives an overview of the current scenario for BOS. By examining diagnostic criteria and possible therapies, methods of prevention are discussed. There is an urgent need for further investigations to deal with BOS as a work-related disease. REFERENCES 1. Maslach C, Schaufeli WB, Leiter MP. Job burnout. Annu Rev Psychol. 2001;52:397-422. 2. Felton JS. Burnout as a clinical entity - its importance in health care workers. Occup Med (Lond). 1998;48(4): 237-50. 3. Valente LE, Truzzi A, Souza WF, Alves GS, Alves CE, Sudo FK, et al. Health self-perception by dementia family caregivers: sociodemographic and clinical factors. Arq Neuropsiquiatr. 2011;69(5):739-44.

5. Burisch M. Das Burnout-Syndrom—Theorie der inneren Erschopfung 2. Auflage. Berlin, Heidelberg: Springer Verlag; 1994. 6. Maslach C, Jackson SE. The measurement of experienced burnout. J Occup Behav. 1981;2:99-113. 7. Hämmig O, Bauer GF. Work, work-life conflict and health in an industrial work environment. Occup Med (Lond). 2014;64(1):34-8. 8. Mateen FJ, Dorji C. Health-care worker burnout and the mental health imperative. Lancet. 2009;374(9690):595-7. 9. Donchin Y, Seagull FJ. The hostile environment of the intensive care unit. Curr Opin Crit Care. 2002;8(4):316-20. 10. Soupios MA, Lawry K. Stress on personnel working in a critical care unit. Psychiatr Med. 1987;5(3):187-98. 11. Poncet MC, Toullic P, Papazian L, Kentish-Barnes N, Timsit JF, Pochard F, et al. Burnout syndrome in critical care nursing staff. Am J Respir Crit Care Med. 2007;175(7):698-704.

12. Embriaco N, Papazian L, Kentish-Barnes N, Pochard F, Azoulay E. Burnout syndrome among critical care healthcare workers. Curr Opin Crit Care. 2007;13(5): 4. Freudenberger HJ. Staff burnout. J Soc Issues. 1974;30: 159-65. 482-8. ■■■■

Suvorexant Found to be Effective for Insomnia in the Elderly New research presented at the American Association for Geriatric Psychiatry (AAGP) 2017 on March 25, 2017 in Dallas, USA has shown suvorexant to be safe and effective for insomnia in older adults, without some of the risks and side effects commonly associated with other drugs.

Depression Tops List of Causes of Ill Health, Says WHO Depression is the leading cause of ill health and disability worldwide. According to the latest estimates from WHO, more than 300 million people are now living with depression, an increase of more than 18% between 2005 and 2015. Lack of support for people with mental disorders, coupled with a fear of stigma, prevent many from accessing the treatment they need to live healthy, productive lives. The new estimates have been released in the lead-up to World Health Day on 7 April, the high point in WHO’s year-long campaign “Depression: let’s talk”. The overall goal of the campaign is that more people with depression, everywhere in the world, both seek and get help. WHO Director-General, Dr Margaret Chan said, “These new figures are a wake-up call for all countries to re-think their approaches to mental health and to treat it with the urgency that it deserves.” One of the first steps is to address issues around prejudice and discrimination. “The continuing stigma associated with mental illness was the reason why we decided to name our campaign Depression: let’s talk,” said Dr Shekhar Saxena, Director of the Dept. of Mental Health and Substance Abuse at WHO... (WHO, March 30, 2017)

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Global Pathway, Current Condition and Challenges in the Management of Autism in Children SATHISH AMIRTHALINGAM

ABSTRACT Autism is a spectrum disorder affecting children, and in the majority of cases, boys. Present from early childhood, characterized by difficulty in communicating and forming relationships with other people and in using language and abstract concepts. The causes of autism spectrum disorder (ASD) are not known. Research suggests that both genes and environment play important roles. There is currently no one standard treatment for ASD. There are many ways to increase your child’s ability to grow and learn new skills. Starting them early can lead to better results. Treatments include behavior and communication therapies, skills training and medicines to control symptoms. Autism requires a proper diagnosis and proper treatment in a multidisciplinary environment.

Keywords: Autism, autism spectrum disorder, global impact, challenges in autism

utism spectrum disorder (ASD) is a group of developmental disability characterized by impairment in reciprocal social interactions, communication skills and the presence of restricted, stereotyped repetitive behaviors and interests. It is an umbrella term that includes autistic disorder (autism), Asperger’s disorder, childhood disintegrative disorder and pervasive developmental disorder not otherwise specified. However, the recent Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) concludes the use of this single term for the diagnosis of autism. Signs of the disorder usually start at a very young age. Possible early sign of ASD is an impairment in social interactions like lack of appropriate eye gaze, lack of warm, joyful expressions, lack of sharing interest or enjoyment and lack of response to name. Additional signs are an impairment in communication, repetitive behaviors and restricted interests.

Lecturer III Dept. of Pharmacy Practice International Medical University, Kuala Lumpur, Malaysia Address for correspondence Dr Sathish Amirthalingam Lecturer III Dept. of Pharmacy Practice International Medical University No.126, Jalan Jalil Perkasa, 19, Bukit Jalil - 57000, Kuala Lumpur, Malaysia E-mail: asathish1981@gmail.com, SathishAmirthalingam@imu.edu.my

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GLOBAL SCENARIO OF AUTISM According to World Health Organization (WHO), the global prevalence of children with ASD is estimated to be one child in every 160, and based on the data from CDC’s Autism and Developmental Disabilities Monitoring (ADDM), the worldwide rate of ASD in children from 2002 to 2008 has increased by approximately 78%. Meanwhile in Malaysia, based on a Modified Checklist for Autism in Toddlers (M-CHAT) test on children of 18-36 months of age, an estimated ASD prevalence of 0.16% has been found in the country. A local organization known as the National Autism Society of Malaysia (NASOM) has recorded a 30% increase in the intake of autistic children for past 3 years. This trend is supported by a survey done by Poh-Chua (2012) whereby ASD is the fastest growth disorder, which has approximately 12,800 reported cases and is expected that 1 out of 600 children are affected by autism in Malaysia. Meanwhile, the National Survey of Children’s Health (NSCH) in the United States (US) have provided data stating the prevalence of children affected by ASD in 2011 and 2012 was 2.0% for children aged 6-17. The United Kingdom (UK) on the other hand, recorded a prevalence rate of 1.1%. Meanwhile in Malaysia, the prevalence rate is only 0.16% as aforementioned (Fig. 1).

PSYCHIATRY IMPACT OF AUTISM

PATHOPHYSIOLOGY OF AUTISM: AN OVERVIEW

The pervasive and severe shortcomings that come with ASD can cause a plethora of difficulties in individuals, parents and the society is summarized in Figure 2.

Definitive mechanisms in the development of autism are poorly understood and mostly unknown, yet several theories are suggesting the disruption of normal cerebral development and its subsequent implications on brain function. Among these pathophysiological theories are genetic contributions, neurochemical imbalances, oxidative stress and autoimmune responses (Fig. 3). Potential mechanisms depicting the role of oxidative stress and mitochondrial dysfunction in the development and pathophysiology of autism is shown in Figure 4.

2.5

Percentage (%)

2 1.5 1

ASSESSMENT AND DIAGNOSIS

0.5 0 Global

Malaysia

Figure 1. The global prevalence of children with ASD in comparison with US, UK and Malaysia.

Based on Simons Foundation Autism Research Initiative (SFARI), the gold standards for diagnosing autism are Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview-Revised (ADI-R). Similar to the global management of autism, autism Clinical Practice Guideline (CPG) Malaysia also advocates the

Social phobia Risk of depression Physical & social impairment

Limited employment opportunities

Individual

Associated comorbidity

Physical High parental stress Stereotyped behavior

Parent

Family

Affect maternal quality-of-life Financial issue

Higher mortality

Siblings

Precocious responsibility

Feeling neglected Fewer friendship

ADHD, sleep disorders, epilepsy, gastrointestinal problems, motor coordination, other psychiatric disorders

Impact

Social embarrassment

Poor social life

Loneliness

Higher risk of bullying & victimization

Society/ Country

Criminal cases

Cost

Healthcare, special education, long-term facilities

Figure 2. Summary of the impact of autism in individuals, families and the society.

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PSYCHIATRY

Genetic contribution

Neurochemical imbalances

Oxidative stress

Increase susceptibility

Increase serotonin level

Concomitantly found in patients with fragile X syndrome, tuberous sclerosis and other genetic conditions

Low level of dopamine

Ex: nucleotide polymorphism in MET

Decrease antioxidants in plasma Increase oxidative stress

Decrease GABA proteins and GABA receptors

Causing hyperpermeable blood-brainbarrier, apoptosis, neurodegeneration and demyelination

Changes in catecholaminergic, peptidergic, and cholinergic systems

Autoimmune responses

Increase autoantibodies in the brain and altered immune cell responses

Other

GI difficulties Food intolerance

Low levels of IgA Increase inflammatory cytokines

Allergics Mitochondrial dysfunction Defective detoxification

Figure 3. Pathophysiology of autism.

Deficit in mitochondrial electron transport chain complexes

Environmental risk factors (prenatal, perinatal, postnatal)

Impaired oxidative phosphorylation, impaired energy (ATP) production

Increased generation of free radicals

Mitochondrial dysfunction

Oxidative Stress

Genetic susceptibility factors

Reduced antioxidant defense yyGlutathione redox imbalance yy ↓Antioxidant enzymes (superoxide dismutase, catalase, glutathione peroxidase) yy ↓Fe2+/Cu2+ transport proteins (ceruloplasmin, transferrin)

↓DNA methylation ∧ Lipid peroxidation ∧ Protein oxidation

Inflammation

Altered immune response

Epigenetic dysregulation

∧ DNA oxidation

Pathogenesis and clinical development of autism

Figure 4. Potential mechanisms depicting the role of oxidative stress and mitochondrial dysfunction in the development and pathophysiology of autism.

use of ADI-R and ADOS with the addition of Diagnostic Interview for Social and Communication Disorders (DISCO), and Childhood Autism Rating Scale (CARS). The guideline has also proposed the diagnosis of autism to be based on three areas - social accordance, communication and confined interests and activities with minimum onset of 3 years of age. According to CPG Malaysia, ADI-R can be concluded as the best diagnosis method due to its high sensitivity and specificity values. In comparison to Malaysia, among

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the differences found in CPG New York (US) is that the latter suggested Pre-Linguistic Autism Diagnosis Observation Schedule (PL-ADOS) test instead of ADOS and CPG New York also proposed a screening test known as the CHAT as a preliminary assessment tool for autism (Table 1). Furthermore, based on National Institute for Health and Care Excellence (NICE) guidelines (UK) the diagnostic method for autism is relatively similar to CPG Malaysia.

PSYCHIATRY Table 1. Diagnostic and Assessment Tools for Autism Test

Description

Autism Diagnostic InterviewRevised (ADI-R)

A structured interview

Sensitivity of test

Specificity of test

1.0

>0.97

0.8

0.79

2 years old: 0.79

2 years old: 0.80

4 years old: 0.86

4 years old: 0.80

0.82

0.60

N/A

To measure behavior in areas of:

yy Reciprocal social interaction yy Communication and language yy Behavior patterns

Diagnostic Interview for Social and A semi-structured interview Communication Disorders (DISCO) To identify the impairment of:

yy Social interaction yy Social communication yy Social imagination yy Associated repetitive behavior

Childhood Autism Rating Scale (CARS)

15-item behaviors observation rating scale to identify and differentiate children with ASD

Autism Diagnostic Observation Schedule (ADOS)

A semi-structured assessment To assess

yy Communication yy Social interaction yy Play

Pre-Linguistic Autism Diagnosis Observation Schedule (PL-ADOS)

Direct observation of childâ&#x20AC;&#x2122;s behavior as elicited by the examiner. Multidisciplinary intake assessment in diagnosis of children with ASD.

Checklist for Autism in Toddlers (CHAT)

Questionnaire Observations of five brief interactions between child and examiner

NONPHARMACOLOGICAL INTERVENTIONS In recent years, a small number of early intervention programs are being developed intensively for autistic children. These programs are structured for the development of efficient and consistent management strategies during childhood, which in turn strengthen the developmental progress and reduce behavioral issues. Applied behavioral analysis (ABA) is the process of applying behavioral principles to daily situations, which targets to increase desirable adaptive behaviors as well as reducing interfering maladaptive ones. This intervention is known to be safe and effective, making it the dominant approach in treating autistic children. As one of the core elements in defining autism is communication deficits, specific interventions such as speech, language and communication are essential components in the management of ASD in children. A study conducted by Stone (2001) stated that 4 years old showed a major improvement in expressive

language skills after receiving speech and language therapies between 2 to 3 years of age. These therapies include Responsive Education and Prelinguistic Milieu Teaching (RPMT), Reciprocal Imitation Training (RIT), Picture Exchange Communication System (PECS) and Augmentative and Alternative Communication (AAC). To cope with social impairment in children with ASD, occupational therapy is used to provide assessment and intervention that include social skills, self-help skills, sensory integration therapy, joint attention intervention and perceptual motor training. A systematic review (SR) done by Cochrane supported the effectiveness by showing improvement in friendship quality (effect size [ES] = 0.41, 95% confidence interval [CI] 0.02-0.81) and overall social competence (ES = 0.47, 95% CI 0.16-0.78) in children with ASD. The use of treatments categorized as Complementary and Alternative Medicine (CAM) has increased considerably in children over the last two decades. CAM is generally safe; however, it exhibits unknown

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PSYCHIATRY efficacy and there is speculation that the physiology and psychology of autism are associated with excessive opioid activity linked to peptides from gluten and casein. Despite this, CPG Malaysia, along with CPG New York and NICE guideline came to an agreement that exclusion diet is ineffective and not recommended to be practiced on children with ASD (Table 2). The CPG New York has raised an interesting method of massage that involves rubbing the body using moderate pressure known as touch therapy. Improvement in sensory profile and subjective decrease in gastrointestinal and sleep problems were reported; however, no adequate evidence has been found to address the effectiveness of touch therapy. Further research is necessary before implementing touch therapy as CAM in Malaysia.

PHARMACOLOGICAL INTERVENTIONS Pharmacological interventions are much useful, when psychosocial or other interventions have failed in the treatment of co-existing mental health or medical problems in children with autism. A list of pharmacological agents used for various dysfunctional behavioral issues in ASD are given in Table 3. Among medical problems commonly associated with ASD are behavioral challenges, attention-deficit hyperactivity disorder (ADHD), sleep problem, gastrointestinal problem, motor coordination and other psychological disorders. As of today, only atypical antipsychotics, risperidone and aripiprazole, are approved by the Food and Drug Administration (FDA) to treat behavioral challenges in children with ASD due to their reduced propensity of causing extrapyramidal symptoms.

Table 2. Comparison Between Nonpharmacological Interventions Practiced in Malaysia, US, UK Nonpharmacological interventions

Malaysia

US-NY

UK-NICE

Applied Behavior Analysis (ABA)

A



Speech, Language and Communication Interventions

A



Naturalistic Approach

I

Augmentative and Alternative Communication

III



Picture Exchange Communication System speech generating device (SGD)

I

Video modeling

III



Neurofeedback

A

Occupational therapy Social skills and self-help skills

I



Sensory integration therapy (SIT)

I

XNE

I



II-1

Social stories

I

DIR/Floor time

I

XNE



XNE

Auditory Integration Training

XXNB

Facilitated communication

Parent education and support

A



Cognitive behavior therapy (CBT)

A



Treatment and Education of Autistic and Related Communication Handicapped Children (TEACCH)



XNB

XNE

XIII Joint Attention Intervention Perceptual motor training Other Interventions/Programs

Music therapy Touch therapy

Diet

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PSYCHIATRY ...Cont'd

Traditional and complementary medicine Chelation

XNE

Secretin

XNE

Fatty acids

XNE

Vitamin B6-magnesium

XNE

Acupuncture

XNE

Hyperbaric oxygen therapy

XNE

Vitamin B12

Immunologic therapies

Anti-Yeast therapies

XNE

NE = No evidence; NB = No benefit; â&#x2C6;&#x161; = Recommended; X = Not recommended; XX = Not be used; - = Not mentioned.

Levels of Evidence and Grades of Recommendation

Levels of Evidence yy I: Evidence from at least one properly randomized controlled trial (RCT) yy II-1: Evidence obtained from well-designed controlled trials without randomization yy II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or group yy II-3: Evidence from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence yy III: Opinions of respected authorities based on clinical experience, descriptive studies and case reports or reports of expert committees Grades of Recommendation yy A: At least one meta-analysis, systematic review or RCT or evidence rated as good and directly applicable to the target population yy B: Evidence from well-conducted clinical trials, directly applicable to the target population and demonstrating overall consistency of results; or evidence extrapolated from meta-analysis, systematic review or RCT yy C: Evidence from expert committee reports, or opinions and/or clinical experiences of respected authorities; indicates absence of directly applicable clinical studies of good quality

Table 3. A List of Pharmacological Agents Used for Various Dysfunctional Behavioral Issues in ASD Repetitive, stereotyped behavior

Anxiety

Clomipramine

Fluvoxamine@

Fluoxetine

Aggression, irritability, self-injury

Haloperidol

Risperidone

Olanzapine

Hyperactivity inattention

Methylphenidate

Atomoxetine

Melatonin

Sleep disturbances

Letter A to D refer to the level of evidence and grades of recommendation in Singapore CPG; @ = Used mainly in adults with limited evidence in children.

According to NICE guideline, the prescription of these medications are to be made only by pediatrician or psychiatrist and given at the lowest effective dose. This is coherent with the conditions set by the CPG in Malaysia and advocated by the prescription of risperidone at a low dose of 2.5 mg/day in children weighing from 20 to 45 kg and up to 3.5 mg/day for those weighing over

45 kg. Aripiprazole on the other hand, is given at 15 mg/day. The practice of using atypical antipsychotics to manage comorbid behavioral disorders of ASD have also been supported by Singapore and the US. Certain CPGs for autism in Malaysia, Singapore, UK and US have recommended the stimulant drug, methylphenidate, in the treatment of ADHD in children

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PSYCHIATRY with ASD. In the event methylphenidate is ineffective or intolerant in the treatment of ADHD due to autism, NICE guideline proposes that atomoxetine should be considered. The same proposal has been made by CPG Singapore and Malaysia. However, NICE guideline does not advocate any pharmacological interventions for pre-school children aged less than 6 years with ADHD and it also states that the FDA approval age for methylphenidate intervention is 6 years and older. Dexamfetamine is also recommended for pre-schoolers with ADHD that are unresponsive to the maximum tolerated dose of methylphenidate or atomoxetine. Management of sleeping disorders such as insomnia with melatonin in children with ASD has been highlighted in CPG Malaysia. It is stated to be statistically most efficacious when combined with cognitive behavioral therapy (CBT) based on recent randomized controlled trials (RCTs). The favorable side effect profile of melatonin has also made it the drug of choice in Singapore and the US for poor sleep maintenance. Children with ASD are five times more common to have feeding problems with an increased incidence of constipation. NICE guideline has advocated an escalating dose regimen of polyethylene glycol 3350 combined with electrolytes as the first-line treatment. Dose adjustments to be done according to symptoms and the response. The guideline also proposes stimulant laxatives as an addition to the first-line treatment if patient is found to be unresponsiveness and as a substitute if the patient is intolerant. Meanwhile, management of psychological disorders such as anxiety, depression, obsessive compulsive disorder (OCD) and conduct disorder in children with ASD generally involves antipsychotic, AAD, tricyclic antidepressants (TCA) and selective serotonin reuptake inhibitors (SSRIs). However, other than risperidone and aripiprazole, the use of other medications are still offlabel and should be used with caution. COMMUNITY SUPPORT FOR CHILDREN WITH ASD At the point of diagnosis, children with ASD should be registered as persons with disabilities (PWD) at any office of the District Social Welfare and Education Department to be qualified for benefits such as special needs education and welfare support. Alongside government support, many private nonprofitable organizations including NASOM, Early Autism Project and Autism Link have been established to offer

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life-long care, support and education services and programs to people with autism. For instance, NASOM has established 14 early intervention programs and 3 vocational programs for people inflicted with autism in Malaysia. CONCLUSION Although the prevalence rate is lower, but the diagnostic methods for autism in CPG Malaysia are in line with the global trend. In regards to nonpharmacological interventions, there is an overall agreement between CPG Malaysia and New York, and to a lesser extent, NICE guideline. These interventions proposed by CPG Malaysia appear to be complete except for conflicting recommendation regarding DIR and music therapy. Additional new therapies with inadequate evidences in the US will require more clinically significant research. The pharmacological interventions by CPG Malaysia have covered medications that can be used in the treatment for autism-related symptoms and the recommendations are in line with other guidelines from the US, UK and Singapore. Broader treatment options can be found in NICE guideline whereby the focus of treatment has been shifted to comorbid diseases associated with autism. For example, physicians are recommended to treat inattention and hypersensitivity in children with ASD in line with the ADHD guideline. CPG Singapore contains a table summary for the management of autism based on its comorbid disorders along with the treatment options available that makes it very convenient for physicians to refer as a guideline. In general, CPG Malaysia is competent as a guideline for the management of autism as the diagnostic tools and treatment options are in line with the global trend. Improvements can be made on data presentation by incorporating a table summary as mentioned in CPG Singapore. In addition to this, the treatment options can be brought into line by implementing a stepwise management as advocated by NICE guideline. SUGGESTED READING 1. Meeting report: Autism spectrum disorders and other developmental disorders: from raising awareness to building capacity. World Health Organization, Geneva, Switzerland; 16-18 September 2013. 2. Highlights of changes from DSM-IV-TR to DSM-5. http://www.dsm5.org/Documents/ Available at: changes%20from%20dsm-iv-tr%20to%20dsm-5.pdf.

PSYCHIATRY 3. WebMD. Autism Spectrum Disorders Health Center. 2014; Available at: http://www.webmd.com/brain/autism/ understanding-autism-basics. 4. A Parentâ&#x20AC;&#x2122;s Handbook: Your Guide to Autism Programs. British Columbia: Ministry of Children and Family Development; 2013. 5. World Health Organisation. Questions and answers about autism spectrum disorders (ASD). Available at: http:// www.who.int/features/qa/85/en/. 6. Baio J. Prevalence of autism spectrum disorder among children aged 8 years - autism and developmental disabilities monitoring network, 11 sites, United States, 2010. MMWR 2014;63(2):1-21. 7. Annual Report Ministry of Health 2008. Ministry of Health Malaysia. 2008:1-21. 8. The National Autism Society of Malaysia. Available at: http://www.nasom.org.my/. 9. Poh-Chua S, Siew-Huei T. A survey on quality of life and situational motivation among parents of children with autism spectrum disorder in Malaysia. IPEDR. 2012;56(18):89-94. 10. Dolah J, Jaafar W, Chong T, Mohamed A. Identifying autism symptoms using autism spectrum quotient (ASQ): a survey amongst Universiti Sains Malaysia Students. Procedia - Soc Behav Sci. 2012;64:618-25. 11. Blumberg SJ, Bramlett MD, Kogan MD, Schieve LA, Jones JR, Lu MC. Changes in prevalence of parentreported autism spectrum disorder in school-aged U.S. children: 2007 to 2011-2012. Natl Health Stat Report. 2013;(65):1-11, 1 p following 11. 12. The National Autistic Society. How many people in the UK have autism? 2013. Available at: http://www.autism. org.uk/about-autism/myths-facts-and-statistics/ statistics-how-many-people-have-autism-spectrumdisorders.aspx. 13. Singer E. Simons Foundation Autism Research Initiative. Gold Standards. 2013. Available at: http://sfari.org/newsand-opinion/blog/2013/gold-standards. 14. Clinical Practice Guidelines. Management of Autism Spectrum Disorder in Children and Adolescents. Malaysia: Malaysian Health Technology Assessment Section (MaHTAS); 2014. 15. Clinical Practice Guidelines. Quick Reference Guide for Parents and Professionals: Autism/Pervasive Developmental Disorders, Assessment and Intervention for Young Children (Age 0-3 Years). United States: New York State Department of Health; 2009. 16. Autism diagnosis in children and young people. Recognition, referral and diagnosis of children and young people on the autism spectrum. United Kingdom: National Institute for Health and Care Excellence (NICE); 2011. 17. Watts TJ. The pathogenesis of autism. Clin Med Pathol. 2008;1:99-103.

18. Augustyn M, Patterson M, Bridgemohan C, Torchia M. Autism spectrum disorder: Diagnosis. Sep 19, 2014. Available at: http://www.uptodate.com.ezp.imu. e d u . m y / c o n t e n t s / a u t i s m - s p e c t r u m - d i s o r d e rdiagnosis?source=see_link&anchor=H10#H1. 19. Centres for Disease Control and Prevention. Autism Spectrum Disorder (ASD): Facts About ASD. Nov 12, 2014. Available at: http://www.cdc.gov/ncbddd/autism/ facts.html. 20. Holt R, Monaco AP. Links between genetics and pathophysiology in the autism spectrum disorders. EMBO Mol Med. 2011;3(8):438-50. 21. Coutinho AM, Sousa I, Martins M, Correia C, Morgadinho T, Bento C, et al. Evidence for epistasis between SLC6A4 and ITGB3 in autism etiology and in the determination of platelet serotonin levels. Hum Genet. 2007;121(2):243-56. 22. Robson B. Autism spectrum disorder: A review of the current understanding of pathophysiology and complementary therapies in children. Aust J Herb Med. 2013;25(3):128-37. 23. Ratajczak HV. Theoretical aspects of autism: biomarkers a review. J Immunotoxicol. 2011;8(1):80-94. 24. Raymond LJ, Deth RC, Ralston NV. Potential role of selenoenzymes and antioxidant metabolism in relation to autism etiology and pathology. Autism Res Treat. 2014;2014:164938. 25. Onore C, Careaga M, Ashwood P. The role of immune dysfunction in the pathophysiology of autism. Brain Behav Immun. 2012;26(3):383-92. 26. Compart PJ. The pathophysiology of autism. Glob Adv Health Med. 2013;2(6):32-7. 27. Fatemi SH, Aldinger KA, Ashwood P, Bauman ML, Blaha CD, Blatt GJ, et al. Consensus paper: pathological role of the cerebellum in autism. Cerebellum. 2012;11(3):777-807. 28. Stone WL, Yoder PJ. Predicting spoken language level in children with autism spectrum disorders. Autism. 2001;5(4):341-61. 29. Autism: The management and support of children and young people on the autism spectrum. United Kingdom: National Institute for Health and Care Excellence (NICE); 2013. 30. Mental Health Medications. United State: National Institute of Mental Health; 2010. 31. National Institude of Mental Health. Autism spectrum Disorder: What is Autism Spectrum Disorder? Available at: http://www.nimh.nih.gov/health/topics/autismspectrum-disorders-asd/index.shtml#part6. 32. Autism Spectrum Disorders in Pre-School Children. AMSMOH Clinical Practice Guidelines 1/2010. Singapore: Ministry of Health Singapore; 2010. 33. Attention deficit hyperactivity disorder. Diagnosis and management of ADHD in children, young people and adults. United Kingdom: National Institute for Health and Clinical Excellence; 2008.

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PSYCHIATRY 34. Constipation in children and young people. United Kingdom: National Institute for Health and Care Excellence; 2010.

parenting stress in parents of children with and without autism spectrum disorder. J Autism Dev Disord. 2013;43(3):629-42.

35. Jabatan Kebajikan Masyarakat. Registration of Persons with Disabilities. Available at: http://www.jkm.gov.my/ content.php?pagename=pendaftaran_orang_kurang_ upaya&lang=en.

43. Locke J, Rotheram-Fuller E, Kasari C. Exploring the social impact of being a typical peer model for included children with autism spectrum disorder. J Autism Dev Disord. 2012;42(9):1895-905.

36. See C (Ed.). Autism and Its Treatment in Malaysia. Holistic Care for Autistic Children; August 17-18, 2005. Malaysia: University Science Malaysia; 2008.

44. Sharpe D, Baker D. Financial issues associated with having a child with autism. J Fam Econ Issues. 2007;28(2):247-64.

37. Early Autism Project: Services. Available at: http://www. autismmalaysia.com/services/. 38. Autism Link: Our services. Available at: http://www. autism.my/our-services.html. 39. Costing Statement: The management and support of children and young people on the autism spectrum. United Kingdom: National Institute for Health and Care Excellence; 2013. 40. Autism Action Partnership. What is Autism: Facts and Figures. 2015. Available at: http://www.autismaction. org/about-autism/what-is-autism/facts-and-figures/. 41. Malaysian Psychiatric Assiciation. Money and distance letting down children with autism. 2010; Available http://www.psychiatry-malaysia.org/article. at: php?aid=1249.

45. Cheely CA, Carpenter LA, Letourneau EJ, Nicholas JS, Charles J, King LB. The prevalence of youth with autism spectrum disorders in the criminal justice system. J Autism Dev Disord. 2012;42(9):1856-62. 46. van Roekel E, Scholte RH, Didden R. Bullying among adolescents with autism spectrum disorders: prevalence and perception. J Autism Dev Disord. 2010;40(1):63-73. 47. Walsh L, Lydon S, Healy O. Employment and vocational skills among individuals with autism spectrum disorder: predictors, impact, and interventions. Rev J Autism Dev Disord. 2014;1(2):266-75. 48. Benderix Y, Sivberg B. Siblings’ experiences of having a brother or sister with autism and mental retardation: a case study of 14 siblings from five families. J Pediatr Nurs. 2007;22(5):410-8.

49. Duchan E, Patel DR. Epidemiology of autism spectrum 42. Hayes SA, Watson SL. The impact of parenting stress: a disorders. Pediatr Clin North Am. 2012;59(1):27-43, ix-x. meta-analysis of studies comparing the experience of ■■■■

World Autism Awareness Day: Toward Autonomy and Self-Determination World Autism Awareness Day is an internationally recognized day on the 2nd of April every year, encouraging Member States of the United Nations to take measures to raise awareness about children with autism throughout the world. Autism is a lifelong neurological condition that manifests during early childhood, irrespective of gender, race or socioeconomic status. The theme for the year 2017 is “Toward Autonomy and Self-Determination”.

World Health Day ‒ “Depression: Let's talk” World Health Day is celebrated every year on April 7 to mark the anniversary of the founding of the World Health Organization (WHO). It is an opportunity to draw global attention to and increase public awareness about a topic of public health importance. This year, the World Health Day focuses on depression with the theme “Depression: Let's talk” with the aim that more people with depression, in all countries, seek and get help.

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SURGERY

Blunt Abdominal Trauma: “Pandora’s Box Revisited” - A Prospective Study VENKATESH SUBBIAH*, BENITA FLORENCE†, SOMASUNDARAM S‡

ABSTRACT With an increase in urbanization and changing demographics, trauma especially road traffic accidents (RTAs) become a major yet neglected and growing health problem. According to the World Health Statistics 2008, RTAs will soon become the fifth leading cause of death. Blunt abdominal trauma (BAT) is the 7th leading cause of mortality, abdomen being the third region most commonly involved. In patients with BAT, intra-abdominal injuries have been noted in about 13%. This study was undertaken at Velammal Medical College Hospital and Research Institute, Madurai, an urban tertiary care trauma center in the state of Tamil Nadu over a period of 1 year (June 2015 to June 2016). The aim was to identify the pattern of BAT presenting to the hospital emergency department and to emphasize the importance of early resuscitation, serial clinical examinations, radiographic assistance, well-timed surgery and their outcome.

Keywords: Blunt abdominal trauma, FAST, MSCT, trauma protocol

mergency medical and surgical care is becoming the need of the hour. With an increase in urbanization and changing demographics, trauma, especially road traffic accidents (RTAs) become a major yet neglected and growing health problem. Trauma, by 2020, will be the first or second cause of “loss of productive years of life” according to the World Health Organization (WHO).1 Though India has only 1% of the world’s vehicles, we account for 10% of road accidents.2

Trauma, thus is becoming a major health hazard worldwide affecting the so called bread winners in the productive years of life. According to the World Health Statistics 2008, RTAs will soon become the fifth leading cause of death. Abdomen has always been considered as a Pandora’s box even by the best surgeon. Blunt abdominal trauma (BAT) is the 7th

*Assistant Professor Dept. of General Surgery †Dept. of Emergency Medicine ‡Professor and HOD Dept. of General Surgery Velammal Medical College and Hospital, Madurai, Tamil Nadu Address for correspondence Dr Venkatesh Subbiah Assistant Professor Dept. of General Surgery Velammal Medical College and Hospital, Madurai, Tamil Nadu

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leading cause of mortality, abdomen being the third region most commonly involved.3 In patients with BAT, intra-abdominal injuries have been noted in about 13%.4 Polytrauma patients presenting to the emergency department (ED) pose a challenge to the trauma team (general surgeons, orthopedic surgeons, radiologists and an ED consultant who acts as team leader) as most of the time they may be unconscious due to the severity of the injury or many a times under the influence of alcohol. After initial stabilization of the victim, the primary radiological survey (which includes an anteroposterior view of the pelvis, a posteroanterior view of the chest and lateral view of the cervical spine including C7) is undertaken within minutes of patient’s arrival in the ED. Focussed assessment with sonography for trauma (FAST) and spiral computed tomography and multidetector/multislice CT (MSCT) have been used as adjuncts in identifying life- threatening injuries. Though CT scan has been used as part of the secondary survey in hemodynamically stable patients, with the advent of new technologies and the whole process being less time consuming, MSCT is being used as part of the primary survey even in unstable patients where resuscitation takes place side by side. It has to be kept in mind that initial resuscitation and stabilization is not compromised in the process of imaging and the

SURGERY decision depends on the trauma team leader and the surgeon.5 This study was done to identify the pattern of BAT presenting to our hospital ED, to emphasize the importance of early resuscitation, serial clinical examinations, radiographic assistance, well-timed surgery and their outcome. MATERIAL AND METHODS This prospective study was performed at Velammal Medical College Hospital and Research Institute, Madurai, an urban tertiary care trauma center in the state of Tamil Nadu over a period of 1 year (June 2015 to June 2016). The study included all patients in the age group of 15-65 years presenting primarily to our ED with history suggestive of blunt trauma to the abdomen or clinical features in favor of BAT. Children and pregnant women were excluded. Also patients who presented with penetrating injuries, severe head injury or other distracting orthopedic injuries and severe chest injury were excluded.

Our institution polytrauma protocol (Fig. 1) was followed and all patients fulfilling our inclusion criteria were included in the study. A questionnaire was filled in the ED on presentation after resuscitation. It included the patientsâ&#x20AC;&#x2122; demographic details, history, details of physical examination, initial resuscitative measures taken, investigations done to arrive at a diagnosis and the provisional diagnosis. This questionnaire was completed during discharge with surgical/conservative management received, the final diagnosis, the number of days in the hospital, the outcome of the patient.

Clinical Presentation All 45 patients presented to the ED with complaints of abdominal pain, 38 of them had vomiting. Abdominal distension was present in 15 patients, 3 of them had hematuria. On clinical examination, 5 patients had an absolutely soft abdomen with no signs of hemoperitoneum. These patients had presented

Primary Survey Assessment of ABCs and Resuscitation CXR AP, X-ray PBH, C spine lateral X-ray, FAST

Stable

Unstable

Head to toe assessment

Damage Control

Polytrauma CT Protocol

A, B - Intubation & Mechanical ventilation, ICD C â&#x20AC;&#x201C; IV fluids/O-negative blood

Stable

Reassessment

Stable

yyIntensive care unit yyDelayed primary surgery yyFollow-up CT

Unstable

yyBleeding -? Extra-abdominal yy?Retroperitoneal yy?To OR

ABC = Airway, Breathing and Circulation; CXR AP = Chest X-ray anteroposterior view; X-ray PBH = X-ray pelvis with both hip joints; C spine lateral X-ray = Cervical spine lateral view X-ray with C7; FAST = Focused assessment with sonography for trauma; Polytrauma CT Protocol = CT brain, whole spine screening including thorax and abdomen; OR = Operating room.

Figure 1. Polytrauma Algorithm (All patients - Nil by mouth till further orders).

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SURGERY immediately to the hospital within 3-4 hours of injury; 22 of them had signs of external injury with contusion and abrasion.

Males

Eight patients presented to the ED with hypotension and all others had tachycardia with heart rate ranging from 102 to 130 per minute.

Females

Management

CT abdomen was done for all patients after initial stabilization and resuscitation with the primary survey wherever necessary.

No. of patients

30 25 20 15 10

Fall from height

Assault

5 0

RTA

Figure 3. Etiology of BAT.

40 35 30 25

15 10

Preoperative orders of injection tetanus toxoid with a test dose of injection lidocaine were followed with antibiotic coverage, fluid resuscitation and analgesics. Patients, who had extensive abrasion or contaminated wounds, were given injection tetanus immunoglobulin 250 units intramuscular.

Figure 4. Clinical features on presentation.

RESULTS

Features on Presentation

Demographic Details Our study included 45 patients with BAT. Among them 37 (82.2%) were males (Fig. 2). The mean age was 32 years.

Epidemiological Details The reasons for trauma in 35 (77.8%) patients were due to RTAs, 5 (11.1%) due to fall from height and 5 (11.1%) assaults (Fig. 3).

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3 a Na us e

g itin Vo m

ia Ab di do st m en in sio al n Ab co ras nt io us ns io n

0 m i pa nal in

A surgical profile which included complete blood count, renal function tests, blood grouping an typing and viral markers was done for all patients.

Ab do

All patients had bedside imaging - Chest X-ray, pelvis X-ray and cervical spine X-ray. After primary and secondary survey with necessary interventions, FAST was done in all patients and free fluid detected in 32 patients.

Figure 2. Sex-wise distribution of patients.

No. of patients

All patients were cannulated with large bore intravenous (IV) cannulas, fluid resuscitation started and kept nil by mouth (NBM). Analgesics (opioids given as per the pain score), antacids (injection pantoprazole 40 mg IV stat), antiemetics (injection ondansetron 8 mg IV stat), injection tranexamic acid 1 g IV and broad-spectrum antibiotic given (injection cefoperazone sulbactam). Blood was reserved for all patients in whom BAT was suspected; 3 patients required urgent O-negative blood transfusion as blood pressure did not improve with fluid resuscitation.

The clinical features on presentation have been summarized in Figure 4. Abdominal pain accompanied by nausea and vomiting was the commonest presentation. Other clinical features included abdominal contusion, abdominal distension and hematuria. The injuries noted included bowel perforation, perineum/external genitalia, bladder/ urethral injury, adrenal hematoma, kidney contusion, retroperitoneal hematoma, splenic injury and liver laceration have been depicted in Figure 5.

SURGERY

25 20

No. of patients

20 15 10 5 0

2 Bowel perforation

Perineum/ external genitalia

Adrenal hematoma

Bladder/ urethral injury

Kidney contusion

Retroperitoneal hematoma

Splenic injury

Liver laceration

Figure 5. Injuries which occurred due to BAT.

It was seen that 4 patients had both splenic and liver injury and patients with kidney contusion had adrenal hematoma. Retroperitoneal hematoma was noted in association with liver or splenic injury also. Thirty patients underwent surgeries ranging from splenectomy, bowel repair and resection, perforation seal, bladder repair and repair of the external genitalia. Also, patients who underwent splenectomy were treated with pneumovac vaccine. Most of the patients with isolated liver laceration were managed conservatively. Fifteen patients were managed conservatively with nasogastric tube, IV fluids, analgesics, antiemetics, antacids, vitals charting, abdominal girth charting and input-output charting. Patients were admitted on an average of 10-15 days. Post-op period for all 30 patients were uneventful. DISCUSSION Abdominal trauma has always remained a mysterious diagnostic challenge and even the best of surgeons find it confusing on initial clinical presentation. Hemoperitoneum may not be present in 40% of the patients. Symptoms may be masked by other injuries like low Glasgow Coma Scale (GCS), other distracting orthopedic injuries, hemodynamic stability or no signs of injury to the abdomen. These factors may contribute to a preventable death when unrecognized.3 A structured search study conducted by Nishijima et al have given in their limitations that most of the studies were at least 15 years ago and standards of care and technology have changed over the years. Multislice CT scanners are available 24 Ă&#x2014; 7 in all tertiary care hospitals just next to the ED. Diagnostic peritoneal lavage (DPL) has not been used as a sole reference study and is time consuming, with false positive rates and is invasive.4

FAST has been a bedside useful tool in the ED especially for hemodynamically unstable patients. It is noninvasive and can be repeated as and when required. The only drawback being it is operator-dependent and cannot identify retroperitoneal hematomas and locate the exact site of bleeding. The reason CT scans were deferred a few years ago was due to the fact that patients had to be shifted out of the resuscitation bay for scans. CT, these days, is less time consuming, detect clinically unsuspected injuries and help in identifying retroperitoneal injuries. In a study where DPL was positive, CT imaging of the abdomen modified the treatment in 58% cases.6 CT imaging especially in BAT is being suggested and implemented at times with the primary survey. Most of the patients can be resuscitated in the ED and stabilized for a CT abdomen. In patients who are hemodynamically unstable, to identify life-threatening injuries, CT scan with contrast should be used as an adjunct to primary survey.5 A loading dose of tranexamic acid 1 g IV helps in reducing bleeding and mortality in trauma patients.7 Studies have shown that it is no longer necessary to rush every patient with hemoperitoneum to the operating room and also those who can be transiently stabilized are candidates for CT evaluation.8 Though NOM (nonoperative management) of solid organ injuries have been suggested and practiced, our patients who underwent surgery had a good outcome and were discharged with a follow-up plan after 6 months. It has to be kept in mind that all imaging modalities are complementary to the physical examination and hence have to be used wisely.

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SURGERY CONCLUSION

REFERENCES

In our study of 45 adult patients with isolated blunt injury abdomen, it was observed that 82.2% were male patients and the mean age group was 32 years. All of the patients had complaints of abdominal pain. Liver was the most common organ involved. A protocol developed in each institution based on the commonly encountered injury pattern is beneficial and helps in an organized and systematic approach. With a systematic approach, appropriate imaging and timely surgery a catastrophe of BAT causing high mortality can be averted.

1. Mock CN, Jurkovich GJ, nii-Amon-Kotei D, Arreola-Risa C, Maier RV. Trauma mortality patterns in three nations at different economic levels: implications for global trauma system development. J Trauma. 1998;44(5):80412; discussion 812-4.

LIMITATIONS ÂÂ

Feeder area restricted to one district in a state of Tamil Nadu. The limited area covered is a major drawback.

ÂÂ

Limited number of cases over a short period of 1 year.

ÂÂ

A multicenter study around the country with data collection over a period of 5-10 years would be beneficial.

Acknowledgment

2. Accidental Damages. The Times of India. Chennai Edition, Oct 23, 2008. Available at: http://www.timesofindia. indiatimes.com//home/opinion/edit-page/AccidentalDamage/articleshow/3630126.cms. 3. Ravikanth J, Gejji SB, Karthik Reddy CH. Our experience in blunt trauma abdomen. IJSR. 2015;4(8):75-7. 4. Nishijima DK, Simel DL, Wisner DH, Holmes JF. Does this adult patient have a blunt intra-abdominal injury? JAMA. 2012;307(14):1517-27. 5. Banerjee P, Rudra S, Ghosh M, Panose P. CT scans in primary survey for polytrauma patients. Adv Comput Tomogra. 2013;2:46-51. 6. Kane NM, Dorfman GS, Cronan JJ. Efficacy of CT following peritoneal lavage in abdominal trauma. J Comput Assist Tomogr. 1987;11(6):998-1002. 7. CRASH-2 trial collaborators, Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, et al. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebocontrolled trial. Lancet. 2010;376(9734):23-32.

8. Wallis A, Kelly MD, Jones L. Angiography and We sincerely thank Dr Marriappan (Dept. of Radiology) for embolisation for solid abdominal organ injury in adults a current perspective. World J Emerg Surg. 2010;5:18. all the timely expertise and guidance. ■■■■

Excise at least Half of Parathyroid Gland to Reliably Rule Out Hyperfunction Researchers say that unless half of a parathyroid gland is biopsied during radio-guided parathyroidectomy, the 20% rule cannot reliably rule out the presence of a hyperfunctional parathyroid lesion. According to a small retrospective analysis of surgical data published online in JAMA Otolaryngology-Head & Neck Surgery, removal of half or more of the gland had 96.6% accuracy with gamma probe.

Knee Surgery does not Improve QOL for Many Patients Data from two studies, Osteoarthritis Initiative (OAI) and the Multicenter Osteoarthritis Study (MOST), within the US health system show that the current practice of total knee replacement in patients with knee osteoarthritis had minimal effects on quality-of-life (QOL) and quality-adjusted life years (QALYs) at the group level. The study published online March 28, 2017 in the BMJ suggests that if the procedure were restricted to more severely affected patients, its effectiveness would rise.

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Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

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PICTORIAL CME

Pseudocardiomegaly BHAVANA VENKATA NAGABHUSHANA RAO*, BVS RAMAN

13-year-old boy was referred to us from a primary healthcare provider, because of cardiomegaly on chest X-ray, to evaluate further for cardiac disease (Fig. 1). He has been suffering from cough, evening fever and breathlessness. Breathlessness is increasing in the night, wakes him in the middle of the night.

At a closer look at the skiagrams, it was suspected that there was a retrocardiac mass. Contrastenhanced computed tomography (CECT) showed huge retrocardiac cystic swelling in the posterior mediastinum (Figs. 2 and 3). The patient was provisionally diagnosed to have foregut duplication or bronchogenic cyst. CT guided aspiration yielded very little fluid, which showed inflammatory cells only. It was not possible to remove the cyst in toto at thoracotomy, hence marsupialization was done.

Histopathological examination of cyst wall confirmed tuberculous etiology. Magnetic resonance imaging (MRI) scan of thoracolumbar spine did not reveal any caries spine. He responded well to antituberculous treatment given for 1 year (Fig. 4). The mediastinum is a complex structure embryologically and anatomically. Hence, cysts arising in this area are of varied etiology and pathological

Figure 2. CT scan chest vertical view cyst resembling cardiac shadow.

Figure 1. Chest X-ray PA view showing apparent cardiomegaly.

*Dept. of Medicine Queenâ&#x20AC;&#x2122;s NRI Hospital, Visakhapatnam, Andhra Pradesh Address for correspondence Dr Bhavana Venkata Nagabhushana Rao Dept. of Medicine Queenâ&#x20AC;&#x2122;s NRI Hospital, Visakhapatnam - 530 013, Andhra Pradesh E-mail: bhavanavnrao@gmail.com

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Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

Figure 3. CT scan chest horizontal view depicting the posterior location of cyst.

PICTORIAL CME bronchogenic cyst and masses from aberrant thyroid and parathyroid tissue may be found. Neoplasms in the middle mediastinum area are usually of lymphatic or of neurogenic origin. Bronchogenic, esophageal, gastric and pleuropericardial cysts may frequent middle mediastinum. Neurogenic neoplasms are most common masses in the posterior mediastinum. Tumors arising from lymphatic, vascular or mesenchymal tissue can also be found in addition to bronchogenic and neurenteric cysts. Cystic masses from caseating lymph nodes and spine have also been reported in the posterior mediastinum from developing nations. Mediastinal cysts or tumors are often found as an incidental radiological finding in asymptomatic patients. They may present with cough, chest pain, wheezing, dyspnea or rarely stridor. Paraesophageal cysts may present with dysphagia or regurgitation. Complex neurenteric cysts with spinal extension produce neurological symptoms. Figure 4. Normal chest X-ray post 1 year antituberculous treatment.

processes. Mediastinum is divided anatomically into anterior, middle and posterior mediastinum. Most common tumors arising from anterior mediastinum are of thymic, lymphatic or germ cell origin. Rarely

Surgical procedure is the treatment of choice to be followed with specific antitubercular treatment in rare occasions like the case described above. Nevertheless, surgery may not be essential unless cyst is symptomatic, infected, potentially malignant, present at an atypical location, progressively growing, compromising airways or present in children.

■■■■

Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

1081

CONFERENCE PROCEEDINGS

69th Annual National Conference of Indian Psychiatric Society (ANCIPS 2017) TELEPSYCHIATRY: OPPORTUNITIES AND CHALLENGES

ÂÂ

There are various legislations pertaining to health information disclosure in India e.g., Consumer Protection Act, 1986; Indian Medical Council Act, 1956; Right To Information Act, 2005; Protection of Children from Sexual Offences Act, 2012 and Criminal Law Amendment Act, 2013, etc.

ÂÂ

Whenever the patients themselves request for information, it should be provided to them after looking into safety, decision making capacity and their best interest.

Dr Naresh Vadlamani, Hyderabad ÂÂ

Telepsychiatry or Video Consultation makes psychiatric care affordable, accessible and approachable.

ÂÂ

Telepsychiatry offers psychiatric care to remote populations, prisoners and elderly with mobility issues and disabled populations.

ÂÂ

Time and distance Telepsychiatry.

ÂÂ

Government Care institutions, NGOs and startups like TALKADOC have started to offer Telepsychiatry as another modality of psychiatric care delivery system.

Whereas, if the request has been raised by a person other than the patient, the decision of disclosure may be taken considering public interest at large, if public interest overweighs patient’s consent.

ÂÂ

In case of doubt, decision of disclosure shall be left to the courts.

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There is a need for amendment in legislation requiring mandatory reporting of health information.

can

overcome

ÂÂ

Not everyone is ‘technology-savvy’ and empathetic personal care takes a backseat.

ÂÂ

High rates of dropouts and continuity of care due to lack of mutual and personal bonding.

ÂÂ

Legal and Licensing issues need to be addressed in case of any litigious issues.

ÂÂ

Security, storage, confidentiality, privacy and ownership of data is very challenging and also cost consuming to keep pace with the changing technology.

ÂÂ

Ethical code of practicing Telepsychiatry needs to be developed.

ÂÂ

Indian Telepsychiatry Society needs to be established under Indian Psychiatric Society to embrace the opportunities and challenges thrown by newer technological developments in the field of Psychiatry.

CAN HEALTH PRIVACY BE DISCLOSED? Dr Shobhit Jain, Varanasi ÂÂ

Health privacy deals with the responsibility of healthcare professionals of not disclosing information learned during treatment and care to any one without the patient’s permission.

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Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

BIOMARKERS IN BIPOLAR DISORDER: BACKGROUND, CONCEPT AND RELEVANCE Dr Rajesh Sagar, New Delhi ÂÂ

Bipolar disorder is a severe, recurrent, mood disorder with a national prevalence of around 1%. It has been associated with significant morbidity and mortality and a number of medical comorbidities, such as anxiety disorder, substance use disorder and ADHD.

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Early detection of bipolar disorder is important as the disease develops at a relatively young age. It is also vital considering the fact that it has high relapse rates, chronic recurrent course, causes cognitive dysfunction in the long run and can overall affect the well-being.

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Current diagnostic procedures are more subjective than objective, which means higher chance of misdiagnosis and thus poorer outcomes. This signifies the requirement of more robust and specific diagnostic procedures. In the recent years, a number of clinical and animal studies have identified several biomarkers, which may in

CONFERENCE PROCEEDINGS near future revolutionize the current approach to detection of bipolar disorder. ÂÂ

ÂÂ

Potential biomarkers in bipolar disorder Neural circuitry dimension: Use of neuroimaging

in measuring the brain activity, connectivity, white matter connectivity, etc. and exploring these features to identify potential BP specific biomarkers.

Molecular dimension: Oxidative stress measures,

peripheral biomarkers.

Approach to neuroimaging biomarkers: Neuroimaging, when used as a biomarker in bipolar disorder, offers several advantages. Different aspects of brain physiology such as brain area, brain circuit and blood flow and neurochemical levels in the brain can be explored.

Genetic biomarkers: Genotype assessment for

ÂÂ

These biomarkers have the potential to serve different functions and may benefit patients and relatives; accurate and early diagnosis, monitoring of disease progression, early intervention, monitoring treatment response, prognosis, prediction of treatment response and guiding further novel therapies.

Brain area: Earliest studies on CT findings have shown a positive association between BD and lateral ventricle enlargement. Studies exploring structural MRI have suggested changes in the white matter volume as the most consistent finding.

ÂÂ

Brain circuit: Studies on diffusion tensor imaging/ tractography indicate a significant decrease in FA in BD patients vs. healthy controls. Functional MRI findings highlight two important aspects of function circuit in BD; hyperactivity of ventrallimbic brain network and hypoactivity of dorsal brain structure.

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Blood flow: PET studies exploring BD biomarkers are limited. However, results obtained from these studies indicated decreased metabolic activity in dorsolateral prefrontal cortex (PFC), medial PFC, orbital PFC, subgenual anterior cingulate cortex.

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Neurochemical flow: Meta-analysis evaluating neurochemical metabolites on MR spectroscopy in BD patients have shown decreased level of N-acetylaspartate in basal ganglia and hippocampus. Increase in frontal and total brain glutamate plus glutamine level has also been associated in BD patients.

identification of candidate genes as biomarkers.

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NEUROIMAGING AND GENETIC BIOMARKERS IN BIPOLAR DISORDER Dr Ananya Mahapatra, New Delhi Approach to genetic biomarkers: Genetics has a role in bipolar disorder and data from clinical studies on twins indicated the concordance of 70% for monozygotic twins and 23% for dizygotic twins. ÂÂ

Linkage studies have shown significant results for bipolar disorders. Best evidence for linkage includes areas on chromosome 1q, 2p, 4p, 4q, 6q, 8q, 11p, 12q, 13q, 16p, 16q, 18p, 18q, 21q, 22q and Xq.

ÂÂ

Genome wide association studies (GWAS) have identified several genes that have shown consistent association with bipolar disorder. Few important examples are brain-derived neurotrophic factor (BDNF), catechol-O-methyl transferase (COMT) and serotonin transporter (5-HTT) genes. Meta-analysis of GWAS have also identified several candidate risk loci in BD, such as alpha 1C subunit of the L-type voltage-gated calcium channel (CACNAC1C) and ankyrin 3 (ANK3).

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Transcriptomic studies analyzing genes using microarray techniques have also proposed genes in numerous pathways that may play a role in the pathophysiology of BD.

Convergent function genetic approach that integrates the data from genomics on human and animal obtained from linkage analysis and GWAS gene expression data have also identified some potential genetic biomarkers including ARNTL, ALDH1A1 and KLF12.

DEPRESSION AND ANXIETY FOLLOWING CABG: CURRENT INDIAN SCENARIO Col (Dr) Rajiv Kumar Saini, Pune ÂÂ

Epidemiological studies have shown a high prevalence of CAD among the Indian population.

ÂÂ

Due to increasing availability and affordability of tertiary care in many parts of India, carefully selected patients undergo CABG surgery to improve cardiac function. However, the procedure is commonly associated with depression and anxiety, which can adversely affect overall prognosis.

ÂÂ

Depression and CAD are highly comorbid conditions with estimates of comorbidity ranging from 14% to 47%.

Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

1083

CONFERENCE PROCEEDINGS ÂÂ

The prevalence of anxiety disorder ranges from 9% to 11%, with generalized anxiety disorder being the commonest manifestation.

ÂÂ

Patients should be screened for depression and anxiety following CABG surgery.

NEUROBIOLOGICAL FACTORS IN SUICIDAL BEHAVIOR: BIOMARKERS PERSPECTIVE Dr Yogesh Dwivedi, USA ÂÂ

Suicide is a growing health concern across the globe and estimates suggest that nearly 1 million people commit suicide per year. In US, 42,000 deaths occur per year due to suicide and it is the 3rd leading cause of death in individuals aged 15-24 years.

ÂÂ

MiRNAs are members of the noncoding RNA. They bind to the 3’ UTR site of a specific gene and regulate its expression post-transcriptionally. By regulating the entire gene circuitry, these molecules can induce disease phenotype.

ÂÂ

Recent evidence suggests that miRNAs may have a link with the suicidal tendency in an individual.

ÂÂ

One study assessing this link of miRNA-suicide has demonstrated an aberrant response of miRNA in depression and suicidal individual. The MDD suicidal group in the study showed extensive interconnected network between 29 miRNA levels when compared with control group.

ÂÂ

Findings from few recent in vitro and animal studies have indicated that these regulatory miRNAs extracted from exosomes have the potential to be biomarkers for suicidal behavior and treatment response.

PSYCHIATRISTS NEED TO BE SENSITIVE TOWARDS WOMEN’S MENTAL HEALTH ISSUES

My observation always has been that Medical professionals are also, many a time, talented artists. But due to lack of time they waste their talents. Being a professional Bharatanatyam dancer and Choreographer myself, along with being a Psychiatrist, I have thought even if we don’t use it as a profession, art forms can be great stressbusters. Psychoeducation, mental health promotion done through art forms by a Psychiatrist can be very effective. I consider that this way, through my dance performances, I promote the mental health of thousands of people at a time like how I treat at my clinic one patient at a time! As a woman, I feel psychiatrists need to be sensitive towards women’s mental health, doing away with the biases and traditional attitudes towards women in their clinical settings. While sitting in the chair of a psychiatrist, you need to be neither male nor a woman! Try to genuinely understand the woman’s viewpoint and then treat. Being proactive in the issues of domestic violence, violence-abuse at traditional healthcare settings is required on the part of Psychiatrist and can be immensely useful. SOCIODEMOGRAPHIC PROFILE AND PATTERN OF SUBSTANCE ABUSE AMONG PATIENTS PRESENTING TO A DE-ADDICTION CENTER IN A TERTIARY CARE HOSPITAL OF PUNJAB Dr Deepali Gul, Jalandhar ÂÂ

Substance abuse has become one of the major public health problems of present society.

ÂÂ

Recently, there has been an increase in the incidence of substance abuse including that of opioids worldwide.

ÂÂ

Although opioid-dependence has become one of the most prevalent psychiatric illnesses during recent years, very few studies have looked into the profiles of opioid-dependent patients in this part of the world.

ÂÂ

Geographical location of Punjab is such that the transit of drugs is possible across the state.

ÂÂ

Many reports in the regional newspapers have, of late, pointed at the widespread drug abuse in the state of Punjab.

ÂÂ

The present study was aimed at determining the sociodemographic profile and pattern of substancedependence in patients attending the de-addiction center in a tertiary care hospital in Jalandhar, Punjab.

Dr KS Pavitra, Shimoga, Karnataka As mental health professionals, I think we need to take care of our mental health as well! Hence, even if it means taking leave from a busy OPD (which is equal to losing money of course!), spending money on travel and attending the Annual Conference ‘ANCIPS’, which means a lot to me! I consider this as not only an opportunity to present my work in the last 1 year and updating my knowledge about the recent happenings of Psychiatry but also an opportunity connecting to the world of Psychiatrists in its truest sense. Long Live ANCIPS!!

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Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

CONFERENCE PROCEEDINGS ÂÂ

ÂÂ

Three hundred consecutive treatment seeking subjects, fulfilling American Psychiatric Association’s DSM-IV-TR criteria for substancedependence were included in the study. Proper assessment of the current trends and pattern of substance abuse can be helpful in more effective intervention to check this menace.

TELEPSYCHIATRY IN INDIA: A STEP TOWARDS BETTER MENTAL HEALTHCARE

path, offered in a positive way that resists any temptation to be punitive. ÂÂ

The child-parent relationship has a major influence on most aspects of child development.

ÂÂ

With the rise of successful ‘working women’ group, parents have to play a dual role: the ‘nurture’ and ‘structure’ role.

ÂÂ

All parents have their own style of parenting their way of bringing up their children. The traditional styles ‘authoritarian’, ‘authoritative’ and ‘indulgent-permissive’ styles are being adapted in changing socio-developmental milieu.

ÂÂ

Earlier, parents were more concerned with raising non-self-centered, obedient children, whereas today, there’s a stronger emphasis on building a child’s autonomy, self-esteem and individuality.

ÂÂ

Rather than a rigid view of parenting, parents can modify their expectations, adapting to the changing needs of their growing children.

ÂÂ

The role of father in parenting is immense as evidenced in PACT (Parent and Child Together Study).

ÂÂ

Research across families from all ethnic backgrounds suggests that fathers’ affection and increased family involvement help promote social and emotional development of children.

ÂÂ

The difference, however, lies in the fact that Indian families have their own set of values, which are sometimes in conflict with the values of other cultures.

ÂÂ

Respect for elders is a very Indian value and it stems from time immemorial. Children must be taught to be tough and resilient and have the courage to bounce back after adversities.

Dr Shobhit Jain, Varanasi ÂÂ

Telepsychiatry uses information technology to offer psychiatric services from a distant place to the needy patients.

ÂÂ

Telepsychiatry has both clinical utility and nonclinical uses such as administrative, learning and research applications.

ÂÂ

Telepsychiatry has the advantage of providing psychiatric services where there is shortage of psychiatrists. Access to psychiatrists by people living in remote areas becomes feasible.

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Telepsychiatry practices can be wisely used in developing countries like India for improving training, diagnosis and treatment of psychiatric illnesses.

ESSENCE OF POSITIVE PARENTING IN CHANGING SOCIOECONOMIC DEVELOPMENTAL MILIEU AND PARADIGM SHIFT OF PARENTAL ROLE IN INDIAN CONTEXT Dr Ranjan Bhattacharyya, Dr Rajarshi Neogi, Dr Kaustav Chakraborty; Kolkata ÂÂ

Positive parenting, sometimes called positive discipline, gentle guidance or loving guidance, is simply guidance that keeps our kids on the right ■■■■

Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

1085

CONFERENCE PROCEEDINGS

72nd Annual Conference of the Association of Physicians of India (APICON 2017) NEW MEDICATIONS FOR TREATMENT OF DIABETES: WE SHOULD BELIEVE IN DATA OF SAFETY, EFFICACY & CARDIOVASCULAR OUTCOME

The lessons that cases such as these teach us are as follows:9 ÂÂ

Collection of good population efficacy and safety data takes a long time

ÂÂ

Regulatory approvals have to be backed by robust evidence

ÂÂ

Study of pharmacodynamics and pharmacokinetics of drugs could go a long way in proving its safety.

Dr Anoop Misra, New Delhi Our training as doctors enables us to practice medicine with decisions backed by the latest research. But, how is this done in a clinical setting? Dr David Sackett defines evidence-based medicine as “The conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient. It means integrating individual clinical expertise with the best external clinical evidence from systematic research”.1 Currently, many medical therapies are being used for the management of diabetes, with metformin (biguanides) being the first-line treatment, as they can effectively deal with the original pathogenic triumvirate theory for T2DM. Since, there was no other agent that could improve the health of the beta cells and cause glucosedependent insulin release, they continued to remain the main therapy for treatment for long. However, this scenario somewhat changed once the role of the incretin system in the pathogenesis of T2DM was discovered. The US FDA, however, recommends caution. It emphasizes that every new drug should have several phases of studies conducted to ensure efficacy and safety. Sadly, history is replete with examples of drugs being widely accepted and used, only to be suspended later due to startling evidence coming to light. One of the most common examples that can be cited is the ‘rosiglitazone debacle.6,7 Rosiglitazone, an oral hypoglycemic agent, was approved by the FDA in 1999, based only on efficacy of glycemic control. There were inadequate studies to determine its macrovascular safety, which is of concern, since 65% diabetic deaths are caused by cardiovascular complications. A meta-analysis conducted by Nissen and Wolski in 2007, concluded that rosiglitazone increased the risk of cardiovascular events, even with short-term therapy. This led to the suspension of rosiglitazone by the FDA in 2010.6,8

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Indian Journal of Clinical Practice, Vol. 27, No. 11, April 2017

There are many examples of drugs being sold in India without adequate safety and efficacy profile; while nonstandard and inadequate data are provided as evidence to unsuspecting physicians (Luthra A, Misra A. The marketing of unproven drugs for diabetes and dyslipidaemia in India. Lancet Diabetes Endocrinol. 2015;3(10):758-60. doi: 10.1016/S2213-8587(15)00328-9.). Besides other drugs mentioned by us in previous publication, an example could be Teneligliptin, a recently launched gliptin in India. Currently, Teneligliptin is approved for use only in three countries other than India.10 An interesting fact is, there are only around 15 trials on Teneligliptin from Japan and Korea with very limited number of patients.14 More importantly, very limited evidence is available in Indian patients.2 In the era of evidence-based medicine, a criterion that matters is the weight of evidence. Data gathered reflects that the most number of clinical trials were conducted on sitagliptin and vildagliptin, followed by saxagliptin, linagliptin with teneligliptin as poor last position.11 The US FDA states that it is important that all antidiabetic drugs should prove cardiovascular safety. One contentious issue regarding Teneligliptin is prolongation of QT interval as seen in some studies, and also questioned by Japanese regulators when application of this drug was in consideration for licensing (https://www.pmda.go.jp/files/000153594.pdf). This adverse reaction must be kept in mind when treating patients with cardiovascular disease or other drugs that might prolong QT (in diabetes commonly used are; erythromycin, amitryptyline and domperidone). Gliptins have most decidedly heralded a change in the management of diabetes. They have been proven

CONFERENCE PROCEEDINGS to reduce HbA1c levels effectively and safely and this new class of drugs is here to stay. Guidelines have acknowledged the use of gliptins for their lack of adverse effects and recommend their use for patients struggling to reach their HbA1c goals. To reiterate, as healthcare practitioners we have been trained in evidence-based medication, and have the responsibility to make wise choices.5 Our clinical decision while choosing a medication should encompass our expertise, the best evidence available and patient benefits.

References: 1. Marschall M. EBM (Evidence Based Medicine). Available [Online] at URL: http://boards.medscape.com/ forums/?128@@.2a7cdc6e!comment=1. Accessed on 16 January, 2017. 2. Ghosh S, et al. Diabetes Metab Syndr Obes. 2016;9:347-53. 3. Diabetes in India. 2015. Available [Online] at URL: http:// www.idf.org/membership/sea/india Accessed on 16 January, 2017. 4. Holt R. US Endocrinology. 2010;6:34-41. 6. Nissen and Wolski. N Engl J Med. 2007;356:2457-71. 7. Misbin RI. Diabetes Care. 2007;30(12):3141-4.

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Non-VKA-OACs are not indicated in moderate-tosevere mitral stenosis, mechanical valve prosthesis and during pregnancy.

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India faces the double jeopardy of more for non-VKA-OAC because of low TTR and availability of INR testing and at the same poor affordability of non-VKA-OAC due to cost.

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Rhythm control strategy is ideal, but often not feasible and not sustainable. Also, side effects of antiarrhythmic drugs are often unacceptable.

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Rate control is often all that is needed and achieved. Careful diagnosis and correction of precipitating factors are important.

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National Registry of prevalence and treatment of AF is needed.

ADVANCES IN MANAGEMENT OF CHRONIC PANCREATITIS Dr D Nageshwar Reddy, Hyderabad ÂÂ

Pain in chronic pancreatitis is multifactorial (nociception and neuropathy).

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Oxidative stress has been associated with causation of pancreatic pain in chronic pancreatitis.

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Methionine-containing antioxidant supplements should be started early in chronic pancreatitis.

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Endotherapy (ESWL + ERCP) is the first-line of management for painful pancreatic duct stones.

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Recurrence of pain after endotherapy or surgery should be treated with antioxidant and pregabalin combination.

8. Cheung BM. Expert Rev Clin Pharmacol. 2010;3(6):723-5. 9. Shenfield G. Aust Prescr. 2013;36:38-9. 10. Maladkar M, et al. J Diabetes Mellitus. 2016;6:113-31. 11. Based on a systematic search in PubMed for clinical trials restricted to human studies up until 26-May-2016. 12. Van Noord C, et al. Br J Clin Pharmacol. 2010;70(1):16-23. 13. Sicras-Mainar A, Navarro-Artieda R. Drug Des Devel Ther. 2014;8:811-8. 14. Based on systematic PubMed search of clinical trials with ‘teneligliptin’ in title/abstract, as on 17-Jan-2017.

MANAGEMENT OF ATRIAL FIBRILLATION IN INDIAN SCENARIO Prof Dr Saumitra Ray, Kolkata ÂÂ

Atrial fibrillation (AF) is the commonest persistent arrhythmia.

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Rheumatic valve disease is still an important cause of AF in India.

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AF is the commonest cause of stroke with paroxysmal AF being increasingly recognized as a culprit.

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Oral anticoagulant, both VKA-OAC and non-VKAOAC, are the mainstay of treatment to prevent stroke.

need poor time their

CLINICAL IMPACT OF NEWER INSULINS FOR THE MANAGEMENT OF T2DM Dr Marc Evans, Cardiff, UK Achieving good glycemic control while avoiding hypoglycemia, in order to delay or prevent the longterm complications in patients with T2DM is important. Although, insulin plays a vital role in the management of diabetes, conventional human basal insulins like NPH have certain limitations, which have led to the development of more stable and peak less analogs. Although the first generation basal insulin analogs, insulin glargine and insulin detemir are an improvement over NPH, they still exhibit subtle peak effect and some patients may need twice-daily administration. Insulin degludec is an ultra-long acting basal insulin analog with flat, stable glucose-lowering profile

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CONFERENCE PROCEEDINGS with half-life of >25 hours and glycemic variability is found to be four times lesser than that of insulin glargine. It is also safe for usage in patients with renal and hepatic impairment without any stacking. A co-formulation of 70% insulin degludec with 30% rapid-acting insulin aspart i.e., IDegAsp is also available wherein the characteristics of both individual components are retained and no clinically relevant differences have been observed in the PK/PD of IDeg or IAsp in patients with renal or hepatic failure. In comparison to insulin glargine, when IDegAsp was administered once-daily in insulin-naïve patients with T2DM, there was superiority in lowering HbA1c with numerically lower confirmed and nocturnal hypoglycemic episodes. In another study, comparing twice-daily administration of IDegAsp versus basalbolus in prior insulin users, the final HbA1c was comparable although noninferiority was not achieved. But, the insulin dose was 12% lower using combination insulin and confirmed and nocturnal hypoglycemia were 19% and 20% lower respectively and significantly lesser weight gain was seen with IDegAsp. IDegAsp is a novel co-formulation indicated for once- or twice-daily subcutaneous administration with the main meals, which offers patients with progressive T2DM, a smart way of initiating and intensifying insulin therapy with simplicity, improved safety and superior efficacy.

This group of affected persons has longer disease duration and exposure to the adverse diabetic state leading to higher risk of premature development of complications with significant morbidity and mortality occurring at much unexpected early age. As a result, the young and productive workforce, who actually is the future of the society, may be lost or become less effective together with the financial cost of treating these complications and daily man power loss. ÂÂ

In absence of definite worldwide accepted guideline based on large prospective multi-centric trials, there is also hesitancy or therapeutic inertia as a consequence of clinicians’ uncertainty in treating these young individuals, which adds to the problem.

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We need early diagnosis and preventive measures, particularly in terms of obesity. Awareness should be created amongst the primary care physicians, people at large, school teachers and should be started from the school level. Every school and college must have compulsory playground and play/exercise intervals, teaching about healthy food habits and its canteen should not vendor unhealthy fast foods.

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We need better understanding of the factors involved in the development of T2DMY and its complications. This effort should be coupled with the implementation of public health initiatives to control and avert future increases in obesity to prevent this impending devastating disease of the society.

ADULT IMMUNIZATION Dr OP Sharma, New Delhi ÂÂ

Adult immunization is the need of hour to protect older adults from vaccine preventable diseases by immunization during their years of diminishing immunity.

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Respiratory vaccines have a great role in preventing respiratory infections in older adults. Influenza is endemic in India and annual immunization against it is helpful.

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Pneumococcal vaccine is recommended in older adults for prevention against invasive pneumococcal disease.

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Influenza and pneumococcal vaccine are recommended in immunocompromised older adults.

HEADACHE AND MIGRAINE: DIAGNOSIS TO TREATMENT Dr K Ravishankar, Mumbai ÂÂ

‘Headache’ accounts for almost 25% of an Internist’s OPD practice.

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‘Migraine’ is the commonest cause for recurrent, disabling headaches seen in practice. Yet migraine is largely underdiagnosed and undertreated. Migraine now needs to be looked upon not just as a ‘vascular’ headache, but as a ‘neurovascular’ disorder that begins in the brain.

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Treatment of migraine involves treatment of the acute attack in the short-term and also management of the disorder with prophylactics in the long-term.

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For mild attacks, NSAIDs and antiemetics will suffice but for moderate-to-severe attacks, triptans, which are 5HT receptor agonists are the drugs of choice.

TYPE 2 DIABETES IN YOUNG Prof Dr Samar Banerjee, Kolkata ÂÂ

The condition of type 2 diabetes mellitus in young (T2DMY) raises both clinical and social problems.

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CONFERENCE PROCEEDINGS ÂÂ

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Optimal treatment of the acute attack can be achieved by combining sumatriptan and naproxen in a single tablet. There are many drugs that can be used as prophylactics, but the drug of first choice is propranolol, if there are no contraindications. If first-line prophylaxis fails, one may need to add antiepileptic drugs such as divalproex or topiramate as add-on prophylaxis. When migraine becomes chronic and refractory, one may rarely need to resort to the use of onabotulinumtoxin A or neurostimulation. Last, but not the least, nonpharmacological measures and proper patient education is necessary to treat all migraine patients.

vaccine is available in Kyasanur Forest disease. Prevention is a better option for viral hemorrhagic fever management as there is no cure. YOUNG HYPERTENSIVES: DO WE NEED TO LOOK AT THEM DIFFERENTLY? Dr Sanjay Kalra, Karnal ÂÂ

Physicians across India are observing youngsters with diabetes and heart failure.

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One condition which must be controlled among youngsters is HT.

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Young hypertensives are different and exhibit unique psychosocial issues. Ensuring BP control among young hypertensives is our best chance to prevent diabetes and heart failure.

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Clinicians need to address the Octet of Ss. These include Sex, Salt, Sugar, Sleep, Smoking, Stress, Sunlight and Sedentary behavior.

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As clinicians, we need to inform our young hypertensives on each of above 8 Ss. E.g., a simple measure, which can improve adherence among young hypertensives is to inform them that “Controlling BP will improve sexual health”.

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Popping NSAIDs is also an area, which needs awareness, especially among young hypertensives.

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Drugs such as telmisartan have well-documented evidence in reducing the risk of new onset of diabetes. Metabolic health, including prevention of diabetes, investigated by the reduction of newonset diabetes in endpoint trials, should be a central criterion for the quality assessment of CV protection drug intervention especially among young hypertensives.

PROGNOSTIFICATION: A LOST SKILL IN MEDICINE Dr M Raveendran, Coimbatore ÂÂ

Doctors face two challenges in prognosticating near the end of life: Formulating accurate predictions and communicating them.

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If doctors are better able to anticipate death, they will be likely to help the patient and his family to make judicious use of medical treatments.

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Increased accuracy of prognosis helps patients and family to make directive decisions, allow for preparations and help avoid burdensome treatments.

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Hippocratic writers characterized the physician’s role thus: “Declare the past, diagnose the present, foretell the future; practice these arts.”

VIRAL HEMORRHAGIC FEVER Dr Debasis Chakrabarti, Siliguri, West Bengal ÂÂ

Hemorrhagic worldwide.

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Diseases may range from insidious mild hemorrhagic symptoms to rapid severe bleeding, DIC, Shock and MOF.

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viruses

are

distributed

Most recent devastating outbreak of Ebola in West Africa (2014), being the largest outbreak of viral hemorrhagic fever till now, accounted for around 11,000 deaths among 29,000 of reported cases.

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Treatment of viral hemorrhagic fever is mostly supportive though antiviral ribavirin is effective in some cases like arenavirus and bunyavirus.

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Live attenuated vaccines are available in argentine HF, Rift Valley fever, Yellow fever and under study in Crimean-Congo HF, Ebola and Marburg. Killed

CLINICAL PRESENTATION AND SYSTEMIC MANIFESTATIONS OF ZIKA VIRUS Dr RR Chaudhary, Patna ÂÂ

Zika virus is an emerging pathogen that is transmitted among nonhuman primates and humans by Aedes mosquitoes.

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Human infections are usually benign and are most likely misdiagnosed as dengue or influenza. Zika virus infection is characterized by influenzalike clinical signs, including fever, headaches and malaise.

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A maculopapular rash, conjunctivitis, myalgia and arthralgia usually accompany or follow those manifestations.

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MEDILAW

A Doctor, Like Any Other Professional, can Take Leave if Felt Necessary by Him

I had to go out of town as my father was critically ill. I had advised shifting the patient to the ICU.

This doctor left town when my father was still hospitalized and under his care without giving instructions to another doctor.

A doctor can take leave if it is necessary. The patient was in a hospital, so he would have been taken care of by another doctor in the hospital. There is no negligence on the part of the doctor. Complaint is dismissed.

Proceed

Lesson: In a judgement, the NCDRC said, “A doctor, like any other professional can take leave if felt necessary by him on account of his personal reasons or otherwise. If that happens it is for the hospital in which the patient is admitted to make alternative arrangement for the treatment of the patient in the hospital… the patient was admitted in a hospital and not in the clinic of Dr…, who could not have been expected to remain with the patient or in the hospital 24 hours of the day. Like other normal human being he also needs to take rest and his meals and then get ready for the duty to be performed on the next day.” Shri Manishbhai Kantilal Joshi vs Sheth P. T. Surat General Hospital, Surat, National Consumer Disputes Redressal Commission, New Delhi, Consumer Case No. 366 of 2014, dated: 09 Feb 2016.

COURSE OF EVENTS ÂÂ

19.11.2012: The patient, an 86-year-old man was hospitalised in Hospital X (hereby referred to as Opposite Party No. 1). He was admitted by another doctor, but was later put under the treatment of Dr ‘A’ (hereby referred to as Opposite Party No. 2), a chest physician.

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20.11.2012: The patient was under the care of Dr ‘B’ (hereby referred to as Opposite Party No. 3), after Dr ‘A’ had retired for the day.

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21.11.2012: The patient died at about 2.30 am while on ventilator in the intensive care unit (ICU).

COMPLAINANT ALLEGATIONS The son of the patient (hereby referred to as complainant) filed a complaint of negligence in the treatment of his father before the National Consumer Disputes Redressal Commission (NCDRC) seeking compensation of `. 2 crores along with cost of litigation quantified at `. 50,000/-. ÂÂ

Dr ‘A’ had left for outstation when the deceased was still admitted in the hospital and was under his treatment.

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ÂÂ

Dr ‘A’ left without giving the instructions to Dr ‘B’.

ÂÂ

Dr ‘B’ was not a qualified specialist in the relevant field.

SOME SALIENT COURT OBSERVATIONS ÂÂ

Dr ‘A’ (OP 2) stated that the patient had chronic end-stage respiratory disease, severe chronic obstructive pulmonary disease, fibrotic lung lesion and bronchiectasis. Though the patient had been admitted under another doctor, he had also been treating the patient since last few months as an outpatient.

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The patient had been on nebuliser and home oxygen therapy for 6 months prior to his death. His advanced age ruled him out as a good lung transplant candidate and so steroid treatment was started.

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Dr ‘A’ (OP 2) planned to leave on 20.11.2012 as his father had taken critically ill in the evening on the same day. He therefore advised that the patient be moved from the ward to the ICU, where the patient was first put on noninvasive ventilation, and then shifted to invasive ventilatory support on account

MEDILAW of the worsening condition after taking the consent from the complainant. The patient’s condition was informed to the family members before taking the consent. ÂÂ

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Dr ‘B’, the Commission observed that the patient records maintained by the hospital include all relevant information of the patient such as clinical history, treatment administered. Any “suitably qualified doctor attending the patient” could manage the patient in the absence of the previous doctor. Hence, “no such briefing would be necessary”.

Dr ‘A’ (OP 2) last saw the patient on 20.11.2012 around 8 pm. “It is stated in the reply that the patient was duly taken care of treating his treatment in the hospital and there was absolutely no negligence in the said treatment.” In his reply, Dr ‘A’ (OP 2) said that the patient succumbed to long existing chronic end-stage respiratory disease.

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In their statement, both Dr ‘B’ (OP 3) and Hospital X (OP 1) have concurred with Dr ‘A’ (OP 2) and stated that “the patient was admitted with past history of Bilateral Centrilobulor Emphysema in the form of Hyperinflated lung with flattening of lobes, Minimal subpleural opacity in the right upper lobe suggest fibrotic/old granulomatous lesion, Atherosclerotic aortic changes and degenerative spinal changes along with Rounding of Trachea and filling defect in upper trachea.” And that the patient had been treated as per the standard protocol by Dr ‘A’ (OP 2) “but the patient succumbed to the chronic disease despite adequate treatment given to him.” They also said that Dr ‘B’ (OP 3) is “a qualified doctor, who was employed on regular basis with the OP 1.”

“So long as the doctor treating the patient in the absence of the previous doctor is a competent doctor he should have no difficulty in treating the patient on the basis of the record prepared in the hospital.” And Dr ‘B’ (OP 3) has not stated that “he was handicapped in any manner in the treatment of the patient on account of having not been adequately briefed” by Dr ‘A’ (OP 2). The Commission did not accept the complainant’s contention that the leave taken by Dr ‘A’ (OP 2) was responsible for his father’s death.

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Dr ‘B’ (OP 3) could manage the patient as he had an MD degree and “it is not as if only a super specialist in chest related disease can treat such a patient.” The Commission observed: “A doctor, who has done Post Graduation in Medicine, in our opinion, is fully competent to treat the patient. In fact, in almost all the hospitals, Senior Doctors normally retire for the day in the evening/night and it is only Junior Doctor such as Junior Residents and Senior Residents who remain on duty. The consultant is called if necessary, depending upon the condition of the patient.” Hence, the commission disregarded the allegation that Dr ‘B’ (OP 3) was not qualified enough to treat the father of the complainant in the absence of Dr ‘A’ (OP 2).

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Dr ‘A’ (OP 2) had last seen the patient on 20.11.2012 at about 8 pm. The patient died at about 2.30 am on 21.11.2012 i.e., “within a span of 6 ½ hours” after he had left the hospital.

COURT OPINION ÂÂ

The Commission found no merit in the allegation that Dr ‘A’ (OP 2) had left “without giving proper instructions” to Dr ‘B’ (OP 3) about the treatment of the patient.

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There was no evidence to support the complainant’s allegation that Dr ‘A’ (OP 2) had left town on 20.11.12. The medical records also corroborate the statement by Dr ‘A’ (OP 2) that he had last seen the patient at 8 pm on 20.11.12. “Be that as it may, even if we proceed on the assumption that Dr ‘A’ had taken leave and left for outstation on 20.11.2012 that by itself does not make out any negligence on his part in the treatment of the patient.”

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“A doctor, like any other professional can take leave if felt necessary by him on account of his personal reasons or otherwise. If that happens it is for the hospital in which the patient is admitted to make alternative arrangement for the treatment of the patient in the hospital. We have to keep in mind that the patient was admitted in a hospital and not in the clinic of Dr ... Therefore, in the absence of Dr … the patient was to be treated by some other doctor available in the hospital or called by the hospital from outside. No case of negligence on the part of the Dr … is therefore made out even if we assume that he had left for outstation on 20.11.2012.” In response to the complainant’s allegation that Dr ‘A’ had left without giving instructions to

FINAL JUDGEMENT The Commission ruled in favour of Dr ‘A’ (OP 2) and said that “he could not have been expected to remain with the patient or in the hospital 24 hours of the day. Like other normal human being he also needs to take rest and his meals and then get ready for the duty to be performed on the next day.” As there was no evidence of any negligence on the part of Dr ‘A’ (OP 2) in leaving the hospital and the patient being treated by Dr ‘B’ (OP 3) in his absence, the Commission dismissed the allegations of the complainant with no order as to costs. REFERENCE 1. Shri Manishbhai Kantilal Joshi vs Sheth P. T. Surat General Hospital, Surat, National Consumer Disputes Redressal Commission, New Delhi, Consumer Case No. 366 of 2014, Hon’ble Mr. Justice V.K. Jain, Presiding Member and Hon’ble Dr. B.C. Gupta, Member, Dated: 09 Feb 2016.

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AROUND THE GLOBE

News and Views A New e-portal to Check Substandard Drugs and Antimicrobial Resistance The Health Ministry has proposed to create an online portal to help it regulate and plug gaps in the sale of medicines in India through various platforms, including e-pharmacies through an autonomous body as reported in ET Health on March 17, 2017. This autonomous body would develop and maintain this e-platform, which will require registration. Once registered, drug makers, stockists, wholesalers, distributors, licensed chemists and e-pharmacies are expected to enter complete data relating to the drugs being sold by them…

CT Angiography + CT Perfusion may Help Predict Adverse Cardiovascular Events

Addition of Evolocumab to Statins Reduces Cardiovascular Events

The use of two bisphosphonates as adjuvant therapy should be considered for all postmenopausal women with early breast cancer who are deemed to be candidates for adjuvant therapy, according to a new joint clinical practice guideline from Cancer Care Ontario and the American Society of Clinical Oncology (ASCO) published online March 6 in the Journal of Clinical Oncology.

According to results from the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab, a monoclonal antibody, also decreased major CV-events risk in addition to significantly lowering levels of LDL-C. The trial is published in the New England Journal of Medicine, online March 17, 2017.

Precision Medicine Platform Now Open for Collaborative Discovery About Cardiovascular Diseases The American Heart Association Precision Medicine Platform—a global, secure data discovery platform, recently developed in collaboration with Amazon Web Services (AWS)—is now open for use. Researchers, physicians, computational biologists, computer engineers and trainees from around the globe can leverage this cloud-based resource to access and analyze volumes of cardiovascular and stroke data to accelerate the care of patients at risk of the number one killer in the United States and a leading global health threat.

Prophylactic Platelet Transfusion not Beneficial in Dengue Infection A new research reported online March 7, 2017 in The Lancet says that prophylactic platelet transfusion is no better than supportive care in preventing bleeding in patients with dengue infection. In the study, clinical bleeding rates by Day 7 or hospital discharge did not differ significantly between the transfusion group (21%) and the control group (26%).

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CT angiography combined with CT perfusion enables similar prediction of 2-year major adverse cardiovascular event (MACE), late MACE and event-free survival similar to that enabled by invasive coronary angiography (ICA) and single photon emission CT, says the CORE320 Multicenter Study reported in the journal Radiology, March 14, 2017.

ASCO Guidelines on Adjuvant Bisphosphonates in Breast Cancer

Doxycycline may be an Alternative to Steroid in Bullous Pemphigoid According to the UK Dermatology Clinical Trials Network BLISTER study, doxycycline is noninferior to standard treatment with oral prednisolone for shortterm blister control and significantly safer in the longterm in patients with bullous pemphigoid. The study is published in The Lancet, March 6, 2017.

South-East Asia Countries Adopt Call for Action to Accelerate Efforts to End TB Health Ministers from countries in WHO South-East Asia Region which bear half the global tuberculosis (TB) burden, and WHO today signed a Call for Action for Ending TB, pledging to scale-up efforts and implement adequately funded, innovative, multisectoral and comprehensive measures to achieve the global target to end the disease by 2030. “We need to make ending TB our central priority. The disease continues to be a leading cause of death and lost productive years in the crucial age group of 15-49 years causing catastrophic expenses, financial losses, outright impoverishment of individuals and households and massive aggregate costs to national economies. Ending TB is paramount

AROUND THE GLOBE for health and development across the Region,” said Dr Poonam Khetrapal Singh, Regional Director for WHO South-East Asia, told the Ministerial Meeting Towards Ending TB in the South-East Asia Region … (SEARO, March 16, 2017)

A New ICHRON Score can Predict Risk of Chronic Disease According to results of a study presented March 17, 2017 at the American College of Cardiology’s 66th Annual Scientific Session, which concluded in Washington, DC, the Intermountain Chronic Disease Risk Score (ICHRON) was 78% accurate in identifying patients who would be diagnosed with a chronic disease within 3 years of testing. Women with moderate ICHRON scores were 3 times more likely to be diagnosed with a chronic disease, while men with a moderate score were 5.6 times more likely to be diagnosed with a chronic disease within 3 years.

Antenatal Vitamin D Supplementation does not Benefit Bone Health in Children Results of a study published online March 1, 2017 in The Lancet Diabetes & Endocrinology show that 25-hydroxyvitamin D (25[OH]D) levels in the pregnant mother and newborn have no association with childhood bone health. 25(OH)D concentrations during childhood might be more relevant for bone outcomes than 25(OH) D concentrations during fetal life.

Study Defines a New Biomarker to Predict Outcome Post-traumatic Brain Injury The Recovery After Pediatric Brain Injury (RAPBI) study reported in the journal Neurology demonstrated that early measures of interhemispheric transfer time (IHTT) can predict which children will recover after moderate-tosevere traumatic brain injury (msTBI) and which will continue to decline neurologically and cognitively more than a year following injury.

Study Suggests Metastases as a Clinically Relevant Endpoint in Prostate Cancer A report published online February 27, 2017 in the Journal of Clinical Oncology says that the primary endpoint of active surveillance trials should be reconsidered because metastatic disease, not death from prostate cancer, is the more meaningful clinical endpoint to patients, and as such, it should serve as a benchmark against which different treatment protocols are compared.

Prediabetes should be Aggressively Managed to Prevent Future Microvascular Events, Says Study A post-hoc analysis of participants from the Swedish Obese Subjects (SOS) study published online February 22, 2017 in Lancet Diabetes & Endocrinology show that bariatric surgery was associated with reduced risk of microvascular complications in all subgroups, but the greatest relative risk reduction was observed in patients with prediabetes at baseline.

Elderly Patients with Epilepsy at Increased Risk of Stroke Elderly patients with seizures have an increased risk for future stroke, says a study presented at the recent International Stroke Conference (ISC) 2017 in Houston, Texas. The elderly patients with epilepsy had a much greater burden of comorbid vascular disease and risk factors, such as hypertension, atrial fibrillation, peripheral vascular disease and coronary artery disease. Compared to 1.79% in patients who did not have epilepsy, the annual incidence of stroke or acute myocardial infarction was 3.28% in those who had epilepsy.

Health Ministry Sets up Task Force to Combat Glaucoma New Delhi, Mar 18 (PTI) A National Task Force has been set up by the Health Ministry to reduce the incidence of irreversible blindness caused due to glaucoma. Glaucoma is caused when the optic nerve, which connects the eye to the brain, becomes damaged, and it is prevalent in the country and is the cause of 12 per cent of blindness seen in India, Dr Ramanjit Sihota, HOD of Glaucoma at AIIMS said. “The aim is to train district ophthalmologists across the country on early diagnosis and appropriate management of glaucoma to prevent loss of vision. If detected and treated early on, blindness can be completely prevented,” Dr Sihota said. There is lack of awareness in district ophthalmologists, especially in rural areas and thus it is necessary that they are trained and made aware about the importance of early detection, she said. According to Chief of RP Centre for Ophthalmic Sciences, AIIMS, 50% of people in India do not know they have glaucoma as it is generally asymptomatic. Also regular eye practice is not prevalent in India. “It is a progressive eye disease which may lead to irreversible blindness, usually without warning, until it reaches an advanced stage. It is more prevalent among people over the age of 40,” Dr Sihota said.

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AROUND THE GLOBE The National Task Force comprises of four members Dr Sihota, HOD of Glaucoma at Dr RP Centre, AIIMS, Dr Sushmita Kaushik from PGI, Chandigarh, Dr MD Singh from RML Hospital and Dr Suneeta Dubey of Dr Shroff’s Charitable Eye Hospital. With the World Glaucoma Week on, the doctors stressed that people who are over 40 years, have a family history of glaucoma, are using steroids or are diabetic and hypertensive should go for a yearly eye check-up when they go to change their glasses. According to the World Health Organization (WHO), glaucoma is the second leading cause of blindness in the world.

UN Announces Interagency Group to Coordinate Global Fight Against Antimicrobial Resistance The United Nations has announced the establishment of an Interagency Coordination Group on Antimicrobial Resistance, which will be co-chaired by Deputy Secretary-General Amina Mohammed and World Health Organization (WHO) Director General Dr Margaret Chan. “As we enter the era of sustainable development, I would like to emphasize that antimicrobial resistance (AMR) really does pose a formidable threat to the attainment of the Sustainable Development Goals (SDGs), particularly in our developing countries,” Ms Mohammed told reporters at UN Headquarters in New York. Ms Mohammed said the creation of the UN joint agency group to combat AMR and advise on the global effort, is a sign of how seriously UN Member States were taking the threat. She said AMR is a “multi-sectoral problem” affecting human and animal health, agriculture, as well as the global environment and trade. Clean water, sustainable food production and poverty alleviation are but a few of the challenges it poses. The group will be comprised of high-level representatives from relevant UN agencies, other international organizations and individual experts across different sectors, including animal health, agriculture and environment. It will produce a report to the Secretary General for the UN General Assembly session starting in September 2018…. (UN, March 16, 2017).

FDA Alert About Adverse Cardiac Events with Bioresorbable Vascular Scaffold The Food and Drug Administration (FDA) is informing healthcare providers treating patients with Absorb GT1 Bioresorbable Vascular Scaffold (BVS) that there is an increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients

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treated with the approved metallic XIENCE drug-eluting stent. The FDA recommends that healthcare providers: ÂÂ

Follow the instructions for target heart vessel selection (e.g., avoiding BVS use in small heart vessels) and optimal device implantation that are included in the BVS physician labeling.

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Advise patients experiencing any new cardiac symptoms such as irregular heartbeats, chest pain or shortness of breath to seek clinical care. For more information about risks associated with the BVS, refer to the BVS physician labeling.

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Advise BVS patients to follow the recommendations for DAPT prescribed by their healthcare providers.

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Report any adverse events related to the BVS that come to your attention.

AGA Obesity Practice Guide The American Gastroenterological Association (AGA) has created an Obesity Practice Guide published February 24, 2017 in Clinical Gastroenterology and Hepatology. The POWER (Practice guide on Obesity and Weight management, Education and Resources) white paper provides physicians with a comprehensive, multidisciplinary process to guide and personalize innovative obesity care for safe and effective weight management. The POWER program care cycle is circular in order to represent the fact that obesity is a chronic disease that requires a lifelong multidisciplinary approach for effective, long-term therapy.

Favorable Outcomes with FFR-guided Multivessel Revascularization in STEMI Patients In patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease who underwent primary percutaneous coronary intervention (PPCI) of an infarct-related artery, the addition of fractional flow reserve (FFR)-guided complete revascularization of noninfarct-related arteries in the acute setting resulted in a risk of a composite cardiovascular outcome that was lower than the risk among those who were treated for the infarct-related artery only. These findings from the COMPAREACUTE trial were presented at the American College of Cardiology (ACC) 2017 Scientific Sessions and also simultaneously published online in the New England Journal of Medicine.

Radiotherapy + Temozolomide Prolongs Survival in Elderly Patients with Glioblastoma In elderly patients with glioblastoma, the addition of temozolomide to short-course radiotherapy resulted

AROUND THE GLOBE in longer survival than short-course radiotherapy alone, says a study published March 16, 2017 in the New England Journal of Medicine. The median overall survival was 13.5 months with radiotherapy + temozolomide versus 7.7 months with radiotherapy alone in patients with methylated O6-methylguanine– DNA methyltransferase status.

A Disrupted Sleep at Home Increases Risk for Postoperative Delirium Compared to those who did not have sleep disruption, older people aged 65 years and above with sleep disruption at home had a 1.21 higher risk of developing postoperative delirium. Sleep disruption in the hospital may further heighten this risk, says a study published March 17, 2017 in the Journal of the American Geriatrics Society.

Eating More Fruits and Vegetables Lowers Risk of Developing COPD Results of a population-based prospective cohort study of men from Sweden indicate that high consumption of fruits and vegetables is associated with reduced chronic obstructive pulmonary disease (COPD) incidence in both current and ex-smokers but not in never-smokers. Each one serving per day increment in total fruit and vegetable consumption decreased risk of COPD significantly by 8% in current smokers and by 4% in ex-smokers. The study is reported in the journal Thorax February 22, 2017.

Eradicating Yaws India was declared free of yaws in 2016, yet 13 countries, with a combined population of 89 million people, still remain endemic for the disease. Field studies have confirmed that a single dose of oral azithromycin is enough to cure the disease. Interrupting transmission in some countries by 2020 is possible, provided a sustainable supply of azithromycin is available. Some key facts on yaws: ÂÂ Yaws is a chronic disfiguring and debilitating childhood infectious disease caused by Treponema pallidum subspecies pertenue. ÂÂ It is one of the first diseases targeted for eradication by WHO and UNICEF in the 1950s. WHO renewed global efforts to eradicate yaws in 2012. ÂÂ The disease affects skin, bone and cartilage. Humans are currently believed to be the only reservoir, and transmission is from person to person.

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Yaws is cured with a single oral dose of an inexpensive antibiotic called azithromycin.

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There are 13 countries currently known to be endemic for yaws, of which only 8 regularly report data to WHO.

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There are 73 countries previously endemic for yaws that need to confirm the current status of the disease. (WHO, March 10, 2017)

A Handbook for Applicants and Reviewers of Clinical Trials of New Drugs in India The Indian Council of Medical Research (ICMR) jointly with the Central Drugs Standard Control Organization (CDSCO) has developed a Handbook for Applicants and Reviewers of Clinical Trials of New Drugs in India as guidance for applicants and reviewers. The handbook highlights regulatory, administrative and scientific review processes for applicants and reviewers of clinical trials.… (CDSCO)

Age of Onset of Hypertension Influence Cardiovascular Outcomes According to a study presented March 8, 2017 at the recently concluded Epidemiology and Prevention/ Lifestyle and Cardiometabolic Health 2017 Scientific Sessions in Portland, Oregon, Compared to nonhypertensives, hypertension onset at age <45 conferred a 2.2-fold odds of CVD death and 2.3-fold odds of coronary death, whereas hypertension onset at age ≥65 conferred a lower-magnitude 1.5-fold odds of CVD death and 1.4-fold odds of coronary death.

Parameters to Predict Progression of Arthralgia to Rheumatoid Arthritis A EULAR Task Force has defined a set of clinical characteristics for patients with arthralgia who are at risk of progression to rheumatoid arthritis (RA) published in the March 2017 issue of the journal Annals of the Rheumatic Diseases. Seven relevant parameters were identified: symptom duration <1 year, symptoms of metacarpophalangeal (MCP) joints, morning stiffness duration ≥60 minutes, most severe symptoms in early morning, first-degree relative with RA, difficulty with making a fist and positive squeeze test of MCP joints. For a sensitive definition, arthralgia at risk of RA can be defined by the presence of ≥3 parameters and the presence of ≥4 parameters yielded a high specificity.

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LIGHTER READING

HUMOR

Lighter Side of Medicine THREE PROFESSIONALS A Mechanical, Electrical and Computer Engineer were riding together to an Engineering Seminar; the car began jerking and shuttering. The mechanical engineer, said, “I think the car has a faulty carburettor.” The electrical engineer said, “No, I think the problem lies with the alternator.” The computer engineer brightened up and said, “I know, let’s stop the car, all get out of the car and get back in again!” SALESMAN TO POLICEMAN A salesman, tired of his job, gave it up to become a policeman. Several months later, a friend asked him how he liked his new role. “Well,” he replied, “the pay is good and the hours aren’t bad, but what I like best is that the customer is always wrong.” AFTER A BAD ACCIDENT Patient: I’m in a hospital! Why am I in here? Doctor: You’ve had an accident involving a train. Patient: What happened? Doctor: Well, I’ve got some good news and some bad news. Which would you like to hear first? Patient: Well... The bad news first...

My father took the paper and, after studying it, sheepishly replied, “It says that you should write more legibly.” BASEBALL There were these two friends, Bill and Bob, and they both loved baseball. So, they made a promise to each other, the first one to die, will come back and let the other know if there’s baseball in heaven. Well, the day comes and Bob passes. Weeks turn to months while Bill is still waiting to hear from his friend. Then one day, Bill is walking down the street, and Bob appears. Bill all excited says: “I’ve been waiting forever! So tell me, is there or isn’t there Baseball in heaven?” Bob kinda perks up and says: “I’ve got good news and bad news.” “1st, there is Baseball in heaven! The bad news is you’re pitching Friday!” WELL LET’S JUST WAIT AND SEE WHAT DEVELOPS A man came running in the office and yelled, “Doctor, doctor! My son just swallowed a roll of film!” The doctor calmly replied, “Well let’s just wait and see what develops.”

Dr. Good and Dr. Bad SITUATION: A female with rheumatoid arthritis became pregnant while taking leflunomide.

Doctor: Your legs were injured so badly that we had to amputate both of them. Patient: That’s terrible! What’s the good news?

You can continue to take it

Stop it immediately

Doctor: There’s a guy in the next ward who made a very good offer on your slippers.

As an English professor, my father would often write little notes on student essays. Often he worked late, and as the hours passed, his handwriting deteriorated. One day, a student came to him after class with an essay that had been returned. “Mr McDonald,” he said, “I can’t make out this comment you wrote on my paper.”

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YOU SHOULD WRITE MORE LEGIBLY

LESSON: In women with rheumatoid arthritis who become pregnant

while taking leflunomide, healthy pregnancy outcomes usually occur, if the drug is discontinued at the earliest and a cholestyramine drug elimination procedure is done.

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.

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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.

Indian 1.____________Foreign 1.________________

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. –

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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. 11, April 2017

6. Suggestions for reviewers (name and postal address)

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