Ijcp september 2016

Indexed with IndMED

ISSN 0971-0876

www.ijcpgroup.com

Volume 27, Number 4

September 2016, Pages 301–400

Single Copy Rs. 300/-

Peer Reviewed Journal

yy American Family Physician yy Anesthesiology yy Cardiology yy Community Medicine yy Critical Care yy Diabetology yy Internal Medicine yy Neurology yy Obstetrics and Gynecology yy Oncology

an i c i ys ians

yy Orthopedics

Phly Physic y l mi ami

yy Special Article

Fademy of F n ica Aca

yy Medilaw yy Conference Proceedings

er merican m A eA

yy Around the Globe

ingurnal of th t a or d Jo

yy Lighter Reading

rp-reviewe o c In eer AP

Full text online: http://ebook.ijcpgroup.com/ijcp/

www.emedinexus.com

Online Submission

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

Volume 27, Number 4, September 2016 FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

305 The New Draft Surrogacy (Regulation) Bill, 2016

AMERICAN FAMILY PHYSICIAN

307 Treatment of Adult Obesity with Bariatric Surgery

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.

Robin Schroeder, T. Daniel Harrison, Shaniqua L. McGraw

314 Practice Guidelines 315 Photo Quiz

MD, Group Executive Editor

IJCP Editorial Board

KK Aggarwal

ANESTHESIOLOGY

318 Adjuvant Use of Intravenous Lidocaine for Procedural Pain Relief in Burn Patients: A Prospective Study

Dipti Saxena, Sushil Chand Verma, Sadhana Sanwantsarkar, Neetu Gupta, Deepak Soni

322 Minimal Intubating Dose of Succinylcholine: A Comparative Study of 0.4, 0.5 and 0.6 mg/kg Dose

Ajit Gupta, Saurav Shekhar, Ankesh, Rajesh Kumar, Jay Prakash

326 Prevention of Critical Events in Pediatric Surgery: Set Guidelines and Protocols Save Neonate from Unnecessary Tracheoesophageal Fistula Surgery

Ajit Gupta, Mumtaz Hussain, Vinit Kr Thakur, Jai Prakash

CARDIOLOGY

328 Pulseless Disease Due to Infective Aortitis

Manish N Mehta, Hemang K Acharya, Ajay C Tanna, Jemima Bhaskar, Pratik M Vora

COMMUNITY MEDICINE

331 Study of Breastfeeding Practices in Coastal Region of South India: A Cross-sectional Study

Swetha R, J Ravikumar, R Nageswara Rao

CRITICAL CARE

336 Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Critical Care Challenge

Shashi Kant, Ajit Gupta, Arvind Kumar, Ritesh Kumar, KH Raghwendra

DIABETOLOGY

340 Diabetes Reversal Technique

JS Rajkumar, S Akbar, JR Anirudh

INTERNAL MEDICINE

346 Mucopolysaccharidosis Type 1: Hurler Syndrome Case Report

Bharath Raj Kidambi, Kalpana Ramanathan, Srinivasagalu K

NEUROLOGY

353 Childhood Multiple Sclerosis: A Diagnostic Challenge

Sakshi Singh, Jemima Bhaskar, Manish Mehta, SS Chatterjee

OBSTETRICS AND GYNECOLOGY

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

357 Role of Resveratrol in Management of Endometriosis

Urman Dhruv

360 Vulval Leiomyoma: A Rare Case Report

Akshaya Mahapatro, Indumathi Joy, Thankam Verma, Sarah Kuruvilla

363 An Evaluation of Antepartum and Intrapartum Surveillance with Nonstress Test in Cases of FGR and Its Correlation with Perinatal Outcome

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

Copyright 2016 IJCP Publications Ltd. All rights reserved.

Meenal Jain, Mukesh Chandra, Saroj Singh, Urvashi Verma, Poonam Agarwal

ONCOLOGY

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.

367 Bilateral Primary Ovarian Amelanotic Malignant Melanoma Arising in a Mature Teratoma in Pediatric Age Group

Hiral Ankitbhai Shah, Kalpana Chandra, Ankitbhai Atulbhai Shah, Pranab Kumar Verma

ORTHOPEDICS

Editorial Policies

370 Diagnostic Dilemma and Limb Salvage Surgery of a Large Giant Cell Tumor of Fibular Head Involving Posterior Tibial Vessels: A Case Report

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.

Mantu Jain, Ritesh Runu, Santosh Kumar, Avnish Sheel, Ritika Choudhry

SPECIAL ARTICLE

375 In Defense of a Profession… A Doctor’s Perspective

Dharamvira Gandhi

MEDILAW

378 Always Take Informed Consent CONFERENCE PROCEEDINGS

383 ANCIPS 2016: 68th Annual National Conference of Indian Psychiatric Society 386 CRITICARE 2016: 22nd Annual Conference of Indian Society of Critical Care Medicine 389 NIC 2016: Cardiological Society of India - National Interventional Council (CSI-NIC) Mid-Term Meet 2016

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.

AROUND THE GLOBE

392 News and Views LIGHTER READING

396 Lighter Side of Medicine

IJCP’s EDITORIAL & BUSINESS OFFICES Delhi

Mumbai

Kolkata

Bangalore

Chennai

Hyderabad

Dr Veena Aggarwal 9811036687 E - 219, Greater Kailash, Part - I, New Delhi - 110 048 Cont.: 011-40587513 editorial@ijcp.com drveenaijcp@gmail.com Subscription Dinesh: 9891272006 subscribe@ijcp.com Ritu: 09831363901 ritu@ijcp.com

Mr. Nilesh Aggarwal 9818421222

Ritu Saigal GM Sales & Marketing 9831363901

H Chandrashekar GM Sales & Marketing 9845232974

Venugopal GM Sales & Marketing 9849083558

7E, Merlin Jabakusum 28A, SN Roy Road Kolkata - 700 038 Cont.: 24452066 ritu@ijcp.com

Arora Business Centre, 111/1 & 111/2, Dickenson Road (Near Manipal Centre) Bangalore - 560 042 Cont.: 25586337 chandra@ijcp.com

Chitra Mohan GM Sales & Marketing 9841213823 40A, Ganapathypuram Main Road Radhanagar Chromepet Chennai - 600 044 Cont.: 22650144 chitra@ijcp.com

GM: General Manager

Unit No: 210, 2nd Floor, Shreepal Complex Suren Road, Near Cine Magic Cinema Andheri (East) Mumbai - 400 093 nilesh.ijcp@gmail.com

H. No. 16-2-751/A/70 First Floor Karan Bagh Gaddiannaram Dil Sukh Nagar Hyderabad 500 059 venu@ijcp.com

FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

Dr KK Aggarwal

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

The New Draft Surrogacy (Regulation) Bill, 2016 ÂÂ

Commercial surrogacy is banned in most developed countries, including Australia, UK, Canada, France, Germany, Sweden, New Zealand, Japan and Thailand.

ÂÂ

Now the new bill has banned it in India too.

ÂÂ

But the bill allows altruistic surrogacy, where women (near relative) can legally carry someone else’s child if no money (other than medical cost and insurance), favor or coercion is involved.

ÂÂ

Under the proposed law, only infertile Indian couples who have been married for at least 5 years can opt for surrogacy, while those who already have a child cannot do so.

ÂÂ

The law that insists that a surrogate woman has to be a close relative of the infertile couple would be 'impractical' and may also raise the risk of the surrogacy industry, driven by demand, moving underground, spawning illegal transactions. People will start making fake documents that they are near relatives.

ÂÂ

The Bill has penalty provisions for those violating the law, when it comes into effect. The penalties include a huge monetary fine (10 lakhs), and imprisonment (10 years) and even striking down the name from medical register. This will increase paper work. The records will have to be kept for 5 years and not 2 years.

ÂÂ

Imprisonment clause is now coming in every new bill - PNDT, CEA, Health Data Bill and now the Surrogacy Bill. To err is human. Doctors are not criminals.

ÂÂ

There will be no role of brokers, agents or intermediators and the onus of proof in the case of negligence will be with the clinic and not surrogate or an egg donor.

ÂÂ

It will affect medical tourism.

ÂÂ

There are more than 50 million infertile couples in the world and their desperation for a biological child has turned commercial surrogacy into a booming business. Thousands of infertile couples rent wombs from poor women for 9 months, so they can take a baby back home.

ÂÂ

India has estimated 12-15 million infertile couples.

ÂÂ

There is a big market for sperm and ova banking, embryo implantation and surrogate womb services.

ÂÂ

Celebrities also rent wombs.

ÂÂ

An end to commercial surrogacy will be a big blow to many infertile couples. Infertile couples generally do not discuss in vitro fertilization (IVF) or third-party reproduction (surrogacy) with close relatives. This is kept as secret as possible, particularly from their close family members - so how are they going to find altruistic close relatives.

ÂÂ

Finding women from within the close family willing to be surrogates will not be easy. Many infertile couples are likely to find themselves in distress.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

305

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

There are medical grounds when surrogacy is justified - imagine a woman who has lost her uterus during childbirth or a woman born without a uterus.

ÂÂ

The proposed surrogacy law might even lead to break-up of marriages. This may lead to an increase in second marriages - if surrogacy is not allowed, some couples are likely to break up.

Here is what Smt Sushma Swaraj said: ÂÂ

Cabinet has given approval to a bill to ban commercial surrogacy. It is an important bill and it will be revolutionary in improving the condition of females.

ÂÂ

In the last few years, a new business of renting a womb has come up, where a poor woman's womb is used to produce a child and then the woman is left to her misery.

ÂÂ

More than 2,000 surrogate clinics are currently working in India.

ÂÂ

There is a complete ban on commercial surrogacy.

ÂÂ

There was also an angle that there are couples who are not able to produce kids but their relatives are willing to help then why should the government come in between. This is what is called altruistic surrogacy and this is the main point of this bill.

ÂÂ

National Surrogacy Board will be constituted under the chairmanship of health minister. Three female MPs will be members of the board and two MPs will be from the Lok Sabha.

ÂÂ

Only Indian nationals will be allowed for altruistic surrogacy. Foreign nationals or even NRI or OIC will not be allowed.

ÂÂ

Only married couples will be allowed to opt for surrogacy. Gay, single, live-in couples are not allowed.

ÂÂ

The marriage should be minimum of 5 years and the age of the woman should be from 23-50 years and for the man, 26-55 years.

ÂÂ

There should be a medical certificate that the couple is not able to produce their own child.

ÂÂ

Parents who have their own child or have an adopted one will not be eligible to go for surrogacy.

ÂÂ

A woman can be a surrogate mother only once.

ÂÂ

The surrogate child will have all the rights at par with the biological child including property.

ÂÂ

It would be mandatory for surrogacy clinic to maintain the record of that child for 25 years. If the clinic violates any rule then they will face 10 years of imprisonment and fine of 10 lakhs.

Surrogacy Bill 2016 will legalise surrogacy in India, which exists in a legal grey area right now. ÂÂ

Commercial surrogacy will be banned in the country.

ÂÂ

Only Indian couples with proven infertility will be allowed to take help of surrogate mothers.

ÂÂ

The Bill also makes it illegal for any foreign national to seek surrogate mothers in India.

ÂÂ

Parents will only be allowed to meet medical bills of surrogate mothers, and no other payments can be made.

ÂÂ

The new framework also envisions a national regulator to oversee clinics that offer surrogate services.

ÂÂ

The Bill also has guidelines for regulating clinics and hospitals that allow surrogacy.

ÂÂ

The Surrogacy Bill 2016 also outlines rights of surrogate mothers over their infants and simplifies issues of parentage.

ÂÂ

It is proposed that candidates for surrogates will be limited to 'close relatives' only and not others.

ÂÂ

The Bill also has provisions for providing legal aid to surrogate mothers. (NDTV) ■■■■

306

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

AMERICAN FAMILY PHYSICIAN

Treatment of Adult Obesity with Bariatric Surgery ROBIN SCHROEDER, T. DANIEL HARRISON, SHANIQUA L. McGRAW

ABSTRACT In 2013, approximately 179,000 bariatric surgery procedures were performed in the United States, including the lapa­roscopic sleeve gastrectomy (42.1%), Roux-en-Y gastric bypass (34.2%), and laparoscopic adjustable gastric banding (14.0%). Choice of procedure depends on the medical conditions of the patient, patient preference, and expertise of the surgeon. On average, weight loss of 60% to 70% of excess body weight is achieved in the short term, and up to 50% at 10 years. Remission of type 2 diabetes mellitus occurs in 60% to 80% of patients two years after surgery and per­sists in about 30% of patients 15 years after Roux-en-Y gastric bypass. Other obesity-related comorbidities are greatly reduced, and health-related quality of life improves. The Rouxen-Y procedure carries an increased risk of malabsorp­tion sequelae, which can be minimized with nutritional supplementation and surveillance. Overall, these procedures have a mortality risk of less than 0.5%. Cohort studies show that bariatric surgery reduces all-cause mortality by 30% to 50% at seven to 15 years postsurgery compared with patients with obesity who did not have surgery. Dietary changes, such as consuming protein first at every meal, and regular physical activity are critical for patient success after bariatric surgery. The family physician is well positioned to counsel patients about bariatric surgical options, the risks and benefits of surgery, and to provide long-term support and medical management postsurgery.

Keywords: Bariatric surgery, weight loss, type 2 diabetes mellitus, nutritional supplementation, dietary changes

O

besity is a disease that has seri­ous physical, psychological, and economic implications for patients, and poses major chal­lenges for the physicians caring for them.1 Approximately 35% of the U.S. adult popu­lation is obese.2 Obesity affects every organ system (Table 11,3-5); the related pathologic processes create a health burden for patients and an economic burden for the health care system. The U.S. Preventive Services Task Force recommends screening all adults for obesity. Patients with a body mass index (BMI) of 30 kg per m2 or higher should be offered or referred to intensive, multicom­ponent behavioral interventions.6 These interventions can result in clinically signifi­cant weight loss (5% or greater) in patients with obesity and can be initiated by the family physician.6 Surgical treatment of obe­sity results in greater weight loss, greater reduction in comorbidities, and prolonged survival compared with nonsurgical inter­ ventions.3,7-9 Recent emphasis has shifted from weight

ROBIN SCHROEDER, MD, is an associate professor in the department of Family Medicine at the Morsani School of Medicine, University of South Florida, and is the medical director of the Weight Management Center at Lehigh Valley Health Network, Allentown, Penn.

T. DANIEL HARRISON, DO, is a bariatric surgeon at Lehigh Valley Health Network.

SHANIQUA L. McGRAW, MD, is a resident in the Department of Family Medicine at Lehigh Valley Health Network.

Source: Adapted from Am Fam Physician. 2016;93(1):31-37.

loss outcomes to the metabolic effects of these surgical ily physicians are well positioned procedures.10 Fam­ to counsel patients about bariatric surgical options, as well as provide long-term support and medi­ cal management postsurgery.

INDICATIONS AND ELIGIBILITY Worldwide, more than 340,000 bariatric procedures were performed in 2011.11 According to the American Society for Met­abolic and Bariatric Surgery, about 179,000 were performed in the United States in 2013.12 Eligibility criteria were established by the 1991 National Institutes of Health Con­sensus Development Conference Panel and have changed little in the ensuing years.13 Selection and exclusion criteria are listed in Table 2.10 PREOPERATIVE CONSIDERATIONS Evaluation of the surgical candidate is often conducted by a multidisciplinary team with expertise in nutrition, psychology or psychiatry, surgery, and medicine.

Components of the preoperative evaluation are described in a 2013 clinical practice guideline from the American Association of Clinical Endocrinologists, The Obesity Society, and the American Society for Metabolic and Bariatric Surgery (Table 3).10 In practice, third-party payers and surgeon preference often determine the

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

307

AMERICAN FAMILY PHYSICIAN Table 1. Conditions with Higher Prevalence in Adults with Obesity Cardiovascular

Endocrine

Gastrointestinal

Genitourinary

Musculoskeletal

Other

Atrial fibrillation

Hypoandrogenism

Colorectal cancer

Breast cancer

Hypothyroidism

Esophageal cancer

Dyslipidemia

Infertility

Gallbladder cancer

Chronic kidney disease

Chronic low back pain

Dementia

Cardiomyopathy

Immobility

Hypertension

Metabolic syndrome

Endometrial cancer

Malignant melanoma

Long QT syndrome

Pancreatic cancer

Gastroesophageal reflux

Kidney stones

Obstructive sleep apnea

Polycystic ovary syndrome

Hiatal hernia

Ovarian cancer

Irritable bowel syndrome

Prostate cancer

Liver cancer

Urinary incontinence

Thromboembolism

Type 2 diabetes mellitus

Osteoarthritis

Leukemia

Renal cell cancer

Nonalcoholic fatty liver disease Information from references 1, and 3 through 5.

Table 2. Selection and Exclusion Criteria for Bariatric Surgery Selection criteria Able to adhere to postoperative care (e.g., follow-up visits and tests, medical management, use of dietary supplements) BMI ≥ 40 kg per m2 without coexisting medical conditions BMI ≥ 35 kg per m2 and one or more severe obesity-related comorbidities

Table 3. Preoperative Evaluation for Bariatric Surgery Recommended measures Age- and risk-appropriate cancer screening Complete history and physical examination (e.g., assess comorbidities, weight loss history, commitment to postsurgical lifestyle modifications, exclusions for surgery)

BMI 30 to 34.9 kg per m2 with diabetes mellitus or metabolic syndrome (evidence is limited)

Laboratory studies* (e.g., A1C level, complete blood count, complete metabolic profile, folic acid, iron studies, lipid profile, prothrombin time, urinalysis, vitamin B12, 25-hydroxyvitamin D), additional evaluation as indicated

Exclusion criteria

Nutrition evaluation

Cardiopulmonary disease that would make the risk prohibitive

Pregnancy counseling†

Current drug or alcohol abuse

Psychosocial and behavioral evaluations

Lack of comprehension of risks, benefits, expected outcomes, alternatives, and required lifestyle changes

Tobacco cessation counseling for optimal wound healing

Reversible endocrine or other disorders that can cause obesity

Cardiopulmonary evaluation (e.g., polysomnography, electrocardiography, additional evaluation if cardiac disease or pulmonary hypertension suspected)

Uncontrolled severe psychiatric illness BMI = Body mass index.

Information from reference 10.

scope of presurgical evaluation and preparation.

The patient evaluation should include a complete history and physical examination with attention to obesity related comorbidities and weight loss– attempt history; three to six months of medical weight management; psychosocial, behavioral, and nutrition evaluations; and appropriate laboratory studies. The purpose of this eval­uation is to identify and optimally manage conditions that may negatively affect the perioperative period and increase morbidity. Because patients with obesity may avoid preventive medical visits, age- and risk-appropriate cancer screening should be performed at this time.10 In high-risk patients with an enlarged or fatty liver,

308

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Additional evaluations to consider

Gastrointestinal evaluation (Helicobacter pylori screening in high-prevalence areas; gallbladder evaluation, upper endoscopy if clinically indicated) *Results useful in identification and optimization of the most common obesity-related and postoperative conditions. †Pregnancy

is not recommended preoperatively and for 12 to 18 months postoperatively because of the degree of weight loss in the first year.

Information from reference 10.

preoperative weight loss can reduce liver vol­ume and, therefore, may improve the technical aspects of the surgery.

CHOICE OF PROCEDURE Most bariatric surgeries are performed laparoscopically; this is preferred to open procedures because of decreased

AMERICAN FAMILY PHYSICIAN mortality, fewer complications, shorter hospital stays, and more rapid recovery.14 Currently, three procedures are commonly performed: laparoscopic adjustable gastric banding, laparoscopic sleeve gastrectomy, and Roux-en-Y gastric bypass.

Laparoscopic Adjustable Gastric Banding In laparoscopic adjustable gastric banding, a hollow, flex­ible silicone band is placed around the upper stomach, which causes a restrictive effect, reduces stomach capac­ity, and produces rapid feelings of satiety. The band is tightened by injecting saline into it through a subcutane­ous port, which is located just inferior to the sternum or lateral to the umbilicus (Figure 115). Because of a higher complication rate and less weight loss compared with the other two most common procedures, the demand for gastric banding is decreasing in the United States.16

Laparoscopic Sleeve Gastrectomy The laparoscopic sleeve gastrectomy resects most of the body and all of the fundus of the stomach, creating a long, narrow, tubular stomach (Figure 215). This procedure was first used as an initial step before a malabsorptive proce­dure in very high-risk patients, but is now used as a primary stand-alone procedure and is increasing in popularity.17

Roux-en-Y Gastric Bypass In Roux-en-Y gastric bypass, a small gastric pouch is formed by dividing the upper stomach and joining it with the resected end of the jejunum, so that food bypasses the stomach and upper small bowel, thereby restricting the size of the stomach and causing some malabsorption (Figure 315). Roux-en-Y gastric bypass may be a better choice in patients who are more obese and in those with type 2 diabetes mellitus.18,19 The choice of procedure depends on patient prefer­ence, the expertise of the surgeon and surgical center, and risk stratification.10 In 2013, laparoscopic sleeve gastrectomy was reported to be the most common procedure (42.1%), followed

by Roux-en-Y gastric bypass (34.2%) and laparoscopic adjustable gastric banding (14.0%). Six percent of surgeries were for revision of a previous procedure.12 PATHOPHYSIOLOGY These surgical procedures were previously conceptualized as restrictive (create a much smaller stomach), mal­absorptive (bypass normal anatomy), or

a combination. Research now indicates that the mechanisms of action include multiple physiologic variables that affect endo­crine and neuronal signaling.20 Improvements in blood glucose levels, dyslipidemia, and other obesity-related comorbidities occur earlier than can be fully explained by the actual weight loss.

In addition to decreased caloric intake, multiple mechanisms contribute to the dramatic improvement of type 2 diabetes after procedures that alter gastrointestinal anatomy. Levels of glucagon-like peptide-1 and peptide YY, which are secreted by intestinal L cells, increase after Roux-en-Y gastric bypass and laparoscopic sleeve gas­trectomy procedures. Glucagon-like peptide-1 enhances insulin secretion, whereas peptide YY increases sati­ety and delays gastric emptying through receptors in the central and peripheral nervous systems.

Ghrelin, secreted primarily by the gastric fundus and proximal small intestine, acts via the hypothalamus to stimulate appetite and suppress energy expenditure and fat catabo­lism. Procedures that bypass the gastric fundus seem to reduce the secretion of ghrelin and reduce appetite. Neu­rotransmitters and hormones of the gut, brain, central and peripheral nervous systems, and adipocytes interact in a complex neuroendocrine system to regulate energy homeostasis.20 POSTOPERATIVE MANAGEMENT The bariatric surgeon generally provides early postoperative management, including surveillance for com­plications. The progression of diet from clear liquids to regular food over the first four weeks is facilitated by consultation with a dietician.10 After bariatric surgery, patients are encouraged to eat and journal three structured meals and one or two highprotein snacks per day. Each meal should begin with protein to ensure adequate intake of 80 to 90 g per day to minimize the loss of lean body mass. Food intolerances are patient specific, but very dry foods, bread, and fibrous vegetables are often problematic. Patients should be advised to eat slowly and chew thoroughly.

Fluids should be avoided for 15 to 30 minutes before, during, and after meals because ingested food will pass easily through the pouch opening if it is mixed with fluid, and sensation of fullness will not be achieved.

Carbonated beverages should be avoided because of the added gas. Cold intolerance, hair loss, and fatigue are common but tend to diminish rapidly as weight loss stabilizes.

All patients who have had weight loss surgery should avoid nonsteroidal anti-inflammatory drugs and

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

309

AMERICAN FAMILY PHYSICIAN smoking because they increase the risk of anastomotic ulcer­ations. Women should avoid becoming pregnant for 12 to 18 months after surgery. This period of rapid weight loss may increase the risk of nutritional deficiencies and small-for-gestational-age status in infants (Table 4).10 Continued lifestyle modification is necessary, including regular physical activity and individualized behavioral interventions to address food impulse control. Ongoing participation in postsurgical support groups is highly recommended.

Quarterly assessment of nutritional status and supplementation needs, food intolerances, and procedure-related symptoms should occur for the first year after bariatric surgery. A variety of micronutrient Table 4. Follow-up After Bariatric Surgery Adjust postoperative medications, as needed Avoid nonsteroidal anti-inflammatory drugs Avoid pregnancy for 12 to 18 months Bone density measurement with dual energy x-ray absorptiometry at 2 years Laboratory studies (e.g., complete blood count, complete metabolic profile, folic acid, iron studies, intact parathyroid hormone level, lipid profile, vitamin B12, 24-hour urinary calcium excretion, 25-hydroxyvitamin D) Monitor adherence to dietary, behavioral, and physical activity recommendations Information from reference 10.

deficien­cies have been identified after malabsorption procedures and even after some restrictive procedures because of decreased capacity for food intake. Vitamin supplemen­tation will likely be required throughout the patient’s lifetime, and annual metabolic and nutritional monitor­ing is recommended (Table 5).10 EFFECTIVENESS Summarizing and quantifying the compara­tive outcomes of bariatric surgery have been challenging because of the evolution of sur­gical procedures, the availability of laparo­scopic vs. open techniques, categorization of short- vs. long-term sequelae, and the differ­ence in presurgical risk among patients.3,16,21-23 The National Institutes of Health–initiated Longitudinal Assessment of Bariatric Sur­ gery Consortium is conducting prospective, multicenter, cohort studies using standard­ized techniques to assess the safety and clini­cal response of bariatric surgery.22 In general, Roux-en-Y gastric bypass seems to lead to the greatest weight loss dur­ing the first two postsurgical years, followed by laparoscopic sleeve gastrectomy and laparoscopic adjustable gastric banding. It is unclear if there is a significant long-term difference in weight loss between Roux-en-Y gastric bypass and laparoscopic sleeve gas­trectomy (Table 67-10,16,18,19,21-27).

Increasing evidence that laparoscopic adjustable gastric banding results in more long-term complications, more reoperations, and less weight loss has made

Table 5. Supplementation After Bariatric Surgery Supplement

Laparoscopic adjustable gastric banding

Laparoscopic sleeve gastrectomy

Roux-en-Y gastric bypass

Comments

Calcium citrate

1,200 to 1,500 mg per day

1,200 to 1,500 mg per day

1,500 to 2,000 mg per day

Split doses; monitor for osteoporosis

Elemental iron

45 to 60 mg per day, including multivitamin

45 to 60 mg per day, including multivitamin

45 to 60 mg per day, including multivitamin

Take iron and calcium supplements at least 2 hours apart

1 per day Multivitamin with minerals (including iron, folic acid, copper, and thiamine)

2 per day

2 per day

Liquid or chewable for 3 to 6 months

Vitamin B12

1,000 mcg per day

1,000 mcg per day

1,000 mcg per day

Sublingual, subcutaneous intramuscular, or oral, if adequately absorbed

Vitamin D3

At least 3,000 IU per day

At least 3,000 IU per day

At least 3,000 IU per day

Titrate to 25-hydroxyvitamin D level greater than 30 ng per mL (75 nmol per L)

Information from reference 10.

310

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

AMERICAN FAMILY PHYSICIAN Table 6. Comparison of Outcomes for Bariatric Surgical Procedures Outcome

Overall

Laparoscopic adjustable gastric banding

Laparoscopic sleeve gastrectomy

Roux-en-Y gastric bypass

Median excess body weight lost (%)* 1 to 2 years

60 to 70

29 to 56

33 to 85

48 to 85

3 to 6 years

50 to 60

39 to 72

46 to 66

53 to 77

7 to 10 years

50

14 to 60

—

25 to 68

Remission of diabetes mellitus (%) < 1 year

80

27 to 29

56 to 68

56 to 84

1 to 3 years

72

28

80

46 to 81

15 years

30

—

—

—

≤ 30 days

0.08

0.02 to 0.07

0.296

0.20 to 0.50

> 30 days

0.31

0.21 to 0.50

0.11 to 0.34

0.14 to 0.21

Mortality (%)

7 to 15 years

30% to 50% lower than those not having surgery

*Excess body weight is the total preoperative weight minus ideal weight.

Information from references 7 through 10, 16, 18, 19, and 21 through 27.

this procedure less common.28 Dyslipidemia, type 2 diabetes, hypertension, and perception of quality of life improved after weight loss surgery.3,21 Remission of type 2 diabetes occurs in 60% to 80% of Roux-en-Y gastric bypass patients at one to two years postsurgery.18,23-25 Recent longer-term studies indicate that this remission is retained in approximately 40% of patients at 10 years and 30% at 15 years.9,19 Several recent reviews support bariatric surgery for the treatment of dia­betes in patients with a BMI less than 35 kg per m2.26 The Swedish Obese Subjects prospective cohort study found that surgery was associated with a 29% lower mortality risk from any cause after 16 years.8 In a retrospective cohort study of almost 8,000 patients undergo­ing bariatric surgery, mortality from disease, including cardiovascular disease and cancer, decreased by 40% compared with the control group.7 In a more recent ret­rospective cohort study of 2,500 surgical patients and 7,462 matched controls receiving care in the Veterans Administration system, the surgical patients had a sig­nificant reduction in 10-year all-cause mortality.27 Weight regain is a concern in a subset of patients following weight loss surgery; the etiology appears to be multifactorial. A systematic review from 2013 identified nutritional indiscretion, mental health issues, endocrine and metabolic alterations, physical inactivity, and anatomic surgical failure as principal causes.29

Endoscopic or surgical revision is an option in some patients who experience weight regain. Further study is necessary to determine predictors of suboptimal weight loss and weight regain, as well as the effectiveness of treatment with surgical revision or other modalities.28-30 COST It is estimated that obesity accounts for 16.5% of all medical spending, an estimated $168 billion per year direct cost to the health care system.31 Whether bariatric surgery procedures are ultimately cost-effective or cost saving requires additional long-term study. Measures of improved health and well-being, with direct costs of bar­iatric surgery and subsequent health care costs, must be compared with those for patients with obesity who do not have surgery to allow for better informed decisions in the future.31-33 Note: For complete article visit: www.aafp.org/afp.

REFERENCES 1. Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014;(8):CD003641.

2. Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814.

3. Gloy VL, Briel M, Bhatt DL, et al. Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of ran­domised controlled trials. BMJ. 2013;347:f5934.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

311

AMERICAN FAMILY PHYSICIAN 4. Dynamed [Internet]. Ipswich (MA): EBSCO Publishing.

2015, Bariat­ric Surgery. http://www.dynamed.com/home (registration and login required). Accessed November 2, 2015.

5. Essential Evidence Plus. Obesity and weight loss (bariatric surgery). 2015. http://www.essentialevidenceplus.com (subscription required). Accessed October 27, 2015.

6. U.S. Preventive Services Task Force. Screening for and management of obesity in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157(5):373-378.

7. Adams TD, Gress RE, Smith SC, et al. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007; 357(8):753-761.

8. Sjöström L, Narbro K, Sjöström CD, et al.; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese sub­jects. N Engl J Med. 2007;357(8):741-752.

9. Sjöström L, Peltonen M, Jacobson P, et al. Association of bariatric sur­gery with long-term remission of type 2 diabetes and with microvascu­ lar and macrovascular complications. JAMA. 2014;311(22):2297-2304.

10. Mechanick JI, Youdim A, Jones DB, et al.; American Association of Clini­cal Endocrinologists; Obesity Society; American Society for Metabolic & Bariatric Surgery. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient—2013 update: cosponsored

by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Meta­ bolic & Bariatric Surgery. Obesity (Silver Spring). 2013; 21(suppl 1):S1-S27.

11. Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013;23(4):427-436.

12. American Society for Metabolic and Bariatric Surgery (ASMBS). New procedure estimates for bariatric surgery: what the numbers reveal. Connect. May 2014. http:// connect.asmbs.org/may-2014-bariatric-surgery-growth. html. Accessed July 18, 2015.

13. National Institutes of Health. NIH Consensus Statement.

Gastrointestinal surgery for severe obesity. http:// consensus.nih.gov/1991/1991gisurgeryobesity084html. htm. Accessed February 12, 2015.

14. Banka G, Woodard G, Hernandez-Boussard T, Morton JM. Laparoscopic vs open gastric bypass surgery: differences in patient demographics, safety, and outcomes. Arch Surg.

2012;147(6):550-556.

15. Schroeder R, Garrison JM Jr, Johnson MS. Treatment of adult obesity with bariatric surgery. Am Fam Physician.

2011;84(7):805-814.

16. Chang SH, Stoll CR, Song J, Varela JE, Eagon CJ, Colditz GA. The effec­tiveness and risks of bariatric surgery: an updated systematic review and meta-analysis, 2003-2012.

JAMA Surg. 2014;149(3):275-287.

17. Nguyen NT, Nguyen B, Gebhart A, Hohmann S. Changes in the makeup of bariatric surgery: a national increase in use of laparoscopic sleeve gastrectomy. J Am Coll Surg.

2013;216(2):252-257.

312

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

18. Schauer PR, Bhatt DL, Kirwan JP, et al.; STAMPEDE Investigators. Bar­iatric surgery versus intensive medical therapy for diabetes—3-year out­comes. N Engl J Med. 2014;370(21):2002-2013.

19. Davies SW, Efird JT, Guidry CA, et al. Long-term diabetic response to gastric bypass. J Surg Res. 2014;190(2):498-503.

20. Cho YM. A gut feeling to cure diabetes: potential mechanisms of diabe­tes remission after bariatric surgery [published correction appears in Dia­betes Metab J. 2015;39(2):175]. Diabetes Metab J. 2014;38(6):406-415.

21. Puzziferri N, Roshek TB III, Mayo HG, Gallagher R, Belle SH, Livingston EH. Long-term follow-up after bariatric surgery: a systematic review. JAMA. 2014;312(9):934-942.

22. Courcoulas AP, Christian NJ, Belle SH, et al.; Longitudinal Assessment of Bariatric Surgery (LABS) Consortium.

Weight change and health out­comes at 3 years after bariatric surgery among individuals with severe obesity.

JAMA. 2013;310(22):2416-2425.

23. Yip S, Plank LD, Murphy R. Gastric bypass and sleeve gastrectomy for type 2 diabetes: a systematic review and meta-analysis of outcomes. Obes Surg. 2013;23(12): 1994-2003.

24. Mingrone G, Panunzi S, De Gaetano A, et al. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012;366(17):1577-1585.

25. Courcoulas AP, Goodpaster BH, Eagleton JK, et al.

Surgical vs medi­cal treatments for type 2 diabetes mellitus: a randomized clinical trial. JAMA Surg. 2014; 149(7):707-715.

26. Müller-Stich BP, Senft JD, Warschkow R, et al. Surgical versus medical treatment of type 2 diabetes mellitus in nonseverely obese patients: a systematic review and meta-analysis. Ann Surg. 2015;261(3):421-429.

27. Arterburn DE, Olsen MK, Smith VA, et al. Association between bariatric surgery and long-term survival. JAMA. 2015;313(1):62-70.

28. Coblijn UK, Verveld CJ, van Wagensveld BA, Lagarde SM. Laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy as revi­sional procedure after adjustable gastric band—a systematic review. Obes Surg.

2013;23(11):1899-1914.

29. Karmali S, Brar B, Shi X, Sharma AM, de Gara C, Birch DW. Weight recidivism post-bariatric surgery: a systematic review. Obes Surg. 2013;23(11):1922-1933.

30. Cooper TC, Simmons EB, Webb K, Burns JL, Kushner RF. Trends in weight regain following Roux-en-Y gastric bypass (RYGB) bariatric sur­gery. Obes Surg. 2015;25(8): 1474-1481.

31. Weiner JP, Goodwin SM, Chang HY, et al. Impact of bariatric surgery on health care costs of obese persons: a 6-year follow-up of surgical and comparison cohorts using health plan data. JAMA Surg. 2013;148(6):555-562.

32. Maciejewski ML, Arterburn DE. Cost-effectiveness of bariatric surgery. JAMA. 2013;310(7):742-743.

33. Wang BC, Furnback W. Modelling the long-term outcomes of bariatric surgery: a review of cost-effectiveness studies.

Best Pract Res Clin Gas­troenterol. 2013;27(6):987-995.

AMERICAN FAMILY PHYSICIAN

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

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

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

Infants were considered high risk if they did not have a history of egg tolerance, but did have a wheal diameter of at least 6 mm on a skin prick test when exposed to raw hen’s egg white; had a wheal diameter of at least 3 mm when exposed to pasteurized hen’s egg white, as well as associated allergy symptoms; had severe eczema requiring topical corticoste­roids or

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

314

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

calcineurin inhibitors that lasted at least 12 of 30 days twice in infants younger than six months or 12 of 30 days twice in the past six months in children older than six months; or scored at least a 40 on the modi­fied SCORAD (scoring atopic dermatitis) evaluation.

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

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

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

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

AMERICAN FAMILY PHYSICIAN

Photo Quiz SKIN ULCERS OF UNKNOWN ETIOLOGY A 41-year-old woman presented to the emergency department with leg ulcers and ecchymoses on her ears that began to develop one month prior. The leg ulcers began as painful, fluid-filled blisters and evolved into ulcers with a black crust. The lesions had appeared and resolved several times over the previous three years, but she did not seek medical attention. She took prednisone intermittently for psoriasis and had a long history of cocaine abuse.

Figure 1.

Physical examination showed multiple ulcerated lesions on the anterior aspect of both lower extremities (Figure 1) and multiple tender purpuric lesions on both ears (Figure 2). The examination showed psoriatic plaques on her legs, elbows, and fingers. Her vital signs were normal. A complete blood count, comprehensive met­abolic panel, and coagulation laboratory test results were normal. Urine toxicology testing was positive for cocaine. She had an elevated C-reactive protein level (96.3 mg per L [917.16 nmol per L]) and erythrocyte sedimentation rate (48 mm per hour).

Question Based on the patient’s history and physical examination findings, which one of the fol­lowing is the most likely diagnosis?

A. Levamisole-induced vasculitis.

B. Necrobiosis lipoidica diabeticorum.

Figure 2.

C. Pyoderma gangrenosum.

D. Septic emboli.

E. Wegener granulomatosis.

SEE THE FOLLOWING PAGE FOR DISCUSSION.

Source: Adapted from Am Fam Physician. 2016;93(1):57-58.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

315

AMERICAN FAMILY PHYSICIAN Discussion

Summary Table

The answer is A: levamisole-induced vasculitis. A skin biopsy showed a leukocytoclastic vasculitis consistent with levamisole-induced vasculitis. Levamisole is an antihelminth drug that was used as an antineoplastic agent, but adverse effects such as agranulocytosis and an ulcer-causing vasculopathy have now limited its use to veterinary medicine. It is commonly used to lace cocaine because of its psychoactive effects. It is estimated that 70% of cocaine in the United States contains levamisole.1,2

Condition

Cause

Characteristics

Levamisoleinduced vasculitis

Levamisole exposure

Purpura on the ears, nose, cheeks; skin ulcers with a hemorrhagic base

Necrobiosis lipoidica diabeticorum

Unknown but associated with diabetes mellitus

Single or multiple asymptomatic red to yellow, shiny plaques; gradual enlargement and possible ulceration

Pyoderma gangrenosum

Neutrophil dysfunction

Painful pustules and rapidly progressive ulcers with violaceous undermined borders, surrounding erythema, and a purulent base

Septic emboli

Heart valve infection

Sudden development of painful, purpuric skin ulcers; other systemic signs of bacteremia

Wegener granulomatosis

Autoimmune vasculitis

Necrotic ulcers, palpable purpura, digital infarcts; skin, lung, and kidney involvement

The lesions associated with levamisole exposure are most commonly purpura on the ears, nose, and cheeks.

Skin ulcers with a hemorrhagic base may also occur.

These lesions usually resolve spontaneously within a few weeks of discontinuing the drug, but can recur with subsequent exposure.2-4 Necrobiosis lipoidica diabeticorum occurs in patients with diabetes mellitus or a strong family history of the disease. It is characterized by single or multiple asymptomatic red to yellow, shiny plaques that gradually enlarge and contain dermal blood vessels.

Ulceration of the plaques is common and can occur with or without trauma. The pathogenesis is unknown, but biopsy can confirm the diagnosis.5 Pyoderma gangrenosum is an idiopathic condition associated with inflammatory bowel disease, arthritis, joint inflammation, and malignancy. It is charac­terized by painful pustules and rapidly progressive ulcers with violaceous undermined borders, surround­ing erythema, and a purulent base. The pathogenesis is believed to be related to neutrophil dysfunction. It is a diagnosis of exclusion.5 Bacteria and pus from vegetations on an infected heart valve may cause septic emboli. They travel via the blood­stream and can cause the sudden development of painful, purpuric skin ulcers. They are associated with other sys­temic signs of bacteremia, including fever, malaise, myal­gias, arthralgia, and elevated white blood cell count.6,7 Wegener granulomatosis is a small to medium vessel autoimmune vasculitis that is characterized by skin, lung, and kidney involvement. Skin findings include necrotic ulcers, palpable purpura, and digital infarcts.

Patients with this condition have lung nodules, upper respiratory tract disease, and segmental necrotizing glomerulonephritis.5,7

REFERENCES 1. Metwally O, Hamidi M, Townsend L, Abualula H, Zaitoun A, Lall T. The cocaine trail: levamisole-induced leukocytoclastic vasculitis in a cocaine user. Subst Abus.

2013;34(1):75-77.

2. Pillow MT, Hughes A. Levamisole-adulturated cocaine induced vasculitis with skin ulcerations. West J Emerg Med. 2013;14(2):149-150.

3. Abdul-Karmin R, Ryan C, Rangel C, Emmett M. Levamisole-induced vasculitis. Proc (Bayl Univ Med Cent). 2013;26(2):163-165.

4. Lee G, Negash D, Arseneau R. Chronic levamisoleinduced vasculitis: a case report. BCMJ. 2012;54(6): 302-304.

5. Panuncialman J, Falanga V. Unusual causes of cutaneous ulceration. Surg Clin North Am. 2010;90(6): 1161-1180.

6. Zembowicz A, Navarro P, Walters S, Lyle SR, Moschella SL, Miller D. Subcutaneous thrombotic vasculopathy syndrome: an ominous condi­ tion reminiscent of calciphylaxis: calciphylaxis sine calcifications? Am J Dermatopathol. 2011;33(8):796-802.

7. Suresh E. Diagnostic approach to patients with suspected vasculitis. Postgrad Med J. 2006;82(970):483-488.

■■■■

316

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

ANESTHESIOLOGY

Adjuvant Use of Intravenous Lidocaine for Procedural Pain Relief in Burn Patients: A Prospective Study DIPTI SAXENA*, SUSHIL CHAND VERMA†, SADHANA SANWANTSARKAR‡, NEETU GUPTA#, DEEPAK SONI$

ABSTRACT Background: In spite of increasing emphasis on pain assessment and management as an integral part of total burn care, burn wound care-related pain continues to be documented as an ongoing issue and unsolved problem. Current pain management regimes in burn care are mostly based on opioid analgesics, which are frequently prescribed in large doses over long periods.

However, prolonged opioid use presents several problems as opioids can lead to respiratory depression, produce sedation and delay hospital discharge. Some evidence suggests that systemic lidocaine improves analgesic efficacy and minimizes escalating opioid dose use in patients with severe burn. Aims and objectives: To compare the efficacy of intravenous lidocaine with placebo in reducing pain scores during burn wound care procedures: To assess whether adjuvant use of lidocaine is associated with reduced opioid requirements; to compare pain scores between both groups and to determine the hemodynamic changes and adverse effects. Material and methods: Fifty patients with severe burn who underwent wound care procedures on 2 consecutive days, were randomized to either the intervention or control condition on the first dressing day and received the alternate condition on the second dressing day. A random sequence generator was used to allocate the patients into lidocaine group (L) and placebo group (P). All the patients received fixed dose of anesthetic drugs: Group L received an intravenous bolus of lignocaine 2% 1 mg/kg, followed by two more repeat boluses of 0.5 mg/kg at 5-minute intervals. Group P received 0.9% saline following a similar schedule. The primary outcome, we measured was pain. Pain was assessed using Grimace scale and verbal selfrating scale, during pre-, intra- and post-procedure period. Secondary outcomes included total opioid consumption during the procedure, anxiety and hemodynamics. We also monitored any adverse effects during or after the procedure. Result and conclusion: Lignocaine is a good adjuvant to opioids for post burn procedure under anesthesia.

Keywords: Pain management, opioids, lidocaine, Grimace scale, verbal self-rating scale

B

urn wound care-related pain continues to be documented as an ongoing issue and unsolved problem.1 Current pain management regimes in burn care are mostly based on opioid analgesics.

Prolonged opioid use (morphine), can lead to respiratory depression, sedation, mental clouding, nausea or vomiting. Rapid tolerance, leads to poor pain control and delays hospital discharge.2 Some evidence suggests that systemic lidocaine improves analgesic efficacy and minimizes opioid use in burn

*Associate Professor †Post Graduate ‡Professor and Head of Dept. #Assistant Professor $Senior Resident Sri Aurobindo Medical College and PG Institute, Indore, Madhya Pradesh Address for correspondence Dr Sushil Chand Verma Post Graduate Sri Aurobindo Medical College and PG Institute, Indore, Madhya Pradesh E-mail: drsushil1182@gmail.com

318

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

patients.3 Several mechanisms have been proposed for this action, namely that systemic lidocaine depresses conduction in afferent nerves, inhibits dorsal horn neural transmission and modifies cerebral perception of pain.4 Lidocaine’s anti-inflammatory properties may also contribute to pain suppression.5 MATERIAL AND METHODS ÂÂ

After approval from Institutional Ethical Committee, an informed and written consent was taken from patients and their relatives.

ÂÂ

Study type: A prospective randomized crossover study.

ÂÂ

To compare intravenous lidocaine versus placebo in 50 patients in each group with burns who underwent wound care procedures (i.e., dressing change ± debridement) on 2 consecutive days.

ÂÂ

A random sequence generator was used to allocate the patients into lidocaine group (L) and placebo group (P).

ANESTHESIOLOGY ÂÂ

All the patients were induced with fixed dose of anesthetic drugs: intravenous glycopyrrolate, midazolam, fentanyl, ketamine and propofol.

ÂÂ

The lidocaine group received an intravenous bolus of 1 mg/kg, followed by two more repeat boluses of 0.5 mg/kg at 5-minute intervals. The placebo group received similar dose of 0.9% saline in a similar schedule.

ÂÂ

The primary outcome was to measure pain by using Grimace scale and verbal self-rating scale (VRS), during pre-procedure, intra-procedure and post-procedure period.

ÂÂ

Secondary outcomes that were monitored were total opioid consumption during the procedure, anxiety (VRS) and hemodynamics. We also noted any adverse effects during or after the procedure.

OBSERVATIONS AND RESULTS A total of 100 patients serving as control and study group (50 in each group) were recruited for the study. Age, weight, gender, the American Society of Anesthesiologists (ASA) grades, % of burn were comparable in between (L) and (P) groups.

Assessment of Pain The 'p' value obtained for intra- and post-Grimace scores was statistically significant (p < 0.05), which shows that there was a statistically significant difference in the mean Grimace score of intra- and postoperative periods. The mean grimace score in lidocaine group was much lesser as compared to placebo group (Table 1).

The 'p' value obtained for intra-VRS and post-VRS was statistically significant (p < 0.05), which shows that there is a statistically significant difference in mean intra-VRS score and post-VRS score between the two groups. Pain perceived by the patients in the lidocaine group was much lesser in comparison to the placebo group (Table 2).

In the lidocaine group, the opioid requirement was (36%) less as compared to the placebo group (48%) (Table 3). The 'P' value obtained for pre-VRS score was not statistically significant (p > 0.05), thus mean preVRS score was similar in both the groups.

The 'P' value obtained for post-VRS score was found to be statistically significant (p < 0.05), the mean post-VRS score in lidocaine group was much lesser as compared to mean post-VRS score in placebo group (Table 4).

Table 1. The Grimace Scores of Both the Groups were Compared Using Student's Unpaired ‘t’ Test VRS (Pain)

Lidocaine group (n = 50)

Placebo group (n = 50)

(Mean ± SD)

(Mean ± SD)

‘t’ value

P value

Preoperative

1.86 ± 0.35

1.82 ± 0.44

0.505

p = 0.615

Intraoperative

3.74 ± 0.72

Postoperative

1.54 ± 0.76

5.52 ± 1.04

-9.970

p = 0.0001

3.44 ± 0.81

-12.067

p = 0.0003

Table 2. Assessment of Pain by VRS VRS (Pain)

Lidocaine group (n = 50)

Placebo group (n = 50)

(Mean ± SD)

(Mean ± SD)

‘t’ value

P value

Preoperative

1.86 ± 0.35

1.82 ± 0.44

0.505

p = 0.615

Intraoperative

3.74 ± 0.72

Postoperative

1.54 ± 0.76

5.52 ± 1.04

-9.970

p = 0.0001

3.44 ± 0.81

-12.067

p = 0.0004

Table 3. Opioid Requirement in Both the Lidocaine and Placebo Groups Opioid requirement

Lidocaine group (n = 50)

Placebo group (n = 50)

No.

%

No.

%

Required

18

36.0

24

48.0

Not required

32

64.0

26

52.0

Total

50

100.0

50

100.0

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

319

ANESTHESIOLOGY Table 4. Anxiety Score in both the (L) and (P) Groups by VRS VRS (Anxiety)

Lidocaine group (n = 50)

Placebo group (n = 50)

(Mean ± SD)

(Mean ± SD)

‘t’ value

P value

Preoperative

1.86 ± 0.35

1.80 ± 0.49

0.70

p = 0.486

Postoperative

1.56 ± 0.79

3.44 ± 0.81

-11.758

p = 0.0003

Table 5. Distribution of Patients according to Rescue Time Rescue time (min) 0-30

Lidocaine group (n = 50)

Placebo group (n = 50)

No.

%

No.

%

0

0.0

7

14.0

31-60

4

8.0

28

56.0

61-90

17

34.0

8

16.0

91-120

12

24.0

7

14.0

>120

17

34.0

0

0.0

Total

50

100.0

50

100.0

Table 6. Distribution of Patients according to Side Effects Side effects

Lidocaine group (n = 50)

Placebo group (n = 50)

No.

%

No.

%

Twitching

15

30.0

2

04.0

Nausea

16

32.0

7

14.0

Vomiting

16

32.0

7

14.0

In the lidocaine group, the rescue time was later as compared to very early rescue time requirement in the placebo group (Table 5). Table 6 shows the distribution of patients according to side effects in lidocaine and placebo groups. Postoperative twitching was seen in 15 (30%) patients in the lidocaine group, while in the placebo group 2 (4%) patients had twitching. Postoperative nausea was seen in 16 (32%) patients in lidocaine group, while 7 (14%) placebo group patients had postoperative nausea. Postoperative vomiting was seen in 16 (32%) patients in the lidocaine group and 7 (14%) patients in the placebo group. Postoperative twitching, nausea and vomiting were more in lidocaine group in comparison to placebo group.

DISCUSSION This study was primarily aimed to evaluate and compare the safety and effectiveness of intravenous lidocaine as an adjuvant therapy for procedural pain relief in burn

320

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

patients, and secondarily to assess whether adjuvant use of lidocaine was associated with reducing opioid requirements and also to compare pain scores between patients receiving lidocaine and placebo. Intravenous lidocaine has been a well-documented treatment for other clinical conditions such as cardiac arrhythmias and neuropathic pain.

On reviewing literature, we found a single study which compared the efficacy of intravenous lidocaine with placebo in reducing pain scores and that use of lidocaine was associated with reduced opioid requirements during burn wound care procedures.

However, there are several studies that have compared the efficacy and analgesic potency of lidocaine other than in burn patients. Wasiak et al6 reported that VRS scores were significantly lower for lidocaine (0.34) compared with placebo (0.70) when measured before, during and after the procedure (difference [95% CI] = 0.36 [0.17-0.55], p value < 0.001), which is comparable with our study.

However in their study, there was no significant reduction in anxiety scale, opioid requirement, which was not comparable with our study. In our study, we observed that hemodynamic stability was more in lidocaine group as compared to placebo, which was not documented in their study.

We also noted postoperative side effect of lidocaine in form of twitching in 15/50 (30%) patients, nausea was seen in 16/50 (32%) patients and vomiting was seen in 16/50 (32%) patients.

CONCLUSION From our study of 100 patients we conclude that lidocaine as an analgesic is effective. Lidocaine does reduce opioid consumption intraoperatively and increases duration of rescue analgesia. We also conclude that the pain score and anxiety score were significantly low as compared to placebo group. However, we noted side effects as nausea, vomiting and muscle twitch in some patients. As the study group is small, further evaluation on more patients is recommended.

ANESTHESIOLOGY REFERENCES 1. Carrougher GJ, Ptacek JT, Sharar SR, Wiechman S, Honari S, Patterson DR, et al. Comparison of patient satisfaction and self-reports of pain in adult burn-injured patients.

J Burn Care Rehabil. 2003;24(1):1-8.

2. Cepeda MS, Delgado M, Ponce M, Cruz CA, Carr DB. Equivalent outcomes during postoperative patientcontrolled intravenous analgesia with lidocaine plus morphine versus morphine alone. Anesth Analg.

1996;83(1):102-6 3. Martin F, Cherif K, Gentili ME, Enel D, Abe E, Alvarez JC, et al. Lack of impact of intravenous lidocaine on analgesia, functional recovery, and nociceptive pain threshold after total hip arthroplasty. Anesthesiology. 2008;109(1): 118-23.

acid-induced priming in human neutrophils. Anesth Analg. 2001;92(4):1041-7.

5. Koppert W, Ostermeier N, Sittl R, Weidner C, Schmelz M. Low-dose lidocaine reduces secondary hyperalgesia by a central mode of action. Pain. 2000;85(1-2):217-24.

6. Wasiak J, Spinks A, Costello V, Ferraro F, Paul E, Konstantatos A, et al. Adjuvant use of intravenous lidocaine for procedural burn pain relief: a randomized double-blind, placebo-controlled, cross-over trial. Burns.

2011;37(6):951-7.

7. Wasiak J, Mahar P, McGuinness SK, Spinks A, Danilla S, Cleland H. Intravenous lidocaine for the treatment of background or procedural burn pain. Cochrane Database Syst Rev. 2012;(6):CD005622.

8. Yon JH, Choi GJ, Kang H, Park JM, Yang HS. Intraoperative systemic lidocaine for pre-emptive analgesics in subtotal 4. Fischer LG, Bremer M, Coleman EJ, Conrad B, Krumm B, gastrectomy: a prospective, randomized, double-blind, placebo-controlled study. Can J Surg. 2014;57(3):175-82.

Gross A, et al. Local anesthetics attenuate lysophosphatidic ■■■■

Pre-emptive Analgesia with Three Agents in Cancer Patients Following Laparotomy Pre-emptive use of pregabalin-acetaminophen-naproxen (PAN) seems to decrease the intensity of pain and morphine consumption in cancer patients after laparotomy without significant complications, suggested a new study published recently in the journal Anesthesiology and Pain Medicine. Patients in the PAN group had significantly lower universal pain assessment tool (UPAT) scores at 0, 2, 4, 6, 12, 24 and 48 hours after the surgery than the control group and the mean dose of postoperative morphine consumption in the PAN group was 37% less than the control group.

Burst Stimulation from St. Jude Medical Provides Superior Pain Relief Results from the SUNBURST study have demonstrated that Burst stimulation from St. Jude Medical is superior to traditional tonic spinal cord stimulation (SCS) in relieving chronic pain. The findings were presented at the 19th annual meeting of the North American Neuromodulation Society (NANS).

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

321

ANESTHESIOLOGY

Minimal Intubating Dose of Succinylcholine: A Comparative Study of 0.4, 0.5 and 0.6 mg/kg Dose AJIT GUPTA*, SAURAV SHEKHAR†, ANKESH*, RAJESH KUMAR, JAY PRAKASH

ABSTRACT Muscle relaxants are integral part of modern balanced anesthesia and succinylcholine, a depolarizing drug, is in use despite its adverse effects. The excellent intubating condition, fastest onset and shortest duration of action make it an excellent choice for anesthesiologists. The conventional dose of 1.5-2 mg/kg is commonly used for obtaining relaxation for intubation. This study was conducted with much smaller dose of succinylcholine as 0.4, 0.5 and 0.6 mg/kg to evaluate the acceptable intubating dose at 60 seconds, which was unlikely to have any untoward/side effects.

Keywords: Succinylcholine, low dose, intubation

M

uscle relaxants are integral part of balanced anesthesia since first dose of curare in 1942. For last-half century, succinylcholine continues to be used as relaxant for rapid intubation due to its unparallel efficacy, rapid onset with short duration of action thus providing excellent intubating conditions.

Succinylcholine is considered the best drug in the hands of anesthesiologists in emergency condition for rapid sequence intubation due to its rapid onset.

In conventional dose of 1.5-2 mg/kg, various side effects of succinylcholine can become evident. Various adverse events such as cardiac arrhythmias, exaggerated potassium reflux, increased intraocular and intracranial pressure, masseter spasm, myalgia due to muscle fasciculations can occur susceptible population at usual conventional doses.

Rocuronium has recently gained popularity as relaxant for fast intubating conditions but has longer duration of action, which is undesirable in various situations. In spite of all claims by newer muscle relaxants, benefits of succinylcholine cannot be overlooked. Knowing the

*Professor and Head ‡Senior Resident Dept. of Anesthesiology Indira Gandhi Institute of Medical Sciences, Patna, Bihar Address for correspondence Dr Ajit Gupta Professor and Head Dept. of Anesthesiology Indira Gandhi Institute of Medical Sciences, Patna - 800 014, Bihar E-mail: ajpta_igims@yahoo.co.uk

322

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

potential side effects of succinylcholine at conventional doses, minimal dose should be used to avoid possible complications.

AIMS OF STUDY This study was aimed to assess three minimal doses of succinylcholine for muscle relaxation for intubation.

In present study, we compared succinylcholine in three minimal doses of 0.4, 0.5 and 0.6 mg/kg for its efficacy in providing satisfactory intubating condition.

Inclusion Criteria ÂÂ

Age 15-65 years of either sex posted for elective surgery.

ÂÂ

American Society of Anesthesiologist (ASA) Grade I and II.

Exclusion Criteria ÂÂ

Patient refusal.

ÂÂ

Posted for any emergency surgery.

ÂÂ

Patients with coexisting diseases such as any cardiac, renal, diabetes, hypertension, electrolyte imbalance, etc.

ÂÂ

Any history of allergic reaction to any drugs involved.

ÂÂ

Anticipated difficult airway.

MATERIAL AND METHODS After institutional ethical clearance, total of 120 patients (40 in each group) were included in this prospective,

ANESTHESIOLOGY randomized double-blind study inclusion and exclusion criteria.

after

applying

ÂÂ

Group A: 0.4 mg/kg diluted into total of 2 mL volume with normal saline.

ÂÂ

Group B: 0.5 mg/kg diluted into total of 2 mL volume with normal saline.

ÂÂ

Group C: 0.6 mg/kg diluted into total of 2 mL volume with normal saline.

Vitals Monitoring and Statistical Analysis

Methodology After obtaining prior written informed consent, detailed pre-anesthetic check-up were done for all patients included in the study. Patients were shifted to operation theater after overnight fasting of 6 hours and standard monitors (NIBP, SpO2, ECG, capnography) were attached.

All patients were pre-medicated with injection glycopyrrolate 0.2 mg and injection fentanyl 2 mg/kg intravenously (IV) and pre-oxygenated with 100% oxygen for 3 minutes. Patients were induced with injection propofol 2 mg/kg IV. After loss of eyelash reflex, set dose of succinylcholine was administered to the patient by a helping colleague not involved in the study. After 1 minute (60 seconds), laryngosopy to assess intubating condition was done by the investigator and patient was intubated.

Maintenance of anesthesia was done with oxygen, nitrous oxide (50:50), isoflurane, vecuronium and intermittent positive pressure ventilation (IPPV).

Patients were reversed with injection neostigmine 0.05 mg/kg and injection glycopyrrolate 0.01 mg/kg at the end of surgery and extubated after thorough oral suctioning.

Clinically, intubating conditions were observed as described by Cooper et al as in the following: Score

Jaw relaxation

Vocal cord

Response to intubation

0

Poor (impossible)

Closed

Severe coughing/ bucking

1

Minimal

Closing

Mild cough

2

Good (easy)

Minimal movement

Mild diaphragmatic movement

3

Excellent

Open

None

Total score:

If difficult/poor intubating conditions were encountered, then additional dose of injection propofol 0.5 mg/kg was given and return of spontaneous ventilation was awaited. Injection vecuron 0.1 mg/kg was then given and patient was then intubated after 3 minutes.

Such patients automatically had score of 0 or poor intubating condition. In no circumstances, second dose of succinylcholine was given.

Vitals (heart rate, systolic blood pressure, diastolic blood pressure) were noted at pre-induction state and then at 0, 1, 2, 3, 5 and 10 minutes post-intubation. All data were compared statistically using Epi Info 3.3.2 database and analysis of variance (ANOVA) analysis was used for inter-group comparison. P value <0.05 was considered significant and p value <0.001 was highly significant.

RESULTS We were able to intubate all patients with different observations. On analysis of demographic profile, maximum proportion (46.6%) was from age group 15-25 and 35-45 years. All the three study groups were comparable with demographic profile and were found to be statistically insignificant (Tables 1-3). In our study, we found that intubating condition was dosedependent at fixed time interval of 60 seconds. Eighty percent of patients with 0.4 mg/kg, 95% with 0.5 mg/kg and 100% patients with 0.6 mg/kg had excellent to fair intubating condition (Table 4).

Table 1. Group-wise Age Distribution Age (years)

Group A

Group B

Group C

Total

15-25

8 (20%)

9 (22.5%)

11 (27.5%)

28 (23.3%)

25-35

7 (17.5%)

8 (20%)

6 (15%)

21 (17.5%)

35-45

10 (25%)

8 (20%)

10 (25%)

28 (23.3%)

45-55

3 (7.5%)

8 (20%)

9 (22.5%)

20 (16.7%)

55-65

12 (30%)

7 (17.5%)

4 (10%)

23 (19.2%)

Total

40 (100%)

40 (100%)

40 (100%)

120 (100%)

Table 2. Group-wise Sex Distribution

8-9: Excellent

Sex

Group A

Group B

Group C

Total

6-7: Good

Male

22 (55%)

24 (60%)

23 (57.5%)

69 (57.5%)

3-5: Fair

Female

18 (45%)

16 (40%)

17 (42.5%)

51 (42.5%)

0-3: Poor.

Total

40 (100%)

40 (100%)

40 (100%)

40 (100%)

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

323

ANESTHESIOLOGY Our study revealed that all patients with 0.6 mg/kg succinylcholine, had excellent intubating condition with onset of action as fast as 1.0 mg/kg dose. Thus in our view, dose higher than 0.6 mg/kg has no added advantage and unnecessarily produces side effects. There was maximum proportion (90%) showing excellent intubating condition in Group C as compared to Groups A and B. On the other side, good condition was found maximum (55%) in Group B compared to Group A and C. Fair and poor condition was found maximum in Group A (55% and 20%, respectively) (Table 5).

It was observed that 20% patients in 0.4 mg/kg group and 5% patients in 0.5 mg/kg group had poor intubating condition with some movement of Table 3. Group-wise Weight Distribution Weight (kg)

Group A

Group B

Group C

Total

30-40

3 (7.5%)

4 (10%)

4 (10%)

11 (9.2%)

40-50

8 (20%)

11 (27.5%)

10 (25%)

29 (24.2%)

50-60

8 (20%)

11 (27.5%)

10 (25%)

29 (24.2%)

60-70

15 (20%)

14 (35%)

16 (40%)

45 (37.5%)

70-80

6 (15%)

3 (7.5%)

1 (2.5%)

10 (8.3%)

Total

40 (100%)

40 (100%)

40 (100%)

120 (100%)

Table 4. Clinical Intubating Condition in Different Groups Group A

Group B

Group C

Jaw relaxation Poor

1 (2.5%)

Nil

Nil

Minimal

7 (17.5%)

2 (5%)

Nil

Good

11 (27.5%)

12 (30%)

8 (20%)

Excellent

21 (52.5%)

26 (65%)

32 (80%)

Nil

Nil

Nil

Vocal cord movement Closed Closing

6 (15%)

1 (2.5%)

Nil

Minimal movement

12 (30%)

14 (35%)

6 (15%)

Open

22 (55%)

25 (62.5%)

34 (85%)

1 (2.5%)

Nil

Response to intubation Severe coughing/ bucking Mild cough

2 (5%) 6 (15%)

1 (2.5%)

Nil

Mild diaphragmatic movement

13 (32.5%)

12 (30%)

2 (5%)

None

19 (47.5%)

26 (65%)

38 (95%)

324

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Table 5. Distribution of Intubating Condition Among Study Groups Condition

Group A

Group B

Group C

Excellent

Total

0 (0)

12 (30%)

36 (90%)

48 (40%)

Good

10 (25%)

22 (55%)

2 (5%)

34 (28.4%)

Fair

22 (55%)

4 (10%)

2 (5%)

28 (23.3%)

8 (20%)

2 (5%)

0 (0%)

10 (8.3%)

Poor Total

40 (100%) 40 (100%) 40 (100%) 120 (100%)

vocal cords. However, post-extubation none of the endotracheal (ED) tube showed any blood on its tip. In our study, we did not use neuromuscular monitoring and solely depended on clinical judgment, hence exact onset and recovery time could not be assessed. We solely concentrated on minimal intubating dose and associated intubating condition.

DISCUSSION The usual intubating dose for succinylcholine is 1.0-1.5 mg/kg IV to achieve satisfactory intubating condition at 1 minute. This dose is associated with various adverse effects1 and has drawbacks, which attracted too many adverse comments. Succinylcholine still enjoys patronage of many anesthesiologists because it provides excellent intubating conditions and has shorter onset of action. The efficacy of small dose of succinylcholine for providing acceptable intubating conditions at 60 seconds was reported by Stewart et al2 in their study titled “Comparison of high and low doses of succinylcholine”. Later Nimmo et al3 reported “Effectiveness and sequelae of very low-dose of succinylcholine”. These studies did not get attention because of fear that respiration will return faster and intubation will be difficult. Stewart et al2 reported that 26 (96%) of 27 patients receiving 1.5 mg/kg succinylcholine and 30 (94%) of 32 patients receiving 0.5 mg/kg had acceptable intubating conditions. However, in patients with a full stomach or in those with raised intracranial pressure, excellent intubating conditions are warranted.

ED 95 of succinylcholine is 0.3 mg/kg and traditional dose of 1.0-1.5 mg/kg is too high (3 × ED) and produces side effects, which has been well proven in study conducted by Smith et al.4 Same has been proposed by Kopman5 study. Naguib et al6 compared 0.3, 0.4, 0.5, 1.0 and 2.0 mg/kg dose of succinylcholine and found no difference of intubating condition at 60 seconds with doses of 1.0 and 2.0 mg/kg. Naguib et al7,8 also found the incidence of excellent intubating conditions following induction with 2 μg/kg fentanyl and 2 mg/kg

ANESTHESIOLOGY propofol to be 43.3%, 60.0%, 63.3%, 80.0% and 86.7% of patients after 0.3, 0.5, 1.0, 1.5 and 2.0 mg/kg succinylcholine, respectively. El-Orbany et al9 in their study found that small doses of succinylcholine like 0.5, 0.6 and 0.8 mg/kg are sufficient for good intubating conditions at 60 seconds.

Benumof et al10 observed that recovery occurred much earlier with 0.5 mg/kg than with 1.0 mg/kg dose of succinylcholine and this created additional benefits.

Another study by Ellango et al11 opined that intubating condition was much better with 1.0 mg/kg compared to 0.5 mg/kg but desaturation was more with 1.0 mg/ kg dose. Ezzat and colleagues12 studied the optimal succinylcholine dose for intubating emergency patients in a retrospective comparative study. They studied succinylcholine as a muscle relaxant agent in doses of 0.45 mg/kg, 0.6 mg/kg or 1 mg/kg and found that increasing the succinylcholine dosage shortened the onset time, prolonged the duration of action and the duration of abdominal fasciculation significantly.

Tracheal intubation was 100% successful in the three groups of patients.

Sorensen et al13 studied rapid sequence induction and intubation with rocuronium-sugammadex compared with succinylcholine in a randomized trial. They used either succinylcholine (1 mg/kg-1) or rocuronium (1 mg/kg-1) and found that median time from tracheal intubation to spontaneous ventilation was 406 seconds with succinylcholine and 216 seconds with rocuroniumsugammadex. The median time from tracheal intubation to 90% recovery of the first twitch in trainof-four (T1 90%) was 518 seconds with succinylcholine and 168 seconds with rocuronium-sugammadex and intubating conditions and time to tracheal intubation were not significantly different.

Few studies have shown desaturation of oxyhemoglobin during apneic period. Though we did not include it in our protocol, none of the patients enrolled in our study showed any sign of desaturation as all were preoxygenated for 3 minutes and intubated at 60 seconds.

CONCLUSION Succinylcholine due to its rapidity of onset and offset with excellent effect still enjoys patronage of many anesthesiologists. By using low dose of succinylcholine many side effects can be avoided and can be safely used in patients.

REFERENCES 1. Savarese JJ, Caldwell JE, Lien CA, Miller RD. Pharmacology of muscle relaxants and their antagonists.

In: Miller RD (Ed.). Anesthesia. 3rd Edition, New York: Churchill Livingstone; 2000. pp. 412-90.

2. Stewart KG, Hopkins PM, Dean SG. Comparison of high and low doses of suxamethonium. Anaesthesia.

1991;46(10):833-6.

3. Nimmo SM, McCann N, Broome IJ, Robb HM. Effectiveness and sequelae of very low-dose suxamethonium for nasal intubation. Br J Anaesth. 1995;74(1):31-4.

4. Smith CE, Donati F, Bevan DR. Dose-response curves for succinylcholine: single versus cumulative techniques.

Anesthesiology. 1988;69(3):338-42.

5. Kopman AF, Klewicka MM, Neuman GG. An alternate method for estimating the dose-response relationships of neuromuscular blocking drugs. Anesth Analg.

2000;90(5):1191-7.

6. Naguib M, Samarkandi A, Riad W, Alharby SW. Optimal dose of succinylcholine revisited. Anesthesiology.

2003;99(5):1045-9.

7. Naguib M, Samarkandi AH, El-Din ME, Abdullah K, Khaled M, Alharby SW. The dose of succinylcholine required for excellent endotracheal intubating conditions.

Anesth Analg. 2006;102(1):151-5.

8. Naguib M, Samarkandi AH, Abdullah K, Riad W, Alharby SW. Succinylcholine dosage and apnea-induced hemoglobin desaturation in patients. Anesthesiology.

2005;102(1):35-40.

9. El-Orbany MI, Joseph NJ, Salem MR, Klowden AJ. The neuromuscular effects and tracheal intubation conditions after small doses of succinylcholine. Anesth Analg.

2004;98(6):1680-5.

10. Benumof JL, Dagg R, Benumof R. Critical hemoglobin desaturation will occur before return to an unparalyzed state following 1 mg/kg intravenous succinylcholine.

Anesthesiology. 1997;87(4):979-82.

11. Ellango AP, Krishna HM, Gurudas K. Comparative evaluation of low dose succinylcholine against standard intubating dose in children. J Anesth Clin Pharmacol.

2009;25(4):413-6.

12. Ezzat A, Fathi E, Zarour A, Singh R, Abusaeda MO, Hussien MM. The optimal succinylcholine dose for intubating emergency patients: retrospective comparative study. Libyan J Med. 2011;6:10.

13. Sørensen MK, Bretlau C, Gätke MR, Sørensen AM, Rasmussen LS. Rapid sequence induction and intubation with rocuronium-sugammadex compared with succinylcholine: a randomized trial. Br J Anaesth.

2012;108(4):682-9.

■■■■

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

325

ANESTHESIOLOGY

Prevention of Critical Events in Pediatric Surgery: Set Guidelines and Protocols Save Neonate from Unnecessary Tracheoesophageal Fistula Surgery AJIT GUPTA*, MUMTAZ HUSSAIN†, VINIT KR THAKUR‡, JAI PRAKASH#

ABSTRACT In this article, we present the case of a 6-day-old neonate, who was taken up for emergency correction of tracheoesophageal fistula/esophageal atresia. Before induction of anesthesia, the standard protocol of nasogastric tube insertion to clear the upper esophageal pouch and oropharynx was followed to prevent further soiling of lungs through the fistula. This led to the detection of esophageal web, a rare condition and so surgery could be deferred. It is important to follow the set protocols, not only to prevent lungs and respiratory passage from soiling as in the present case, but also because it may save the child from unnecessary surgery and critical events.

Keywords: Critical event reporting, esophageal atresia, nasogastric tube

A

n event that can lead to undesirable outcome (if not identified in time) can lead to morbidity and mortality. Critical event monitoring was started in Aviation industry by Flanagan1 and its introduction in anesthesiology in 1978 by Cooper led to reduction in slips, lapses, violation of set guidelines and protocols with improvement in patient care.2 “To err is human” but this can be minimized as critical event monitoring allows reporting, analysis, evaluation and audit.3 Critical event reporting reduces knowledge-based mistakes, prevents violation of set protocols and reduces hospital stay as well as death or permanent disability.4 CASE REPORT A 6-day-old neonate was planned for emergency correction of tracheoesophageal fistula/esophageal

*Professor and Head †Assistant Professor Dept. of Anesthesiology and Critical Care ‡Associate Professor Dept. of Pediatric Surgery #Junior Resident Dept. of Anesthesiology and Critical Care Indira Gandhi Institute of Medical Sciences, Patna, Bihar Address for correspondence Dr Ajit Gupta Professor and Head, Dept. of Anesthesiology and Critical Care Indira Gandhi Institute of Medical Sciences, Patna - 800 014, Bihar E-mail: ajpta_igims@yahoo.co.uk

326

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

atresia and was examined by the Pediatrician and Pediatric Surgeon. The neonate had a history of vomiting since birth after each attempted feed. Neonate was full-term and weighed 2.6 kg. The pulse rate was 120/min, respiratory rate 30/min; the neonate was restless, SpO2 was 94% and investigations (biochemical and hematological) were within normal limit and there were no other associated VACTERL congenital anomalies: vertebral defects, anal atresia, cardiac defects, renal anomalies and limb abnormalities.

On clinical examination, neonate was pink in color, no cyanosis or jaundice, no dribbling of saliva, choking, chest retractions or grunting was present, with normal breath sound on auscultation. Chest X-ray (PA view) showed clear lung fields; the nasogastric tube was found to be coiled in the oropharynx, which raised doubt about the diagnosis and the Surgeon was communicated.

As per guideline, before induction of anesthesia, insertion of nasogastric tube to clear the upper esophageal pouch and oropharynx was decided as this is a standard protocol to prevent further soiling of lungs through the fistula.5,6 The child was transferred to operation room and put on 100% oxygen. The nasogastric tube 6 French size was removed, which got coiled on every attempt of earlier insertion.

A higher size nasogastric tube 8 French was selected by the senior anesthetist, stiffer than the previous.

ANESTHESIOLOGY After properly lubricating the tube, nasogastric tube was inserted down the esophagus under laryngoscopic vision, which slipped in with very little resistance and a ‘pop’ feel in upper part of esophagus. To confirm the position of tube, few milliliters of air was pushed in nasogastric tube and the hissing of air in stomach was heard with diaphragm of the stethoscope placed over the epigastrium. On gentle suction of the tube, a small column of yellow-tinged fluid (containing bile) was noticed in the tube.

To further confirm the position of tip of tube, under vision of image intensifier, 1 mL of radiopaque dye was pushed into nasogastric tube that could be visualized in the stomach. We did not do a bronchoscopy or used newer technology to remove esophageal web by endoscopic method7 as we did not have the propersized endoscope. But, in cases of persistent esophageal web in young children, this is the method of choice.

The nasogastric tube was removed and neonate was allowed to be breast-fed gradually under supervision of a senior nursing staff. As there was no vomiting, regurgitation or choking during feeds, the patient was discharged with instructions to visit pediatric OPD for subsequent care and surgery was eventually deferred.

DISCUSSION Many a time neonates present with symptoms mimicking a major congenital anomaly and parent do not give proper history. Occurrence of tracheoesophageal fistula/esophageal atresia is about 3,000-4,000 but presence of esophageal web is a rare presentation, 20,000-40,000 live births. With the advent of reporting such events, protocol is developed that leads to prevention of further mishaps.

In this case, surgery could be deferred only because the anesthetist tried to evacuate the upper esophageal pouch before induction of anesthesia and could detect the esophageal web, which is a rare condition.

Esophageal web is a true entity in which a partial or

complete shelf may be found consisting of, usually a layer of mucosa and submucosa.8 Such webs are rarely complete to cause obstruction and mimic esophageal atresia, as was this case. As suggested by Gupta et al,6 in this case, the guideline to evacuate proximal esophageal pouch before induction of anesthesia led to the detection of web.

CONCLUSION Anesthetists practicing pediatric anesthesia should be aware of this rare condition and follow the set protocol, not only to prevent lungs and respiratory passage from soiling but also because it may save the child from unnecessary surgery and critical events.

REFERENCES 1. Flanagan JC. The critical incident technique. Psychol Bull.

1954;51(4):327-58.

2. Cooper JB, Newbower RS, Long CD, McPeek B. Preventable anesthesia mishaps: a study of human factors.

Anesthesiology. 1978;49(6):399-406.

3. Rooksby J, Gerry RM, Smith AF. Incident reporting schemes and the need for a good story. Int J Med Inform.

2007;76 Suppl 1:S205-11.

4. Cooper JB, Newbower RS, Kitz RJ. An analysis of major errors and equipment failures in anesthesia management: consideration for prevention and detection.

Anesthesiology. 1984;60(1):34-42.

5. Kumra VP. Anesthetic considerations for specialized surgeries particular to paediatric age group. Indian J Anaesth. 2004;48(5):376-86.

6. Gupta A. Tracheo oesophageal fistula, oesophageal atresia & anaesthetic management. Indian J Anaesth.

2002;46(5):353-5.

7. Chao HC, Chen SY, Kong MS. Successful treatment of congenital esophageal web by endoscopic method. J Pediatric Surg. 2008;43(1):e13-5.

8. Hillemeier C, Touloukian R, McCallum R, Gryboski J. Esophageal web: a previously unrecognized complication of epidermolysis bullosa. Pediatrics. 1981;67(5):678-82.

■■■■

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

327

CARDIOLOGY

Pulseless Disease Due to Infective Aortitis MANISH N MEHTA*, HEMANG K ACHARYA†, AJAY C TANNA‡, JEMIMA BHASKAR#, PRATIK M VORA¥

ABSTRACT Pulseless disease refers to Takayasu’s arteritis where the pulses are absent due to noninfective aortitis, which causes sclerosis of the origin of the main branches of the aortic arch. But our patient had bicuspid aortic valve with infective endocarditis and infective aortitis, the vegetations blocking the flow of blood in the arch and its branches causing absent pulses.

Keywords: Infective aortitis, bicuspid aortic valve, aortic dilatation, vegetations, pulseless, cardiac surgery, Marfan’s

syndrome

P

atient presented with severe aortic stenosis (AS) due to bicuspid aortic valve with absent pulses and Marfanoid features. Since absent pulses is not a feature of AS, the cause for the absent pulses could not be made out clinically. However, on the operating table, the cause was found to be multiple aortic vegetations on a dilated aorta due to Marfan’s syndrome, blocking the flow of blood.

CASE REPORT Mr S, aged 20 years, was admitted with a history of low-grade fever associated with weight loss for 2 months, breathlessness on exertion for 1 month, cough with minimal sputum for 15 days, no history of chest pain, swelling of feet and oliguria. There was no history of palpitation or syncope. On examination, patient was conscious, oriented, thin built, had Marfanoid features - arm span greater than height, lower segment greater than upper segment, high arched palate, dorsal kyphoscoliosis, wrist sign positive. He was afebrile and did not have dyspnea or anemia. There was no pedal edema, pulses were absent in all the four limbs and blood pressure (BP) could not be recorded.

*Professor and Head of Dept. †Professor and Unit Head ‡Assistant Professor #Senior Resident ¥First Year Resident Dept. of Medicine Govt. MP Shah Medical College and GG Hospital, Jamnagar, Gujarat Address for correspondence Dr Jemima Bhaskar Flat No. 404, Kings Palace, Mehul Nagar (Opp. Telephone Exchange) Jamnagar - 361 006, Gujarat

328

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

On cardiovascular examination, an ejection systolic murmur could be heard in aortic area. Abdomen was soft with no organomegaly. Pectus excavatum was present on examination of respiratory system with bilateral vesicular breath sounds.

Investigations Laboratory investigations revealed the following results: Total leukocyte count (TLC)

10,400/mm3

Differential leukocyte count (DLC)

P75,L23,E1,M1

Platelet count

2,79,000/mm3

Hemoglobin (Hb)

10.8 g/dL

Erythrocyte sedimentation rate (ESR)

30 mm/1st hour

Peripheral smear

Microcytic hypochromic anemia, adequate platelets, no malarial parasites seen

Blood urea

26 mg/dL

Random blood sugar

63 mg/dL

C-reactive protein (CRP)

44.9 mg/L

Serum RVD (retroviral disease)

Negative

Serum creatinine

0.6 mg/dL

Antinuclear antibody (ANA) Negative profile (Immunodot) Prothrombin time

14.8 sec

International normalized ratio (INR)

1.37 control 10.8 sec

Blood culture

Streptococcus viridans

CARDIOLOGY Table 1. Quick Guide to Diagnosis of Marfan Disease

Major criteria

Cardiovascular

Skeletal system

Ocular system

Pulmonary system

Skin and Dura integument

Family history/ genetics

One required:

Four required:

Ectopia lentis

None

None

Dilatation of Asc A (+ AR), involving sinuses of Valsalva

Pectus carinatum

Parent, child or sibling with Marfan disease

AAD

Dural ectasia

Pectus excavatum (requiring surgery)

FBN1 mutation

Reduced upper-tolower segment ratio or increased arm span-to-height ratio Positive wrist and thumb signs Elbow extension reduced <170° Pes planus Protrusion acetabulae

Minor criteria

MVP ( ± prolapse)

Pectus excavatum (moderate)

Flat corneas

Spontaneous Striae pneumothorax

Dilatation of the main PA (patients younger than 40 y)

Hypermobile joints

Increased axial length of globe

Apical blebs

Crowding of teeth or highly arched palate

Recurrent or incisional hernias

Two major or one major and one minor criterion

One major or two minor criterion

One minor criterion

One minor criterion

One major Involvement (required to say or one minor criterion organ system involved)

None

None

Major criterion

Major criterion

Hypoplastic iris or ciliary muscles causing decreased miosis

Diagnosis requires: yy For index case (without documented mutation): Major criteria in two organ systems plus involvement of another organ system. yy For index case (with documented mutation): Major criterion in one organ system plus involvement of another organ system. yy For a relative of a known case: Major criterion in the family history plus major criterion in one organ system plus involvement of another organ system.

Chest X-ray showed cardiomegaly. ECG revealed left ventricular hypertrophy (LVH). Findings on 2D echocardiography were aortic valve thickened/bicuspid/ moderate LV dysfunction/concentric LVH/severe AS. Transesophageal echocardiography (TEE) showed bicuspid aortic valve/severe AS/mild-to-moderate mitral regurgitation (MR). Computed tomographic (CT) angiography of thoracic aorta was normal. Doppler study of arteries of both upper limbs and lower limb were normal. Patient was diagnosed as bicuspid aortic valve with severe stenosis with Marfanoid features. He was treated for cardiac failure and referred to cardiac

surgeon. On the operating table, we were in for a surprise. The ascending aorta had aneurysmal dilatation with multiple vegetations on the jet strike area of aorta.

The bicuspid valve was thickened, severely stenosed and had multiple vegetations.

The aorta was opened and the aortic wall vegetations were removed. The aortic valve was excised. Aortic valve replacement was done with 21 mm regent St. Jude’s valve. The postoperative period was uneventful.

Pulses returned to all the four limbs. The BP became recordable. Repeat 2D echocardiogram showed an ejection fraction (EF) of 55%. Repeat CRP was 19 mg/L.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

329

CARDIOLOGY DISCUSSION Aortitis is defined by inflammation of the aorta due to infective syphilitic aortitis, infective nonsyphilitic (bacterial or fungal) aortitis and noninfective aortitis due to large vessel vasculitis (Takayasu’s arteritis).

Infective agents destroy the medial layers of the aortic wall by direct invasion and subsequent inflammation.

Bacterial infection may trigger a noninfectious vasculitis by generating immune complexes. By analogy with infective endocarditis, bacterial aortitis often develops following bacteremia in the place of least resistance (pre-existing aneurysm). Infective aortitis can be due to Gram-positive Staphylococcus aureus and streptococci and Gram-negative Salmonella and Proteus.

Tuberculosis and fungal aortitis are rare.

Autoimmune disorders can affect the aorta. They are diverse, such as systemic lupus erythematosus (SLE), rheumatoid arthritis, Behcet’s disease, cryoglobulinemia, Wegener’s granulomatosis, etc. Aortitis can be due to Takayasu’s arteritis and temporal arteritis, which is due to chronic inflammation of unknown origin.

Histologically, aortitis is characterized by inflammatory infiltrates within the medial layers of the aortic wall, smooth muscle and fibroblast necrosis and fibrosis of the vessel wall. The inflammatory reaction within the aortic wall may cause aortic dilatation up to aneurysm formation. Diagnosing aortitis can be clinically challenging. Symptoms can be nonspecific as malaise, joint aches and low-grade fever and raised markers of inflammation. Inflammatory stenosis of major arterial branches leads to absent peripheral pulses, ocular and neurological problems. Aortitis related aneurysm of ascending aorta may present with new murmurs and

cardiac failure. This patient presented with an early systolic murmur (ESM) in aortic area and cardiac failure. He was diagnosed as having bicuspid aortic valve with Marfanoid features. The absent pulses in all the limbs was an unsolved enigma. When aortic valve replacement was done the puzzle was solved.

The ascending aorta had aneurysmal dilatation with multiple vegetations. Once the vegetations were removed, pulses returned. It has been found that bicuspid aortic valve has a high incidence of dilatation of the aorta compared to the normal population.

CONCLUSION Pulseless disease need not be only due to Takayasu’s arteritis involving the aortic valve as is commonly understood but rarely, other acute infective causes of aortitis can make the patient to be pulseless as proved by this case.

SUGGESTED READING 1. Colledge NR, Walker BR, Ralston S, Davidson S. In: Davidson’s Principles and Practice of Medicine. 21st Edition, Edinburgh, New York: Churchill Livingstone/ Elsevier; 2010. pp. 795-834.

2. Fauci AS, Kasper DL, Longo DL, Braunwald E, Hauser SL, Jameson JL, et al. In: Harrison’s Principles of Internal Medicine. Volume 2, 17th Edition, New York: McGrawHill; 2008.

3. Fuster V, Walsh RA, Harrington RA, et al. In: Hurst’s: The Heart. 13th Edition, Volume 1, New York: McGraw-Hill; 2011.

4. The ESC Textbook of Cardiovascular Medicine. European Society of Cardiology: Blackwell Publishing; 2007.

5. Fuster V, Walsh RA, Harrington RA, et al. In: Hurst’s: The Heart. 13th Edition, Volume 2, New York: McGraw-Hill; 2011.

■■■■

Stroke and Heart Disease Risk Might Increase Before Menopause An increase has been noted in risk factors for stroke, heart disease and diabetes in the years leading up to menopause, as opposed to after. Published in the Journal of the American Heart Association, the findings showed that metabolic syndrome severity increased rapidly during the last few years of premenopause and the transition phase to menopause (perimenopause). The study analyzed 1,470 records of white and African American women, with the latter noticing a more rapid spike, but a fainter rate of increase after menopause than white women.

Link Between Arterial Pulse Amplitude Change and Ischemic Heart Disease A study printed in the SpringerPlus journal analyzed the association between change in arterial pulse amplitude under conditions of increased shear stress and the development of ischemic heart disease. The findings revealed that reduction of arterial pulsation amplitude during flow-mediated dilation appears to be a valuable marker for predicting ischemic heart disease.

330

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

COMMUNITY MEDICINE

Study of Breastfeeding Practices in Coastal Region of South India: A Cross-sectional Study SWETHA R*, J RAVIKUMAR†, R NAGESWARA RAO‡

ABSTRACT Background: Breastfeeding has many health and developmental advantages for infants and mothers. Breastfeeding promotion is a significant child survival strategy. Interventions to improve early and correct infant feeding practices can result in considerable reduction in infant morbidity and mortality. Objectives: 1) To study the breastfeeding practices. 2) To determine the factors affecting the breastfeeding practices. Material and methods: A cross-sectional study was conducted in Vijayawada city, one of the major cities in coastal Andhra Pradesh from a period of June 2010 to May 2011. Among 109 slums and 59 wards, 10 slums and 10 wards were randomly selected by lottery method. Mothers of children less than 24 months were included in the study. Results: Among 304 babies, 58.22% received prelacteal feeds. Sugar water (33.33%) and honey (32.78%) were the most common types of prelacteal feed given. Only 40.46% of the mothers initiated breastfeeding within 1 hour of the delivery.

Maternal surgery was the most common reason for delay in initiation in 27.62% of the mothers. Colostrum was discarded by 28.29% of the mothers and 62.33% of the mothers practiced exclusive breastfeeding. Almost 30.26% of the mothers had given artificial feeding. Insufficient milk was the major reason for starting artificial feeding in 44.57% of mothers. Conclusion: The present study showed better indicators compared to national level data; however, increased efforts are still needed to improve the infant feeding practices to attain millennium development goals.

Keywords: Prelacteal feeds, breastfeeding, colostrum

B

reastfeeding is the first fundamental right of the child. It provides a unique biological and emotional basis for the health development of the children. It offers infants and young children complete nutrition and early protection against illness and promotes growth and development of the baby. Early initiation of breastfeeding lowers the mother’s risk of postpartum hemorrhage and anemia. It also boosts the mother’s immune system and reduces the incidence of diabetes and cancers.1,2 Exclusive breastfeeding for the first 4-6 months of life and timely introduction of weaning foods are important for laying down proper

*Assistant Professor Dept. of Community Medicine Sri Siddhartha Medicine College, Tumkur, Karnataka †Professor and Head Dept. of Community Medicine Pinnamaneni Siddhartha Medicine College, Vijayawada, Andhra Pradesh ‡Professor and Head Dept. of Community Medicine Guntur Medical College, Guntur, Andhra Pradesh Address for correspondence Dr Swetha R Sridevi Nilaya, Near Manjushree Convent, Manjunatha Nagar, Sira, Tumkur, Karnataka - 572 137 E-mail: drswetha226@gmail.com

foundations of growth in later childhood.3 This is due to the fact that by 5-6 months of age, babies need additional food besides breast milk, which supplies energy, protein and other nutrients. Since this is one of the most sensitive periods, the combined effects of inadequate and unhygienically prepared supplemented food that is prone to infections may ultimately lead to increased risk of growth retardation.4 The beneficial effects of breastfeeding depend on breastfeeding initiation, its duration and age at which the breast-fed child is weaned. Breastfeeding practices vary among different regions and communities. In India, breastfeeding practices are influenced by rural and urban residence, cultural and socioeconomic factors, psychological status, religious values and literacy, especially a low level of mother’s education, mother’s employment.5-8 In rural areas, feeding was started only after a ritual performed on the third day after childbirth. A common belief was that the mother was capable of secreting sufficient quantity of milk to feed the baby only after second or third day.

Such practices make the mother more vulnerable to postpartum hemorrhage.5 There was a common belief in rural areas that the first milk (colostrum) has some unusual constituents in it, which could be hazardous

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

331

COMMUNITY MEDICINE for the newborn infant and the breast needs to be squeezed free of this. Thus, the baby was put to the breast only after 3 days and most of the times, the first feed to the infant had been other than breast milk.5 Hence, the study with these relationships helps in orienting the breastfeeding promotional activities and for preventing a decline in initiation and duration of breastfeeding practices.6

of children aged less than 24 months by house to house visit. The information regarding the study variables were recorded on pre-tested structured questionnaire.

Ethical clearance was obtained from the institution.

Breastfeeding has declined worldwide in recent years as a result of urbanization, socioeconomic reasons, changes in living patterns, advertisements, marketing of infant milk formulae and maternal employment outside the home.9,10 Since there is inadequate information regarding breastfeeding practices in coastal Andhra Pradesh, the present study was undertaken to understand the prevailing breastfeeding practices.

RESULTS

MATERIAL AND METHODS A cross-sectional study was conducted in Vijayawada city, which is one of the major cities in coastal Andhra Pradesh. The study was conducted from a period of June 2010 to May 2011. Vijayawada city had a total population of 8.45 lakhs according to census 2001, in which slum population was 2.6 lakhs. According to Municipal Corporation, Vijayawada city has 109 slums and 59 wards. Permission was taken from the chief medical officer of Municipal Corporation to conduct the study. Among 109 slums and 59 wards, 10 slums and 10 wards were selected randomly by lottery method.

Population of each ward and slum ranged from 5,000 to 25,000. Definition of slum was according to census 2001 and non-slum area was defined as the area, which had proper housing condition, proper sanitation and water supply with availability of social and health services.

After reaching each slum or non-slum area, all the lanes were numbered and out of them, one lane was selected randomly. All the houses were numbered within the selected lane. The first household was selected randomly from this house and subsequent houses were visited following the right hand rule. Mothers of children less than 24 months were included in the study. Mothers with known chronic illness like tuberculosis, diabetes, hypertension and human immunodeficiency virus (HIV) infection and those who refused to participate in the study were excluded from the study. The same procedure was followed till desired. Sample of 15 mothers in each ward and slum was obtained. Sample of 16 was collected from last 2 wards and slums to get a complete sample of 152. The purpose of study was explained and consent was taken from each participant.

Data collection was done by interviewing the mothers

332

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Data analysis was done by using MS Excel spread sheet.

Chi-square test was applied to test the significance.

Statistical significance was accepted at p < 0.05.

Among 304 babies, 177 (58.22%) had received prelacteal feeds; 93 (52.54%) children in slum areas and 84 (47.46%) children in non-slum areas had received prelacteal feeds. There was no significant difference between both areas. Sugar water (33.33%) and honey (32.78%) were the most common types of prelacteal feed given; animal milk, tinned milk and castor oil were other prelacteal feeds given. Significantly higher number of mothers who underwent cesarean section had given prelacteal feeds in slum (p = 0.00127) and Table 1. Sociodemographic Distribution Variable

Slum area (%)

Non-slum area (%)

Total (%)

Age 15-20 years

25.66

9.21

17.43

21-25 years

54.60

46.72

50.66

26-30 years

18.42

26.97

22.70

31-35 years

1.32

17.1

9.21

Literate

56.58

96.71

76.61

Î&#x2122;lliterates

43.42

3.29

23.39

Education

Occupation Employed

25.00

26.97

25.99

Unemployed

75.00

73.03

74.01

APL

75.65

100

87.83

BPL

24.35

0.0

12.17

Economic status

Religion Hindu

63.16

72.37

67.76

Christian

31.58

19.74

25.66

Muslim

5.26

7.89

6.58

Nuclear family

71.05

69.74

70.39

Three generation family

19.74

27.63

23.68

Joint family

9.21

2.63

5.93

Type of family

APL = Above poverty line; BPL = Below poverty line.

COMMUNITY MEDICINE

Slum

Non-slum

6.45%

6.56%

29.03%

1.64%

41.94% 45.90%

45.90%

22.58%

Insufficient milk

Pregnancy

Insufficient milk

Pregnancy

Getting back to work

Others

Getting back to work

Others

Figure 1. Pie diagram showing the reasons for starting artificial feeding.

Other reasons included: advertisements, advice by relatives and friends, mother perception that artificial feeds increase babies weight.

non-slum area (p = 0.0006). Only 40.46% of the mothers initiated breastfeeding within 1 hour of the delivery.

Almost 29.60% of the mothers initiated breastfeeding within 1-4 hours, 15.46% of them initiated between 5-24 hours. Only 14.47% initiated after 1 day. There was no difference in initiation in slum and non-slum areas (p = 0.1287). Maternal surgery was the most common reason for delay in initiation in 27.62% of the mothers, lack of milk secretion (21.55%), religious belief (18.23%), difficulty in sucking (17.13%) and lack of awareness (15.47%) were other reasons. Significantly, higher number of literates initiated breastfeeding on appropriate time compared to illiterates (p = 0.00041).

Initiation was delayed among mothers who underwent cesarean section compared to mothers who has normal vaginal delivery in both slum (p = 0.00092) and nonslum area (p = 0.000095). There was no significant association between the gender and the initiation of breast milk.

Colostrum was discarded by 28.29% of mothers.

Higher percentage of mothers in the slum area (37.50%) discarded colostrum compared to the mothers in nonslum area (19.08%) and this difference was significant (p = 0.00036). There was significant association between literacy and discarding of colostrums in slum area (p = 0.000000127). The most common reason for discarding colostrum was advice by relatives and friends (43.02%); other reasons were: mother felt it is not healthy for the baby (19.77%), unhygienic (17.44%), social customs (8.14%) and another 11.63% discarded it without any reason. Almost 87.50% of the mothers breast-fed the baby on demand; another 12.50% gave scheduled feeds. Among 223 children who were more

than 6 months old, 62.33% of babies had received exclusive breastfeeding. There was no difference among children in both the areas. Significantly, higher number of employed mothers did not practice exclusive breastfeeding in slum (0.03086) and nonslum area (0.0000068927). Almost 30.26% of the mothers had given artificial feeding. Higher number of mothers in non-slum area (40.13%) had given artificial feeding compared to mothers in slum area (20.39%) (p < 0.00018). Insufficient milk was the major reason for starting artificial feeding in 44.57% of mothers. Almost 61.84% of the babies were given breastfeeding during illness. Among 180 babies, weaning 30.56% of babies were weaned at less than 6 months of age, 41.11% babies at 6 months and 28.33% received supplementary food after 6 months.

DISCUSSION In the present study, 52.54% of mothers in slum area and 47.46% of mothers in non-slum areas had given prelacteal feeds. Higher percentages have been reported

by Chhabra et al (76.9%),11 Tiwari et al12 (76.0%), Jain et al13 (34% of doctors, 61.5% of nurses), while lower percentage are reported by Kulkarni et al14 (36.1%) and Kumar et al15 (40%). This difference can be attributed to social customs prevailing in the area.

Types of prelacteal feed given varied from place to place. In the present study, the most common prelacteal feed given was sugar water for 26.88% of infants; similar findings were observed by Adhisivam et al.16 In the study by Chhabra et al,11 a preparation of jaggery called â&#x20AC;&#x2DC;Gur Ghuttiâ&#x20AC;&#x2122; was the most popular prelacteal feed and in the study by Dash et al17, the first feeding

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

333

COMMUNITY MEDICINE ‘Janam Ghunti’ was given to neonates with the belief that it helps to prevent stomach disorder, dehydration and acts as a tonic.

In the present study, 40.46% of mothers initiated breastfeeding within 1 hour. Initiation of breastfeeding was higher in present study compared to the National Family Health Survey (NFHS)-318 - Andhra Pradesh (28.9% urban, 21.5% rural) and Gupta et al19 (30%).

Adhisivam et al16 reported 51% mothers initiated breastfeeding within 1 hour. Maternal surgery (27.62%) and lack of milk secretion (21.55%) were the common reasons for delayed initiation, whereas Kumar et al15 reported family restrictions (38.8%) and social customs plus religious belief (25.2%) as the common reasons for delay.

Initiation of breastfeeding was significantly associated with literacy and type of delivery, whereas no association was observed with parity and gender.

Similar findings have been reported by other Indian studies.4,6,14,15,20,21 In contrast Dasgupta et al,22 in their study reported that early initiation of breastfeeding was more in multiparous mothers.

In the present study, higher number of the mothers in slum (37.5%) discarded the colostrum. In urban slums of Gwalior, 26.2% of mothers discarded colostrum and in Chandigarh only 15.9% of mothers discarded colostrum.12,15 Most common reasons for discarding colostrum were the advice given by the relatives and friends (43.02%). Similarly in the study by Yadav et al,25 the most common reason to discard colostrum was elder’s advice in 36.6%. Other studies reported heavy or not good for the newly born child, family restrictions as the reasons to discard the colostrums.9,15,26 In the present study, literacy was significantly associated with colostrum feeding; similar findings have been reported by others studies.14,23,19 Demand feeding was the commonest practice (87.50%), majority of the Indian studies reported similar feeding practices, whereas in Nepal, scheduled feeding was commonly practiced.4,6,16,17,23 Exclusively breastfeeding was practiced by 62.33% of the mothers; our study findings were in accordance with NFHS-3 (62.7%).11 Lower rates of exclusive breastfeeding were found according to other Indian studies.6,23 Higher number of nonworking mothers practiced exclusive breastfeeding compared to mothers working away from home; similar findings were observed by Aggarwal et al.27 In the present study, majority of the mothers in the non-slum area had given artificial feeding.

Artificial feeding was higher in our study compared to other Indian studies.14,19 In the present study, the most common reasons for starting artificial feeding were

334

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

insufficient milk secretion (41.94%), next pregnancy (29.03%) and resuming the work (45.09%) was the most common reason in non-slum area. Insufficient milk production was the commonest reasons according to other studies.19,28 Complementary food was started at 6 months for 41.11% of children; similar results were reported by other studies.6,28,29 Early weaning practices were common in non-slum areas, whereas late weaning was prevalent in slum areas.

CONCLUSIONS Better feeding practices were observed in non-slum area compared to slum area. Higher number of mothers in non-slum area had given artificial feeds. The present study shows better indicators than the national level data but emphasis should be made to improve the breastfeeding practices. Regular Information, Education and Communication (IEC) activities and health education regarding the importance of breastfeeding practices should be included in slum areas. More emphasis should be given to improve the breastfeeding practices in working women. Day care services or creche facilities should be provided at work place in order to facilitate breast-feeding.

Acknowledgment I would like to express my gratitude to Dr Satyanarayana Raju, Chief Medical Officer, Municipal Corporation-Vijayawada for the support during conducting the study.

REFERENCES 1. Park K. Park’s Textbook of Preventive and Social Medicine.

21st edition, Jabalpur: M/s Banarsidas Bhanot; 2011: pp. 488-97.

2. Bhutta ZA, Labbok M. Scaling up breastfeeding in developing countries. Lancet. 2011;378(9789):378-80.

3. Bavdekar SB, Bavdekar MS, Kasla RR, Raghunandana KJ, Joshi SY, Hathi GS. Infant feeding practices in Bombay slums. Indian Pediatr. 1994;31(9):1083-7.

4. Rasania SK, Sigh SK, Pathi S, Bhalla S, Sachdev TR. Breastfeeding practices in a maternal and child health centre in Delhi. Health and Population. 2003;26(3):110-5.

5. Sharma D, Sharma S. Bottlenecks to breast feeding in rural Rajasthan. Indian J Community Med. 2005;30(4):155-6.

6. Madhu K, Chowdary S, Masthi R. Breast feeding practices and newborn care in rural areas: a descriptive crosssectional study. Indian J Community Med. 2009;34(3):243-6.

7. Singh R, Kumar OA, Rana RS. Breast feeding and weaning practices among urban Muslims of district Lucknow.

Indian Pediatr. 1992;29(2):217-9.

8. Kumar D, Goel NK, Mittal PC, Misra P. Influence of infant-feeding practices on nutritional status of under-five children. Indian J Pediatr. 2006;73(5):417-21.

COMMUNITY MEDICINE 9. Singh K, Srivastaa P. The effect of colostrum on infant mortality: urban rural difference. Health and Population perspectives and issues. 1992;15(3&4):94-100.

20. Kapil U, Kaul S, Vohra G, Chaturvedi S. Breast feeding practices amongst mothers having undergone cesarean section. Indian Pediatr. 1992;29(2):222-4.

10. Emery JL, Scholey S, Taylor EM. Decline in breast feeding.

Arch Dis Child. 1990;65(4 Spec No):369-72.

21. Nayak S, Jay P, Patel S, Gharat V, Patel S, Choksi V, et al.

Breast feeding in urban community of Surat city. Nat J Community Med. 2010;1(2):111-3.

11. Chhabra P, Grover VL, Aggarwal OP, Dubey KK. Breast feeding patterns in an urban resettlement colony of Delhi.

Indian J Pediatr. 1998;65(6):867-72.

12. Tiwari R, Mahajan PC, Lahariya C. The determinants of exclusive breast feeding in urban slums: a community based study. J Trop Pediatr. 2009;55(1):49-54.

22. Dasgupta A, Bhattacharya S, Das M, Chowdhury KM, Saha S. Breast feeding practices in a teaching hospital of Calcutta before and after the adoption of BFHI (Baby Friendly Hospital Initiative). J Indian Med Assoc.

1997;95(6):169-71, 195.

13. Jain S, Kumari S, Aggarwal J. Current trends of breast feeding among health professionals. J Neonatol.

2004;18(1):43-4.

23. Singh P, Bhalwar R. Breast feeding practices among families of armed forces personnel in a large cantonment.

Med J Armed Forces India. 2007;63(2):134-6.

14. Kulkarni RN, Anjeneya S, Gujar S. Breast feeding practices in an urban community of Kalamboli, Navi Mumbai.

Indian J Community Med. 2004;XXIX(4):179-80.

24. Kumari S, Saili A, Jain S, Bhargava U, Gandhi G, Seth P. Maternal attitude and practices in initiation of newborn feeding. Indian J Pediatr. 1988;55(6):905-11.

15. Kumar D, Agarwal N, Swami HM. Socio-demographic correlates of breast-feeding in urban slums of Chandigarh.

Indian J Med Sci. 2006;60(11):461-6.

25. Yadav RJ, Singh P. Knowledge attitude and practices of mothers about breast-feeding in Bihar. Indian J Community Med. 2004;29(3):130-1.

16. Adhisivam B, Srinivasan S, Soudarssanane MB, Deepak Amalnath S, Nirmal Kumar A. Feeding of infants and young children in tsunami affected villages in Pondicherry.

Indian Pediatr. 2006;43(8):724-7.

26. Gupta P, Srivastava V, Kumar V, Jain S, Masood J, Ahmad N, et al. Newborn care practices in urban slums of Lucknow city, UP. Indian J Community Med. 2010;35(1):82-5.

17. Dash M, Choudhury RK. Breast feeding practices among Santals and non-Santals of Orissa. Anthropologist.

2005;7(4):283-7.

27. Aggarwal A, Arora S, Patwari AK. Breastfeeding among urban women of low-socioeconomic status: factors influencing introduction of supplemental feeds before four months of age. Indian Pediatr. 1998;35(3):269-73.

18. International Institute for Population Sciences (IIPS) and Macro International. National Family Health Survey (NFHS-3) (2005-06). India. Volume I, Mumbai: IIPS; 2007.

28. Kasla RR, Bavdekar SB, Joshi SY, Hathi GS. Exclusive breastfeeding: protective efficacy. Indian J Pediatr.

1995;62(4):449-53.

29.

19. Gupta AK, Patil VM, Tenglikar SG, Reddy S, Vijayanath V. Breast feeding practices among mothers in urban field practice area of MR Medical College, Gulbarga. J Pharm Biomed Sci. 2011;4(4):1-3.

■■■■

Taneja DK, Saha P, Dabas P, Gautam VP, Tripathy Y, Mehra M. A study of infant feeding practices and the underlying factors in a rural area of Delhi. Indian J Community Med. 2003;28(3):107-11.

Physical Activity may Lower Risk of Five Diseases​ People who achieve total physical activity levels several times higher than the current recommended minimum level significantly lower their risk of five diseases namely breast and bowel cancer, diabetes, heart disease and stroke, says a systematic review and dose-response meta-analysis for the Global Burden of Disease Study 2013 published August 9, 2016 in the BMJ. This is the first meta-analysis, which has quantified dose-response association between total physical activity across all domains and the risk of five chronic diseases and analyzed data from 174 cohort studies. Compared with individuals with total activity <600 metabolic equivalent (MET) minutes/ week, the risk reduction for those in the highly active category (≥8,000 MET minutes/week) was 14% for breast cancer, 21% for colon cancer, 28% for diabetes, 25% for ischemic heart disease and 26% for ischemic stroke. These results suggest that total physical activity needs to be several times higher than the recommended minimum level of 600 MET minutes/week for larger reductions in the risk of these diseases. The WHO recommends at least 600 MET minutes of total activity (irrespective of domains) per week for health benefits i.e., about 150 minutes/week of brisk walking or 75 minutes/week of running. This high level of total activity can be achieved by combining different types of physical activity into the daily routine. Focusing on a particular domain such as leisure time physical activity, which represents only a small fraction of total activity, as was done by most studies, restricts the scope of applicability of the findings.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

335

CRITICAL CARE

Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Critical Care Challenge SHASHI KANT*, AJIT GUPTA†, ARVIND KUMAR‡, RITESH KUMAR‡, KH RAGHWENDRA#

ABSTRACT Stevens-Johnson syndrome (SJS) is a rare life-threatening disorder. Toxic epidermal necrolysis (TEN) is the more serious form.

Medications are the major culprits, though infection and rarely cancer are also known to cause SJS. The exact pathophysiology for the development of these diseases is not well understood. SJS/TEN is an emergency situation and intensive care is required.

The mainstays of treatment include withdrawal of suspected cause, care of skin and mucosal lesions, prophylactic antibiotics, fluid and electrolyte management and nutritional support through parenteral or enteral route. Prevention of complications is the goal of management.

Keywords: Adverse drug events, life-threatening, body surface area, nutrition

C

linicians have to use drugs for the treatment of different medical problems, without knowing how the host will respond to such intervention and idiosyncratic/hypersensitivity reaction are also such responses, other than the beneficial effects. Adverse drugs event is also a concern in the field of medical practice known as pharmacovigilance. Stevens-Johnson syndrome (SJS) is a rare life-threatening disorder occurring in approximately 1-2 per million populations, while the serious form of toxic epidermal necrolysis (TEN) occurs in 0.42-1.2 per million populations.1 SJS is a milder form of TEN.2,3 First recognized in 1922,3 it may be caused by medications, infection and rarely due to cancer.1 The exact pathophysiology for the development of these diseases initially has not been well-understood but histopathology study suggests lymphohistiocytic inflammation and infiltration around vessels leading to degeneration of epithelium.

The prodromal phase of SJS begins with fever, sore throat and fatigue and later the lesions appear in the

*Senior Resident †Professor and Head ‡Assistant Professor #Professor Dept. of Anesthesiology Indira Gandhi Institute of Medical Sciences, Patna, Bihar Address for correspondence Dr Ajit Gupta Professor and Head, Dept. of Anesthesiology Indira Gandhi Institute of Medical Sciences, Patna - 800 014, Bihar E-mail: ajpta_igims@yahoo.co.uk

336

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

mucous membranes in the mouth, lips, genitals and regional rashes in the form of round lesions up to 1 inch in size appear on the face, trunk, arms and legs sparing the scalp.4 The distinction between SJS and TEN is based on the type of lesions and the amount of the body surface area with blisters and erosions.5 Blisters and erosions cover between 3% and 10% of the body in SJS, 11-30% in SJS/TEN overlap and over 30% in TEN.6 The skin pattern most commonly associated with SJS is widespread, often joined or touching (confluent), purpuric spots (macules) or flat small blisters or large blisters, which may also join together.6 These occur primarily on the torso.5 SJS and TEN overlap can be mistaken for erythema multiforme.4 In studies on some East Asian populations, carbamazepine- and phenytoin-induced SJS is strongly associated with human leukocyte antigen (HLA)-B*1502 (HLA-B75), an HLA-B serotype of the broader serotype HLA-B15.7-9 A study in Europe suggested the gene marker is only relevant for East Asians.9,10 Based on the Asian findings, similar studies in Europe showed that 61% of allopurinolinduced SJS/TEN patients carried the HLA-B58. One study concluded that even when HLA-B alleles behave as strong risk factors, as for allopurinol, they are neither sufficient nor necessary to explain the disease.11 Drugs as a cause of SJS/TEN are prime culprits and the list is long. Paracetamol, nonsteroidal anti-inflammatory

CRITICAL CARE Table 1. Classification of TEN/SJS as per Involvement of Body Surface Area and Nature of Dermal Involvement SJS

yy Skin detachment <10% total BSA yy Widespread erythematous or purpuric macules or flat atypical targets

Overlap SJS/TEN

yy Detachment between 11% and 30% of BSA yy Widespread purpuric macules or flat atypical targets

TEN with spots

yy Detachment >30% of BSA yy Widespread purpuric macules or flat atypical targets

TEN without spots

yy Detachment of >10% of BSA yy Large epidermal sheets and no purpuric macules

BSA = Body surface area.

drugs (NSAIDs), antibiotics, sulfonamides, antiviral, anticonvulsants, barbiturates, all have been reported to cause SJS. Next in line is infection particularly in children and young with viral infections (influenza, hepatitis, mumps, herpes), bacterial infection (diphtheria, mycobacterium, typhoid) and other infestations with malaria, protozoa, etc.12,13 PATHOPHYSIOLOGY SJS/TEN can be taken as delayed hypersensitivity reaction, with minimal inflammation leading to separation of stratum corneum. It has been found that the liver of diseased person fails to detoxify drug metabolites resulting in increased production of sulfonamide hydroxylamine via cytochrome P-450 pathway. These drug metabolites interact with host tissue and make them behave like antigens. Many factors like tumor necrosis factor (TNF), perforine, cytotoxic T lymphocytes have been found to cause apoptosis of keratinocytes, with separation of epidermis from dermis. SJS is not only limited to outer skin surface but also affects the epithelial lining of conjunctiva, gastrointestinal system, etc. and so conjunctivitis, ulcers in mouth, anal and genital system are common.4,14 MANAGEMENT SJS/TEN is an emergency situation like burns and the patient needs intensive care. Withdrawal of suspected cause, care of skin and mucosal lesions and supportive therapy constitute the mainstay of treatment.15 Although the separation of epidermis from dermis leads to loss of protective mechanism of skin, invites infection, loss of fluid, debridement of lesion is not advocated as this may lead to further exposure of

Figure 1. Showing lesions of SJS.

deeper layer to infection and more fluid and electrolyte loss. Dermatologists advocate application of 0.5% silver nitrate or 0.05% chlorhexidine, soframycin tulle, gentian violet or local anesthetic gel that helps to keep the skin soft and less painful.

The help of ophthalmologist, treatment of conjunctivitis and use of antibiotic ointment is treatment of choice.

Mucosal lesions on tongue, cheek, lips, nasal mucosa, anal and genital area need care and application of antiseptic gel. Povidone-iodine, chlorhexidine are preferred for the purpose, application of tobramycin, amphotericin and polymyxin paste over mouth/tongue ulcer after oral toileting is very beneficial.

Corticosteroids, either locally or systemically, have not been found to be useful and have remained controversial.

Use of immunoglobulins has been reported to reduce inflammatory reaction and hospital stay. Retrospective studies suggest that use of steroids leads to longer hospital stay and increased complications.14,16,17 Use of prophylactic antibiotic/macrolides for infection is always advisable. As there is loss of skin function, hypothermia is to be prevented by keeping patient in a warm environment. Fluid management has to be done as for superficial burn patient and a balance between

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

337

CRITICAL CARE input and output is important for prevention of hypotension, perfusion to vital organs and preservation of renal function, as cause of death in such cases are multiple organ dysfunction syndrome (MODS) or the most neglected part in almost all critical care set ups is nutritional support.

Patient are unable to feed, either fluids or solid, due to ulcers on lips, mouth, tongue. It is not uncommon to find dehydrated patients losing weight rapidly. It is advisable to give nutrition either through parenteral or enteral route, whichever is suitable as per patient need.16,17 There is a lot of controversy over parenteral versus enteral nutrition but initially the only option is parenteral route, which cannot be overlooked although several studies suggest that it increases morbidity and hospital stay. Switch over to enteral feed should always be tried, but placing a nasogastric tube in such patients leads to bleed from ulcer but Freka tubes are also an option to start enteral feed early, which helps in gut-associated lymphoid tissue (GALT) function.

Many workers have found that early enteral nutritional supplement drastically reduces hospital stay and fasten recovery. Riboflavin (vitamin B2) in higher dose (normal 1-1.5 mg/day) has also been found to improve immune function, healing of mucosal lesion/mouth ulcer.16 Thus, for SJS/TEN, the management is only supportive and prevention of complication is the goal.

REFERENCES 1. National Institutes of Health (NIH). Research directions in genetically-mediated Stevens-Johnson syndrome/toxic epidermal necrolysis. 2015. Available at: http://www. genome.gov/27560487.

2. Rehmus WE. Stevens–Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). In: Porter RS (Ed.). The Merck Manual (Online Version). 19th Edition, Whitehouse Station, NJ: Merck & Co.; 2013.

3. Ward KE, Archambault R, Mersfelder TL. Severe adverse skin reactions to nonsteroidal antiinflammatory drugs: A review of the literature. Am J Health Syst Pharm. 2010;67(3):206-13.

4. Auquier-Dunant A, Mockenhaupt M, Naldi L, Correia O, Schröder W, Roujeau JC; SCAR Study Group. Severe Cutaneous Adverse Reactions. Correlations between clinical patterns and causes of erythema multiforme majus, Stevens-Johnson syndrome, and toxic epidermal necrolysis: results of an international prospective study.

Arch Dermatol. 2002;138(8):1019-24.

5. Mockenhaupt M. The current understanding of StevensJohnson syndrome and toxic epidermal necrolysis. Expert Rev Clin Immunol. 2011;7(6):803-13; quiz 814-5.

6. Chung WH, Hung SI, Hong HS, Hsih MS, Yang LC, Ho HC, et al. Medical genetics: a marker for StevensJohnson syndrome. Nature. 2004;428(6982):486.

7. Locharernkul C, Loplumlert J, Limotai C, Korkij W, Desudchit T, Tongkobpetch S, et al. Carbamazepine and phenytoin induced Stevens-Johnson syndrome is associated with HLA-B*1502 allele in Thai population.

Epilepsia. 2008;49(12):2087-91.

8. Man CB, Kwan P, Baum L, Yu E, Lau KM, Cheng AS, et al. Association between HLA-B*1502 allele and antiepileptic drug-induced cutaneous reactions in Han Chinese. Epilepsia. 2007;48(5):1015-8.

9. Alfirevic A, Jorgensen AL, Williamson PR, Chadwick DW, Park BK, Pirmohamed M. HLA-B locus in Caucasian patients with carbamazepine hypersensitivity.

Pharmacogenomics. 2006;7(6):813-8.

10. Lonjou C, Thomas L, Borot N, Ledger N, de Toma C, LeLouet H, et al; RegiSCAR Group. A marker for Stevens-Johnson syndrome ...: ethnicity matters.

Pharmacogenomics J. 2006;6(4):265-8.

11. Lonjou C, Borot N, Sekula P, Ledger N, Thomas L, Halevy S, et al; RegiSCAR study group. A European study of HLA-B in Stevens-Johnson syndrome and toxic epidermal necrolysis related to five high-risk drugs. Pharmacogenet Genomics. 2008;18(2):99-107.

12. Stevens-Johnson syndrome. mayoclinic.com/

Available

at:

www.

13. Stevens-Johnson syndrome/Toxic epidermal necrolysis.

Available at: www.dermnetnz.org.

14. Tigchelaar H, Kannikeswaran N, Kamat D. Stevens– Johnson syndrome: an intriguing diagnosis. 2008.

Available at: http://www.pediatricsconsultantlive.com/ UBM Medica.

15. Balint B, Stepic N, Todorovic M, Zolotarevski L, Ostojic G, Vucetic D, et al. Ibuprofen-induced extensive toxic epidermal necrolysis - a multidisciplinary therapeutic approach in a single case. Blood Transfus. 2014;12(3):438-9.

16. Kardaun SH, Jonkman MF. Dexamethasone pulse therapy for Stevens-Johnson syndrome/toxic epidermal necrolysis. Acta Derm Venereol. 2007;87(2):144-8.

17. Jagadeesan S, Sobhanakumari K, Sadanandan SM, Ravindran S, Divakaran MV, Skaria L, et al. Low dose intravenous immunoglobulins and steroids in toxic epidermal necrolysis: a prospective comparative openlabelled study of 36 cases. Indian J Dermatol Venereol Leprol. 2013;79(4):506-11.

■■■■

338

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

2016

Delays Insulin Therapy

DIABETOLOGY

Diabetes Reversal Technique JS RAJKUMAR*, S AKBAR†, JR ANIRUDH†

ABSTRACT Apart from a case report of successful remission of diabetes through surgery, in this article, we explain the rationale for achieving remission of diabetes mellitus (DM) by surgical manipulation of the gut endocrine axis, and present the scientific evidence available thus far in support of the same. The evolution of ‘metabolic’ surgery is presented here. The reduction in mortality and comorbidity is presented. The two main theories of causation of euglycemia are discussed in detail. Most authors now believe in both the theories, and the gastric bypass and the biliary pancreatic diversion are the procedures with the highest rate of remission. Finally, in the context of reappearance of hyperglycemia, the beneficial effects of a prolonged period of normal blood sugar are discussed.

Keywords: Diabetes mellitus, remission, gastric bypass, biliary pancreatic diversion

CASE REPORT A 62-year-old male, known diabetic for the past 10 years, came to us for permanent remission of diabetes.

His fasting and stimulated C-peptide levels were 2.2 IU and 6.8 IU, respectively (high levels); hence, a fit candidate for metabolic surgery. The patient’s body mass index (BMI) was 25.3, so we opted for sleeve gastrectomy + ileal transposition (SGIT), which is one of the recommended procedures for diabetic patients with lower BMI. After obtaining fitness from Diabetologist, Physician, Cardiologist and Anesthetist, patient was taken up for the procedure.

A loose sleeve gastrectomy (since weight loss should be minimum) + transposition of a 270 cm ileal segment to the mid jejunum level (Fig. 1) was performed laparoscopically. Postoperatively, the patient recovery was uneventful. His diabetic control was achieved within the first month and complete remission of diabetes mellitus was seen in the third month after surgery. After follow-up, he remains euglycemic without any oral hypoglycemic agents.

*Chief Surgeon †Assistant Surgeon Lifeline Institute of Minimal Access Surgery Chennai, Tamil Nadu Address for correspondence JS Rajkumar Chief Surgeon Lifeline Institute of Minimal Access Surgery Chennai - 600 010, Tamil Nadu

340

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Figure 1. Sleeve gastrectomy + Transposition of a 270 cm ileal segment to the mid jejunum level.

DISCUSSION Ever since the monumental article in 1955, outlining the normalization of sugar levels after gastrectomy, a causal link between gut surgery and correction of diabetes was suspected. However, it was also attributed to the weight loss suffered by gastric cancer patients or the liver metastases interfering with hepatic glycogenolysis. Subsequently, an epoch-making article appeared in the Annals of Surgery (1995), documenting long-term control for both obesity and diabetes with a gastric bypass. Authored by Walter Pories, this paper analyzed results based on 14 years of gastric bypass

DIABETOLOGY surgery and 608 patients. This was a serendipitous finding in a cohort group that had the bypass but essentially as a weight reduction (bariatric) procedure.

This was the first time that a direct link between gastric bypass surgery and blood sugar normalization was established. It was then believed by most surgeons and other researchers that the loss of weight, the reduction of caloric intake and the diminished insulin resistance accounted for these effects. However, the last 20 years of research into gastrointestinal endocrine molecules has completely changed the direction of surgical logic.

Based on the varied metabolic effects of these procedures, the American Bariatric Surgery Society renamed itself as the American Society of Metabolic and Bariatric Surgeons (ASMBS).

Let us study the available procedures: ÂÂ

ÂÂ

ÂÂ

ÂÂ

Gastric banding: In this procedure, a silastic or polyvinyl chloride (PVC) band is inserted 2 to 3 cms below the esophagogastric junction, causing a functional obstruction of the upper gastric segment, and restriction of food intake. It is not a very effective form of bariatric surgery and seems to have very little metabolic component. Although mild reductions of plasma glucose have been documented, its effects are more due to weight loss and resetting insulin resistance than due to a hormonal effect. Therefore, there will be no more discussion about this procedure in this article.

Sleeve gastrectomy: In this increasingly popular procedure, a sleeve is made of the stomach by resecting the greater curvature and three-fourths of the left part of the stomach. This results in a maximal reduction of the gastric size, and also effects some endocrine changes by reducing serum levels of ghrelin. Although this operation was initially thought to be merely restrictive, we now know that it has a prominent role in endocrine manipulation.

Gastric bypass: In this operation, the stomach is divided into a tiny proximal pouch and a large segment distally, which is bypassed. The proximal jejunum is divided 50 cm from the duodenojejunal flexure and the distal limb is anastomosed to the stomach (Fig. 2). The proximal jejunum is now anastomosed to the distal jejunum 100-150 cm from the site of the GJ. This operation has been proved to be the most efficacious to restore euglycemia.

Ileal transposition: The newest of the procedures, interposing a considerable length of ileum within the proximal jejunum in an isoperistaltic manner, is a technique of incretin stimulation by the pathways

Figure 2. Gastric bypass.

described in greater detail later. The advantage of this operation is its use in lower BMI individuals, between 22 and 30 BMI. When used for higher BMI patients, a sleeve gastrectomy is added and the procedure is known as sleeve gastrectomy with ileal transposition (SGIT). However, compared to the sleeve and the bypass, this is still an experimental procedure.

Bariatric and Metabolic Surgery Although the procedures described for bariatric and metabolic surgery are the same, the latter term is used specifically for lower BMI individuals undergoing surgery for control of diabetes, dyslipidemias, hypertension or any other component of the metabolic syndrome.

Pathophysiology Weight loss per se leads to reduction in blood sugar, a common finding in obese or overweight patients with diabetes in the Indian subcontinent. Almost all diabetics undergoing metabolic surgery manifest normalization of sugars within 2-3 weeks of surgery, whereas weight loss takes several weeks or months to be achieved. There are two main pathophysiological

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

341

DIABETOLOGY theories put forth to explain the correction of diabetes in these patients. They are the foregut and the hindgut theories.

Foregut Theory This theory was first propounded by Rubino et al.

According to this group of workers, the mucosa of the duodenum, coming in contact with the food, releases glucagon, which accounts for immediate postprandial hyperglycemia, a consistent feature of the pre-diabetic and diabetic state. A number of studies have shown that excess glucagon, rather than insufficient insulin, is the major derangement in diabetes. Patients undergoing Roux-en-Y gastric bypass procedure (RGBP) exhibit minimal or no increase in serum level of glucagon in the postprandial phase. The ‘Rubino’ factor refers to the putative duodenal contact cell, which triggers off the glucagon release.

Recent advances: Based on the Rubino hypothesis, the newest noninvasive treatment for diabetes mellitus is a loose and floppy plastic sleeve that completely coats the duodenum up to the jejunum and is introduced endoscopically. This is known as the endo gastrointestinal barrier and is said to be the treatment of choice in the future for low BMI patients with diabetes mellitus.

Hindgut Theory Proponents of the hindgut theory of diabetes control after RGBP invoke a set of internal insulin like secretions known as incretins. These are released from specialized cells of the ileal mucosa (K and L cells), which release a peptide known as glucagon-like peptide-1 (GLP-1).

The latter is one of the most powerful insulin agonists known to man. It increases the serum insulin by whipping the beta cells of the pancreas. It is also antiapoptotic towards the beta cells, putatively prolonging their lifespan. Indeed, there have been a few cases reported of nesidioblastosis or idiopathic hypertrophy of the beta cells, which in post bypass cases is said to be mediated by GLP-1.

The other incretin that is released by the ileal cells as part of the “ileal brake mechanism” in response to early passage of semi-digested chyme into the distal reaches of the ileum, is the peptide called gastric inhibitory peptide (GIP).

Peptide YY (PYY) is another peptide that is released after gastric bypass. Both GIP and PYY have antiglucagon effects, effectively tipping the balance in favor of insulin and pro-insulin molecules. Incretins are especially

342

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

involved in the immediate postprandial glucoseinsulin synergy. It is notable that high incretin levels in the post bypass patients correlate positively with lower postprandial sugar levels. Most bariatric surgery protagonists subscribe to the combination of foregut and hindgut theories. What is beyond debate; however, is the rapid fall of blood sugars seen immediately after surgery. Figure 3 depicts the mechanism of correction of diabetes with surgery while Figure 4 shows the pathways of adiposity and satiety signals.

Time to Euglycemia Significant weight loss occurs about 4 weeks after bariatric surgery, about 8-10 kg. The common statement of physicians that improved glycemic control is a direct result of weight loss, cannot hold water as normalization of sugars takes an average of about 2-3 weeks, when the weight loss is barely 4-6 kg. This minimal loss of weight cannot account for complete euglycemia. It is now said to be a combination of two factors: ÂÂ

Incretin levels especially GLP-1.

ÂÂ

The sudden near total caloric restriction that occurs postoperatively washes out the fat from the cytoplasm of the beta cells, in which fat accumulation prevents adequate and appropriate release of insulin. This is known as lipotoxicity, and lipid washout is putatively a cause for early normalization of blood sugar.

How Effective are Metabolic Surgeries?

Looking at the data of Buchwald, Schauer, Gagner and Scopinaro, several hundred thousand patients have been followed up in careful detail, and the average figures of diabetes remission (no drugs, no insulin) are 83% for gastric bypass, 67% for sleeve, and 48% for the band, in the Caucasian population. This figure approaches 95% for the biliopancreatic diversion of Scopinaro. Our own experience over the last 11 years and that of several other Indian workers indicate a much higher percentage of remission in the Indian patient. Perhaps insulin resistance, which comes down sharply after bariatric surgery is an important factor, as is the viability of beta cells in our population.

C-peptide Evaluation In diabetics who are on insulin injections, the serum C-peptide represents their indigenous insulin output, as all injected insulins have only the A and B peptides.

Finding a serum C-peptide of >3 ng/mL is a sign of a fairly well-functioning pancreas with sufficient reserve to be stimulated by the incretins.

DIABETOLOGY

Figure 3. Mechanism of correction of diabetes with surgery.

Figure 4. Pathways of adiposity and satiety signals.

Other Comorbidities

Impact on Lifespan

Diabetes is often one of a host of diseases like hypertension, dyslipidemia, gout and hypertension.

Several studies have shown significant resolution of these other ailments, to the tune of 80-90%. Also, like with diabetes, these parameters normalize very rapidly usually within a few weeks of the bariatric surgery.

The World Health Organization (WHO) figures and the Framingham study figures indicate that an obese smoker loses about 13 years of his life, and an obese nonsmoker about 10. Definite evidence has accumulated that these operations significantly increase the lifespan of the patient. Death due to vasculopathy of the

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

343

DIABETOLOGY coronary and cerebral vessels is especially prevented by this surgery. Also, the fluctuating insulin levels seen in poorly controlled diabetes trigger instability of the DNA, and trigger off the neoplastic process. Reversal of the diabetic state decreases the risk of cancer occurrence in this group of patients.

Small Vessel Disease Diabetic retinopathy and nephropathy occur in up to 38% of patients who have well-controlled sugars. The disease process seems more related to the duration of the diabetes. Effecting a reversal of diabetes in these patients will move them to a 0% risk group as in the nondiabetics. This is a very powerful reason for attempting reversal of diabetes through surgical procedures.

How Long Do They Last?

A recent slew of articles has indicated that 5-10% of patients who undergo metabolic surgery return to the diabetic stage when followed up for 10-15 years.

The medical community was quick to denounce these operations as merely temporary successes. However, careful follow-up data now indicates that even in this small percentage of patients who relapse into the hyperglycemic state, the arteriolar disease when followed up longitudinally, is much less than their nonoperated counterparts. Thus, the current understanding is that a period of euglycemia of 10-15 years is remembered by the cells with a much better vascular prognosis in this group of patients. This phenomenon is called “metabolic memory” of the cell, and is evoked to explain the overall better prognosis.

CONCLUSION The last word about metabolic surgery has not been spoken, and will not be spoken for a long time. What emerges from a vast amount of data is that there definitely seems to be a role for attempting to reverse the diabetic process, and that doing so positively impacts upon the health and longevity of the individual. Until futuristic magic pills arrive upon the scene, the most efficacious treatment available right now is metabolic surgery.

For the higher BMI individual (32 and above), the RGBP remains the best option. In lower BMI individuals, the ileal transposition is an attractive alternative. Definite slowing down or reversal of microangiopathy has been documented in patients undergoing these operations.

Incretin release either through the foregut or hindgut theory seems to explain return to euglycemia, which

344

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

occurs within a few weeks of the procedure. Metabolic memory of the cell gives a survival and morbidity advantage, even in the small percentage of metabolic surgery patients who return to a hyperglycemic state, thus vindicating this procedure.

SUGGESTED READING 1. Conn JW, Seltzer HS. Spontaneous hypoglycemia. Am J Med. 1955;19(3):460-78.

2. Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995;222(3): 339-50; discussion 350-2.

3. Rubino F, Forgione A, Cummings DE, Vix M, Gnuli D, Mingrone G, et al. The mechanism of diabetes control after gastrointestinal bypass surgery reveals a role of the proximal small intestine in the pathophysiology of type 2 diabetes. Ann Surg. 2006;244(5):741-9.

4. Fried M, Ribaric G, Buchwald JN, Svacina S, Dolezalova K, Scopinaro N. Metabolic surgery for the treatment of type 2 diabetes in patients with BMI <35 kg/m2: an integrative review of early studies. Obes Surg. 2010;20(6): 776-90.

5. Rubino F, Schauer PR, Kaplan LM, Cummings DE. Metabolic surgery to treat type 2 diabetes: clinical outcomes and mechanisms of action. Annu Rev Med. 2010;61:393-411.

6. Rubino F, Gagner M. Potential of surgery for curing type 2 diabetes mellitus. Ann Surg. 2002;236(5):554-9.

7. Scopinaro N, Gianetta E, Adami GF, Friedman D, Traverso E, Marinari GM, et al. Biliopancreatic diversion for obesity at eighteen years. Surgery. 1996;119(3):261-8.

8. Lundell L. Principles and results of bariatric surgery. Dig Dis. 2012;30(2):173-7.

9. Sjöström L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, et al; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery.

N Engl J Med. 2004;351(26):2683-93.

10. Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292(14):1724-37.

11. Ferchak CV, Meneghini LF. Obesity, bariatric surgery and type 2 diabetes - a systematic review. Diabetes Metab Res Rev. 2004;20(6):438-45.

12. Cummings DE, Overduin J, Foster-Schubert KE. Gastric bypass for obesity: mechanisms of weight loss and diabetes resolution. J Clin Endocrinol Metab. 2004;89(6): 2608-15.

13. Izzedine H, Coupaye M, Reach I, Deray G. Gastric bypass and resolution of proteinuria in an obese diabetic patient.

Diabet Med. 2005;22(12):1761-2.

DIABETOLOGY 14. Torquati A, Wright K, Melvin W, Richards W. Effect of gastric bypass operation on Framingham and actual risk of cardiovascular events in class II to III obesity. J Am Coll Surg. 2007;204(5):776-82; discussion 782-3.

15. Schauer PR, Burguera B, Ikramuddin S, Cottam D, Gourash W, Hamad G, et al. Effect of laparoscopic Rouxen Y gastric bypass on type 2 diabetes mellitus. Ann Surg.

2003;238(4):467-84; discussion 84-5.

16. Schwartz ML, Drew RL, Chazin-Caldie M. Laparoscopic Roux-en-Y gastric bypass: preoperative determinants of prolonged operative times, conversion to open gastric bypasses, and postoperative complications. Obes Surg.

2003;13(5):734-8.

17. Rubino F, Gagner M, Gentileschi P, Kini S, Fukuyama S, Feng J, et al. The early effect of the Roux-en-Y gastric bypass on hormones involved in body weight regulation and glucose metabolism. Ann Surg. 2004;240(2):236-42.

gastric bypass surgery: a time course study. Obes Surg.

2005;15(4):474-81.

19. Patriti A, Facchiano E, Sanna A, Gullà N, Donini A. The enteroinsular axis and the recovery from type 2 diabetes after bariatric surgery. Obes Surg. 2004;14(6):840-8.

20. Clements RH, Gonzalez QH, Long CI, Wittert G, Laws HL. Hormonal changes after Roux-en Y gastric bypass for morbid obesity and the control of type-II diabetes mellitus. Am Surg. 2004;70(1):1-4; discussion 4-5.

21. Rosa G, Mingrone G, Manco M, Euthine V, Gniuli D, Calvani R, et al. Molecular mechanisms of diabetes reversibility after bariatric surgery. Int J Obes (Lond).

2007;31(9):1429-36.

22. Camastra S, Manco M, Mari A, Greco AV, Frascerra S, Mingrone G, et al. Beta-cell function in severely obese type 2 diabetic patients: long-term effects of bariatric surgery. Diabetes Care. 2007;30(4):1002-4.

18. Wickremesekera K, Miller G, Naotunne TD, Knowles G, 23. Available at: https://www.framinghamheartstudy.org/ Stubbs RS. Loss of insulin resistance after Roux-en-Y ■■■■

Assessing the Efficacy and Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus Maegawa and coworkers performed an interim analysis at 3 months of a 3-year prospective study to assess the efficacy and safety profiles of ipragliflozin in Japanese patients with type 2 diabetes mellitus. The results printed in the Journal of Expert Opinion on Pharmacotherapy demonstrated that this drug is effective for improving glycemic control. In addition, it ameliorates the concentration of lipids and blood pressure. Its use is associated with low rates of adverse drug reactions.

Use of Brief Cognitive Tests for Patients with Diabetes As type 2 diabetes mellitus heightens the risk of mild cognitive impairment and dementia in individuals of both middle- and old age, the researchers conducted a systematic review to assess the use of brief cognitive tests in studies involving patients with type 2 diabetes mellitus. The results printed in the Journal of the American Medical Directors Association demonstrated that the Montreal Cognitive Assessment supplemented by the Digit Symbol Substitution test may be a promising approach for screening cognitive impairment in this patient population.

Efficacy of Apatinib-loaded Nanoparticles in Diabetes-induced Retinal Vascular Leakage As vascular endothelial growth factor (VEGF) plays a vital role in retinal vascular leakage, the investigators conducted a study to determine the effect of apatinib (a selective inhibitor of VEGF) in inhibiting VEGF-mediated retinal vascular hyperpermeability. In addition, its action on diabetes-induced retinal vascular leakage was also assessed. The results printed in the Journal of International Journal of Nanomedicine revealed that apatinib-loaded nanoparticles may offer high potential for the prevention and treatment of diabetes-induced retinal vascular disorders.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

345

INTERNAL MEDICINE

Mucopolysaccharidosis Type 1: Hurler Syndrome Case Report BHARATH RAJ KIDAMBI*, KALPANA RAMANATHAN†, SRINIVASAGALU K‡

ABSTRACT Mucopolysaccharidosis type 1 is a rare autosomal recessive disorder of varied phenotypic expressions. Diagnosis is suspected primarily with clinical features but requires few special tests to confirm it. Early diagnosis and treatment can lead to improved quality-of-life with lesser complications.

Keywords: Mucopolysaccharidosis, Hurler syndrome, Hurler-Scheie syndrome, attenuated Hurler, glycosaminoglycan, alpha-L-iduronidase, aldurazyme, laronidase, dysostosis multiplex

M

ucopolysaccharidosis type 1, is a lysosomal storage disorder due to deficiency of enzyme alpha-L-iduronidase (IDUA). Based on the recent clinical data and therapeutic outcomes, mucopolysaccharidosis type 1 is classified into Hurler (severe phenotype), Hurler-Scheie (intermediate phenotype) and Scheie (mild phenotype) syndromes.1 The glycosaminoglycan, dermatan sulfate and heparin sulfate, which provide structural support to the body is not degraded properly in this disorder. This leads to excessive accumulation within the lysosomes and lead to multiorgan damage. Diagnosis is done by identifying the deficient enzyme activity by a dried filter paper test. Treatment options and diagnostic testing are not available in most parts in India and the enzyme replacement therapy is quite costly. Uncertainty among primary physicians is due to rarity of the disease and the lack of well randomized trials and treatment guidelines.2,3

and progressive breathlessness (New York Heart Association [NYHA] Class IV at presentation) with history of orthopnea and paroxysmal nocturnal dyspnea. Family history revealed a similar history in the firstborn child who died due to suspected cardiac problem at 8 years. Developmental history suggested delay in development for all milestones. There was no history suggestive of congenital heart disease, or of any renal, liver or thyroid problem. On examination, he appeared of short stature, had craniofacial disproportion, coarse facies (gargoyle), saddle-shaped nose, thick lips and bilateral corneal clouding (Figs. 1 and 2).

CASE REPORT A 13-year-old male child, presented to our emergency department with swelling of both legs, gradual onset

*Junior Resident †Assistant Professor ‡Professor and Director Institute of Internal Medicine, Rajiv Gandhi Government General Hospital Chennai, Tamil Nadu Address for correspondence Dr Bharath Raj Kidambi No. 5 - Gokulam Colony, No. 2 - Ramavaram Main Road Valasaravakkam, Chennai - 600 087, Tamil Nadu E-mail: drbkid@gmail.com, drbkid@icloud.com

346

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Figure 1. Coarse facial features, thick lips, saddle nose and short neck typical of mucopolysaccharidosis.

INTERNAL MEDICINE Auscultation showed a pansystolic murmur in the mitral area radiating to the axilla. Abdomen was distended and there was hepatosplenomegaly (Fig. 3).

Central nervous system (CNS) examination revealed moderate mental retardation and a waddling gait.

Figure 2. Demonstrating cloudy cornea.

Chest X-ray with PA and lateral view, showed cardiomegaly and spatula-shaped ribs. X-ray of the wrist joint demonstrated irregularly shaped carpal bones and pointed (bullet-shaped) metacarpals.4 Collectively, the X-ray findings of mucopolysaccharidosis are termed as dysostosis multiplex (Figs. 4-6). Special tests were done to diagnose the suspected mucopolysaccharidosis; 24-hour urinary heparin sulfate and urinary acid albumin was positive. Alpha-L-IDUA levels were only 0.2 Âľmol/L (deficient - less than 2% of normal).

Echocardiography showed moderate mitral regurgitation with severe pulmonary hypertension and severe tricuspid regurgitation. It also showed right atrial and ventricular dilatation and bulging of interatrial septum into the left atrium. Patientâ&#x20AC;&#x2122;s condition deteriorated rapidly and he succumbed to refractory heart failure.

Figure 3. Generalized distension of abdomen with hepatosplenomegaly.

Figure 4. Chest X-ray PA view showing paddle- or oar-shaped ribs and huge cardiomegaly, short and thick clavicles, teeth malformation.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

347

INTERNAL MEDICINE phenotype (Hurler syndrome) is known to have an early involvement of the musculoskeletal system and there is CNS involvement.1,6 It is usually progressive and leads to an early death within the first two decades. Death in severe phenotype is usually due to cardiorespiratory failure. Attenuated forms of Hurler syndrome (Hurler-Scheie and Scheie) usually grow into adulthood. Life expectancy is good and CNS involvement is uncommon in intermediate and mild phenotype. Disease progression is much slower, and the disease has variable characteristics. Delineation between phenotypes is based on age of presentation, rate of progression and genotyping.

Recently, Indian studies have been done for screening mucopolysaccharidosis type 1 and 2 with heparin cofactor 2 as a biomarker. However, its utility in differentiating subtypes and monitoring disease progression is limited.7,8

Figure 5. Chest X-ray lateral view showing paddle-shaped ribs which are widened anteriorly and tapered posteriorly.

There are currently two treatment options for mucopolysaccharidosis type 1, hematopoietic stem cell transplantation and enzyme replacement therapy.9 The indications, optimal dose, efficacy and safety profile are still being studied. Hematopoietic stem cell transplantation is the treatment of choice, if patient is younger than 2.5 years. It is also indicated in patients with severe phenotype and CNS involvement. The procedure-related mortality was initially high, but improved with better drug therapy. Using enzyme replacement as an adjunct before the stem cell transplantation improves the clinical condition.

All patients who are not candidates for hematopoietic stem cell transplantation, usually benefit from laronidase therapy. Laronidase is an intravenous enzyme replacement therapy. It cannot cross the bloodbrain barrier, however, and so is of limited use in treating CNS manifestations of mucopolysaccharidosis type 1.

Figure 6. X-ray wrist and hand taken at 2 years shows hypoplastic carpal bones irregularly shaped metacarpal bones.

DISCUSSION Mucopolysaccharidosis type 1 is a rare disorder.

It is inherited in an autosomal recessive manner. There are more than a 100 different mutations of IDUA gene.5 Due to the varied phenotypic presentation, the natural history of the disease is not well-known for intermediate and mild phenotype. However, severe

348

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Both the treatment options work better if started earlier in the course. The optimal dose of laronidase is approximately 100 IU/week. However, due to the rarity of this condition, much larger trials are needed before deciding on the dosage and safety. Life-threatening anaphylaxis are reported after laronidase infusion.

Finally, treating mucopolysaccharidosis type 1 is a multimodal approach and team work is needed.

REFERENCES 1. Muenzer J, Wraith JE, Clarke LA; International Consensus Panel on Management and Treatment of Mucopolysaccharidosis I. Mucopolysaccharidosis I:

INTERNAL MEDICINE management and treatment guidelines. Pediatrics.

2009;123(1):19-29.

2. Vijay S, Wraith JE. Clinical presentation and followup of patients with the attenuated phenotype of mucopolysaccharidosis type I. Acta Paediatr.

2005;94(7):872-7.

3. Pastores GM, Arn P, Beck M, Clarke JT, Guffon N, Kaplan P, et al. The MPS I registry: design, methodology, and early findings of a global disease registry for monitoring patients with mucopolysaccharidosis type I. Mol Genet Metab. 2007;91(1):37-47.

4. Schmidt H, Ullrich K, von Lengerke HJ, Kleine M, Brämswig J. Radiological findings in patients with mucopolysaccharidosis I H/S (Hurler-Scheie syndrome).

Pediatr Radiol. 1987;17(5):409-14.

6. Neufeld EF, Muenzer J. The mucopolysaccharidosis. In: Scriver C, Beaudet A, Sly W, et al (Eds.). The Metabolic and Molecular Bases of Inherited Disease. New York, NY: McGraw-Hill; 2001. pp. 3421-52.

7. Randall DR, Colobong KE, Hemmelgarn H, Sinclair GB, Hetty E, Thomas A, et al. Heparin cofactor II-thrombin complex: a biomarker of MPS disease. Mol Genet Metab.

2008;94(4):456-61.

8. Clarke LA, Winchester B, Giugliani R, Tylki-Szymańska A, Amartino H. Biomarkers for the mucopolysaccharidoses: discovery and clinical utility. Mol Genet Metab.

2012;106(4):395-402.

9. Wraith JE, Clarke LA, Beck M, Kolodny EH, Pastores GM, Muenzer J, et al. Enzyme replacement therapy for mucopolysaccharidosis I: a randomized, double-blinded, 5. Banikazemi M. Mucopolysaccharidosis type I. eMedicine placebo-controlled, multinational study of recombinant pediatrics; Genetics and metabolic diseases. Available human alpha-L-iduronidase (laronidase). J Pediatr. at: http://emedicine.medscape.com/article/1599374.

[Updated on Oct 13, 2014] 2004;144(5):581-8.

■■■■

New AAN Guidelines on Treating Stroke Patients with PFO A practice advisory update from the American Academy of Neurology (AAN) warns against routinely offering percutaneous closure of patent foramen ovale (PFO) in patients with cryptogenic ischemic stroke outside of a research setting. But, in rare circumstances, such as recurrent strokes despite adequate medical therapy with no other mechanism identified, the Amplatzer PFO Occluder (St. Jude Medical Inc) may be offered, if it is available.

The update was published online July 27 in Neurology.

Early Treatment Lowers Risk for Renal Scarring in Febrile UTI Delaying initiation of antibiotic therapy in children with febrile urinary tract infections (UTIs) may contribute to renal scarring, suggested a retrospective cohort study published online in JAMA Pediatrics. Researchers found that 7.2% children had evidence of new renal scarring and noted an association between renal scarring and initiation of antibiotic therapy. The median duration of fever in children with renal scarring was 72 hours compared with 48 hours among children with no renal scarring.

Symptom Exacerbations are Common After Pediatric Concussion About one in three adolescents experience symptom exacerbations after pediatric concussion, report new findings from a study published online August 1 in JAMA Pediatrics. Researchers used data from a previous randomized clinical trial of prescribed rest versus usual care for pediatric concussion to characterize symptom exacerbations ("spikes") as well as their antecedents and potential consequences over a 10-day observation period after concussion in 63 participants aged 11-18 years. Twenty children were noted to have at least one symptom spike, four had a second symptom spike, and none had more than two symptom spikes. The first symptom spike occurred on average on Day 5. Participants with symptom spikes had higher baseline postconcussion symptom scale scores and a less steep symptom improvement trajectory, compared with those who had no symptom spikes.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

349

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

NEUROLOGY

Childhood Multiple Sclerosis: A Diagnostic Challenge SAKSHI SINGH*, JEMIMA BHASKAR†, MANISH MEHTA‡, SS CHATTERJEE#

ABSTRACT Neurological problems presenting in childhood are generally due to congenital lesions, head trauma or central nervous system infections. Multiple sclerosis is rarely considered as a diagnosis in a child living in the tropics but the presentation of recurrent and persistent central nervous system deficits in this child which was confirmed by associated magnetic resonance imaging findings, led us to establish this rare diagnosis.

Keywords: Multiple sclerosis, demyelination, dissemination in time and space, recurrent central nervous system deficits

M

ultiple sclerosis (MS) is a demyelinating disorder of central nervous system (CNS) with sparing of peripheral nervous system.

There are many clinical episodes of neurological deficits involving the cognitive functions, cranial nerves, motor and sensory system and cerebellum. They are recurring in nature and correlate with magnetic resonance imaging (MRI) changes, which are diagnostic. MS usually occurs in temperate climate zones and are rarely seen in tropical zones.

CASE REPORT A 13-year-old female patient presented with the chief complaints of high-grade fever since 2 days with chills and rigors, irritability, irrelevant talking, weakness of both lower limbs with inability to stand without support. No history of seizures, loss of consciousness and incontinence of bowel/bladder. There was no headache or projectile vomiting.

On systemic examination, patient was conscious, oriented but hyperactive, indicating an euphoric state.

Right facial nerve upper motor neuron (UMN) palsy was present. Power in both lower limbs was Grade 3/5,

*3rd Year Resident †Senior Resident ‡Professor and Head #Head of the Unit Dept. of Medicine MP Shah Government Medical College, Jamnagar, Gujarat Address for correspondence Dr Jemima Bhaskar H. No. - 4041, King’s Palace, Mehulnagar, Opposite BSNL Telephone Exchange, Jamnagar - 361 006, Gujarat E-mail: jemimabhaskar@yahoo.com

tone was normal, the deep tendon reflexes were exaggerated in all limbs and plantars were extensor bilaterally. There was a subjective sense of paresthesia in right lower limb. Cerebellar signs were also present intention tremors on right side, appendicular ataxia, gait ataxia and tandem walking was not possible.

Further investigations showed neutrophilic leukocytosis, peripheral smear negative for malaria, serum C-reactive protein (CRP) - 42 mg/dL; renal function tests and liver function tests were normal. Cerebrospinal fluid (CSF) was normal. Fundus was also normal.

MRI brain showed multiple patchy areas of altered signal intensity white matter in subcortical and periventricular distribution, appeared confluent and involved bilateral frontal, parietal and temporal (right more than left) and bilateral occipital regions, anterior limb of right internal capsule, callososeptal interface, bilateral cerebral peduncles, pons, midbrain, superior and inferior quadrigeminal tubercles. Patient had undergone MRI brain previously for similar illness, which showed similar pattern. Patient recovered with steroids (IV methylprednisolone) under the umbrella of broad-spectrum antibiotics and fluid support.

Patient had significant past history as follows: Around age of 8 years, patient presented with complaints of high-grade fever with chills for 14 days followed by generalized seizures and altered sensorium.

When investigated, she was found to have neutrophilic leukocytosis with smear negative for malaria. CSF showed raised cell count with increased protein though sugar was in normal range. Contrast-enhanced computed tomography (CECT) brain was normal but MRI brain showed T2W hyperintensity lesions in multiple areas with mild communicating hydrocephalus.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

353

NEUROLOGY Tests were also done to rule out glucose-6-phosphate dehydrogenase (G6PD), disorders of fatty acids, amino acids and cystic fibrosis.

Ancillary symptoms, such as heat sensitivity, Lhermitte’s sign are present along with trigeminal neuralgia and facial myokymia.

Patient was treated with steroids under antibiotic cover.

Further serial MRI brain showed similar lesions in brain but spinal cord screening was unremarkable.

The disease presents with 4 clinical types:

Patient improved clinically with subsidence of fever, became more oriented, reacting adequately to vocal commands with improvement in lower limb weakness.

Patient could walk without support though cerebellar signs persisted.

In view of presentation of illness, with precipitation of neurological symptoms with fever and dissemination of demyelinating lesions in brain in time and space, after ruling out possibilities of other causes, we reached a conclusion that the underlying pathology should be MS. DISCUSSION Multiple sclerosis is characterized by a triad of inflammation, demyelination and gliosis of the CNS. Lesions of MS typically occur disseminated in time and space. MS is characterized by periventricular plaques.

Myelin specific antibodies are present promoting demyelination. As lesions evolve, there is prominent astrocytic proliferation (gliosis). There is partial remyelination of the surviving naked axons producing shadow plaques. Many lesions, however, fail to remyelinate although oligodendrocyte precursors are present. Peripheral nervous system is spared.

Due to the demyelination, conduction block occurs and the nerve impulse cannot be propagated but later redistribution of sodium channels allows conduction to occur along the naked axon. Chemical fluctuations occur due to variable conduction block. This explains clinical fluctuations that vary from hour to hour. It may appear with fever mimicking meningoencephalitis.

Multiple sclerosis is threefold more common in women than men. Age of onset is 20-40 years (a little later in males than females). Onset in childhood is 0.2-0.4%.

Prevalence rates are higher in high latitudes. It is uncommon in Japan, Asia, Africa and the Middle East.

The onset may be abrupt or insidious. Symptoms are very varied depending upon location and severity of lesions in the CNS. The usual symptoms and signs are weakness of the limbs, spasticity, optic neuritis, diplopia, ataxia, bladder dysfunction, cognitive dysfunction, fatigue, facial weakness and vertigo.

354

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

ÂÂ

Relapsing remitting MS

ÂÂ

Secondary progressive MS

ÂÂ

Primary progressive MS

ÂÂ

Progressive relapsing MS.

Diagnostic criteria for MS ÂÂ

There should be objective abnormalities of CNS

ÂÂ

Predominant involvement of long tracts

ÂÂ

There should be involvement of two or more areas of CNS, clinically or by MRI

ÂÂ

Clinical pattern must consist of two or more episodes of worsening in different sites of CNS

ÂÂ

The neurologic condition cannot be attributed to another disease.

MRI has revolutionized the diagnosis and management of MS. An increase in vascular permeability is detected by leakage of gadolinium into the parenchyma. This produces a MS plaque, focal areas of hyperintensity, which remain visible indefinitely. Lesions are perpendicular to the ventricular surface corresponding to the pattern of perivenous demyelination. The lesions are multifocal within the brain, brainstem and spinal cord. There are also hypointense lesions (black holes) which are markers of irreversible demyelination and axonal loss.

Evoked potential testing and CSF abnormalities help in diagnosis. CSF protein is usually normal but there is mononuclear pleocytosis and an increase in intrathecally synthesized immunoglobulin G, which is measured by oligoclonal bands. This patient had some rare features of this disease. She presented first at the age of 8, which is very rare. Another uncommon feature was that two of her attacks of MS were precipitated by fever. In some patients attacks of demyelination do occur with fever due to heat in body (Uhthoff’s phenomenon).

During first episode of demyelination at the age of 8, CSF analysis showed a rise in cell count above 50 cells and a rise in protein content, which made the diagnosis of MS unlikely but her serial MRI showed demyelinating plaques disseminated in time and space.

She had multiple episodes over the last 6 years and repeat CSF during another attack precipitated by fever neither showed pleocytosis or rise in protein. She fulfills

NEUROLOGY all the 5 diagnostic criteria for definite MS although her presentation is unusual. Even residence in the tropics has low incidence of MS - another unusual feature.

SUGGESTED READING

CONCLUSION

2. Harrison’s Principles of Internal Medicine: Volume 2: 17th Edition, Chapter 24.

The diagnostic challenges made this case unique.

Although she presented initially with a picture of viral encephalitis, it was later proved to be MS, since it fulfilled the definitive criteria of MS. Hence the presentation.

3. Harrison’s Principles of Internal Medicine: Volume 2: 17th Edition, Chapter 375.

1. Nelson’s Textbook of Paediatrics. Book 2: 15th Edition, Chapter 552.

4. Adam’s Principles of Neurology. 9th Edition, Chapter 36.

5. DeJong’s The Neurologic Examination. 5th Edition, Chapter 1.

■■■■

Right Brain may Aid Speech Recovery after Left-sided Stroke A new study further validates the idea that the right side of the brain is important for recovery of speech after left-sided strokes, giving a new direction for development of therapies to improve fluency in stroke patients.

Gottfried Schlaug, MD, Harvard Medical School in Boston, Massachusetts said, "Our results suggest that the more damage that occurs to the left brain then the more the right brain comes into action.” The study was published online in Neurology on March 30.

Fusion Imaging for DBS Lead Location Safe and Feasible A study, published in the March issue of Movement Disorders, suggests that a new fusion imaging technology that combines preacquired magnetic resonance with live ultrasonography imaging to check the lead location in patients undergoing deep-brain stimulation (DBS) is feasible and safe. The new technology may reduce the need for repeat CT and MRI in patients having DBS, such as those with Parkinson's disease.

Study Links Lifetime Intellectual Enrichment to Less Brain Amyloid Higher-educated people who carry the Alzheimer's disease (AD) risk allele APOE ε4 and remain cognitively active in middle age show lower levels of the AD biomarker amyloid plaque in older age compared with APOE ε4 carriers who do not, says a new study published in the March 22 issue of the journal Neurology. Prashanthi Vemuri, PhD, from the Mayo Clinic, Rochester, Minnesota and first author of the study said, “The baseline amyloid levels were different between highly educated APOE ε4 carriers who engaged in high cognitive activity in midlife compared to those who did not.”

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

355

OBSTETRICS AND GYNECOLOGY

Role of Resveratrol in Management of Endometriosis URMAN DHRUV

ABSTRACT Endometriosis is one of the most mysterious and fascinating benign gynecological disorders. It is one of the commonest causes of chronic pelvic pain in women. It is also the most searched disease in cases of infertility. Despite availability of many new medical therapies and multidirectional surgical therapies of varying extents, the management of endometriosis is still far from perfect.

Newer molecules with safer adverse effect profiles are being tried experimentally after understanding the etiopathogenesis of the disease in depth. Neovascularization has been thought to be one of the most essential necessities for the development of the disease and this has prompted scientists to try agents, which prevent development of new vessel formation. Resveratrol is one of such therapies which may be holding the future optimistic directions in managing endometriosis. It is found to effective in mouse models and is a substance easily available and has no side effects. If the bigger trials in human beings will be successful, we will soon have a safe substance to manage endometriosis.

Keywords: Resveratrol, endometriosis, transvaginal ultrasound

E

ndometriosis is defined as the occurrence of ectopic endometrial tissues outside the cavity of the uterus. These islands of endometriosis are composed of endometrial glands surrounded by endometrial stroma, which are capable of responding to a varying degree to cyclical hormonal stimulation.

The disease owns an unique pathology of a benign proliferative growth process yet having the propensity to invade the normal surrounding tissues. The incidence varies from 1% to 7% in asymptomatic females to 15% of women with chronic pelvic pain.

Endometriosis is a disease of childbearing age. It is extremely rare before menarche and disappears after menopause. Several theories of histogenesis have been proposed although the mechanism by which it develops is still not completely known and no single theory explains all cases of the disease.

Trans-tubal regurgitation or retrograde menstruation with neovascularization have been the most accepted of multiple theories put forward to explain the pathogenesis of the disease. The symptoms vary according to the site, and do not correlate well with the extent of disease. The classic symptom complex

Director Dept. of Internal Medicine and Diabetes HCG Multispecialty Hospital, Ahmedabad, Gujarat E-mail: drurmandhruv@hotmail.com

includes dysmenorrhea, dyspareunia, menorrhagia and infertility. About 30% of patients are asymptomatic.

Transvaginal ultrasound and laparoscopy generally clinch the diagnosis.

MANAGEMENT Minimal asymptomatic cases should be observed for 6-8 months. Infertility should be investigated and treated as necessary. All symptomatic women need treatment, which depends on the age of the patient, need for preserving reproductive functions, severity of the symptoms, extent of disease, response to medical treatment, relief obtained with previous conservative surgery and attitude of the patient towards her problem.

The objective of the treatment is to reverse and if possible, eliminate disease process, alleviate symptoms, facilitate childbearing and enable the patient to lead a good quality-of-life. The treatment, therefore, needs to be individualized. A combination of medical and surgical treatment may serve the purpose in most of the cases.

The treatment of mild and moderate endometriosis with hormonal preparations may not offer any advantage over expectant management in promoting conception.

The medical treatment includes the use of combined oral contraceptive pills, oral progestogens, danazol or gestrinone, gonadotropin-releasing hormone (GnRH) and aromatic inhibitors.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

357

OBSTETRICS AND GYNECOLOGY ROLE OF RESVERATROL IN MANAGEMENT OF ENDOMETRIOSIS

Need for Better Molecules Endometriosis is one of the most mysterious and fascinating benign gynecological disorders. Although it has been extensively investigated in the past century, it remains an enigmatic disease process. The often subtle and varied appearances of endometriosis can make recognition and surgical staging difficult, thereby casting doubt on the utility of the classification systems that have been developed. Nevertheless, the findings of well-designed clinical trials and recent studies that elucidated the pathogenesis of endometriosis, have enabled a more rational approach to the medical and surgical management of endometriosis. However, the association between endometriosis and infertility is still undefined, and there are scanty data to support the many hormonal and surgical therapies that have been proposed. All these controversies and uncertainties have led to use of certain unconventional or less documented therapies, which may be helpful in managing the disease or prevent the complications.

compounds. The latter ones have been successfully used in traditional medicine without inducing severe side effects. Thus, in view of their favorable risk profile, they may be also highly preferable for the safe treatment of endometriosis patients.

What is Resveratrol?

Resveratrol is one such natural phytoalexin, which represents one of the most frequently analyzed phytochemical compounds in life sciences during the last decades. Because resveratrol exerts a broadspectrum of beneficial effects under various pathological conditions, it has been suggested as a promising therapeutic agent for the treatment of cancer as well as several inflammatory, metabolic and cardiovascular diseases.

Sources

The medical therapy for endometriosis is symptomatic rather than curative and most patients experience pain relapse at suspension of treatment because restoration of ovulation and of physiological levels of estrogen restores the metabolic activity of both eutopic and ectopic endometrium. Unfortunately, these approaches often have only modest success and are associated with significant risk of complications and side effects; consequently, the search continues for new, safe and effective long-term treatments. This leads to development of newer modalities in the management of disease.

Resveratrol is a polyphenol synthesized by plants following ultraviolet radiation and fungal infections.

Resveratrol (3,5,4â&#x20AC;&#x2122;-trihydroxy-trans-stilbene) is found in red grape skin, Japanese knotweed (Polygonum cuspidatum), peanuts, blueberries and some other berries. A large amount of resveratrol is produced in the skin of grapes to protect the plant against fungal diseases and sun damage; therefore, wine has higher levels of resveratrol compared to other natural food.

Overall, red wine contains small amounts of resveratrol, <1-2 mg/8 ounces of red wine. However, red wine has more resveratrol than white wine because red wines are fermented with the grape skins longer than white wines. Hence, many of the antioxidants including resveratrol that are naturally present in the grape skins are extracted into the wine. Resveratrol is also present in the seeds and pomace of grapes.

Pathogenesis of Endometriosis

Mechanism of Action

It is widely accepted that peritoneal endometriotic lesions develop from endometrial tissue fragments, which are retrogradley shed through the fallopian tubes during menstruation. During the past few years, numerous studies could demonstrate that the establishment and survival of these lesions is crucially dependent on the formation of blood vessels, which guarantee their oxygen supply. Accordingly, anti-angiogenic agents of different substance groups are currently discussed as promising candidates for future endometriosis therapy.

Besides specific growth factor antagonists, endogenous angiogenesis inhibitors, statins, cyclooxygenase-2 inhibitors and immunomodulators, these antiangiogenic agents also include several phytochemical

Resveratrol is a pleiotropic agent, which dosedependently suppresses the development of new blood vessels. Growing evidence indicates that this compound possesses antineoplastic, anti-inflammatory and antioxidant properties. Resveratrol has also been shown to exhibit profound in vitro and in vivo growth inhibiting and apoptosis - inducing activities in several biological systems, cancer cell lines and animal models of carcinogenesis. These properties have been linked to inhibition of proliferation in association with cell cycle arrest and, in some systems, with increased apoptotic cell death. Mechanisms of action of resveratrol further include multiple cellular targets affecting various signal transduction pathways, including AKT,

358

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

OBSTETRICS AND GYNECOLOGY RPS6KB2 (p70S6K), mitogen-activated protein kinase 1/3 (MAPK1/3; ERK1/2), STAT3, MAPK14 (p38), protein kinase C and peroxisome proliferator-activated receptors (PPARs)-gamma. Importantly, several of these pathways are relevant to the pathophysiology of endometriosis.

Evidences In a study carried out by Bruner-Tran et al, it was shown that resveratrol reduced development of experimental endometriosis, as evidenced by a decreased proportion of animals with endometriotic lesions, a lower number of lesions and a smaller volume of lesions. These protective effects of resveratrol may be related to various mechanisms such as reduction of proliferation of endometrial cells, increased cell death (e.g., apoptosis), and/or reduced ability to attach and to implant. As the duration of treatment did not matter as far as reduction in number of lesions or volume was concerned, it is likely that the primary mode of action of resveratrol may be related to prevention from, or at least reduction of, implantation of endometrial tissues.

In another study, patients who remained symptomatic while using a continuous regimen of a combined pill containing drospirenone and ethinyl estradiol, the concomitant use of resveratrol at a daily dose of 30 mg resulted in a significant reduction in the number of patients reporting the occurrence of pain. This suggests that the combination of oral contraceptives with naturally occurring aromatase inhibitors may show promise for the treatment of endometriosis, particularly in patients who failed to respond satisfactorily to oral contraceptives alone because of the persistence of dysmenorrhea-like pain and breakthrough bleeding.

Adverse Effects Patients who have blood disorders, which can cause bleeding, should be monitored by a physician while taking this product. People undergoing surgery should stop taking resveratrol 2 weeks before the surgery and not take it for 2 weeks after the surgery to reduce the risk of bleeding. Safety of the same has not been established in pregnant or lactating women. Resveratrol has mild estrogenic activity and until more is known,

women with cancers and other conditions that are estrogen sensitive should seek medical advice before taking resveratrol.

CONCLUSION Resveratrol is a potent inhibitor of vascularization in endometriotic lesions. This, most probably, causes the suppression of lesion growth. Accordingly, resveratrol represents a promising candidate therapy for future phytochemical treatment of endometriosis.

Although a large number of studies show encouraging results, it is still premature to recommend it as an accepted line of treatment because the dose, the purity and their possible adverse effects still remain largely unknown. Large population-based studies are required to establish the recommendation. Randomizedcontrolled trials to establish doses and drug safety will give the answers to these questions in future. To date, although resveratrol is widely used as a nutritional supplement, it has not been approved by the Food and Drug Administration for any clinical application and its long-term safety has yet to be proven.

SUGGESTED READING 1. Howkins & Bourne Shaw’s Textbook of Gynecology.

2. TeLinde’s Operative Gynecology.

3. Giudice LC, Kao LC. 2004;364(9447):1789-99.

Endometriosis.

Lancet.

4. Bruner-Tran KL, Osteen KG, Taylor HS, Sokalska A, Haines K, Duleba AJ. Resveratrol inhibits development of experimental endometriosis in vivo and reduces endometrial stromal cell invasiveness in vitro. Biol Reprod. 2011;84(1):106-12.

5. Rudzitis-Auth J, Menger MD, Laschke MW. Resveratrol is a potent inhibitor of vascularization and cell proliferation in experimental endometriosis. Hum Reprod.

2013;28(5):1339-47.

6. Galle PC. Clinical presentation and diagnosis of endometriosis. Obstet Gynecol Clin North Am. 1989;16(1):29-42.

7. Chen Y, Tseng SH. Review. Pro- and anti-angiogenesis effects of resveratrol. In Vivo. 2007;21(2):365-70.

8. Smoliga JM, Baur JA, Hausenblas HA. Resveratrol and health - a comprehensive review of human clinical trials.

Mol Nutr Food Res. 2011;55(8):1129-41.

■■■■

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

359

OBSTETRICS AND GYNECOLOGY

Vulval Leiomyoma: A Rare Case Report AKSHAYA MAHAPATRO*, INDUMATHI JOY†, THANKAM VERMA‡, SARAH KURUVILLA‡

ABSTRACT Leiomyoma is a rare entity in vulva. Most of the vulval leiomyomas are usually misdiagnosed as Bartholin’s cysts and later diagnosis of leiomyoma is established by histopathological examination, only after surgical excision. We present here the case of a 48-year-old perimenopausal multiparous woman who presented with a vulval mass, which following surgical excision proved to be histopathologically a benign spindle cell tumor of smooth muscle origin (vulval leiomyoma) as confirmed by immunohistochemistry. The recommended treatment is surgical excision of the mass with histopathological examination.

Keywords: Leiomyoma, Bartholin's cyst, surgical excision, histopathology, immunohistochemistry

L

eiomyoma of vulva is uncommon and is clinically misdiagnosed as a Bartholin cyst or other soft tissue tumor.1 Leiomyoma develops during the reproductive period and regresses after the menopause.2 Usually, it is diagnosed by histopathological examination after surgical excision.

CASE REPORT A 48-year-old perimenopausal multiparous women came to our hospital with complaints of swelling in the genital region for last 10 years, which was increasing gradually for the past 1 year and she had discomfort in the vulva. She had a past history of laparoscopic cholecystectomy 1 year back. Her bowel and bladder habits were normal. Her systematic examination was normal.

removed completely by sharp dissection (Fig. 2).

Dead space was obliterated with vicryl absorbable interrupted suture and specimen was sent for histopathological examination. She was managed with antibiotic, analgesic and discharged on postoperative Day 3. On gross examination, the mass was firm in consistency, of size 3 × 3 × 2 cm and weighed 15 g.

Cut section showed an encapsulated grayish-white nodular piece of tissue with a firm grayish-white cut surface. Microscopic examination showed a

On local examination, there was a swelling on the right labia majora of size 3 × 4 cm (Fig. 1), mobile, firm inconsistency and nontender. She was provisionally diagnosed as right Bartholin cyst and planned for complete excision of the cyst. A linear incision was given over the vulval swelling at the mucocutaneous junction of the right labia majora and the cyst was

*Fellow †Consultant ‡Medical Director #HOD Pathology Institute of Reproductive Medicine, Madras Medical Mission, Chennai, Tamil Nadu Address for correspondence Dr Akshaya Mahapatro Fellow, Institute of Reproductive Medicine, Madras Medical Mission Chennai, Tamil Nadu - 600 037 E-mail: dr.aks73@gmail.com

360

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Figure 1. Vulval cyst.

OBSTETRICS AND GYNECOLOGY

Figure 5. S-100 negative.

Figure 2. Enucleation of cyst.

well-circumscribed tumor composed of interlacing fascicles of spindle-shaped cells (Fig. 3) with eosinophilic cytoplasm and round to oval nuclei exhibiting rare mitotic activity with evidence of stromal hyalinization.

Immunohistochemical examination by smooth muscle antigen showed intense cytoplasmic positivity (Fig. 4) and S-100 protein was negative (Fig. 5). Correlating immunohistochemistry with histopathology, the features were in favor of a benign spindle cell tumor of smooth muscle origin (leiomyoma of vulva).

DISCUSSION

Figure 3. H&E 40X- showing interlacing fascicles of spindleshaped cells with eosinophilic cytoplasm and round to oval nuclei exhibiting rare mitotic activity.

Figure 4. Smooth muscle antigen showing strong cytoplasmic positivity.

Leiomyoma or fibroid, though seen very commonly in the uterus, is a rare entity in vulva, ovaries, urethra and urinary bladder. However, it has the propensity to arise at any anatomic site.3 Leiomyoma is a hormone sensitive tumor, develops during reproductive age and regresses at menopause. Smooth muscle tumors, though rare, do occur in the vulva. Most of the vulval leiomyomas are usually misdiagnosed as Bartholinâ&#x20AC;&#x2122;s cysts and diagnosis is established as leiomyomas by histopathological examination after surgical excision.4-6 It is important to differentiate vulval leiomyoma from the malignant counterpart.4 The mean age at presentation varies from 13 to 71 years. The average tumor size varies from 0.5 to 15 cm.6 The clinical symptoms and imaging features depend on the location of the lesion and on its growth pattern.

Transperineal ultrasonography is of help in establishing the diagnosis of vulval leiomyoma, while magnetic resonance imaging (MRI) is of help in differentiating benign and malignant forms in doubtful cases.

A characteristic finding of low signal intensity mimicking that of smooth muscle on T2-weighted

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

361

OBSTETRICS AND GYNECOLOGY images is the key to diagnosis.3 Surgical excision is the treatment of choice in all smooth muscle tumors of vulva. Histopathological confirmation of its benign or malignant nature is mandatory. Immunohistochemistry markers such as smooth muscle antigen and S-100 help to differentiate the leiomyoma from other spindle cell lesions. This differentiation is a great challenge to the pathologist. In our patient, we did immunohistochemistry to confirm the diagnosis. Longterm follow-up of all cases is advisable.6 CONCLUSION Extrauterine leiomyomas are rare, and they present a greater diagnostic challenge. Unusual sites of origin include the vulva, ovaries, urinary bladder and urethra.

Differential diagnosis includes Bartholin’s cysts, fibromas, lymphangiomas, soft-tissue sarcomas and neurogenic tumors. Ultrasonography/MRI might be of help in establishing the diagnosis. Labial leiomyomas are usually treated with conservative surgery. After the surgery, long-term follow-up is advised.

REFERENCES 1. Zhou J, Ha BK, Schubeck D, Chung-Park M. Myxoid epithelioid leiomyoma of the vulva: a case report. Gynecol Oncol. 2006;103(1):342-5.

2. Pitukkijronnakorn S, Leelachaikul P, Chittacharoen A. Labial leiomyoma: a case report. J Med Assoc Thai.

2005;88(1):118-9.

3. Fasih N, Prasad Shanbhogue AK, Macdonald DB, FraserHill MA, Papadatos D, Kielar AZ, et al. Leiomyomas beyond the uterus: unusual locations, rare manifestations.

Radiographics. 2008;28(7):1931-48.

4. Youssef A, Neji K, M’barki M, Ben Amara F, Malek M, Reziga H. Leiomyoma of the vulva. Tunis Med. 2013;91(1):78-80.

5. Francis SA, Wilcox FL, Sissons M. Bartholin’s gland leiomyoma: a diagnostic and management dilemma.

J Obstet Gynaecol Res. 2012;38(6):941-3.

6. Nielsen GP, Rosenberg AE, Koerner FC, Young RH, Scully RE. Smooth-muscle tumors of the vulva. A clinicopathological study of 25 cases and review of the literature. Am J Surg Pathol. 1996;20(7):779-93.

■■■■

ACOG Recommends Immediate Postpartum Long-acting Reversible Contraception Obstetric care providers should offer new mothers the option of receiving long-acting reversible contraception (LARC) immediately after delivery or before hospital discharge, recommends a committee opinion published by the American College of Obstetricians and Gynecologists (ACOG) in the August 2016 issue of Obstetrics & Gynecology. Some of the key recommendations are as follows: ÂÂ

Women should be counseled prenatally about the option of immediate postpartum LARC. This should cover the advantages, risks of intrauterine device (IUD) expulsion, contraindications and alternatives to allow for informed decision making.

ÂÂ

Immediate postpartum LARC should be offered as an effective option for postpartum contraception, with are few contraindications to postpartum IUDs and implants. Women should be counseled about the convenience and effectiveness of immediate postpartum LARC, as well as the benefits of reducing unintended pregnancy and lengthening interpregnancy intervals.

ÂÂ

Contraceptive counseling should include information about the increased risk of expulsion, including unrecognized expulsion, with immediate postpartum IUD insertion compared with interval IUD insertion.

362

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

OBSTETRICS AND GYNECOLOGY

An Evaluation of Antepartum and Intrapartum Surveillance with Nonstress Test in Cases of FGR and Its Correlation with Perinatal Outcome MEENAL JAIN*, MUKESH CHANDRA†, SAROJ SINGH‡, URVASHI VERMA*, POONAM AGARWAL#

ABSTRACT Fetal growth restriction (FGR) is one of the leading causes of high risk in pregnancy, which can result in significant fetal/ perinatal morbidity and mortality. The desire to prevent these complications helps in assessing fetal well-being in the womb. The introduction of cardiotocographic monitoring nonstress test to the clinical practice has significantly reduced the incidence of birth asphyxia and other fetal complications. There has been a continuous debate regarding its usefulness compared with intermittent auscultation. There are not enough evidences to recommend the use of antenatal cardiotocography (CTG) for fetal assessment in FGR as CTG changes are manifested relatively late in the disease process. A study was undertaken to analyze the correlation between results shown by CTG (both antepartum and intrapartum) and fetal/perinatal outcome in normal cases as well as in cases of FGR.

Keywords: Fetal growth restriction, perinatal outcome, nonstress test, ultrasonography, surveillance

F

etal growth restriction (FGR) is one of the leading causes of high risk in pregnancy, which can result in significant fetal/perinatal morbidity and mortality if not properly diagnosed and managed. FGR is challenging because of the difficulties in reaching a definitive diagnosis of the cause and planning management. The desire to prevent these complications has prompted the obstetricians to develop methods of assessing fetal condition in utero both antepartum and intrapartum. Fetal heart rate is normally increased or decreased on beat-to-beat basis by autonomic influences from brainstem centers. Besides cardioregulatory centers in brainstem, fetal heart rate also varies with various physiological and pathological conditions in pregnancy like FGR.

*Assistant Professor †Professor ‡Professor and Head #Junior Resident-III Dept. of Obstetrics and Gynecology SN Medical College, Agra, Uttar Pradesh Address for correspondence Dr Meenal Jain Chandra Orthopedic and Maternity Centre 1/198, Civil Lines, Bagh Farzana, Agra - 282 002, Uttar Pradesh E-mail: drmeenalgyne@gmail.com

Cardiotocography (CTG) in itself is a useful and indispensable adjunct to monitor the condition of the (endangered) fetus. There has been a continuous debate regarding its usefulness compared with intermittent auscultation. Both methods in principle provide similar information. However, CTG in comparison with intermittent auscultation results in continuous versus spot-like, and objective versus subjective data.

Role of CTG: It helps in assessing fetal well-being in the womb. The introduction of cardiotocographic monitoring nonstress test to the clinical practice has significantly reduced the incidence of birth asphyxia and other fetal complications. Although CTG is assessed as reactive using criteria graded for gestational age, this is very reassuring. However, a nonreactive CTG has a poor correlation with fetal status unless overtly abnormal patterns are observed.

As far as the role of CTG in cases of FGR is concerned, there are not enough evidences to recommend the use of antenatal CTG for fetal assessment in FGR, as CTG changes are manifested relatively late in the disease process and are usually preceded by abnormal Doppler velocity patterns. Despite the lack of evidence, this technique is widely used and, provided its limitations are well-recognized and traces are interpreted with caution and in combination with other evidence, it may be useful. In the proposed study, our focus will be to

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

363

OBSTETRICS AND GYNECOLOGY analyze the correlation between results shown by CTG (both antepartum and intrapartum) and fetal/perinatal outcome in normal cases as well as in cases of FGR. MATERIAL AND METHODS The present study was carried out in the Dept. of Obstetrics and Gynecology, SN Medical College, Agra in November 2014.

Selection of Cases Antenatal women of more than 32 weeks gestation with or without FGR, attending the outpatient department (OPD) and labor room of Dept. of Obstetrics and Gynecology, SN Medical College, Agra were recruited for the study.

Sample Size The study was carried out in the Dept. of Obstetrics and Gynecology, SN Medical College, Agra. Fifty antenatal patients with more than 32 weeks of gestation and intranatal cases diagnosed as case of FGR by ultrasonography (USG) or clinically, formed the study group to be monitored by CTG. The control group on the other hand comprised of 50 antenatal patients (more than 32 weeks gestation or early labor without any FGR) to be monitored by CTG. The fetal outcome was assessed by thick meconium-stained liquor (MSL), mode of delivery, Apgar score at 1 and 5 minutes, neonatal intensive care unit (NICU) admission and perinatal mortality. CTG was repeated weekly/biweekly depending upon the severity of disease.

According to Table 2a, comparing the mean fetal heart rate in both groups, fetal tachycardia was the more common abnormal heart rate pattern in both the groups but the overall evidence of abnormal heart rate pattern was more common (32%) in study group as compared to control group.

In Table 2b comparing beat-to-beat variability, 20% cases in study group showed decreased variability as compared to 8% cases in control group. Similarly, increased variability was more common in study group (10%) as compared to control group (4%).

Table 3 shows the types of deceleration in both groups.

It was found that 72% had no deceleration in study group as compared to 90% in control group. While the most common types of deceleration in study group was late deceleration (16%) as compared to early deceleration (4%) and variable deceleration (8%). In control group, 8% cases had early deceleration, 2% had late deceleration and none had variable deceleration.

Table 2a. Mean Fetal Heart Rate Baseline FHR (bpm)

Study group

Control group

No.

%

No.

%

110-160

34

68

40

80

Tachycardia (>160)

12

24

8

16

Bradycardia (<110)

4

8

2

4

Table 2b. Beat-to-beat Variability

OBSERVATIONS AND RESULTS According to Table 1, which compared the demographic profile of study and control group: ÂÂ

Thus, the two groups were comparable on the basis of demographic profile.

The mean age in study group was 27.16 years and that in control group for 26.38 years.

ÂÂ

The mean period of gestation in study group was similar to control group i.e., 37.18 months.

ÂÂ

The mean per capita income in study group was ` 634.32 and that in control group was ` 530.1.

Study group

Control group

No.

%

No.

%

Decreased (<5)

10

20

4

8

Normal (5-25)

35

70

44

88

Increased (>25)

5

10

2

4

Total

50

100

50

100

Table 3. Types of Deceleration in Both Groups Deceleration

Table 1. Demographic Profile

Study group

Control group

No.

%

No.

%

72

45

90

Study group

Control group

Absent

36

27.16 ± 93.59

26.38 ± 103.16

Early

2

4

4

8

1.66 ± 1.16

1.36 ± 1.02

Late

8

16

1

2

Mean period of gestation

37.18 ± 186.05

37.18 ± 171.36

Variable

4

8

0

0

Mean per capita income

634.32 ± 429.93

530.1 ± 402.99

Total

50

100

50

100

Mean age Mean parity

364

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

OBSTETRICS AND GYNECOLOGY Table 4 elucidates the interpretation of CTG (antepartum and intrapartum) in both groups. ÂÂ

ÂÂ

In study group, 60% cases showed reassuring trace in antepartum period and 20% during intrapartum period. Test was nonreassuring in 6% subjects in antepartum period, which increased to 14% during the intrapartum period.

In control group, 72% cases had a reassuring trace in antepartum period while 2% cases had a nonreassuring trace in antepartum period, which increased to 10% in intrapartum period.

The results were statistically significant.

Table 5 shows the correlation of CTG change with perinatal outcome.

In the study group, 15% of cases showing reassuring trace had MSL while 80% cases showing nonreassuring trace had MSL. Similarly in the control group, only 2% of reassuring trace had MSL as compared to 83.3% cases showing nonreassuring trace. The mean Apgar score in study cases with reassuring trace was 6.26 as compared to 8.26 in control cases showing reassuring trace. The mean Apgar score in study cases showing nonreassuring trace was 5.56 as compared to 6 in control group. In both the study and control groups, only 5% cases underwent cesarean delivery when showing reassuring trace as compared to 60% cases showing nonreassuring trace in study group and 33.31% in control group.

In study group, 8% of cases showing reassuring trace were admitted in NICU as compared to 4% cases in control group. In cases showing nonreassuring pattern, 20% cases in study group and 4% cases in control group underwent admission in NICU. In the nonreassuring study group, perinatal mortality was 8% as compared to 4% in control group.

DISCUSSION In our study, most of the cases were multigravida between age group 21-25 years. The mean age group in study by Padmagirison et al1 was 27.7. The mean period of gestation was 37.18 weeks. The mean period of gestation in study by Padmagirison et al1 was 34 weeks.

A comparative summary of interpretation of CTG in various studies including the present study is shown in Table 6. Most of the cases in our study belonged to Class IV of BJ Prasad classification. It is the lower socioeconomic class, which is subject to most of the risk factors because of poor nutrition and ignorance about various obstetrical problems. Thirty-two percent cases in study group had abnormal fetal heart rate, while fetal heart rate in control group was abnormal in 20% cases with statistically significant results. Again 20% cases in study group had abnormal fetal heart rate variability as compared to only 12% cases in control group. In our study group, 28% cases showed one or the other types

Table 4. CTG in Both Groups Study group Antepartum Reassuring

Control group Intrapartum

Antepartum

Intrapartum

No.

%

No.

%

No.

%

No.

%

30

60

10

20

36

72

8

16

Nonreassuring

3

6

7

14

1

2

5

10

Total

33

66

17

34

37

74

13

26

Table 5. Correlation of CTG Changes and Perinatal Outcome Study group

Control group

Reassuring

Nonreassuring

Reassuring

Nonreassuring

15

80

2

83.3

6.26

5.56

8.26

6.0

Mode of delivery - cesarean (%)

5

60

5

33.3

Vaginal (%)

95

40

95

66.6

NICU admission (%)

8

20

4

4

Perinatal mortality (%)

0

8

0

4

Occurrence of MSL (%) Mean Apgar score

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

365

OBSTETRICS AND GYNECOLOGY 1.96% but in pathological NST group, it was 92.9%.

The number of NICU admission were far greater in cases showing nonreassuring pattern in study group (20%) as compared to those in control group (4%).

According to a study by Sood,6 admission in NICU were 20%. Similarly, the percentage of perinatal deaths were greater (8%) in study group as compared to control group. Thus, CTG findings surely are important to assess perinatal outcome.

Table 6. Interpretation of CTG in Various Studies Worker

Year

No. of high Interpretation risk cases

Ivanovski et al2

2005

Padmagirison et al1

2006

55

Piyamongkol et al3

2006

270

Present study

2014

78

Reassuring (49) Nonreassuring (29) Reassuring (35) Nonreassuring (20) Reassuring (228) Nonreassuring (42)

50

CONCLUSION

Reassuring (40) Nonreassuring (10)

of deceleration in which 4% had early, 16% had late and 8% had variable deceleration while in the control group only 10% had decelerations (8% had early and 2% had late deceleration).

Late deceleration indicative of uteroplacental insufficiency were the most common type. In Mahomed et al4 study also, late deceleration was the commonest type of pattern observed in study group.

In our study group, 60% had a reassuring CTG in antepartum period, whereas 6% subject had a nonreassuring trace in antepartum period, which increased to 14% in antepartum period.

Coming to the parameters deciding perinatal outcome.

It was found that there was 80% chance of having MSL when CTG found to be nonreassuring in study group.

Similarly, Apgar scores were lower with nonreassuring CTG as compared to reassuring CTG. In study group, cases showing nonreassuring nonstress test 60% cases had a cesarean delivery, while 40% cases delivered vaginally. Out of which, 2 cases had an associated continuing professional development (CPD), 1 patient had complete placenta previa and 2 patients had malpresentations. In a study by Moga et al5 in the reactive group, the rate of cesarean was less than

Cardiotocography is an effective means for fetal surveillance for pregnancies complicated by FGR. An abnormal CTG is an important prediction of poor fetal outcome and is statistically significant to adopt necessary measures to prevent fetal/perinatal morbidity or mortality.

REFERENCES 1. Padmagirison R, Rai L. Fetal Doppler versus NST as predictors of adverse prenatal outcome in severe preeclampsia and fetal growth restriction. J Obstet Gynaecol India. 2006;56(2):134-8.

2. Ivanovski MJ, Lazarevski S, Popovie M. Meddle cerebral artery flow velocity waveform in prediction of adverse outcomes intrauterine growth retarded fetuses. Gynaecol Perinatal. 2005;14(3):133-99.

3. Piyamongkol W, Trungtawatchai S, Chanprapaph P, Tongsong T. Comparison of the manual stimulation test and the nonstress test: a randomized controlled trial.

J Med Assoc Thai. 2006;89(12):1999-2002.

4. Mahomed K, Nyoni R, Mulambo T, Kasule J, Jacobus E. Randomised controlled trial of intrapartum fetal heart rate monitoring. BMJ. 1994;308(6927):497-500.

5. Moga M, Ples L, Martinescu A. Current interpretation and importance of fetal cardiotocographic monitoring. Bulletin of the Transilvania University of Brasov. 2006;13(48):215.

6. Sood AK. Evaluation of non-stress test in high risk pregnancy. J Obstet Gynecol India. 2002;52(2):71-5.

■■■■

Study Detects Zika RNA in Pregnant Women Beyond the Estimated Timeframe Zika virus may be detectable in pregnant women for longer than previously thought, suggests a study published in Obstetrics and Gynecology, July 29, 2016. Analysis of data from the CDC’s US Zika Pregnancy Registry showed that Zika virus RNA was detected in the serum of five pregnant women who had been exposed to the virus at least 2 weeks prior to PCR testing beyond the previously estimated timeframe.

366

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

ONCOLOGY

Bilateral Primary Ovarian Amelanotic Malignant Melanoma Arising in a Mature Teratoma in Pediatric Age Group HIRAL ANKITBHAI SHAH*, KALPANA CHANDRA†, ANKITBHAI ATULBHAI SHAH‡, PRANAB KUMAR VERMA#

ABSTRACT Primary amelanotic melanoma of ovary arising in mature cystic teratoma is extremely rare and frequently may lead to clinical and even histopathological misdiagnosis. Our patient was in pediatric age group and presented with bilateral ovarian mass. On conventional histopathology, it was misdiagnosed and reported as anaplastic dysgerminoma with syncytiotrophoblastic giant cells along with mature teratomatous component in the background. On immunohistochemistry, the final diagnosis rendered was amelanotic epithelioid melanoma with component of mature teratoma.

Keywords: Amelanotic melanoma, ovarian teratoma

M

etastatic malignant melanomas are more common than primary malignant melanomas of the ovaries. If primary malignant melanomas occur, they always manifest in a background of teratomas, as ovaries normally do not contain melanin-producing cells.1 Amelanotic melanomas are a rare subtype of melanomas which are devoid of pigments and constitute about 2-8% of all malignant melanoma cases.2 Here, we report an extremely rare case of bilateral ovarian mature teratoma transformed into primary amelanotic malignant melanoma with multiple metastatic lesions in a 13-year-old female child.

CASE REPORT A 13-year-old female patient presented to our hospital with the complaints of lump and pain abdomen for

*Senior Resident Dept. of Pathology, Mahavir Cancer Sansthan, Patna, Bihar †Assistant Professor Dept. of Pathology, Indira Gandhi Institute of Medical Sciences, Patna, Bihar ‡Third Year DNB Trainee Dept. of Surgery Oncology, Mahavir Cancer Sansthan, Patna, Bihar #Consultant Pathologist Dept. of Pathology, Mahavir Cancer Sansthan, Patna, Bihar Address for correspondence Dr Kalpana Chandra Flat No. 501, Yamuna - 1, Jalalpur City, Near BR Ambedkar Dental College, Ramjaipal Road, Baily Road, Danapur, Patna, Bihar - 801 503 E-mail: kalpana_chandra_14@yahoo.co.in

3 months. She had attained menarche 6 months back with regular cycles. Past and family history were unremarkable. On abdominal examination, she was found to have a hard mobile lump in the periumbilical and hypogastric region with evidence of free fluid.

Computed tomography (CT) scan showed a large heterogeneously enhancing solid cystic mass in the lower abdomen and pelvis with foci of calcification and fat density lobule. Multiple enhancing deposits were seen in the pelvis with multiple retroperitoneal nodes and moderate ascites. Features were suggestive of malignant ovarian teratoma with peritoneal deposits. Laboratory investigations included tumor marker tests (alpha-fetoprotein [AFP], human chorionic gonadotropin [hCG], carcinoembryonic antigen [CEA]), which were within normal limits with exceptionally raised cancer antigen 125 (CA-125) >1,000 U/mL. So, cytoreduction surgery was done which included bilateral salpingo-oophorectomy, bilateral pelvic lymph node dissection, para-aortic lymph node dissection with supracolic omentectomy and preservation of uterus and cervix.

On gross examination, right and left ovaries were wellencapsulated and measured 6.5 × 4 × 3 cm3 and 23 × 13 × 9 cm3, respectively. On cut section, both ovaries were partly cystic containing sebum-like pultaceous material and bunch of hair follicles. Solid area was firm on cut, tan white. Both fallopian tubes were unremarkable. Microscopically, sections from solid area showed sheets and lobules of epithelioid cells. Many

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

367

ONCOLOGY Table 1. Positive and Negative IHC Markers Immunopositive markers

Immunonegative markers

S-100

Cytokeratin

HMB-45

EMA

Melan-A

CA-125

CD56 (focally)

c-Kit (CD117) Oct-4 PLAP Glypican-3 Alpha-fetoprotein Calretinin Mic-2 MITF Inhibin

infiltrates were present on the lobular septa. Cystic area was partially covered by squamous epithelium with many hair follicles, sebaceous glands and adipose tissue present in the underlying stroma. No other structures were identified, which could lead to the diagnosis of epithelial malignancy as suspected by raised CA-125 level. The microscopic cytomorphology, bilaterality and pediatric age group led to the histological diagnosis of anaplastic dysgerminoma with syncytiotrophoblastic giant cells and component of mature dermoid cyst. As there was discrepancy in the histopathology report and clinical diagnosis, immunohistochemistry (IHC) was performed at our center as well as slide was sent for second opinion.

Based on IHC studies, a final diagnosis of bilateral primary amelanotic malignant melanoma with component of mature cystic teratoma was rendered.

DISCUSSION

A

B

C

D

E

F

Figure 1. Microphotographic features of H&E and positive and negative IHC marker slides: A: Tumor with malignant polygonal cells and lymphoid cells (H&E stain; 10x); B: Tumor giant cells (Arrow, H&E, 40x); C & D: Diffuse cytoplasmic positivity for Melan A and HMB-45 (IHC stain, 10x); E and F: Negative for EMA and PLAP, respectively (IHC, 40x; EMA showing cytoplasmic positivity).

of the tumor cells showed multinucleation, bizarre nuclear pleomorphism and brisk atypical mitosis. The nucleoli were prominent. The cytoplasm was abundant, eosinophilic and foamy at places (Fig. 1). No brown pigment was observed in the cytoplasm of tumor cells.

Apart from this, moderate amount of lymphocytic

368

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Mature cystic teratomas are the most common benign germ cell tumors of the ovary, and constitute 15-25% of ovarian tumors overall.3 Malignant changes in dermoid cysts of the ovaries are rare; occurring in 0.2-2% of the cases and squamous cell carcinoma are the commonest, accounting for 88% of all malignancies.4 In the present case, it was very challenging to label it as a primary tumor as bilaterality strongly favored metastatic tumor as per the criterion laid by Boughton et al and Cronje and Woodruff. 5,6 Secondly, our patient was in pediatric age group, whereas youngest female presented with primary malignant melanoma of ovary reported in literature by Carlson and Wheeler et al was 20 years old female.7 Our patient was re-evaluated further and the possibility of melanoma at any other site, mainly skin, central nervous system, eye, vagina, vulva and gastrointestinal tract was ruled out. There was no clinical evidence or previous history of malignant melanoma. As no primary site was identified only one possibility was left as either regression of a cutaneous melanoma or noncutaneous melanoma, which was not picked up on CT scan.

However, the teratomatous component was so welldeveloped in both the ovaries with microscopic breach in the capsule of left ovary, the pathogenesis which we could understand is that initially both the ovaries developed dermoid cyst. Probably, the left ovary developed the dermoid cyst first as evidenced by its size and then gradually due to some unexplained reason the malignant change occurred followed by capsular breach and its metastasis to the contralateral ovary as well as sigmoid colon, pouch of Douglas and

ONCOLOGY peritoneum. Amelanotic form of melanoma is very difficult to diagnose on conventional histopathology techniques as cytomorphology resembles many primary tumors of ovary. IHC plays a vital diagnostic tool for this ovarian neoplasm.

In anaplastic dysgerminoma with syncytiotrophoblastic giant cells, polygonal tumor cells are arranged in lobules or sheets having distinct cell membrane, abundant cytoplasm, round to oval central nuclei with prominent nucleoli. Numerous mitotic figures with syncytiotrophoblastic giant cells are present in the background. CA-125 was raised significantly, which raised the possibility of epithelial malignancy. In both the above differentials, IHC markers were against the diagnosis.

CONCLUSION Primary malignant melanoma of ovary in pediatric age especially amelanotic subtype is extremely rare and presents a diagnosis challenge simulating primary ovarian malignancy. IHC is a valuable diagnostic tool in establishing the definite diagnosis for this type of rare tumors.

Acknowledgment

Radiology of Mahavir Cancer Sansthan for providing me adequate facility, which helped me to carry out this study.

I owe great sense of indebtedness to Dr Anita M Borges for giving her valuable opinion on this case.

REFERENCES 1. Hermann WJ Jr, Humes JJ. A compound nevus in a benign cystic teratoma of the ovary. Am J Clin Pathol.

1976;66(1):54-8.

2. Huvos AG, Shah JP, Goldsmith HS. A clinicopathologic study of amelanotic melanoma. Surg Gynecol Obstet.

1972;135(6):917-20.

3. Lee S, Kim JH, Chon GR, Kim A, Kim BH. Primary malignant melanoma arising in an ovarian mature cystic teratoma - a case report and literature review. Korean J Pathol. 2011;45(6):659-64.

4. Borup K, Leisgård Rasmussen K, Schierup L, Møller JC. Amelanotic malignant melanoma arising in an ovarian dermoid cyst. Acta Obstet Gynecol Scand. 1992;71(3): 242-4.

5. Boughton RS, Hughmanick S, Marin-Padilla M. Malignant melanoma arising in an ovarian cystic teratoma in pregnancy. J Am Acad Dermatol. 1987;17(5 Pt 2):871-5.

6. Cronje HS, Woodruff JD. Primary ovarian malignant melanoma arising in cystic teratoma. Gynecol Oncol.

1981;12(3):379-83.

7.

I take this opportunity to extend my gratitude and sincere thanks to all those who helped me to complete this study.

I am highly thankful to Dept. of Pathology, Surgery and ■■■■

Carlson JA Jr, Wheeler JE. Primary ovarian melanoma arising in a dermoid stage IIIc: long-term disease-free survival with aggressive surgery and platinum therapy.

Gynecol Oncol. 1993;48(3):397-401.

Obesity may Affect Anthracycline Cardiotoxicity Pooled data suggest that excessive body weight is significantly associated with the risk of cardiotoxicity from anthracyclines and sequential anthracyclines and trastuzumab in patients with breast cancer, reported a network meta-analysis of 15 studies involving 8,745 breast cancer patients published online in the Journal of Clinical Oncology. Being obese (BMI of 30 or more) or overweight (BMI of 25 or more) was significantly associated with a greater risk of developing cardiotoxicity after anthracyclines or a sequential anthracyclines and trastuzumab regimen.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

369

ORTHOPEDICS

Diagnostic Dilemma and Limb Salvage Surgery of a Large Giant Cell Tumor of Fibular Head Involving Posterior Tibial Vessels: A Case Report MANTU JAIN*, RITESH RUNU†, SANTOSH KUMAR‡, AVNISH SHEEL#, RITIKA CHOUDHRY¥

ABSTRACT Giant cell tumor (GCT) is common in young age group and is more frequent in females than in males. The upper end of fibula is a rare site for tumors and about one-fifth of all are GCTs. Neurovasculature involvement is a rare and dreaded complication.

This article highlights the associated diagnostic dilemma and management with limb-sparing surgery.

Keywords: Giant cell tumor, proximal fibula, en bloc resection, vascular repair

G

iant cell tumor (GCT) is common in young age group and females are more commonly affected than males. The fibula is a rare anatomic location where both malignant and benign lesions are encountered. Of these, the proximal fibula is the most common area to be involved followed by diaphysis and the distal fibula.1 Osteosarcoma, Ewing’s sarcoma and GCT are the most frequent tumor types to develop at this location even though metastatic lesions have also been reported.

Fibular head tumors account for about 2.5% of total tumor load;2 of these, about 19% are GCTs.3 This location is pathognomonic and the tumor grows for considerable time without causing much symptoms though the adjacent peroneal nerve may be entrapped.

The X-ray findings are characteristic and additional investigations like computed tomography (CT) and

*Assistant Professor Dept. of Orthopedics AIIMS, Bhubaneswar, Odisha †Associate Professor ‡Additional Professor Dept. of Orthopedics #Assistant Professor Dept. of Cardiothoracic and Vascular Surgery ¥Senior Resident Dept. of Pathology Indira Gandhi Institute of Medical Sciences, Patna, Bihar Address for correspondence Dr Mantu Jain 106, Mahadev Orchid, Cosmopolis Road, Dumduma, Bhubaneswar - 751 019, Odisha E-mail: montu_jn@yahoo.com

370

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

magnetic resonance imaging (MRI) are only needed to see the extent and involvement of soft tissues and to plan surgery.

We report a case where the X-ray findings were typical of GCT but contrast MRI suggested telangiectatic osteosarcoma and created a diagnostic confusion.

Intraoperative vessel involvement is rare in GCT. Eventually, the limb was salvaged after vascular reconstruction following tumor excision.

Histopathologic examination proved GCT. CASE REPORT A 19-year-old female presented with swelling around the outer aspect of left knee for 6 months associated with pain while walking and restriction on squatting.

There was no significant contributing history.

On examination, the swelling was 6 × 4 cm in size, firm to hard inconsistency, nontender on deep palpation.

The overlying skin was nonadherent, nonshiny with no associated vessel engorgement. The adjoining peroneal nerve revealed a normal function. All routine hematological investigations were normal and chest radiograph was also normal.

Anteroposterior and lateral radiographs of the knee with leg were taken, which showed single epiphyseal lesion involving the fibular head with little loculations (Fig. 1a). The lesion was expansile more medial than lateral (Fig. 1b). MRI showed lesion about 52 × 50 × 54 mm size with ballooning, cortical thinning and breech at places, hypointense on T1W and isointense

ORTHOPEDICS

Figure 1a. X-ray of the knee joint showing the tumor involving upper end of fibula.

Figure 2a. MRI images of the right knee shows a large welldefined, lobulated mass (black arrows) and in proximal fibula (white arrow in B), the lesion is predominately hyerintense in STIR coronal images.

Figure 2b. T2 sagittal shows lesion is isointense to hyperintense.

Figure 1b. Chest X-ray PA view looks normal.

to hyperintense in T2W, short tau inversion recovery (STIR) and heterogeneous enhancement on post gadolinium images involving the posterior vascular bundle with most likely diagnosis of telangiectatic osteosarcoma (Fig. 2a-d).

Fine-needle aspiration cytology (FNAC) of the swelling was done and giant cells were seen. With an inconclusive preoperative diagnosis, excisional biopsy (type 1 resection) was planned after explaining the prognosis

Figure 2c. STIR post contrast axial showing heterogeneous enhancement.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

371

ORTHOPEDICS

Figure 2d. STIR post contrast coronal showing heterogeneous enhancement.

Figure 3a. Intraoperative picture with peroneal nerve dissection.

to the patient and her husband. With the patient in supine position, a pneumatic tourniquet was applied in the left thigh. Limb exsanguination was not done.

The peroneal nerve was carefully dissected (Fig. 3a).

The fibula was osteotomized distal to tumor area at the normal bone level. The tumor mass was then lifted and carefully dissected bluntly from distal to proximal. On the medial aspect, the post-tibial vessels were adherent with the capsule of tumor. Even with meticulous and slow dissection three tears were found in the posterior tibial vessels. Immediately, a saphenous vein was harvested from contralateral limb and end-toend anastomosis was performed by vascular surgeon (Fig. 3b and 3c).

The lateral collateral ligament and biceps femoris tendon were sutured to adjacent tibia to prevent instability. The wound was thoroughly washed and closed in layers with drain. A postoperative slab with knee in flexion was applied. The mass was sent for biopsy.

Postoperatively patient was heparinized and it was tapered off with warfarin tablets.

Postoperative CT angiography was performed at 7th day, which showed continuity of flow (Fig. 4).

Postoperative radiographs were taken (Fig. 5).

Histopathological examination confirmed GCT (Fig. 6).

Sutures were removed after 2 weeks with removal of slab. Patient was kept nonweight-bearing for 6 weeks and gradually mobilized with range of motion knee brace. The patient had full range of motions with mild weakness of foot evertors in affected limb on follow-up at 1 year.

372

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Figure 3b. Intraoperative picture showing vessel opening held with clamps.

Figure 3c. Intraoperative picture with vascular anastomosis showing continuity.

ORTHOPEDICS

Figure 4. CT angiography demonstrating filling of all three vessels post repair. The stenotic segment of saphenous graft can be noted very well.

Figure 6. Histopathological examination showing multinucleated giant cells dispersed in mononuclear cells.

GCT. It is a benign lesion that is locally aggressive but in rare instances has the potential for metastasis.5 Most patients present with a painless slow-growing mass around the joint with discomfort. Acute symptoms are noted when the lesion erodes the cortex irritating the periosteum or when the weakening of the bone causes pathologic fracture. Rarely, GCT presents with involvement of adjacent neurovascular bundle.6,7 1

X-rays findings are characteristic and usually a geographic, expansile lesion involves whole of the epiphyseometaphyseal area. There is a surrounding ‘egg shell’ rim of calcification indicating an intact periosteum. Internal trabeculations are seen within the tumor. In our case, this soap bubble appearance was absent.

Figure 5. Post-op X-ray showing resected fibula.

DISCUSSION Giant cell tumor (GCT) is the most common bone tumor in the young adults with female preponderance.4 The common sites are epiphyseometaphyseal areas of long bones, most often the distal femur, proximal tibia and distal radius. The proximal fibula is a rare location for 4

The MRI findings are not so specific for particular lesion.

The low to intermediate signal on T1 and intermediate to high signal on T2-weighted images can also be seen in other malignant conditions. The tumor diffusely enhanced with contrast. The MRI nicely demonstrated the local extent of the tumor and involvement of the vascular structures. The lesions displace the peroneal nerve and popliteal blood vessels. But, in our case, vasculature was involved and can be seen in capsule.

There were no ‘fluid-fluid’ levels that would indicate cystic changes.

Giant cells can be seen in many different situations.

The key is that the cells surrounding the giant cells are all mononuclear cells, which coalesce to form the giant cells. Hence, the nuclei are dispersed in giant cells

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

373

ORTHOPEDICS unlike the Langerhan’s giant cells seen in tuberculosis and fungal infections where the nuclei are arranged around the periphery of the giant cell.

Management of fibular head GCT is surgical resection.

Resection of a high-grade primary bone sarcoma of the proximal fibula is a type 2 resection8 involving an en bloc extra-articular resection of the proximal fibula (sacrificing the common peroneal nerve), in contrast to a type 1 resection9 of the proximal fibula for benign aggressive, low-grade malignant tumors (sparing of the covering muscle layer and peroneal nerve). But, even with type 1 resection, the close proximity of neurovascular bundle warrants careful dissection.

Whenever the vessels are sacrificed or inadvertently opened, the surgical team must be prepared for vascular repair.

CONCLUSION Fibular lesions can be associated with vascular involvement in proximal area. For any surgical intervention, the relation of lesion with vessels should be determined by investigations. The GCT can present as telangiectatic type of osteosarcoma. Hence, thorough investigations should be done before surgical resection.

The purpose of this article was to highlight the diagnostic dilemma associated with GCT and proper preoperative preparations and counseling to deliver the outcome.

REFERENCES 1. Bickels J, Kellar K, Malawer M. Fibular resection (Chapter 32). In: Malawer, Sugarbaker (Eds.). Musculoskeletal Cancer Surgery Treatment of Sarcomas and Allied Diseases. 2001. pp. 505-18.

2. Unni KK. Dahlin’s Bone Tumors: General Aspects and Data on 11,087 Cases. Philadelphia, PA: Lippincott-Raven; 1996. pp. 1-9.

3. Abdel MP, Papagelopoulos PJ, Morrey ME, Wenger DE, Rose PS, Sim FH. Surgical management of 121 benign proximal fibula tumors. Clin Orthop Relat Res. 2010;468(11):3056-62.

4. Reddy CR, Rao PS, Rajakumari K. Giant-cell tumors of bone in South India. J Bone Joint Surg Am. 1974;56(3):617-9.

5. Faisham WI, Zulmi W, Mutum SS, Shuaib IL. Natural history of giant cell tumour of the bone. Singapore Med J. 2003;44(7):362-5.

6. Mnif H, Koubaa M, Zrig M, Zammel N, Abid A. Peroneal nerve palsy resulting from fibular head osteochondroma.

Orthopedics. 2009;32(7):528.

7. Cardelia JM, Dormans JP, Drummond DS, Davidson RS, Duhaime C, Sutton L. Proximal fibular osteochondroma with associated peroneal nerve palsy: a review of six cases. J Pediatr Orthop. 1995;15(5):574-7.

8. Malawer MM. Surgical management of aggressive and malignant tumors of the proximal fibula. Clin Orthop Relat Res. 1984;(186):172-81.

9. Capanna R, van Horn JR, Biagini R, Ruggieri P, Bettelli G, Campanacci M. Reconstruction after resection of the distal fibula for bone tumor. Acta Orthop Scand. 1986;57(4):290-4.

■■■■

Diclofenac Best for Arthritis Pain Diclofenac 150 mg/day was the most effective nonsteroidal anti-inflammatory drug (NSAID) for improving both pain and function in knee or hip osteoarthritis (OA), and acetaminophen (paracetamol) was least effective and should not be used in this setting, suggested a new network meta-analysis published online March 17 in The Lancet. Sven Trelle, MD, University of Bern, Switzerland and colleagues noted that single-agent paracetamol had no role in the treatment of patients with OA irrespective of dose. “In view of the safety profile of these drugs, physicians need to consider our results together with all known safety information when selecting the preparation and dose for individual patients,” he stated.

374

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

SPECIAL ARTICLE

In Defense of a Profession… A Doctor’s Perspective DHARAMVIRA GANDHI

ABSTRACT Stories of fast deteriorating patient-doctor relationship are being reported every other day in the media, both print and electronic.

And, it may worsen further, if remedial measures are not taken quickly. In this article, the author has penned his thoughts from a doctor’s perspective “with a hope that all concerned will also respond and initiate a healthy debate, in the best interests of the ailing humanity and society as a whole”.

Keywords: Patient-doctor relationship, professionalism, patient as consumer

I

t is very disturbing and frustrating to read and watch almost daily, the painful stories of the fast deteriorating patient-doctor relationship, in print and electronic media. The increasing incidents of patients’ relatives attacking doctors, ransacking hospitals and doctors retaliating with scuffles and strikes are bound to cause irreparable damage to this age-old historical sacred relationship and bring it to the lowest ebb in near future, if remedial measures are not taken quickly.

Our people and we as doctors cannot afford this tense relationship for long. There is an urgent need for the medical fraternity and the society at large, the community leaders and opinion makers in particular, to discuss threadbare, analyze and sort out the problem at both ends.

Pained by recent unfortunate happenings across the country, I have been moved to write this article from a doctor’s perspective with a hope that all concerned will also respond and initiate a healthy debate, in the best interests of the ailing humanity and society as a whole.

Let us put in sincere efforts and try hard not only to save, but also to take this sacred relationship to new heights of mutual understanding, confidence and glory.

During my medical career spread over 40 years, I have attended to and served my patients to the best of my knowledge and capability, with total devotion and professionalism, surely like my own family members.

During these four decades, I have interacted with and

Member of Parliament, Patiala, Punjab E-mail: dvgandhi1951@yahoo.com

treated lakhs of people and have enjoyed their great affection, respect and gratitude, which continues to be and will always remain till my last breath, the greatest and richest treasure of my life. I have never been and in fact, can never think of being negligent towards my patients. Even at 63 today, I wake up at the first telephone or doorbell ring, not because I need to earn more money, but because of my professional commitment and sensitivity, I love to preserve.

For me, my patient was never and nor will ever be a ‘consumer’. Patient-doctor relationship is a sacred relationship based on absolute and immense faith, which the patient reposes in his doctor, and offers his life or that of his beloved ones to a person (the doctor), with whom he has no blood relation and at times, has met him for the first time. I firmly believe that this faith has no parallel in known human behavior. As a doctor, I have always felt small before this faith of the patient and it is this feeling that keeps me working day-in and day-out, for the welfare of my patients. It is this faith, which compels me to spend tiring and sleepless nights for my patients, swimming and sinking with their clinical state, reflecting upon and affecting not only my own mind and body, but also that of my whole family.

No amount of money, no court, law or legislation can compensate for my 30 years of physical and more importantly, my mental and psychological involvement including that of my wife, my daughter and my son.

Money, if at all is and always was, too small and rather too unimportant part of this whole relationship.

I hereby declare that my patients can never ‘pay’ me for my exhaustive involvement in them. They are rather too poor to do that. They can feel indebted and express gratitude to me throughout their life, as I feel indebted to them for the faith they put in me. It is this superb

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

375

SPECIAL ARTICLE relationship, which differentiates medical profession from any other profession.

Doctors who relish their profession at this emotional and spiritual plane are now made to believe that their patients are now the ‘consumers’. One cannot imagine how much this new definition of sacred patient-doctor relationship has tortured and discouraged people like me during the recent years. I express honestly and frankly, that this ‘patient as consumer’ concept, will adversely affect patients more than doctors. It is the public at large, which is going to be at the receiving end in this game and not doctors, who will become smart enough over time, to escape or safeguard themselves against legal aspects in view of increasing litigations, of course with high-tech investigative plans, taking insurance covers and ensuring bit of more legal formalities. Let somebody convince me as to how one can do justice to his profession and provide scientific, rational and yet affordable treatment to the great majority of patients in this poor country, when one starts conceiving every patient as a potential litigant.

As doctors working in developing countries like India, we have to deal with a patient population, the vast majority of which is too sick and at the same time too poor to afford anything. In a country, where the government is not in a position to meet the health requirements of its people, where health insurance is still a distant dream, where religious heads instead of building health institutions are busy making more and more temples and gurudwaras, where the NGO sector is weak and public at large gullible, it is left to us doctors to carry the burden of providing healthcare to the helpless majority. While dealing with semistarved patients, we doctors often have to act as social activists, as social scientists and many times have to compromise with our knowledge and tailor our science to the sole idea of helping the patients to the best of our ability, with the available resources in hand in the given situation. It is ironical that if such patients turned ‘consumers’ incited by smart ‘friends’ file a case against the doctor, the law wants us to have acted and performed according to the western standards. This attitude and approach is totally divorced from the hard socioeconomic realities, existing in the country today.

This attitude, of the law, state and society will certainly sap the already fast eluding spirit of sympathy and compassion from the doctor community. It will kill their remaining sensitivities and convert them to ‘full businessmen’ for whom patients will be objects and just ‘consumers’ as they are being made to believe today.

376

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Now let me talk of medical science itself and the plight of doctors thereof, from whom the law and ‘consumers’ expect delivery of care with mathematical precision and perfection.

The lawmakers and our ‘consumers’ are perhaps ignorant of the fact that medical science is an ever evolving and completely complex science. The entire medical literature is full of ifs and buts, conflicts and controversies, still grappling with thousands of unresolved questions and mysteries. Till date, it is an imperfect science and probably will continue to remain so, for the times to come and may be for indefinite period.

One would appreciate the fact that human body behavior is yet far from being completely understood.

Numerous mysteries regarding functioning and ‘malfunctioning’ of various human organ systems still remain unsolved and continue to challenge the available global medical wisdom.

Harrison’s Principles of Internal Medicine, often quoted as the ‘Bible of Medicine’, in Chapter 125 of its latest edition, on ‘Fever of unknown origin’ clearly mentions that in spite of best available diagnostic tools and best input of medical knowledge, 19% cases of fever remain undiagnosed and this number is not negligible.

Let people clearly understand that medical science as it stands today, lays only broad guidelines regarding diagnostics and modalities of treatment and does not claim them to be mathematic-specific. These guidelines are based on group data and not on individual data.

This simply means that while generalities may hold good, yet certain subsets of patients can behave and in fact do behave in a totally unpredictable manner, which is beyond the comprehension of available medical knowledge. Moreover, solutions to medical challenges are sought from animal models, while humans are much more advanced and complicated species than their ancestors. You cannot extrapolate results of animal experimental models with that level of precision, as required in humans. For any science to be perfect, it is mandatory that in order to understand the possible ‘wrongs’ with the machine that one wants to master, one should be free to dismantle it step by step and throw it into the dustbin at the end of the day. But medical science is a ‘tied down’ science on the account. You cannot experiment on humans, not even those who have been sentenced to death by hanging, and now not even on animals. It is because of these historical handicaps and limitations that every test, every tablet, every injection, every procedure and every

SPECIAL ARTICLE modality of treatment is fraught with some serious implications and complications. No treatment modality is absolutely safe. The entire medical literature, each chapter of it, makes special mention of some potential dangers, side effects, complications and even morbidity and mortality, associated with every procedure or modality of treatment, which otherwise provides relief and mitigates suffering of many. I can quote several examples where doctors themselves have suffered and even lost their lives, because of these uncertainties of medical science. Whatsoever the complication mentioned in medical literature, and even if its incidence may be one amongst 1 lakh, it does occur.

But, for some ‘smart’ and some ‘ignorant’ people, this may well be a case of ‘negligence’.

Moreover, sicker the patient, more are the chances of facing problems during the procedure or treatment.

Nowhere in the world, not even in advanced countries, can a surgical procedure ensure 100% success.

Nowhere in the world, can an investigative procedure or treatment modality guarantee 100% safety. Because if that were the case, no rich man should ever die, and why a rich man, no doctor in the first place, should ever die. But this is not true.

Out of the thousands of patients one treats in a month, some may not do well in spite of one’s best professional judgment and input and occasionally one may even lose a patient, because of the advanced nature of disease. It is not fair at all, rather it is an utter injustice, to label these unfortunate mishaps as “doctor’s negligence”, without taking into consideration the limitations of medical science and particularities of that case.

It may well be a misplaced argument here, but I cannot help adding new dimensions to the much hyped concept of ‘negligence’. I can quote several instances, where the wards of many patients ignored my advice for getting their seriously sick, old and helpless parent/s admitted to hospital and instead let them die at home for want of required medical care, as they were busy with the exams of their school-going children. Will any law ever book these selfish and insensitive ‘educated’ and ‘not so ignorant’ consumers? In fact, these are the perfect cases of negligence.

Let me emphasize the fact that it is with these historical limitations of medical science that we, the doctors, who practice this science are expected to perform and deliver.

It is against these odds and handicaps that we doctors are destined to work. We, the doctors and our families,

carry daily, the burden of this sickly poor and poorly sick society. In a recent survey conducted in Ahmedabad, researchers could find only two octogenarian doctors in a city with over 30 lakhs population. This finding speaks volumes of the burdening and sickening nature of our job and the price that we, as doctors, pay for the pursuance of our duty and profession.

Unmindful of our problems, hardships and contributions made by us towards the health of the society, the promptness shown by the police in registering case against ‘erring’ doctors without seeking opinion from some independent body of medical professionals and ‘Masala’ stories flashed/published by electronic and print media, without first ascertaining the facts by taking the doctor’s version, only adds to our agony.

I firmly believe that our journalist friends and the custodians of law and order and the law itself, are well aware of the fact that such charges of ‘negligence’ are merely a ploy to extort money from doctors and hospitals, in majority of cases.

In the entire west, it is on the record now that serious students long back stopped opting for medical profession, partly because of sickening nature of profession and mainly because their patients were made ‘consumers’ in mid-seventies, by their capitalist states, driven by laws of capital and profit in every sphere of human and social activity. Health services there are being largely managed today by doctors from India, China, Latin America and other South East Asian countries. With the advent of globalization, new economic policy, structural reforms and privatization drive with resultant consumerism, India is shortly following suit. In fact, the trend has already begun.

It is because of this attitude of some ‘smart’ and some ‘ignorant’ people that we doctors now feel hesitant to treat lawyers, journalists, court people and VIPs, who we think are potential litigators, in case something goes wrong, even in a natural way. We prefer now, to avoid such ‘consumers’ even if we feel competent enough to treat them.

After expressing my heartfelt feelings on the plight of my great profession, let me conclude by saying that no doctor, howsoever ‘bad’ or ‘greedy’ (as some people complain about) he or she may be, will ever like to see his or her case in the postmortem room. This sweeping statement I make as universal truth for all my professional colleagues, even if I differ with most of them on the issues of professional ethics and morality.

■■■■

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

377

MEDILAW

Always Take Informed Consent A patient filed a case with the medical council against his treating doctor stating that he had taken a second opinion about his illness and the doctor had been treating him for a condition, which he did not have.

There is nothing on record to say that the doctor consulted for a second opinion denied the presence of tuberculosis.

He also continued with the antituberculosis treatment in his prescription.

This doctor put me on antitubercular treatment and the next doctor I consulted said that I did not have tuberculosis.

Prima facie no negligence is made out.

Proceed

Lesson: In its order, DMC/DC/F14/Comp.1078/2/2013, the Council found the doctor to be free of any blame in starting antitubercular treatment in a patient with sputum-negative tuberculosis.

When you start a trial of antituberculosis treatment, it is always better to take an informed consent of the patient and let the patient understand and sign your line of management to avoid such litigations.

CASE SUMMARY

Case 1 Patient X (referred to as complainant) filed a complaint with the medical council against Dr ‘A’ alleging medical negligence in the treatment administered to her. The complaint and copy of the medical records supplied by the complainant were examined by the Council.

Course of Events ÂÂ February 19, 2012: Patient X admitted in Hospital 1 with a history of low-grade fever of 1 month duration. A right mid zone opacity was seen on chest X-ray. Antituberculosis treatment (ATT) was started. ÂÂ February 24, 2012: Patient X went leaving against medical advice (LAMA). ÂÂ February 24, 2012: The complainant was admitted in Hospital 2, where the same diagnosis was made and she was continued on ATT. ÂÂ Examination of records showed that patient X went to Hospital 3, where again ATT was continued with streptomycin added to treatment. ÂÂ March 23, 2012: A contrast-enhanced computed tomography (CECT) chest was done, which

378

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

showed right middle lobe disease with mediastinal and right hilar lymphadenopathy. ÂÂ

June 10, 2012: The patient went to Hospital 4, where she was seen by Dr A; she was advised to continue ATT with rifampicin and isoniazid.

ÂÂ

June 12, 2012: The patient got an X-ray chest done from outside imaging centre, which showed improvement of the lesion.

Council Observations The Council observed that patient X was being treated by the doctors as a sputum-negative pulmonary tuberculosis (TB), as is evident from the medical records. Also, as per records nowhere did Dr A deny that patient X did not have TB. Hospital 4 also continued with the same treatment.

Judgement Based on its observations, the Council disposed of the complaint stating that prima facie no case of medical negligence could be made out on the part of Dr A in the treatment administered to the complainant.

Reference 1. DMC/DC/F14/Comp.1078/2/2013/dated 31st May, 2013.

MEDILAW WHAT IS CONSENT? Consent in the context of a doctor-patient relationship, means the grant of permission by the patient on his volition for an act to be carried out by the doctor, such as a diagnostic, surgical or therapeutic procedure.

Regulation 7.16 of the MCI Code of Ethics Regulation, 2002 defines consent as follows: “Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be. In an operation, which may result in sterility the consent of both husband and wife is needed.”

It is the duty of a doctor to obtain informed consent before proceeding with diagnostic tests as indicated and treatment. If a doctor treats a patient without valid consent, he/she is liable under the tort and criminal laws.

Tort is a civil wrong for which the victim or his/her family may seek compensation. The consequences would be payment of compensation (in civil) and imprisonment (in criminal).

Implied vs. Express Consent Implied consent A patient who enters the consultation chambers by his own volition may be considered to have given consent for a clinical diagnosis to be carried out. Consent may be inferred from the general submission by a patient to orders given by a doctor during clinical diagnosis.1 In circumstances such as arranging an appointment with a doctor, keeping the appointment, answering question relating to history and to submit without objection to physical examination, consent is clearly implied.

Express consent

2. Satyanarayana Rao KH. Informed consent: an ethical obligation or legal compulsion? J Cutan Aesthet Surg.

2008;1(1):33-5.

3. Pandit MS, Pandit S. Medical negligence: coverage of the profession, duties, ethics, case law, and enlightened defense - a legal perspective. Indian J Urol. 2009;25(3): 372-8.

CONSENT GIVEN FOR A DIAGNOSTIC PROCEDURE IS NOT VALID ALSO AS CONSENT FOR THERAPEUTIC TREATMENT The two procedures are different and hence require a separate consent for each. In the Samira Kohli vs. Dr Prabha Manchanda and Ors. I (2008) CPJ 56 (SC), the Hon’ble Supreme Court summarised the principles of relating to consent as follows: “32. iii: Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure.

The fact that the unauthorised additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defence in an action in tort for negligence or assault and battery. The only exception to this rule is where the additional procedure though unauthorised, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorised procedure until patient regains consciousness and takes a decision.”

There can be a Common Consent for Diagnostic and Operative Procedures In the same judgement, Samira Kohli vs. Dr Prabha Manchanda, the Hon’ble Supreme Court stated: “32. iv. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery.

Express, rather than implied consent should be obtained for treatments that involve risk or involve more than mild discomfort or when it will result in diminishing of a bodily function or invasive tests or examination especially in a female patient.2

CONSENT TAKEN SHOULD BE EXPLICIT

Express consent may be oral or in writing; written consent is considered superior because of its evidential value.3

i. “A doctor has to seek and secure the consent of the patient before commencing a ‘treatment’ (the term ‘treatment’ includes surgery also). The consent so obtained should be real and valid, which means that the patient should have the capacity and competence to consent; his consent should be voluntary and his consent should be on the basis

References 1. Nandimath OV. Consent and medical treatment: the legal paradigm in India. Indian J Urol. 2009;25(3):343-7.

In DMC/DC/F.14/Comp.1074/2/2014/dated 19th March, 2014, the Council made the following observations regarding consent.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

379

MEDILAW of adequate information concerning the nature of the treatment procedure, so that he knows what is consenting to. ii. The ‘adequate information’ to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balance judgement as to whether he should submit himself to the particular treatment or not. This means that the doctor should disclose (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial risks and (d) adverse consequences of refusing treatment. But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment which may persuade a patient to undergo a fanciful or unnecessary treatment.

A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment. iii. There can be a common consent for diagnostic and operative procedures where they are contemplated.

There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery.”

INFORMED REFUSAL Informed consent is authorisation of an activity, based on an understanding of what that activity entails and in the absence of control by others.1 Informed consent, however, does not always mean that the patient agrees to the treatment plan.2 Informed refusal is a subset of informed consent.

It is the subsequent election by the patient to decline an intervention that has been recommended by the physician. It should be noted that the need for intervention, as well as risks, benefits and alternatives to the intervention, including possible consequences of refusal have all been explained to the patient.

The reason/s why the patient refused the proposed treatment should also be recorded.3 It is not just enough to document that the patient has failed to comply with the medical advice given,4 it is also equally essential to document the informed refusal process.3

References 1. Grady C. Enduring and emerging challenges of informed consent. N Engl J Med. 2015;372(9):855-86.

2. Sfikas PM. A duty to disclose. Issues to consider in securing informed consent. J Am Dent Assoc. 2003;134:1329-33.

3. ACOG Committee on Professional Liability. ACOG Committee Opinion No. 306. Informed refusal. Obstet Gynecol. 2004;104(6):1465-6.

4. Crane M. Documenting noncompliance won’t protect you anymore. Available at: www.medscape.com/ viewarticle/773918.

■■■■

380

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Ind e ISS xed N 0 with 971 -08 IndME 76 D

Volume 1, Number 1

w

w

w

om .c up ro pg jc .i

ww

Pee

rR

e 18,

Volum

h

arc

y y

15

20

y

-M

ary

nu

Ja

y y

ic

em

r5

be

e

m

um

,N

17

In

is

Th

—

wed

I in ial tings MR thy rd ca ee S diac pa l Myoey B ca Car yo nt e of diom logi ile Hon le Issu yo ro Car d S le br ic an tip ter Em ging re Mul s af d er chem ilu Its Fa ing y: ient n an Em -is er al llow Pat tio Non Art rc Ren Fo etic Infa ial ance n te ab ch e fic di ial Acu rctio as Bra ni Bhav fa Non card ial Sig — In ati Ynting fic ical e in MyoDr Sw setor er Edi nc te re Supd Clin lera cu aP n To of A — an om nsio ith are se k yx ew AR co ttac e l M erte ricl ck: Glu t A com tria Hyp nt rs Ve r Blo ft A y — Fi Out Le onar ight cula its e of ulm d R ri re vent Cas e P be io A er m tr m — Sev lis Cha 1 A bo ble-ent 2: n Em ir Dou si atio an yA — Tr sent er Art Pre ry na Cor —

eric

Car

T

an

dio

Com

EN

Gas

Am

logy

mu

nity

w.ij cp

grou

p.co

Jou

rnal

Fam

ily

Med

Jan

Phys

uary

icia

n

icin

troe nte y In rolo fect gy iou y In sD isea tern ses al M y O edic bste ine tric s an Ped dG iatr ynec ics y M rwal edil KK Aggain-Chief olog Dr y aw up Editory M edifi Gro nan ce

d

an

e

-Fe

bru

ary

201

4, P

age

m

Subscription Form Jan-Dec 2016

s1

-64

y

Isch

lu Vo

evie

er 3

Numb

Full

text

onlin

e...

mor

e: h

ttp:/

/eb

With

ook.

Bes

ijcp

gro

t Com

up.c

plim

Subscribe to

All Journals om

ents

/ijcp

from : Mak ers of

SAVE

` 10,500/-

/

` 500/-

Special Discount on Institutional Packages

Yes, I am interested in subscribing to the *Institutional Combo package for one year (Institutional) Yes, I am interested in subscribing to the following journal(s) for one year (Institutional)

JOURNALS

ISSUES

INSTITUTIONAL (` Amount)

(individual)

INDIVIDUAL (` Amount)

Indexed with IndMED ISSN 0971-0876 www.ijcpgroup.com

Indian Journal of Clinical Practice

January-February 2014, Pages 1-64 Peer Reviewed Journal

y

American Family Physician

y

Cardiology

y

Community Medicine

y

ENT

y

Gastroenterology

y y y y y y

Infectious Diseases Internal Medicine

12

5,000/-

1,650/-

4

1,500/-

550/-

4

1,500/-

550/-

4

1,500/-

550/-

4

1,500/-

550/-

Obstetrics and Gynecology Pediatrics Medilaw Medifinance

Full text online: http://ebook.ijcpgroup.com/ijcp/ With Best Compliments from: Makers of

www.ijcpgroup.com

Asian Journal of Clinical Cardiology

In This Issue —

Asian Journal of Diabetology

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

—

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

—

Superficial Brachial Artery: Its Embryological and Clinical Significance

—

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

—

A Case of Left Atrial Myxoma Presenting as Severe Pulmonary Hypertension

—

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

—

Cornary Artery Air Embolism

Volume 17, Number 5

more...

January-March 2015

Volume 1, Number 1

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

Volume 18, Number 3

Dr Swati Y Bhave

Dr KK Aggarwal

Editor

Group Editor-in-Chief

Payment Information

Total `11,000/- for 1 year

Name: .......................................................................................................

Pay Amount: ............................................................................................

Speciality: ................................................................................................

Address: .................................................................................................. ..................................................................................................................

Country: ................................... State: .....................................................

Pincode: ...................................

Dated (dd/mm/yyyy): ...............................................................................

Cheque or DD No.: ..................................................................................

Telephone: ............................... Mobile: ..................................................

E-mail: .....................................................................................................

Drawn on Bank: .......................................................................................

Cheques/DD should be drawn in favor of “M/s IJCP Publications Ltd.” Mail this coupon to:

IJCP Publications Ltd. Head office: E - 219, Greater Kailash Part - 1, New Delhi - 110 048 Telefax: 40587513 Mob.: 9891272006

Subscription office:

7E, Merlin Jabakusum, 28A, S.N. Roy Road Kolkata - 700 038 Mob.: 9831363901 E-mail: subscribe@ijcp.com Website: www.ijcpgroup.com

We accept payments by Cheque/DD only, Payable at New Delhi. Do not pay Cash.

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

Patient Services Offered

Fully Computerizetd Automated Radiology & Imaging Facilities 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

CONFERENCE PROCEEDINGS

ANCIPS 2016: 68th Annual National Conference of Indian Psychiatric Society DIGITAL HEALTHCARE IN PSYCHIATRY - PITFALLS Dr Laxmi Naresh Vadlamani, Hyderabad

PSYCHOSOCIAL INTERVENTIONS AND NONPHARMACOLOGICAL MANAGEMENT OF TECHNOLOGICAL DEPENDENCE

ÂÂ

Appropriate knowledge and training is lacking.

ÂÂ

Empathetic relationship between psychiatrists and patients, psychiatric teachers and students can be affected.

ÂÂ

Total abstinence from the internet use should not be the goal of the therapeutic interventions.

ÂÂ

Confidentiality and privacy will be compromised.

ÂÂ

ÂÂ

Security of electronic health records (EHR) is a big issue.

An abstinence from problematic applications and a controlled or balanced internet usage should be the therapeutic goal.

ÂÂ

Consequences of leaked EHR data are irreversible and unlimited damage.

ÂÂ

ÂÂ

Effective body and laws to govern and guide digital healthcare in psychiatry is the need of the hour.

Counseling and therapy, group support, changing interests and various social issues need to be addressed.

ÂÂ

Motivational interviewing enhances intrinsic motivation by resolving client ambivalence and learning new behavioral skills.

ÂÂ

Cognitive behavior therapy for internet addiction (CBT-IA), a uniquely designed model for treating internet addicts applying CBT with harm reduction therapy (HRT).

Dr Ranjan Bhattacharya, Kolkata

Tilak Venkoba Rao Oration PUBLIC HEALTH INTERVENTIONS FOR PSYCHIATRIC DISORDERS FOCUSING ON SCHIZOPHRENIA: TIME TO RETHINK? Dr Naveen Kumar C, Bangalore ÂÂ

Schizophrenia is a major public health priority.

ÂÂ

There is meager manpower to tackle it.

ÂÂ

Two parallel processes. zz Revamping DMHPs

PRIVATE SECTOR AND PUBLIC MENTAL HEALTH Dr Devashish Konar, Kolkata ÂÂ

Mental health constitutes an estimated 7.4% of the world’s measurable burden of disease.

ÂÂ

The aggregate burden of years lived with disability (YLDs) resulting from mental and behavioral disorders (22.7%) continues to be higher than that resulting from any other disease category.

ÂÂ

Vast gaps in resources persist and seriously compromise access to care.

ÂÂ

Four out of five people in need of mental health services are not getting it, or to be more direct, we are not able to provide them with these services.

ÂÂ

The formulation of the National Mental Health Program (NMHP) in 1982, was an important milestone in the development of mental healthcare in the country.

ÂÂ

There is a need for the growing private sector psychiatry to be involved in the NMHP.

zz Independent, low-cost, effective and innovative

success stories of community treatment of patients with mental disorders, have occurred in some parts of the country.

ÂÂ

ÂÂ

Both government agencies and NGOs have demonstrated that good outcomes with patients can be achieved with CBR approaches.

Majority of persons with schizophrenia can achieve good outcomes by ensuring antipsychotic treatment alone. This could be achieved at a bit more extra cost of mental health professionals having to reach out to the community.

ÂÂ

We may have to take step-wise approach to tackle the whole gamut of psychiatric disorders.

ÂÂ

Prioritization has to be done by addressing the most serious and disabling concerns first and then moving on to the other disorders.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

383

CONFERENCE PROCEEDINGS ÂÂ

People in services and government feel overwhelmed due to their inadequate number and the immensity of the problem.

ÂÂ

Mental health promotion and preventive psychiatry have a crucial role to play in reducing the global burden of disease due to mental disorders.

ÂÂ

If the country considers the private practitioners also as its work force, its sense of failure in catering services will decrease to a great extent.

ÂÂ

ÂÂ

National mental health policy envisages to provide universal psychiatric care to the population, 20% of which are likely to be suffering from some form of mental illness, by 2020. Training of nonpsychiatric doctors and health workers about psychiatric illnesses and treatment is a must to achieve this goal.

It is important to strengthen the undergraduate training in psychiatry and also sensitize the undergraduate medical students with mental health promotion and preventive psychiatry.

ÂÂ

This will also help to strengthen the integration of mental health in general medical care, one of the objectives of the National Mental Health Program.

ÂÂ

The task is so gigantic that government alone cannot do it alone. For success of mental health policy, public-private collaboration is the only rational solution.

ADDICTION TO MODERN GADGETS ACROSS GENERATION Dr Supriya Kumar Mondal, Kolkata ÂÂ

Modern gadgets and technology have become predominant determinants of socioeconomic status and are not only restricted to teenagers but also spreading fast across generations.

ÂÂ

Addiction to technology is causing significant loss of productivity as well as problems in interpersonal relationships.

ÂÂ

It has been postulated that rather than a separate entity, internet addiction is a manifestation of a variety of depression, anxiety, impulse control disorders or pathological gambling.

ÂÂ

There have been rehabilitative measures to correct internet overuse.

ÂÂ

Technophobia is the fear or dislike of modern technology, particularly computers.

ÂÂ

Let us welcome the technological revolution with a widespread awareness of its potential dangers.

The generation of today needs to move ahead with bright vision and better tomorrow.

INDIAN THEORIES AND CONCEPTS RELEVANT TO BEHAVIORAL SCIENCES Dr Prabhakar Korada, Hyderabad ÂÂ

Modern medicine has made many major strides in the field of Psychiatry. Yet, we do not have a clear concept of the Mind, or the Self.

ÂÂ

We take it as our professional right to diagnose the abnormal without knowing what is Normal.

ÂÂ

We give so many lectures on Personality Disorders, but we do not have an idea of what a Normal Personality is.

ÂÂ

These lacunae need to be addressed; this is where the ancient Indian concepts play a significant role.

ÂÂ

The goal of our symposium is to plug the loop holes and bring together the observational skills of the Occident and the deep insights of the Orient, so as to make the subject of Behavioral Sciences richer and more complete.

ÂÂ

Apart from evidence-based talks on the Neuroplasticity in Pranayama and the Energy Meridians, we also offer the concept of Normal Personalities and the Ideal Personality as the Paradigm in the study of Personality Disorders.

RECENT BRAIN RESEARCH IN SCHIZOPHRENIA Dr Uday Chaudhuri, Kolkata ÂÂ

zz Prevention of neurodevelopmental aberration

in schizophrenia must occur before conception and during pregnancy.

PREVENTIVE PSYCHIATRY IN UNDERGRADUATE MEDICAL CURRICULUM: SHOULD IT BE THERE?

zz Epigenetic prevention: Prevent child abuse

Dr Rakesh Kumar Chadda, New Delhi ÂÂ

ÂÂ

384

Mental disorders are a major contributor to the global burden of disease and disability-adjusted life years (DALYs).

India has a gross deficit of mental health resources.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Neurodevelopmental dimension and therapeutic approaches of schizophrenia.

in the first 5 years of life (associated with significantly high risk of psychosis).

ÂÂ

Schizophrenia may be a disorder of brain plasticity. Both hypoplasticity (leading to cognitive and negative symptoms) and pathological

CONFERENCE PROCEEDINGS hyperplasticity (leading to psychosis) may be involved. ÂÂ

Our understanding of the pathophysiology of schizophrenia has made remarkable progress…

Golden time has arrived.

ÂÂ

A case of internet sex addiction that did not respond to prescribed antidepressants, psychotherapy (individual and group), or participation in sexual addicts anonymous has been reported.

ÂÂ

Significant improvement only ensued when the opiate antagonist, naltrexone, was added to ongoing sertraline therapy in a trial.

ÂÂ

A clinic in Shandong Province in Eastern China used electric shocks on unanesthetized internet addicts as part of what the clinic’s director has called a ‘holy crusade’ to cure internet addiction.

ÂÂ

Cognitive behavioral therapy, reality therapy, acceptance and commitment treatment, etc. have been found as useful methods of psychotherapy.

But, ÂÂ

Much work remains ahead to translate these observations into real differences for managing and potentially treating this devastating illness.

ÂÂ

Future researchers will benefit from both a creative application of cutting-edge translational neuroscience knowledge and having an open mind to look beyond current conceptual models of this disease.

A STUDY OF DEPRESSION IN DIABETIC PATIENTS: PREVALENCE AND CORRELATION OF DEPRESSION SEVERITY WITH DIABETES SEVERITY

DIAGNOSIS AND MANAGEMENT OF TECHNOLOGICAL DEPENDENCE Dr Kastao Kaustav Chakraborty, West Bengal ÂÂ

There are no evidence-based treatments for internet addiction; both psychotropic medication and psychotherapy have been recommended.

ÂÂ

There are small, open-label studies and case reports claiming benefits by escitalopram, other antidepressants or mood stabilizers.

ÂÂ

Researchers have found that 6 weeks of bupropion sustained-release treatment reduced craving for internet, video game play, total game play time and cue-induced brain activity in dorsolateral prefrontal cortex.

ÂÂ

Dr Rahul Mathur, Dr Dipesh Bhagabati ÂÂ

Patients with long-standing diabetes are more prone to develop depression but duration is not significantly related to severity of depression.

ÂÂ

Young adulthood (specifically in males) is associated with more severe depression in diabetic population.

ÂÂ

We found a high presence of depression in diabetes and that severity of depression increases with severity of diabetes.

ÂÂ

In an era where organic basis of all psychiatric illnesses are being taking into consideration, the comorbidity of two systemic illnesses occurring more than by chance with each other is an important topic to be addressed and researched upon. “Diabetes and Depression” is one such topic and hence our present study has wide implications and applicability.

Methylphenidate has also been found to be effective in reducing internet usage time in video game-playing children with comorbid attention deficit hyperactivity disorders (ADHD).

■■■■

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

385

CONFERENCE PROCEEDINGS

CRITICARE 2016: 22nd Annual Conference of Indian Society of Critical Care Medicine ATM workflow, advertise and train the whole team, collect data for performance assessment.

NEW BIOMARKERS FOR INFECTIONS Dr Konrad Reinhart, Denmark ÂÂ

Diagnostic microbiology stands at the epicenter of the tests for sepsis in patients.

CRITICAL CARE RESEARCH COLLABORATION: THE ANZICS CLINICAL TRIALS GROUP

ÂÂ

Currently, microbiological studies to detect bacteria/ fungi in blood, body fluids or relevant tissues continue to rely mostly on conventional culturebased systems, which remain the gold standard.

Dr Simon Finfer, Australia

ÂÂ

Detection of the inciting pathogens is key. New technologies hold promise to improve the time and the number of positive test results.

ÂÂ

ANZICS CTG formed in 1994.

ÂÂ

The investigator-initiated critical care clinical research enterprise has been unbelievably successful.

ÂÂ

Secrets of success: Dealt with “problem areas right at start” (Authorship, Authorship, Authorship), have written policies for study endorsement, conflicts of interest, competing studies, study management committees (research nurse and junior investigator mandatory), pre-approval of publications, use of data for higher degrees.

ÂÂ

Sepsis biomarkers may help to transform sepsis from a physiologic syndrome to a group of distinct biochemical disorders.

ÂÂ

The ideal sepsis marker is yet to be found. Given the complexity and heterogeneity of sepsis it is unlikely that there will be a single marker.

ÂÂ

Multiplexed transcriptome-based provide additional information.

biomarkers

ÂÂ

ÂÂ

Assessment of the innate immunity by molecular fingerprints might guide studies of pro- and antiinflammatory therapies in the future.

We have moved from national collaborative groups to international collaboration of individuals and collaboration between international trials networks

ÂÂ

The future is bright!

UPDATE ON STEROIDS IN SEPTIC SHOCK

LESSONS LEARNED FROM BRAZIL Dr Flávia Machado, Brazil ÂÂ

First major problem: Absence of data.

ÂÂ

Second major problem: Resources limitation.

ÂÂ

Third major problem: ICU access - There are 7.6 public ICU beds for 1,00,000 habitants, and 25.5 private ICU beds for 1,00,000 habitants.

ÂÂ

Fourth major problem: Inadequate process of care.

ÂÂ

Fifth major problem: Awareness.

ÂÂ

Potential solutions: Increase partnership, raise awareness, quality improvement initiatives; train the whole hospital, use a very sensitive triage strategy, involve the Govt., create a sepsis team, empower nurses, get support from the pharmacists and lab people, write a treatment protocol, write a guide for empiric antibiotics, define triage strategies for each setting, define lab exams workflow, define

386

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Prof Dr Charles L Sprung, Israel ÂÂ

The use of steroids in septic shock remains extremely controversial.

ÂÂ

The latest large multicenter studies to offer guidance in treatment are the Annane (Annane D. JAMA. 2002:288:862-71) and Sprung (Sprung CL. N Engl J Med. 2008;358:111-24) studies.

ÂÂ

Since these studies, many reviews and metaanalyses have attempted to add further help in deciding, which patients benefit from steroids in septic shock.

ÂÂ

Unfortunately, these studies included many different trials and came to different conclusions further confusing the issue.

ÂÂ

The current ADRENAL trial may provide important information as to which patient should receive steroids in septic shock.

CONFERENCE PROCEEDINGS ÂÂ

Unfortunately, as the mortality of patients with septic shock has been decreasing it is unlikely that the study will show a positive effect of steroids.

ÂÂ

In the meantime, physicians should follow the latest 2012 Surviving Sepsis Campaign recommendations (Dellinger P. Crit Care Med. 2013;41:580-637) including: “We suggest not using IV hydrocortisone in adult septic shock patients if adequate fluid resuscitation and vasopressor therapy are able to restore hemodynamic stability. In case this is not achievable, we suggest IV hydrocortisone max dose of 200 mg/day.”

ÂÂ

In addition, “We recommend that corticosteroids not be administered for the treatment of sepsis in the absence of shock.”

MANAGING YOUR DATA AND PRESENTING YOUR RESULTS

ÂÂ

POSTOPERATIVE MYOCARDIAL ISCHEMIA Dr Maitree Pandey, New Delhi ÂÂ

Cardiac complications constitute the most common cause of post-op morbidity and mortality.

ÂÂ

In patients with or at risk of CAD, the incidence of perioperative ischemia ranges from 20% to 63% (N Engl J Med. 2005;353:349-61).

ÂÂ

Myocardial ischemia means inadequate myocardial oxygenation (demand is more than supply); it is a precursor to MI.

ÂÂ

Identify variables preoperatively associated with postoperative myocardial ischemia.

ÂÂ

Postoperative tachycardia, hypotension, HT, anemia, hypoxemia are common causes of myocardial ischemia and infarction in patients with CAD.

ÂÂ

Long duration ST segment changes (>20-30 min or cumulative duration (>1-2 h) are associated with adverse cardiac outcome.

ÂÂ

To prevent myocardial ischemia, avoid tachycardia and hemodynamic aberration (hypotension/ hypertension), attenuate pressure response to laryngoscopy, intubation and extubation.

ÂÂ

It should be treated aggressively.

ÂÂ

It is silent; transient ECG changes, even minor troponin elevations predict early and late morbidity and mortality.

Dr Mohan Gurjar, Lucknow ÂÂ

ÂÂ

There are reporting guidelines available for almost all study types like CONSORT for randomized trials, STROBE for observational studies, PRISMA for systematic reviews, CARE for case report, STARD for diagnostic and prognostic studies, SQUIRE for quality improvement studies, etc.

Usually any original/research manuscript should have at least 2 tables (one for baseline demographic/ clinical characteristics of the study sample and second table for primary analysis).

ÂÂ

Additional tables may be used for analysis of other results. There is no need of a table if the entire content could be summarized clearly in 1 or 2 sentences.

ÂÂ

Title of table should be brief, informative and may include name of statistical test that was used.

ÂÂ

‘P’ value should not be written as ‘nonsignificant’ or ‘NS’ or ‘<0.05’. ‘P’ value should be written up to 2 or 3 decimal points depending upon value available; if it is too small, then write as ‘<0.001’.

ÂÂ

Kaplan-Meier survival cures should be used for time-to-event in observational studies.

NIV: CURRENT INDICATIONS AND FUTURE DIRECTIONS Dr Rajesh Chawla, New Delhi ÂÂ

Noninvasive ventilation (NIV) has become the standard of care in treating acute respiratory failure over the last 2 decades.

For percentage, no need of decimal, if the sample size is <100. For bigger sample size, percentage up to one decimal should be used.

ÂÂ

NIV is used in ICU as well as other locations such as ER, HDU, general wards. Most critical care ventilators are equipped with NIV mode.

ÂÂ

Zero frequency or mean should be writing as ‘0’.

For missing data, write ‘not applicable’ or ‘missing data’. Do not use hyphen ‘-’ for missing data.

ÂÂ

ÂÂ

Most of time for original studies, ‘Figure 1’ represents overview of the study and includes process and number of participants screened and enrolled for the study.

NIV should be used early in the course of illness to avoid tracheal intubation. When invasive ventilation is indicated, a trial of NIV can be given before intubation in selected patients.

ÂÂ

NIV can be used in patients who refuse intubation and/or during weaning from invasive ventilation to avoid reintubation.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

387

CONFERENCE PROCEEDINGS ÂÂ

NIV is not a substitute for endotracheal mechanical ventilation.

ÂÂ

Goals of NIV: ↓ work of breathing, improves oxygenation and ventilation, avoids intubation, improves survival.

ÂÂ

Complication of NIV: Hypoxemia, COPD exacerbation, acute cardiac pulmonary edema, hypoxemic ARF, hypercapnic-hypoxemic ARF, weaning, post-extubation ARF.

ÂÂ

NIV failure is clinically indicated by ↑RR, ↓ conscious level, hemodynamic instability, drowning in secretions, uncontrolled agitation, worsening gas exchange (↓pH <7.35 or ↓ in PaO2, ↑ 15-20% PaCO2), severe sepsis, ↑ work of breathing, intubation and mechanical ventilation, CPR.

Key Points ÂÂ

Select the right patient, interface and ventilator.

ÂÂ

NIV is associated with frequent uncomfortable or even life-threatening adverse effects, and patients should be thoroughly screened beforehand to reduce potential severe complications.

ÂÂ

Rule out contraindications. Monitor closely: Comfort, air leak and asynchrony

ÂÂ

Dedicated and trained staff.

ÂÂ

Error prevention can be planned by means of retroactive and proactive tools, such as Audit and Failure Mode, Effect & Criticality Analysis (FMECA).

ÂÂ

Information technology systems are the key components of a multifaceted strategy to prevent medication errors and improve patient safety.

ÂÂ

Improving standardization and certification of the design and implementation of such systems should help.

ÂÂ

Creating an economic and policy environment conducive to the financial goals of hospitals and physicians will facilitate wider adoption.

SEDATION IN VENTILATED PATIENTS: SHOULD WE USE BENZODIAZEPINES? Dr Pradeep Bhatia, Jodhpur

The Naysayers ÂÂ

zz Benzodiazepines must be discarded as a

sedative in the ICU as they cause much higher risk of oversedation and delirium in the ICU; long-term cognitive impairment after hospital discharge and mortality.

DRUG ERRORS IN ICU Dr Ghanshyam Yadav, Varanasi ÂÂ

Human beings will always make errors.

ÂÂ

We must understand the reasons for error and work to change our own internal response to error that occurs.

ÂÂ

Naming, blaming and shaming have no remedial value.

ÂÂ

Medication errors have important implications for patient safety and its detection is the first crucial step in improving clinical practice errors, in order to prevent adverse drug events.

ÂÂ

Patient safety must be the first aim in every setting, in order to build safer systems.

ÂÂ

The major methods to detect medical errors and associated adverse drug events are chart review, computerized monitoring, administrative databases and claims data, using direct observation, incident reporting and patient monitoring.

ÂÂ

Use of benzodiazepines to sedate patients in the ICU is an antiquated and dangerous way of managing patients in the ICU.

ÂÂ

Alternative drugs offer superior outcomes with greater hope for full recovery.

The Yeasayers ÂÂ

Benzodiazepines have all the ideal characteristics one would wish for in a sedative, such as rapid onset, rapid recovery, predictable dose response; safe, lack of drug accumulation, absence of toxicity; inexpensive and familiar to physicians; anxiolytic, amnesic, sedating, hypnotic and anticonvulsant effects.

ÂÂ

Despite the apparent advantages of propofol and dexmedetomidine over benzodiazepines for ICU sedation, benzodiazepines remain important for managing agitation in ICU patients, especially for treating anxiety, seizures and alcohol or benzodiazepine withdrawal.

■■■■

388

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Sedation in the ICU should be minimized in general.

CONFERENCE PROCEEDINGS

NIC 2016: Cardiological Society of India National Interventional Council (CSI-NIC) Mid-Term Meet 2016 INSIGHTS FROM OCT: IMPROVING OUTCOMES WITH BVS Dr G Sengottuvelu, Chennai Though the bioresorbable vascular scaffolds (BVS) are promising in type A lesions, Dr Sengottuvelu said that his experience and newer emerging data have shown their feasibility in complex real world lesions with good early outcomes. Being radiolucent with bulkier struts, post implantation, their results need to be assessed by appropriate intravascular imaging techniques for optimal outcomes particularly in complex lesions.

The resolution of OCT is 10 times higher than the IVUS and it is the preferred modality for imaging during PCI with BVS. Dr Sengottuvelu shared his initial experience of OCT in nearly all cases during BVS implantations and subsequently in all complex cases of BVS implantation which included ostial, left main, bifurcations, CTO, calcified lesions, acute MI, vein grafts and in long lesions requiring overlapping scaffolds. He made it clear that “Lessons from OCT have further reinforced the importance of proper lesion predilatation and adequate post dilatation with NC balloon without exceeding the recommended BVS limits.”

The Absorb scaffold is the most imaged device in the history of interventional cardiology and in their OCT/ BVS study, that role of OCT is particularly important in complex lesions and not required for routine implantation of BVS. Malappositions are common in calcified lesions where proper bed preparation is the key and with multiple BVS, malappositions are frequent at the overlapping sites, which needs high pressure post dilatation.

OCT also helps to differentiate tissue and thrombus prolapse, which can appear like a residual lesion on angiography leading to unnecessary post dilation and its associated complications.

Dr Sengottuvelu displayed fascinating 3D OCT reconstruction images of BVS implantation in complex bifurcations showing excellent results and also showed the usefulness of OCT during follow-up.

“OCT with its incredible rich information is an indispensable tool during BVS implantation during complex cases to obtain very optimal results, but definitely not mandatory for every BVS implantation.”

IT’S NOT JUST THE GUIDEWIRES IN CTO: GUIDEWIRE IS PARAMOUNT Dr Viveka Kumar, New Delhi ÂÂ

No doubt choosing the right guidewire is very important in CTO lesion.

ÂÂ

But to begin with, understanding the coronary and aortic anatomy and thus selecting the guide catheter that will give best support and coaxial alignment may be paramount.

ÂÂ

As demonstrated in the case presented, changing the guide from JR to AR resulted in a failed CTO becoming a success.

CTO ANGIOPLASTY: TIPS & TRICKS Dr Sudhir Rathore, UK ÂÂ

Always start with the soft wires as microchannels are sometimes not visible and quickly upgrade to stiffer wires in a step up strategy.

ÂÂ

Components of retrograde procedure: Simultaneous bilateral angiogram (estimate CTO true length and course), collateral channel identification and crossing with wire and microcatheter, crossing the CTO segment, externalization of wire/antegrade wiring.

ÂÂ

Unable to cross device after successful wire crossing: Anchor ballooning, Rotational atherectomy, Tornus/Corsair use.

ÂÂ

Microchannel crossing Fielder XT wire.

ÂÂ

Ensure distal wire in true lumen by contralateral injection before POBA.

ÂÂ

Selection of appropriate CC for retrograde attempt: Selective CC injection in 2 views; reverse CART in some cases.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

389

CONFERENCE PROCEEDINGS 10 COMMANDMENTS OF DEVICE CLOSURE OF ASD & PDA

ÂÂ

There is limited published literature about the axillary artery disease and its endovascular management because of more collaterals to shoulder joint and less symptoms. More attention is given to the lower limb PVD.

ÂÂ

Percutaneous intervention of both coronaries and axillary artery with atherosclerosis etiology in a 70-year-old male is rare.

Dr S Ramakrishnan, New Delhi ÂÂ

Principles of ASD device closure: AGA atrial septal occluder (ASO) is a self-centering circular device.

ASO is made up of NiTiNOL (shape memory alloy i.e., regaining shape after implantation; size is based on waist diameter. ASO waist length is 3-4 mm.

ÂÂ

When selecting device size, keep device size 2-4 mm > ASD size.

ÂÂ

Management of patients with combined CAD and PVD is, in general, extremely complex.

ÂÂ

Circular defects - maximum dimension; oval defects must be individualized.

ÂÂ

Prime importance should be given to risk reduction.

ÂÂ

The LA disc diameter should not exceed total septal length; LA disc diameter is waist + 5-8 mm; RA disc diameter is waist + 4-5 mm.

ÂÂ

Pay attention to the strength of rims that are going to hold the device, unnecessary oversizing may ↑ technical success but may deteriorate in long-term.

ÂÂ

Simple deployment fails because of undersized device, malalignment of the device with respect to LA aspect of the IAS and prolapse through deficient or flimsy rim.

WHEN CAD MEETS AS Dr Wei-Hsian Yin, Taiwan ÂÂ

AS and CAD frequently coexist in elderly patients selected for TAVI.

ÂÂ

PCI has been shown to be feasible and safe in selected high-risk or inoperable patients with symptomatic severe AS; however, the optimal timing of PCI relative to TAVI has been a subject of debate.

ÂÂ

The most frequent approach is staged PCI typically performed a few weeks prior to TAVI; simultaneous interventional revascularization is a sound option for patients with relevant CAD undergoing TAVI.

ÂÂ

Balloon aortic recommended.

valuvloplasty

before

PCI

is

Dr O Adikesava Naidu, Hyderabad ÂÂ

Axillary artery involvement atherosclerosis is rare.

ÂÂ

The usual etiology is trauma, followed by radiation therapy and Takayasu’s disease.

390

Prof Dr Vivek Gupta, New Delhi Symptomatic severe AS has a poor prognosis when treated medically and surgical aortic valve replacement is the standard of care. Prof Alain Cribier pioneered the first TAVI case, a nonsurgical procedure on April 16th, 2002 and now it is available in about 60 countries accumulating to around 2,00,000 implantations in high and moderate risk patients.

Case Report: An 84-year-old patient with severe symptomatic AS with comorbidities of CABG, nephropathy, COPD was treated with TAVI in November 2012 in Rouen, France by Prof Cribier. The Edward XT valve was deployed with 18 F Groin sheath with utilization of Prostar Femoral Closure device in about 40 min duration.

There was immediate reduction of gradient across aortic valve and the patient was discharged on the 3rd day. The patient is clinically doing well and 2D Echo done recently with almost 4 years of follow up shows normally functioning bioprosthetic valve. This was one of the first cases of Edwards valve deployed in an Indian patient. TAVI is a relatively simple procedure in experienced hands with good long term results.

SVG INTERVENTIONS: TIPS & TRICKS Dr Nakul Sinha, Lucknow

ENDOVASCULAR MANAGEMENT OF STENOSIS OF AXILLARY & CORONARY ARTERIES: A RARE ASSOCIATION secondary

TAVI CASE REPORT WITH EDWARDS VALVE: A 4-YEAR FOLLOW-UP

to

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

ÂÂ

Confirm optimal medical therapy and preprocedure medications.

ÂÂ

Intracoronary vasodilators are effective to prevent or treat no reflow.

ÂÂ

Direct stenting is preferred.

ÂÂ

GpII/bIIIa inhibitors offer no benefit.

ÂÂ

Protection devices are a must - use them!

CONFERENCE PROCEEDINGS ÂÂ

Additional mild or moderate lesions should also be treated.

ÂÂ

DES (in large SVGs) do not offer any great advantage.

ÂÂ

Covered stents have not shown any benefit.

10 COMMANDMENTS OF DEVICE CLOSURE OF VSD Dr Manisha Chakraborty

≤0.80, in a prospective, independent, controlled, core laboratory-based environment. ÂÂ

The study supported the diagnostic value of iFR in establishing the functional significance of coronary stenoses, and highlighted its correlation with FFR when used in a hybrid iFR-FFR approach.

PERCUTANEOUS CLOSURE OF GERBODE DEFECT Dr Anshul Kumar Gupta, Bengaluru

ÂÂ

Not to do a device, though tempting, if not indicated.

ÂÂ

ÂÂ

Optimize the timing of device closure related to age and weight of patient (patient selection).

Gerbode defects are rare LV to RA shunt lesions with an incidence ~0.08%.

ÂÂ

ÂÂ

Choose the right VSD.

Surgical closure is the conventional mode of therapy.

Choose the right device.

ÂÂ

ÂÂ

Gerbode defects can also be closed percutaneously both safely and successfully.

ÂÂ

Decide the right route according to VSD location.

ÂÂ

ÂÂ

Planning the protocol and hardware ready.

Amplatzer duct occluder II (ADO II) appears to be an appropriate device for Gerbode defects closure.

ÂÂ

Don’t force on any wire/catheter and re-introduce.

ÂÂ

ÂÂ

More use of echocardiography: Pre, per and post.

Due to relatively softer nature of ADO II (due to absence of polyester fabric), conduction blocks are infrequent and transient complications.

ÂÂ

Angiogram before releasing device to see distance from aortic valve.

ÂÂ

Procedural success rates are high and complications rates are low.

ÂÂ

Follow-up: Immediate till late is required.

ÂÂ

Longer duration follow ups are required.

FFR FOR PCI DECISION IN INTERMEDIATE AS WELL AS MVD PATIENT

CTO IN ANOMALOUS LCX - TREATED ANTEGRADELY

Dr Robert-Jan van Geuns, The Netherlands ÂÂ

ÂÂ

ÂÂ

ÂÂ

The 2014 ESC/EACTS Guidelines on myocardial revascularization recommend FFR to identify hemodynamically relevant coronary lesions in stable patients when evidence of ischemia is not available.

ADVISE study concluded that intracoronary resistance is naturally constant and minimized during the wave-free period, and that the instantaneous wave-free ratio (iFR) calculated over this period produces a drug-free index of stenosis severity comparable to FFR. When coronary resistance is stable - pressure can be used as a surrogate for flow to assess a coronary stenosis.

ADVISE II assessed the diagnostic accuracy of the iFR to characterize, outside of a pre-specified range of values, stenosis severity, as defined by FFR

Dr Manabhanjan Jena, Kolkata ÂÂ

Coronary artery anomalies are found in 0.6-1.5% of all coronary angiograms.

ÂÂ

The most common anomaly is an aberrant LCX occurring in 0.48-0.7% of cases.

ÂÂ

Retroaortic portion of anomalous LCX I selectively predisposed to atherosclerotic disease. It poses technical challenges in coronary intervention, but PCI is feasible.

ÂÂ

For anomalous origin of LCX from RCC, MP1 catheter is a better choice than usual guiding catheter for better support.

ÂÂ

GAIA 1 PTCA guidewire is a better choice for opening of CTO.

ÂÂ

Visible microchannel facilitates penetration of PTCA wire in CTO opening.

ÂÂ

Sequential predilatation is mandatory before stent deployment.

■■■■

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

391

AROUND THE GLOBE

News and Views “Sit Less, Move More” AHA Advisory A new Science Advisory from the American Heart Association (AHA) discourages sedentary behavior and recommends that people move more. This advisory is based on a review of current evidence on sedentary behavior, which suggests that sedentary behavior increases risk of heart disease and diabetes mellitus and could contribute to excess morbidity and mortality. As per the advisory, quantitative guidelines in terms of the appropriate limit to the amount of sedentary behavior required is not possible at present due to insufficient evidence. The advisory titled “Sedentary Behavior and Cardiovascular Morbidity and Mortality” was published online August 15, 2016 in Circulation.

BRICS Disaster Risk Reduction Meet Adopts Udaipur Declaration A 2-day meeting of BRICS (Brazil, Russia, India, China and South Africa) Ministers on Disaster Management ended in Udaipur, Rajasthan with the adoption of the Udaipur Declaration. The meeting laid bare the common thread of challenges on disaster issues faced by all the BRICS nations. The Minister of State for Home Affairs, Shri Kiren Rijiju termed the meeting as a new milestone in collaboration and cooperation among BRICS countries in the field of disaster management. He said that the Udaipur meeting has successfully adopted the Udaipur Declaration whereby we have resolved to set up a dedicated Joint Task Force for Disaster Risk Management for regular dialogue, exchange, mutual support and collaboration among the BRICS countries.

The roadmap for implementation of the 3-year Joint Action Plan (JAP) for BRICS emergency services (201618) was also finalized … (PIB, Ministry of Home Affairs, 23rd August, 2016)

New AAP Guidelines on Preventing Obesity and Eating Disorders in Adolescents The American Academy of Pediatrics (AAP) has issued new evidence-based guidelines on how to help teenagers avoid obesity and eating disorders. It advises pediatricians to promote a positive body image among adolescents and carefully monitor weight loss in an adolescent who needs to lose weight to ensure the adolescent does not develop the medical complications of semistarvation. The guidelines also encourage families

392

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

not to talk about weight but rather to talk about healthy eating and being active to stay healthy and focuses on a healthy lifestyle rather than on weight. The new guidance was published online August 22, 2016 in the journal Pediatrics.

MRI-guided Focused Ultrasound Effective to Treat Essential Tremors According to a study published in the August 25, 2016 issue of the New England Journal of Medicine, treatment with MRI-guided focused ultrasound thalamotomy significantly improves hand tremors and quality-of-life in patients with essential tremor. Patients who received the treatment showed almost 50% improvement in their tremors and motor function after 3 months and retained a 40% improvement after a year.

Study Evaluates Role of Chest X-ray in the Initial Evaluation of Acute Stroke A chest X-ray done before administering IV thrombolytics prolongs door-to-needle time in patients with acute ischemic stroke than in those without pre-treatment radiography; 75.8 versus 58.3 minutes, says a study reported in Neurology August 23, 2016. The authors suggest that chest x-ray should be reserved for situations wherein acute cardiopulmonary conditions would otherwise preclude the administration of IV thrombolytics or substantially influence management.

Late-onset Asthma Increases Risk of Cardiovascular Events In the prospective observational Wisconsin Sleep Cohort study of adults followed for over a decade, participants with late‐onset asthma, but not early‐onset asthma, had a 1.6‐fold higher rate of cardiovascular events compared to nonasthmatics. The 10‐year CVD‐event rates were 12.7% for those with late‐onset asthma, 3.8% (for those with early‐onset asthma and 8.9% for nonasthmatics.

The study is published August 24, 2016 in the Journal of the American Heart Association.

Circulating Biomarkers may Predict Risk of Ischemic Stroke Four biomarkers - C-reactive protein (CRP), tumor necrosis factor 2 (TNF2), total homocysteine (tHcy) and vascular endothelial growth factor (VEGF) - have been

AROUND THE GLOBE identified to be associated with increased risk of incident ischemic stroke in a study reported online August 24, 2016 in the journal Neurology.

Baseline Metabolic Tumor Volume is Prognostic in Follicular Lymphoma Baseline total metabolic tumor volume (TMTV) is a strong independent predictor of outcome in follicular lymphoma and in combination with the Follicular Lymphoma International Prognostic Index-2 (FLIPI2) score, it identifies patients at high risk of early progression, according to a multivariable analysis in the Journal of Clinical Oncology reported August 22, 2016. Combining the two facilitates risk stratification into poor-, intermediate- and favorable-risk groups.

Cardio-Oncology: An Emerging Multidisciplinary Specialty Patients undergoing cancer treatment or post-treatment face cardiac risks that are being increasingly managed by cardiologists. This year, the International Cardi-Oncology Society (ICOS) and Canadian Cardiac Oncology Network (CCON) published their recommendations for cardiooncology training in a multidisciplinary specialty in the June 2016 issue of the Journal of Cardiac Failure.

The American College of Cardiology (ACC) launched its Cardio-Oncology Council. The European Society of Cardiology (ESC) will release a cardio-oncology position paper at its annual Congress in Rome, Italy.

Sugamya Pustakalaya - An Online Library for Persons with Visual Disabilities Launched “Sugamya Pustakalaya: A step towards an Accessible Digital India” (An online library for persons with visual disabilities) was launched by Shri Ravi Shankar Prasad, Minister for Law and Justice and Electronics and Information Technology at a function organized by Dept. of Empowerment of Persons with Disabilities, Ministry of Social Justice and Empowerment. “Sugamaya Pustakalaya” is an online platform that makes accessible content available to print-disabled people. Books are available in accessible formats for people with visual impairment and other print disabilities. There are over 2 lakhs books in diverse languages integrating libraries across India and the Globe, including the largest international library, ‘Bookshare’… (PIB, Ministry of Social Justice & Empowerment, 24th August, 2016)

DASH Diet Reduces Serum Uric Acid The DASH diet lowered serum uric acid in patients with pre- or stage 1 hypertension and this effect was greater among the study subjects with hyperuricemia, reports

a study August 14, 2016 in Arthritis and Rheumatology.

The DASH diet reduced serum uric acid by -0.35 mg/dL with a higher effect (-1.3 mg/dL) among participants with a baseline serum uric acid ≥7 mg/dL. Increasing sodium intake from the low level, decreased serum uric acid by -0.3 mg/dL during the medium sodium level and by -0.4 mg/dL during the high sodium level.

Psoriasis Stronger Predictor of Atherosclerosis Risk Than Diabetes Patients with psoriasis have high rates of subclinical atherosclerosis based on their increased coronary artery calcium scores, similar to those of patients with type 2 diabetes, according to a study published online August 24, 2016 in JAMA Dermatology. Moderate-to-severe psoriasis more strongly predicted coronary calcification than having type 2 diabetes. These findings highlight the need for early cardiovascular risk assessment and aggressive risk factor modification in these patients.

rTMS Safe and Effective for Phantom Limb Pain in Landmine Victims In a study published in the August 2016 issue of the Journal of Pain, high-frequency transcranial stimulation (rTMS) on the contralateral primary motor cortex of traumatic amputees induced a clinically significant pain reduction up to 15 days after treatment.

It was also well-tolerated.

Beta-blockers do not Improve Cardiovascular Outcomes Post-elective PCI According to NCDR registry analysis, prescribing β-blockers at discharge among patients ≥65 years of age with stable angina without prior MI, LV systolic dysfunction (LVEF <40%), or systolic HF undergoing elective PCI in routine clinical practice did not reduce post-discharge mortality, revascularization or rehospitalization related to MI or stroke at 30-day and at 3-year follow-up. The study is published in the August 22, 2016 issue of JACC: Cardiovascular Interventions.

Absent Scleroderma Pattern at NFC Excludes Scleroderma in Raynaud’s Phenomenon The absence of systemic sclerosis (SSc) nail-fold capillaroscopy (NFC) pattern is very valuable in the exclusion of systemic sclerosis in patients with Raynaud’s phenomenon or suspected connective tissue disease, says a study in the journal BMC Musculoskeletal Disorders published August 15, 2016. For identifying patients who met either the VEDOSS or 2013 ACR/EULAR criteria for SSc, detection of an SSc NFC pattern had a sensitivity

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

393

AROUND THE GLOBE of 71%, specificity 9%, positive predictive value 8% and negative predictive value of 90%.

Obeticholic Acid Effective in Primary Biliary Cholangitis Results from the POISE phase III trial show that obeticholic acid administered with ursodiol or as monotherapy for 12 months reduced alkaline phosphatase and total bilirubin levels in patients with primary biliary cholangitis, earlier called primary biliary cirrhosis. The study is reported August 18, 2016 in The New England Journal of Medicine. Although the incidence of serious adverse events was greater with obeticholic acid, all resolved without sequelae.

global implementation of maternal death surveillance and response”, helps countries strengthen their maternal mortality review process in hospitals and clinics.

Delay in Treatment Intensification Common in Newly Diagnosed Type 2 Diabetes After Metformin Failure A large number of newly diagnosed type 2 diabetes patients have delay in intensification of therapy within 6 months of metformin monotherapy failure with poor glycemic control, according to a study published online August 12, 2016 in Diabetes Care. And, early intervention in cases of metformin monotherapy failure led to more rapid achievement of target A1C.

By 2030, Viral Hepatitis to be Eliminated from the African Region

As-needed Acetaminophen does not Worsen Childhood Asthma Control

By 2030, the African Region wants to eliminate viral hepatitis as a major public health threat. With the launch of the document “Prevention, Care and Treatment of Viral Hepatitis in the African Region: Framework for Action 2016-2020”, WHO provides guidance to Member States in the Region on how to implement the first-ever Global Health Sector Strategy on viral hepatitis, which was adopted last May at the World Health Assembly.

“Over the next five years, the African Region should have one third less chronic viral hepatitis B and C infections,” says Dr Matshidiso Moeti, WHO Regional Director for Africa. “In addition, we also want to bring down the number of viral hepatitis B and C related deaths by 10%,” Dr Moeti continues… (WHO Africa Region, 21st August, 2016)

As-needed use of acetaminophen versus as-needed use of ibuprofen was not associated with a higher incidence of asthma exacerbations in young children with mild persistent asthma, says a study published in the New England Journal of Medicine, August 18, 2016.

Similarly, there were no significant differences between acetaminophen and ibuprofen in percentage of asthmacontrol days (85.8% and 86.8%, respectively), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively), unscheduled healthcare utilization for asthma (0.75 and 0.76 episodes per participant) or adverse events.

Three WHO Publications to Help Countries Better Report Their on Stillbirths and Maternal and Neonatal Deaths The WHO launched 3 publications to help countries improve their data on stillbirths and maternal and neonatal deaths. The 1st publication, the “WHO Application of the International Classification of Disease-10 to deaths during the perinatal period” (ICD-PM), is a standardized system for classifying stillbirths and neonatal deaths. The 2nd publication, “Making Every Baby Count: Audit and Review of Stillbirths and Neonatal Deaths”, is a guide to help countries review and investigate individual deaths, so they can recommend and implement solutions to prevent similar ones in the future. It also incorporates ICD-PM classification in order to help countries complete at least a basic death review, which is an in-depth investigation into causes and circumstances surrounding the death. The 3rd WHO publication, “Time to respond: a report on the

394

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Elderly Onset IBD does not Increase Risk of Malignancy, Says Study According to a population-based cohort study in the American Journal of Gastroenterology, reported online August 2, 2016, patients with elderly-onset inflammatory bowel disease (IBD) are not at a higher risk for developing intestinal cancer. All IBD patients were at an increased risk of developing malignant lymphoproliferative and myeloproliferative disorders.

These findings are based on review of French registry data from 1988 to 2006 of 844 patients who were diagnosed with IBD after age 60, including 370 with Crohn’s disease and 474 with ulcerative colitis.

FDA Approves Expanded Indication for Sapien XT and Sapien 3 Transcatheter Heart Valves The US Food and Drug Administration (FDA) has approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in

AROUND THE GLOBE patients at high or greater risk for death or complications during surgery. The devices are contraindicated for patients who cannot tolerate blood thinning medication.

They are also contraindicated for those who are currently being treated for a bacterial or other infection

Aclidinium/Formoterol Significantly Improved Lung Function versus Salmeterol/Fluticasone in Stable COPD A phase 3 COPD study evaluating the efficacy and safety of aclidinium/formoterol versus salmeterol/ fluticasone concluded that aclidinium/formoterol significantly improved bronchodilation in patients with stable COPD versus salmeterol/fluticasone, with equivalent benefits in symptom control and reduction in exacerbation risk. Both treatments were well-tolerated and treatment-related adverse events were less common with aclidinium/formoterol. The study is reported online August 1, 2016 in the European Respiratory Journal.

Revascularization Works Better Than Medical Intervention in Intermittent Leg Claudication A study, published online August 17, 2016 in JAMA Surgery has shown that when compared with medical intervention (walking program, smoking cessation counseling and medications), the endovascular or surgical revascularization procedures significantly improved walking distance, speed, stair climb, pain and quality-of-life at 12 months from baseline in patients with intermittent leg claudication.

FDA Gives Go Ahead to First-of-kind Cognitive Tests to Assess Cognitive Skills Post-Head Injury The US Food and Drug Administration (FDA) has permitted marketing of two new devices, Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric, to evaluate the cognitive skills such as word memory, reaction time and word recognition following a concussion or traumatic brain injury. These devices are not meant to be used to diagnose a concussion or chalk out a treatment strategy.

The ImPACT software runs on a desktop/laptop and is intended to be used for individuals aged between 12 and 59 years, while the ImPACT Pediatric runs on an iPad and is designed for children aged 5 to 11 years...

(US FDA, August 22, 2016)

First ‘Exclusive’ Leprosy Vaccine Set to Go Under Trial Five districts in Bihar and Gujarat will be selected for the pilot phase of the first indigenous ‘exclusive’ leprosy vaccine to be launched soon. The vaccine, approved by the DCGI and US FDA, Mycobacterium indicus Pranii (MIP), will be administered as a preventive measure for people who live in close proximity to those infected by the bacteria. Speaking at the National Awareness Convention on Leprosy organized by the Sri Ramakrishna Math, Central Leather Research Institute and Saksham in Chennai on 21st August 2016, the Union Health Minister Shri JP Nadda said that this would be the first such mass vaccination program in the world.

Dr Soumya Swaminathan, Director General, ICMR said this vaccine could reduce the number of cases by 60% within 3 years as shown in trials… (Express News Service)

Gallstones Increase Risk of Heart Disease A history of gallstone disease is associated with increased risk of coronary heart disease and this association was independent of traditional risk factors such as diabetes, obesity or hypertension, says a new study reported in Arteriosclerosis, Thrombosis and Vascular Biology, a journal of the American Heart Association. These findings are based on a Prospective Analysis of 2,70, 000 men and women from 3 US cohorts and meta-analysis: Nurses’ Health Study, Nurses’ Health Study II and Health Professionals Follow-up Study.

Donor Fecal Microbiota Transplantation Safer and More Effective than Self Transplantation Donor fecal microbiota transplantation (FMT) is more effective in preventing recurrent Clostridium difficile infection (CDI) than autologous or self FMT, according to a new study published online 23 August 2016 in Annals of Internal Medicine. It was also safer. Donor FMT restored the gut microbiota similar to that of healthy donors.

Vital Sign Instability on Discharge Increases Risk of Death and Mortality and Rehospitalization A multicenter observational cohort study using electronic health record data has shown that having two or more vital sign instabilities at the time of discharge had a positive predictive value of 22% and positive likelihood ratio of 1.8 for mortality or rehospitalization 1 month after discharge. The study is published online August 8 in the Journal of General Internal Medicine.

■■■■

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

395

LIGHTER READING

HUMOR

Lighter Side of Medicine MORE WORDS

THE VICIOUS CIRCLE

A husband looking through the paper came upon a study that said women use more words than men. It read, “Men use about 15,000 words per day, but women use 30,000.”

The boss calls his secretary and says, “Get ready for the weekend. We are going on a business trip.”

Excited to prove to his wife that he had been right all along when he accused her of talking too much, he showed her the study results.

The wife thought for a while, then finally she said to her husband, “It’s because we have to repeat everything we say.”

The husband said “What?”

COMMUNICATION TECHNICIAN A communication technician drafted by the army was at a firing range. At the range, he was given some instructions, a rifle and 50 rounds. He fired several shots at the target. The report came from the target area that all attempts had completely missed the target.

The technician looked at his weapon, and then at the target. He looked at the weapon again, and then at the target again. He then put his finger over the end of the rifle barrel and squeezed the trigger with his other hand. The end of his finger was blown off, whereupon he yelled toward the target area: “It’s leaving here just fine, the trouble must be at your end!”

The secretary calls husband and says, “Me and my boss are going on a business trip for 2 days, so take care of yourself.”

The husband calls his mistress and says, “My wife is going on a business trip. Come home we can have fun.”

The mistress calls the boy to whom she gives tuition, “No tuition this weekend.”

The boy calls his grandfather, “Grandpa at last we can spend this weekend together.”

Grandpa (The boss) calls his secretary and says, “Business trip is canceled. I’m going to spend weekend with my grandson.”

The secretary calls husband, “I won’t be going” The husband calls his mistress, “I am sorry, my wife is not going.”

The mistress calls boy, “You have tuition.”

Boy calls his grandpa and says, “Sorry grandpa I’ve classes.”

The grandpa calls secretary and…

Dr. Good and Dr. Bad SITUATION: A diabetic patient was advised insulin tolerance test.

MILITARY MEDICAL CLINIC

When I replied that he was a recruiter, the technician smiled slyly and said, “This might hurt a little more than I thought.”

396

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

Don’t go for it

Go ahead

© IJCP Academy

During a visit to a military medical clinic, I was sent to the lab to have blood drawn. The technician there was friendly and mentioned that his mood improved every day because he was due to leave the service in 2 months. As he applied the tourniquet on my arm, he told me that taking the blood wouldn’t hurt much. Then, noticing my Air Force T-shirt, he asked me what my husband did.

LESSON: The insulin tolerance test is a valid and useful test for evaluating the insulin sensitivity of patients with diabetes, even after treatment with insulin.

J Diabetes Investig. 2014;5(3):305-12.

Information for Authors Manuscripts should be prepared in accordance with the ‘Uniform requirements for manuscripts submitted to biomedical journals’ compiled by the International Committee of Medical Journal Editors (Ann. Intern. Med. 1992;96: 766-767).

Indian Journal of Clinical Practice strongly disapproves of the submission of the same articles simultaneously to different journals for consideration as well as duplicate publication and will decline to accept fresh manuscripts submitted by authors who have done so.

The boxed checklist will help authors in preparing their manuscript according to our requirements. Improperly prepared manuscripts may be returned to the author without review. The checklist should accompany each manuscript.

Authors may provide on the checklist, the names and addresses of experts from Asia and from other parts of the World who, in the authors’ opinion, are best qualified to review the paper.

Covering letter –

– –

The covering letter should explain if there is any deviation from the standard IMRAD format (Introduction, Methods, Results and Discussion) and should outline the importance of the paper.

Principal/Senior author must sign the covering letter indicating full responsibility for the paper submitted, preferably with signatures of all the authors.

Articles must be accompanied by a declaration by all authors stating that the article has not been published in any other Journal/Book. Authors should mentioned complete designation and departments, etc. on the manuscript.

Manuscript – Three complete sets of the manuscript should be submitted and preferably with a CD; typed double spaced throughout (including references, tables and legends to figures).

–

The manuscript should be arranged as follow: Covering letter, Checklist, Title page, Abstract, Keywords (for indexing, if required), Introduction, Methods, Results, Discussion, References, Tables, Legends to Figures and Figures.

–

All pages should be numbered consecutively beginning with the title page.

Note: Please keep a copy of your manuscript as we are not responsible for its loss in the mail. Manuscripts will not be returned to authors.

Title page Should contain the title, short title, names of all the authors (without degrees or diplomas), names and full location of the departments and institutions where the work was performed,

name of the corresponding authors, acknowledgment of financial support and abbreviations used.

– The title should be of no more than 80 characters and should represent the major theme of the manuscript.

A subtitle can be added if necessary.

– A short title of not more than 50 characters (including inter-word spaces) for use as a running head should be included.

– The name, telephone and fax numbers, e-mail and postal addresses of the author to whom communications are to be sent should be typed in the lower right corner of the title page.

– A list of abbreviations used in the paper should be included. In general, the use of abbreviations is discouraged unless they are essential for improving the readability of the text.

Summary – The summary of not more than 200 words. It must convey the essential features of the paper.

– It should not contain abbreviations, footnotes or references.

Introduction – The introduction should state why the study was carried out and what were its specific aims/objectives.

Methods – These should be described in sufficient detail to permit evaluation and duplication of the work by others.

– Ethical guidelines followed by the investigations should be described.

Statistics The following information should be given: – The statistical universe i.e., the population from which the sample for the study is selected.

– Method of selecting the sample (cases, subjects, etc. from the statistical universe).

– Method of allocating the subjects into different groups.

– Statistical methods used for presentation and analysis of data i.e., in terms of mean and standard deviation values or percentages and statistical tests such as Student’s ‘t’ test, Chi-square test and analysis of variance or non-parametric tests and multivariate techniques.

–

Confidence intervals for the measurements should be provided wherever appropriate.

Results – These should be concise and include only the tables and figures necessary to enhance the understanding of the text.

Indian Journal of Clinical Practice, Vol. 27, No. 4, September 2016

397

Discussion –

This should consist of a review of the literature and relate the major findings of the article to other publications on the subject. The particular relevance of the results to healthcare in India should be stressed, e.g., practicality and cost.

References These should conform to the Vancouver style. References should be numbered in the order in which they appear in the texts and these numbers should be inserted above the lines on each occasion the author is cited (Sinha12 confirmed other reports13,14...). References cited only in tables or in legends to figures should be numbered in the text of the particular table or illustration. Include among the references papers accepted but not yet published; designate the journal and add ‘in press’ (in parentheses). Information from manuscripts submitted but not yet accepted should be cited in the text as ‘unpublished observations’ (in parentheses).

At the end of the article the full list of references should include the names of all authors if there are fewer than seven or if there are more, the first six followed by et al., the full title of the journal article or book chapters; the title of journals abbreviated according to the style of the Index Medicus and the first and final page numbers of the article or chapter. The authors should check that the references are accurate. If they are not this may result in the rejection of an otherwise adequate contribution.

Examples of common forms of references are: Articles Paintal AS. Impulses in vagal afferent fibres from specific pulmonary deflation receptors. The response of those receptors to phenylguanide, potato S-hydroxytryptamine and their role in respiratory and cardiovascular reflexes.

Q. J. Expt. Physiol. 1955;40:89-111.

Figures – Two complete sets of glossy prints of high quality should be submitted. The labelling must be clear and neat.

– All photomicrographs should indicate the magnification of the print.

– Special features should be indicated by arrows or letters which contrast with the background.

– The back of each illustration should bear the first author’s last name, figure number and an arrow indicating the top. This should be written lightly in pencil only. Please do not use a hard pencil, ball point or felt pen.

– Color illustrations will be accepted if they make a contribution to the understanding of the article.

–

Do not use clips/staples on photographs and artwork.

–

Illustrations must be drawn neatly by an artist and photographs must be sent on glossy paper. No captions should be written directly on the photographs or illustration. Legends to all photographs and illustrations should be typed on a separate sheet of paper. All illustrations and figures must be referred to in the text and abbreviated as “Fig.”.

Please complete the following checklist and attach to the manuscript: 1. Classification (e.g. original article, review, selected summary, etc.)_______________________________ 2. Total number of pages ________________________ 3. Number of tables ____________________________ 4. Number of figures ___________________________

Books

5. Special requests _____________________________

Stansfield AG. Lymph Node Biopsy Interpretation Churchill Livingstone, New York 1985.

6. Suggestions for reviewers (name and postal address)

Articles in Books

2.____________ 2.________________

Strong MS. Recurrent respiratory papillomatosis. In: Scott Brown’s Otolaryngology. Paediatric Otolaryngology Evans JNG (Ed.), Butterworths, London 1987;6:466-470.

3.____________ 3.________________

4.____________ 4.________________

Tables –

These should be typed double spaced on separate sheets with the table number (in Roman Arabic numerals) and title above the table and explanatory notes below the table.

Legends – These should be typed double spaces on a separate sheet and figure numbers (in Arabic numerals) corresponding with the order in which the figures are presented in the text.

–

398

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. 4, September 2016

Indian 1.____________Foreign 1.________________

7. All authors’ signatures________________________ 8.

Corresponding author’s name, current postal and e-mail address and telephone and fax numbers __________________________________________

Online Submission Also e-Issue @ www.ijcpgroup.com For Editorial Correspondence

Dr KK Aggarwal

Group Editor-in-Chief Indian Journal of Clinical Practice E-219, Greater Kailash Part-1 New Delhi - 110 048. Tel: 40587513 E-mail: editorial@ijcp.com Website: www.ijcpgroup.com

R.N.I. No. 50798/1990 Date of Publication 13th of Same Month Date of Posting 13-14 Same Month

POSTAL REGISTRATION NO. DL (S)-01/3200/2015-2017 Posted in N.D. PSO New Delhi