Indian journal of clinical practice december 2014

Indexed with IndMED

ISSN 0971-0876

www.ijcpgroup.com

Volume 25, Number 7

December 2014, Pages 601–700

Peer Reviewed Journal

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American Family Physician

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Community Medicine

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Dermatology

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ENT

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Obstetrics and Gynecology

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Expert View

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IJCP Group of Publications Dr Sanjiv Chopra Prof. of Medicine & Faculty Dean Harvard Medical School Group Consultant Editor Dr Deepak Chopra Chief Editorial Advisor Padma Shri, Dr BC Roy National & National Science Communication Awardee

Dr KK Aggarwal Group Editor-in-Chief

Dr Veena Aggarwal MD, Group Executive Editor

IJCP Editorial Board Obstetrics and Gynaecology Dr Alka Kriplani Dr Thankam Verma, Dr Kamala Selvaraj Cardiology Dr Praveen Chandra, Dr SK Parashar Paediatrics Dr Swati Y Bhave Diabetology Dr CR Anand Moses, Dr Sidhartha Das Dr A Ramachandran, Dr Samith A Shetty ENT Dr Jasveer Singh Dr Chanchal Pal Dentistry Dr KMK Masthan Dr Rajesh Chandna Gastroenterology Dr Ajay Kumar Dr Rajiv Khosla Dermatology Dr Hasmukh J Shroff Dr Pasricha Dr Koushik Lahiri Nephrology Dr Georgi Abraham Neurology Dr V Nagarajan Dr Vineet Suri Journal of Applied Medicine & Surgery Dr SM Rajendran, Dr Jayakar Thomas Orthopedics Dr J Maheshwari

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

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

Volume 25, Number 7, December 2014 FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

606 Patient Solidarity Day 6th December

KK Aggarwal

AMERICAN FAMILY PHYSICIAN

608 What is New in HIV Infection?

Kevin Sherin, Benjamin G. Klekamp, Jeffrey Beal, Nicolle Martin

615 Practice Guidelines 616 Photo Quiz ANESTHESIOLOGY

618 To Evaluate the Effectiveness of Oral Tablet Clonidine as a Premedicant Drug: A Prospective Study of 100 Cases

B Brinda, S Chakravarthy, S Manjunatha Prasad

COMMUNITY MEDICINE

624 Study of Patient Satisfaction at a Super Specialty Tertiary Care Hospital

Param Hans Mishra,Tripti Mishra

636 Prevalence and Pattern of Self-medication Practices in Rural Area of Barabanki

Shyam Sunder Keshari, Priyanka Kesarwani, Mili Mishra

DERMATOLOGY

640 Degos’ Like Nonclear Cell Acanthoma: Could this be a New Entity?

Aditya Kumar Bubna, Leena Dennis Joseph, Mahalakshmi Veeraraghavan, Sudha Rangarajan

DIABETOLOGY

644 Macrovascular and Microvascular Complications in Newly Diagnosed Type 2 Diabetes Mellitus

Deepa DV, Kiran BR, Gadwalkar Srikant R

ENT

652 Non-Hodgkin’s Lymphoma Masquerading as Submandibular Sialadenitis

Kapil Soni, Vineet Panchal, Bhushan Kathuria, SPS Yadav, Rajiv Sen

GASTROENTEROLOGY

655 An Unusual Case of Massive Splenomegaly in Cirrhotic Portal Hypertension

Monika Maheshwari, Rajendra Kumar Verma, Ravi

INTERNAL MEDICINE

657 An Incidental Finding of Polysplenia Syndrome in a Geriatric Patient: A Case Report

Praveen Kumar, Kalpana Chandra, Neeraj Prajapati

660 Super Vasmol Hair Dye: An Emerging Fatal Poison

Rammurthy P, Netto George Mundadan, Sunilkumar N, Suresh C

OBSTETRICS AND GYNECOLOGY

664 A Rare Case of Cor Triloculare Biventriculare Detected in a Postpartum Female

Parneet Kaur, Khushpreet Kaur, Rama Garg, Isha Gupta

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

667 Cervical Molar Pregnancy and Its Future Fertility

Babita Ramani, Rajat Mohanty, Sudipta Patnaik

671 Randomized Controlled Study Comparing Sublingual to Vaginal

Misoprostol for Cervical Priming Prior to Surgical Termination of Pregnancy in First Trimester

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

Nalini Sharma, JK Goel

675 Effectiveness on Knowledge of Necklace Method as a Natural Family Planning Among Reproductive Age Group Mothers

Š Copyright 2014 IJCP Publications Ltd. All rights reserved.

Latha Venkatesan, Dhanalakshmi

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.

678 Lesson Learnt in Anal Melanoma: A Case Report

Lanka Praveen, Vipon Kumar, Aswini Kumar Pujahari

PEDIATRICS

680 Apert Syndrome with Epibulbar Dermoid Cyst in the Eye -

Coincidence or an Additional Clinical Finding: A Case Report

Editorial Policies

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

Dillip Kumar Das, Soumyashree Hota, Samarendra Mahapatro

EXPERT VIEW

683 What Health Problems are Associated with Hypertension?

Rajiv Garg

AROUND THE GLOBE

685 News and Views CSI 2014

687 Proceedings of 66th Annual Conference of Cardiological Society of India: Conversations with Giants and Legends in Cardiology

Dr HK Chopra in conversation with Dr Navin C Nanda, USA

MEDILAW

689 High Risk Consent and Other Issue Related to Consent

KK Aggarwal

INSPIRATIONAL STORY

693 Small Victories LIGHTER READING

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.

694 Lighter Side of Medicine

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FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF Dr KK Aggarwal

Padma Shri, Dr BC Roy National & National Science Communication Awardee Sr. Physician and Cardiologist, Moolchand Medcity President, Heart Care Foundation of India Group Editor-in-Chief, IJCP Group and eMedinewS National Senior Vice President, IMA Member, Ethics Committee, MCI Chairman, Ethics Committee, Delhi Medical Council Director, IMA AKN Sinha Institute (08-09) Hony. Finance Secretary, IMA (07-08) Chairman, IMA AMS (06-07) President, Delhi Medical Association (05-06) emedinews@gmail.com http://twitter.com/DrKKAggarwal Krishan Kumar Aggarwal (Facebook)

Patient Solidarity Day 6th December

W

e have all been patients at some point of time in our lives, or cared for one. Let’s recommit ourselves to provide safe, high quality, equitable and affordable healthcare to all. Let’s make “High quality and Minimal Stay" for our patients our motto. Every person, every patient is equal and all have the right to access the healthcare they need, when they need it.

I met another spiritual guru through our Chief Anesthetist. The fee he paid to me was a spiritual message “Suno, Samjho, Jano, Karo” i.e. Hear, Understand, Wisdom and Do.” He said that hearing is different from listening, listening is different from wisdom and wisdom is different from doing. Unless you hear, understand what you have heard and implement, learning has no value.

We need to unite to ensure that all people, across the world, have fair and impartial access to quality healthcare. Patient Solidarity Day is a day to come together, unite and speak with one voice. It recognizes that regardless of disease, religion or nationality, we all share common problems. Let's all share what our patients have taught us in our practice.

One of my Buddhist patients gave me a spiritual learning, which has helped me a lot in my routine clinical practice. He taught me the basic Buddhist message that there is suffering all over; there is a reason for every suffering and it is possible to maintain sufferings. This message fits into the main message of Hinduism and also the main teaching from Garud Purana.

HERE ARE MINE “During our career, we have learnt a lot of spiritual prescriptions from our patients. Not only did they help us heal our patients, they also changed our perception about health and sickness".

I recall Swami Bodhanand, a disciple of Swami Chinmayananda, was once hospitalized under our care.

When I asked him to give me a spiritual message, he just said two words “Detached Attachment”. He said, “As a doctor you should behave like a lotus leaf. The lotus leaf is wet as long as a there is a drop of water on it, but once the drop is out, the leaf is as dry as if the water was never there.” The message was that “we should be attached to our patients as long as they are with us. The day they die, we should be completely detached from them or else we will not be able to treat other patients.”

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In Hinduism, we know that the very fact that we are born in this life means that in our last life, we could not get liberation because Hinduism believes that after liberation you are not reborn. Not getting liberated in the last birth means that there are some sufferings still left in our life. The basic purpose of this birth, therefore, is to face sufferings. When the basic purpose of our birth is to face sufferings, then why suffer from these sufferings. Every time we suffer, we should thank God that he has reduced one more. The period in between two sufferings is called a Happy period (Sukh). In fact, this period is nothing but a period of rest given to us

by God to prepare our body for the next suffering. This as a concept of counseling helps my patients to manage most of their mental disturbances.

Sometimes not telling a patient that he is suffering from terminal cancer works. The father of one of my patient was found to have extensive cancer of the prostate.

FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF He was 83 years old. Medically, we all gave him three months to live. My patient did not have the courage to tell his father or the family members that he (the father) had extensive cancer. He took me into confidence and played a game with the family. We gathered all the family members and told them that this cancer had been cured with the surgery. A party was organized in the evening to celebrate the cure. The magic happened; he lived almost a symptom-free life for the next 9 years.

I have tried this on many of my patients thereafter and it works. The probable explanation was loss of fear of death, confidence in his doctor and faith in his own self.

The way to live to 100 years is to go on working in life.

My great grandfather-in-law was 75 years old when I got married. That year, he gathered all family members across the world and said that his purpose of life was over; he would like a collective family photograph and

like to quit the world. Nothing happened for a year. On 20th July next year, he again acted in a similar manner.

The whole family from across the world gathered but he remained alive for another year. This went on for three years. Suddenly, we decided to play a spiritual trick on him and told everyone to convince him that he is going to live for 100 years as he still had to carry out lot of work for the family. Every year, we gave him law students from within the family to be taught (he was a lawyer himself), or entrusted him with the responsibility of finding a boy for some eligible girl in the family. We made him teach and search for a prospective bride or groom for eligible family members for years together and he actually died at the age of 100 years.

This is the beauty of a positive attitude in life

■■■■

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AMERICAN FAMILY PHYSICIAN

What is New in HIV Infection?

KEVIN SHERIN, BENJAMIN G. KLEKAMP, JEFFREY BEAL, NICOLLE MARTIN

ABSTRACT Human immunodeficiency virus (HIV) prevention and treatment updates include screening recommendations, fourthgeneration testing, preexposure prophylaxis, and a paradigm shift; treatment is prevention. The U.S. Preventive Services Task Force recommends routine HIV screening in persons 15 to 65 years of age, regardless of risk. Fourth-generation testing is replacing the Western blot and can identify those with acute HIV infection. The U.S. Food and Drug Administration approved the OraQuick In-Home HIV Test; however, there are concerns about reduced sensitivity, possible misinterpretation of results, potential for less effective counseling, and possible cost barriers. Preexposure prophylaxis (effective in select high-risk adult populations) is the combination of safer sex practices and continuous primary care prevention services, plus combination antiretroviral therapy. Concerns for preexposure prophylaxis include the necessity of strict medication adherence, limited use among high-risk populations, and community misconceptions of appropriate use. Evidence supports combination antiretroviral therapy as prevention for acute HIV infection, thus lowering community viral loads. Evidence has increased supporting combination antiretroviral therapy for treatment at any CD4 cell count. Resistance testing should guide therapy in all patients on entry into care. Within two weeks of diagnosis of most opportunistic infections, combination antiretroviral therapy should be started; patients with tuberculosis and cryptococcal meningitis require special considerations.

Keywords: HIV screening, OraQuick In-Home HIV Test, preexposure prophylaxis, combination antiretroviral therapy, CD4 cell count

P

ersistent high rates of human immunodeficiency virus (HIV) transmission in the United States require new strategies to combat the ongoing epidemic. Latest recommendations and evidence address routine HIV screening, implementation of fourth-generation testing, targeted use of preexposure prophylaxis (PrEP) for high-risk adults without HIV, treatment as prevention to lower community viral loads, and treatment guidelines on single fixed-dose combination antiretroviral therapy (CART).1-7

KEVIN SHERIN, MD, MPH, MBA, FAAFP, FACPM, is a clinical professor of family medicine at Florida State University College of Medicine; an associate professor of family medicine at the University of Central Florida College of Medicine; and the public health director of the Florida Department of Health in Orange County, all of which are located in Orlando. He also serves as chair of the Prevention Practice Committee at the American College of Preventive Medicine.

BENJAMIN G. KLEKAMP, MSPH, CPH, is a Florida Epidemic Intelligence Service Fellow with the Florida Department of Health in Orlando.

JEFFREY BEAL, MD, AAHIVS, is a clinical associate professor at the University of South Florida Center for HIV Education and Research and is the principal investigator and clinical director for the Florida/Caribbean AIDS Education and Training Center, both in Tampa. He also is the medical director of the HIV/AIDS and Hepatitis Section in the Bureau of Communicable Diseases at the Florida Department of Health.

NICOLLE MARTIN, MD, MPH, is an assistant professor in the Department of Community Health and Preventive Medicine at the Morehouse School of Medicine in Atlanta, Ga. Source: Adapted from Am Fam Physician. 2014;89(4):265-272.

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WHAT IS NEW IN SCREENING? The U.S. Preventive Services Task Force recommends routine HIV screening, known as opt-out screening, regardless of patient or physician perception of risk for all persons 15 to 65 years of age, unless a patient refuses.1 Those younger than 15 years and older than 65 years with risk factors should also be screened, including men who have sex with men; injection drug users; persons having unprotected vaginal or anal intercourse; persons who have a sex partner with highrisk behaviors; persons with a history of or current concern for other sexually transmitted infections; and sex workers.1 The Centers for Disease Control and Prevention recommends routine HIV testing for all persons 13 to 64 years of age.8 Although little evidence exists to determine the interval for rescreening, at least annual HIV screening is recommended for groups at high risk. Less frequent screening intervals are appropriate for other groups, including those younger than 15 years and older than 65 years.1 Use of rapid tests in screening programs is supported by the evidence, because they have been found to be highly accurate; however, subsequent conventional testing is necessary to confirm an HIV diagnosis.1,9,10 The U.S. Preventive Services Task Force recommends HIV screening in

AMERICAN FAMILY PHYSICIAN all pregnant women (even if in active labor), despite previous pregnancy HIV status.1 The Centers for Disease Control and Prevention recommends HIV screening at entry into care and repeat screening in the third trimester in women living in areas with high HIV rates among pregnant women.8 If HIV infection is detected, effective care and partner notification are essential for disease control.

What are the Advantages of Opt-out Screening?

More persons with HIV can be identified earlier with opt-out screening. Reduction of risky behaviors has been observed following detection of HIV infection and subsequent patient education.11 Effective care can decrease morbidity, mortality, and community viral load.5,12

Is there any Harm from At-risk Opt-in Screening?

Opt-in screening based on demographic, behavioral, or clinical subpopulations is known to lower test rates, but identifies only 75% of patients with HIV,13 resulting in a large number of persons presenting late in disease progression.14 Other limitations include patient perception of risk, reluctance for self-disclosure, and lack of comprehensive risk assessments.

WHAT IS NEW IN TESTING? Serologic testing is enhanced by a newer fourthgeneration algorithm allowing for identification of early HIV infection.15,16 Additionally, the U.S. Food and Drug Administration (FDA) licensed the OraQuick In-Home HIV Test.17 Earlier generation rapid HIV tests should be used for screening in areas where blood collection is not feasible; later generation blood-based rapid fourthgeneration testing is preferred for screening when available.

What is Fourth-generation Testing?

The fourth-generation testing uses combined antibody/ antigen immunoassay (as opposed to antibodies alone) to identify HIV-1 and HIV-2.18 If the results on the primary antibody/antigen assay are positive, another immunoassay differentiates between HIV-1 and HIV-2 antibodies and helps guide the choice of CART. HIV-2, which is less common than HIV-1 and found mostly in West Africa, is resistant to non-nucleoside reverse transcriptase inhibitors and enfuvirtide therapy.7,19 If the results of the second-tier HIV-1/HIV-2 immunoassay are negative, a nucleic acid amplification test is performed to detect HIV RNA viral activity rather than antibodies to HIV.18 A positive result on nucleic acid amplification

testing identifies acute HIV-1 infection (rare falsepositive results are possible). Third-generation assays consist of rapid enzyme immunoassays that look for antibodies or parts of antibodies on the surface of HIV, and one or more confirmatory tests, such as the Western blot. These assays can detect immunoglobulin M antibodies, which increase first, and immunoglobulin G antibodies, which increase later. The less-sensitive Western blot is the confirmatory test that looks for HIV antibodies, which may take up to three months to confirm, with results ranging from positive or negative to inconclusive.20

How much Earlier can a Diagnosis be Made with Fourth-generation Testing?

The window period is from initial HIV infection until any laboratory test detects HIV. Fourth-generation testing incorporates HIV-1/HIV-2 antibody and p24 antigen detection; therefore, the window period can be as early as 15 to 17 days (Figure 1).16 Using fourthgeneration testing, HIV-1 infection can be diagnosed within two to three weeks of risk exposure.16 Qualitative HIV-1 nucleic acid amplification tests and HIV-1 viral load tests are positive around day 10 to 12; however, these tests are not typically used for screening purposes.

A rapid finger stick blood-based test (Alere Determine) that detects and differentiates HIV-1/HIV-2 antibodies and HIV-1 p24 antigen has recently been approved by the FDA.21

What is the Advantage of Fourth-generation Testing?

Fourth-generation testing can screen for and confirm HIV infection in several hours instead of weeks, allows for identification of very early HIV infection, and eliminates the indeterminate Western blot results that could take up to three to six months to confirm.15 Persons at high risk can be retested within three weeks of potential exposure. Identification of acute HIV infection allows for prevention of new infections through risk reduction counseling, earlier intervention with CART, and partner notification.7 Fourthgeneration testing costs more per sample than previous algorithms; however, preliminary cost-effectiveness studies on fourth-generation testing in high-incidence areas found benefits of increased case identification, reduced transmission, and increased quality-adjusted life years.22

What is the New Over-the-Counter Test?

The FDA has approved the OraQuick In-Home HIV Test, which is a rapid test that does not require sample

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AMERICAN FAMILY PHYSICIAN shipment for laboratory confirmation.17 The test, which is available to persons older than 17 years, provides results in 20 to 40 minutes. Positive results require confirmation with a Western blot or fourth-generation testing. A limitation is that it has a sensitivity of 92% when the test is self-administered because of user error and poor technique, compared with a sensitivity of 99% when administered by trained professionals.2 Other limitations are misinterpretation of tests during the window period, potential for less effective counseling, and possible cost barriers.

WHAT IS PrEP? PrEP for sexual transmission of HIV is the combination of continual delivery of counseling on behavioral risk reduction, techniques for medication adherence, easy access to condoms, monitoring of pregnancy status, sexually transmitted infection screening and treatment, and strict adherence to once-daily oral combination therapy of 200-mg emtricitabine/300-mg tenofovir.2,3 Studies support PrEP effectiveness in reducing HIV infections in high-risk settings. Concern exists for development of resistance in settings of nonadherence.23 A consistent observation among PrEP studies of men who have sex with men and of men who have sex with women is remarkably poor adherence to drug regimens, as measured by drug levels.24,25

exposed to emtricitabine/tenofovir have been reported.

Non-PrEP HIV prevention options are available for HIVdiscordant couples trying to conceive.27,29 The Centers for Disease Control and Prevention recommends against prescribing PrEP to breastfeeding women (information submitted to the FDA’s MedWatch) if PrEP is continued during a pregnancy.2 It should be noted that nonadherence to PrEP in clinical trials, as evidenced by drug levels or pill counts, was associated with failure to prevent HIV infection.32 A key study of women was terminated because of lack of efficacy.31

What Do I Need to Emphasize to my Patient Receiving PrEP? It is important that patients receiving PrEP adhere to follow-up appointments and take medication as prescribed; this is not a “just before sex pill.” PrEP effectiveness depends on medication adherence and safer sex practices. Among men who have sex with men, HIV risk reduction was 73% with at least 90% medication adherence. Adherence less than 90% reduced risk by 21%.33 Physicians should inform patients about unknown long-term effects of medication, inquire about medication adherence and adverse effects (e.g., diarrhea, dizziness, nausea), reinforce adherence to behavior changes,1 and provide specific evidence-based HIV behavioral interventions.34,35

Who can Receive PrEP based on Clinical Evidence?

WHAT IS NEW IN PREVENTION AND TREATMENT?

Only HIV-negative persons are candidates for PrEP as a part of a prevention strategy that includes ongoing risk reduction and condom counseling. Assessment for HIV before and routinely during enrollment is required.

PrEP is recommended for adults (i.e., persons older than 18 years) at very high risk (e.g., has a sex partner with known HIV infection), who have negative results on a fourth-generation HIV antibody/antigen test or HIV antibody test at the time of PrEP enrollment, and who agree to repeat HIV testing every three months2-4,24,25 (Table 12,3,26-31). Figure 2 outlines a process to identify potential PrEP candidates.2,3 Guidance for the use of PrEP can be found at http://www.cdc.gov/hiv/ prevention/research/prep/index.html and http://www. truvadapreprems.com.

Treatment as Prevention

Is PrEP Safe for Women Trying to Conceive, and Pregnant or Breastfeeding Women?

Safety information for fetuses and breastfeeding infants of HIV-discordant couples using PrEP is unfinished; no adverse events for fetuses and breastfeeding infants

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The most important evidence-based message is that early treatment is viewed as an integral part of community-based prevention.5,36 Patient adherence to CART, even for early HIV infection (CD4 cell count greater than 350 per mm3 [0.35 × 109 per L]), provides hope of lessening disease progression through control of HIV, and contributing to a lower community viral load and reduced risk of HIV transmission.37 Hence, early treatment is prevention. It may be that there is more community benefit vs. individual benefit with early CART. Ongoing clinical trials to improve understanding are needed.

What is New in Treatment for Cart-naive Patients?

Research shows CART is effective in lowering viral loads to nearly undetectable levels, advancing the concept that CART is prevention.5 Early antiretroviral therapy has shown clinical benefit when initiated at a CD4 cell count between 350 and 550 cells per mm3 (0.35 and 0.55 × 109 per L) by reducing HIV-related clinical

AMERICAN FAMILY PHYSICIAN Table 1. Considerations Before and During Initiation of HIV PrEP Evidence-based clinical guidance

Recommended clinical care

Is my patient truly HIV negative?

PrEP is not indicated in persons with unknown or positive HIV status.2,3

Fourth-generation HIV antibody/antigen testing or HIV antibody testing should be performed before prescribing PrEP; patients should be retested every three months while receiving PrEP.2

Is my patient at very high risk of HIV? PrEP is currently indicated for only very high-risk persons (e.g., has a sex partner with known HIV infection).2,3

Information on safer sex practices should be provided, and care should be provided to the partner with HIV infection.

Is my patient infected with hepatitis B virus?

Stopping emtricitabine/tenofovir abruptly in a person with hepatitis B virus infection may cause a flare-up of hepatitis B virus infection.26

Vaccination for hepatitis B virus should be offered to susceptible persons, and active hepatitis B virus infections should be treated.

All adverse events from PrEP should be reported to the U.S. Food and Drug Administration.2

Is my patient a kidney transplant recipient or does he or she have kidney dysfunction?

PrEP is not indicated for persons who have a creatinine clearance of less than 60 mL per minute per 1.73 m2 (1 mL per second per m2).2

Creatinine clearance should be measured, rechecked three months after initiation of PrEP, and followed in six-month intervals while receiving PrEP.2

Does my patient have an STI? All STIs that are laboratory detected should be treated based on most recent guidance,27,28 because persons with STIs have increased susceptibility to contracting HIV and increased infectiousness of HIV during STI coinfection.27

While receiving PrEP, behavioral risk reduction counseling should be conducted, condoms should be provided, and STI symptoms should be assessed every two to three months; laboratory testing for asymptomatic bacterial STIs should be performed every six months.2

Is my patient pregnant or trying to become pregnant?

Safety information for fetuses and breastfeeding infants of mothers receiving PrEP is unfinished. Breastfeeding women should not receive PrEP.2

Information about non-PrEP HIV prevention methods for HIVdiscordant couples trying to conceive should be provided.29,30 Risks and benefits of continuing PrEP during and after pregnancy should be discussed for an informed patient-centered decision.

Can my patient afford the financial burden of PrEP? The high cost of PrEP, including the cost of transportation for the numerous clinical visits needed for proper PrEP care, might be prohibitive and exacerbate health care inequalities within the community.31

Underserved patients should be linked to community resources to aid in high medication adherence and safer sex practices, which are key to maintain effectiveness of PrEP.

HIV = Human immunodeficiency virus; PrEP = Preexposure prophylaxis; STI = Sexually transmitted infection.

Information from references 2, 3, and 26 through 31.

events.5 A small pilot study of early CART, initiated within the first weeks of infection, resulted in normal CD8 cell activation 48 and 96 weeks after treatment began—comparable to healthy patients without HIV in the control group.38 Further research is needed to evaluate the potential for superior clinical outcomes.38 Patients willing to commit to early CART should understand risks of drug resistance if nonadherent, unknown long-term treatment toxicities,7,37 and ongoing controversies for early treatment.8,39 Also, the aging population with HIV infection and comorbidities increases concern for polypharmacy and drug-drug interactions. The latest clinical and

prevention guidelines for HIV treatment are available at http://aidsinfo.nih.gov/guidelines. Consultation with an expert is advised when early (acute HIV infection) treatment is undertaken.

Should Cart be Initiated in the Setting of Acute Opportunistic Infections?

Within the first two weeks of diagnosis of most opportunistic infections, CART should be started.

Patients with tuberculosis and cryptococcal meningitis are exceptions; these patients may require delayed CART initiation to improve clinical outcomes. Treatment of tuberculosis in the setting of CART is further complicated by drug interactions. Once CART has been

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AMERICAN FAMILY PHYSICIAN PrEP Candidate Protocol Very high-risk, HIV-negative patient: Who is sexually active with an HIV-positive partner(s) and/or Who is sexually active in a high prevalence area or social network or Who has inadequate condom adherence or Who has a sexually transmitted infection or Who uses illicit drugs or has alcohol dependence or Who barters for sex or Who has a partner(s) with unknown HIV-1 status with at least one of the above risk factors Absence of symptoms for acute HIV infection or Negative result on fourth-generation testing and no at-risk activity within the past 11 to 14 days (preferred) or negative result on enzyme-linked immunosorbent assay/Western blot Document patient understanding of risks and benefits, and agreement to be adherent with medication and follow-up visits Patient is candidate for PrEP* Repeat HIV testing at least every three months; provide risk reduction education *More detailed information is available at http://www.truvadapreprems.com/ truvadaprep-resources.

Figure 2. Process to identify potential preexposure prophylaxis (PrEP) candidates.

HIV = Human immunodeficiency virus.

Information from references 2 and 3.

started in patients with tuberculosis or cryptococcal meningitis, close monitoring for and treatment of immune reconstitution inflammatory syndrome, which restores the immune response to the infection with secondary severe inflammatory consequences, is of critical importance. Expert consultation is recommended in these patients. Additional resources are available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/ adultandadolescentgl.pdf and http://aidsinfo.nih.gov/ contentfiles/lvguidelines/adult_oi.pdf.

What Cart is Recommended for Initial Therapy?

Therapy should be guided by resistance testing in all patients on entry into care; however, resistance testing is inconsistently performed.7 Recommendations for CART include preferred combinations of nucleoside/ nucleotide reverse transcriptase inhibitor–, nonnucleoside reverse transcriptase inhibitor–, ritonavir-

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boosted protease inhibitor–, or integrase strand transfer inhibitor–based regimens.7,37 Six classes of HIV medications are approved for initial therapy (Table 27).

Guidance on CART for antiretroviral-naive patients is available at http://aidsinfo.nih.gov/contentfiles/ lvguidelines/adultandadolescentgl.pdfandhttps://www. iasusa.org/content/antiretroviral-treatment-adult-hivinfection-0.

What is New for Cart?

The FDA has approved the one-pill combination of elvitegravir (an HIV-1 integrase strand transfer inhibitor)/cobicistat (a pharmacokinetic booster)/ emtricitabine/tenofovir as an alternative CART regimen for patients with a creatinine clearance greater than 70 mL per minute per 1.73 m2 (1.17 per second per m2).7,37 Stribild was found to be equivalent to efavirenz and atazanavir based regimens. Stribild is well tolerated, but carries potential for drug interactions with its coformulated pharmacokinetic booster, cobicistat. Also, cobicistat, through inhibition of tubular secretion of creatinine, causes a mild increase in serum creatinine of about 0.1 to 1.5 mg per dL (9 to 133 μmol per L).40,41 Of the one pill per day combination CART therapies available, efavirenz/emtricitabine/tenofovir is a preferred regimen and rilpivirine/emtricitabine/ tenofovir and Stribild are alternative regimens approved for use in antiretroviral-naive patients.

Dolutegravir is an integrase strand transfer inhibitor approved by the FDA in August 2013 for treating HIV-1 in treatment-naive adults (including those with prior integrase strand transfer inhibitor exposure), and treatment-naive and treatment-experienced children 12 years and older (weighing at least 88 lb [40 kg]) who have never taken other integrase strand transfer inhibitor medications. Dosing depends on whether the patient is integrase strand transfer inhibitor–naive or experienced with integrase strand transfer inhibitors, on resistance at baseline, and on certain drug interactions. Prescribing information can be found at http://www.accessdata.fda.gov/drugsatfda_docs/ label/2013/204790lbl.pdf.

(For complete article visit. http://www.aafp.org/afp) REFERENCES 1. Moyer VA; U.S. Preventive Services Task Force.

Screening for HIV: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2013;159(1):51-60.

AMERICAN FAMILY PHYSICIAN 2. Centers for Disease Control and Prevention. Interim guidance for clinicians considering the use of

preexposure prophylaxis for the prevention of HIV infection in heterosexually active adults. MMWR Morb Mortal Wkly Rep. 2012;61(31):586-589.

3. Centers for Disease Control and Prevention. Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. MMWR Morb Mortal Wkly Rep. 2011;60(3):65-68.

4. Okwundu CI, Uthman OA, Okoromah CA. Antiretroviral pre-exposure prophylaxis (PrEP) for preventing HIV in high-risk individuals. Cochrane Database Syst Rev. 2012;(7):CD007189.

5. Cohen MS, Chen YQ, McCauley M, et al.; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365(6):493-505.

6. U.S. Department of Health and Human Services. Strategic plan: Division of HIV/AIDS prevention, 2011 through 2015. August 2011. http://www.cdc.gov/hiv/strategy/ dhap/pdf/dhap-strategic-plan.pdf. Accessed June 6, 2013.

7. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. http:// aidsinfo.nih.gov/contentfiles/lvguidelines/adultand adolescentgl.pdf. Accessed June 9, 2013.

8. Branson BM, Handsfield HH, Lampe MA, et al.; Centers for Disease Control and Prevention. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006;55(RR-14):1-17.

9. Torian LV, Forgione LA, Punsalang AE, Pirillo RE, Oleszko WR. Comparison of multispot EIA with Western blot for confirmatory serodiagnosis of HIV. J Clin Virol.

2011;52(suppl 1):S41-S44.

10. Styer LM, Sullivan TJ, Parker MM. Evaluation of an alternative supplemental testing strategy for HIV diagnosis by retrospective analysis of clinical HIV testing data. J Clin Virol. 2011;52(suppl 1):S35-S40.

11. Marks G, Crepaz N, Senterfitt JW, Janssen RS. Metaanalysis of high-risk sexual behavior in persons aware and unaware they are infected with HIV in the United States: implications for HIV prevention programs. J Acquir Immune Defic Syndr. 2005;39(4):446-453.

12. Das M, Chu PL, Santos GM, et al. Decreases in community viral load are accompanied by reductions in new HIV infections in San Francisco. PLoS One. 2010;5(6):e11068.

13. Walensky RP, Losina E, Steger-Craven KA, Freedberg KA. Identifying undiagnosed human immunodeficiency virus: the yield of routine, voluntary inpatient testing.

Arch Intern Med. 2002;162(8):887-892.

14. Bartlett JG, Branson BM, Fenton K, Hauschild BC, Miller V, Mayer KH. Opt-out testing for human immunodeficiency virus in the United States: progress and challenges. JAMA. 2008;300(8):945-951.

15. Owen SM. Testing for acute HIV infection: implications for treatment as prevention. Curr Opin HIV AIDS. 2012;7(2):125-130.

16. Patel P, Bennett B, Sullivan T, Parker MM, Heffelfinger JD, Sullivan PS; CDC AHI Study Group. Rapid HIV screening: missed opportunities for HIV diagnosis and prevention. J Clin Virol. 2012;54(1):42-47.

17. U.S. Food and Drug Administration. OraQuick In-Home HIV Test. Summary of safety and effectiveness. http:// www.fda.gov/downloads/BiologicsBloodVaccines/ BloodBloodProducts/ApprovedProducts/Premarket ApprovalsPMAs/UCM312534.pdf.

Accessed on September 5, 2012.

18. Association of Public Health Laboratories. Issue in brief: HIV diagnostics survey. December 2012. http://www.aphl. org/AboutAPHL/publications/Documents/ID_2012Dec_ HIV-Diagnostics-Survey-Issue-Brief.pdf. Accessed on June 10, 2013.

19. Centers for Disease Control and Prevention. Immigrant and refugee health: Screening for HIV infection during the refugee domestic medical examination. http://www. cdc.gov/immigrantrefugeehealth/guidelines/domestic/ screening-hiv-infection-domestic.html. Accessed on June 10, 2013.

20. Long EF. HIV screening via fourth-generation immunoassay or nucleic acid amplification test in the United States: a cost-effectiveness analysis. PLoS One. 2011;6(11):e27625.

21. Determine.

HIV-1/2 Ag/Ab combo controls [package insert]. http://www.fda.gov/downloads/ BiologicsBloodVaccines/BloodBloodProducts/Approved Products/PremarketApprovalsPMAs/UCM364697. pdf.

Accessed October 30, 2013.

22. Cragin L, Pan F, Peng S, et al. Cost-effectiveness of a fourth-generation combination immunoassay for human immunodeficiency virus (HIV) antibody and p24 antigen for the detection of HIV infections in the United States.

HIV Clin Trials. 2012;13(1):11-22.

23. Golub SA, Kowalczyk W, Weinberger CL, Parsons JT. Preexposure prophylaxis and predicted condom use among high-risk men who have sex with men. J Acquir Immune Defic Syndr. 2010;54(5):548-555.

24. Centers for Disease Control and Prevention. HIV/AIDS: Pre-exposure prophylaxis (PrEP). http://www.cdc.gov/ hiv/prevention/research/prep/index.html.

Accessed June 6, 2013.

25. TRUVADA for a pre-exposure prophylaxis (PrEP) indication. https://www.truvadapreprems.com/hcp.

Accessed June 6, 2013.

26. Truvada (emtricitabine/tenofovir disoproxil fumarate) tablets for oral use [package insert]. http://www.gilead. com/~/media/Files/pdfs/medicines/hiv/truvada/truvada_ pi.pdf. Accessed on January 6, 2014.

27. Lampe MA, Smith DK, Anderson GJ, Edwards AE, Nesheim SR. Achieving safe conception in HIV-

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AMERICAN FAMILY PHYSICIAN discordant couples: the potential role of oral preexposure prophylaxis (PrEP) in the United States. Am J Obstet Gynecol. 2011;204(6):488.e1-488.e8.

28. Centers for Disease Control and Prevention. Update to CDC’s sexually transmitted diseases treatment guidelines, 2010: oral cephalosporins no longer a recommended treatment for gonococcal infections. MMWR Morb Mortal Wkly Rep. 2012;61(31):590-594.

29. Recommendations for use of antiretroviral drugs in pregnant HIV-1- infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. http://aidsinfo.nih.gov/guidelines/html/3/ perinatal-guidelines/0/. Accessed September 5, 2012.

30. Jay JS, Gostin LO. Ethical challenges of preexposure prophylaxis for HIV. JAMA. 2012;308(9):867-868.

31. Baeten JM, Donnell D, Ndase P, et al.; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399-410.

32. Van Damme L, Corneli A, Ahmed K, et al.; FEM-PrEP Study Group. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367(5):411-422.

33. Grant RM, Lama JR, Anderson PL, et al.; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363(27):2587-2599.

34. Centers for Disease Control and Prevention. HIV/AIDS Prevention Research Synthesis Project. http://www.cdc. gov/hiv/topics/research/prs/index.htm. Accessed on December 21, 2012.

35. Cheever LW. Engaging HIV-infected patients in care: their lives depend on it. Clin Infect Dis. 2007;44(11):1500-1502.

36. U.S. Department of Health and Human Services. National HIV/AIDS strategy: Update of 2011-2012 federal efforts to implement the national HIV/AIDS strategy. http:// aids.gov/federal-resources/national-hiv-aids-strategy/ implementation-update-2012.pdf. Accessed on September 5, 2012.

37. Thompson MA, Aberg JA, Hoy JF, et al. Antiretroviral treatment of adult HIV infection: 2012 recommendations of the International Antiviral Society-USA panel. JAMA. 2012;308(4):387-402.

38. Plaeger SF, Collins BS, Musib R, Deeks SG, Read S, Embry A. Immune activation in the pathogenesis of treated chronic HIV disease: a workshop summary. AIDS Res Hum Retroviruses. 2012;28(5):469-477.

39. Cohen MS, Dye C, Fraser C, Miller WC, Powers KA, Williams BG. HIV treatment as prevention: debate and commentary—will early infection compromise treatmentas-prevention strategies? PLoS Med. 2012;9(7):e1001232.

40. DeJesus E, Rockstroh JK, Henry K, et al.; GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012;379(9835): 2429-2438.

41. Sax PE, DeJesus E, Mills A, et al.; GS-US-236-0102 study team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeks [published correction appears in Lancet. 2012;380(9843):730]. Lancet.

2012;379(9835):2439-2448.

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AMERICAN FAMILY PHYSICIAN

Practice Guidelines ACIP RELEASES 2014 ADULT IMMUNIZATION SCHEDULES The 2014 immunization schedule for adults from the Advisory Committee on Immunization Practices (ACIP) has a few changes that are particularly relevant to family physicians. The schedule is available at http:// www.aafp.org/patient-care/immunizations/schedules. html.

With regard to the influenza vaccine, a study has demonstrated that high-dose Fluzone, which is approved for patients 65 years and older, is 24% more effective (regarding relative risk) than regular-dose Fluzone in older adults. The original U.S. Food and Drug Administration approval for high-dose Fluzone was based on data that showed that the antibody response was significantly higher, but this new study shows that the high-dose vaccine is also more effective in the real world. High-dose Fluzone has more adverse effects than regular-dose Fluzone.

To put these benefits and adverse effects in context, if you compare 1,000 patients in the high-dose Fluzone group with 1,000 patients in the regular-dose Fluzone group, you would have 4.6 fewer cases of influenza.

However, for every 1,000 doses of high-dose Fluzone, there would be the following extra adverse effects: 110 cases of mild pain, 40 cases of redness, 30 cases of swelling, 30 cases of myalgia, 40 cases of malaise, 25 cases of headache, and 15 cases of fever.

Family physicians should be able to order more injectable quadrivalent influenza vaccine for the 2014-2015 season. Unlike this current season, the quadrivalent formulation should be readily available for preorder in the spring. Finally, physicians should remember that Flublok is a recombinant DNA influenza

vaccine that does not use eggs in the production process. It is approved for adults 18 to 49 years of age and safe to use in patients allergic to eggs.

Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) revaccination appears to be safe and effective, but the pertussis protection wanes quickly, going from 98% effective at one year to 71% effective at five years. However, the pertussis work group is not recommending a second dose of Tdap because the cost-benefit ratio was judged to be poor. If a tetanus booster is needed and a patient has had Tdap in the past, the recommended booster is tetanus and diphtheria toxoids (Td). The only exception is pregnant women, who should be given the Tdap vaccine with each pregnancy, optimally between 27 and 36 weeks of gestation.

The human papillomavirus (HPV) work group provided data showing a decrease in warts and abnormal Papanicolaou smear results for patients receiving HPV vaccine. The assumption is that over time, this will translate into fewer cervical cancers, but the studies are ongoing. In addition, the Merck pregnancy registry for the quadrivalent papillomavirus vaccine (Gardasil) did not show any increased risk of spontaneous abortion, fetal death, or congenital anomalies. HPV coverage is still poor, with only 50% of adolescent girls receiving one dose, and only 30% receiving all three doses. The HPV vaccination rates for three doses are around 30% for young adult women.

Overall adult vaccination rates are poor, ranging from 15% for the herpes zoster vaccine to 50% to 60% for pneumococcal and tetanus vaccines. We have a long way to go towards protecting our adult patients against vaccine-preventable diseases.

Source: Adapted from Am Fam Physician. 2014;89(4):302.

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Photo Quiz UNILATERAL WEAKNESS OF THE MUSCLES OF FACIAL EXPRESSION A 26-year-old man presented with weakness on the right side of his face that occurred abruptly when he awoke that morning.

He also had excess lacrimation in his right eye. About three days before onset of the facial weakness, he experienced mild right otalgia that resolved the same day. He did not have fever, visual changes, numbness, or hearing loss, but his sense of taste was altered. He had no significant medical history.

Physical examination revealed profound weakness of the muscles of facial expression on the right side (Figure 1).

Figure 1.

He was unable to activate the right brow depressors (Figure 2) or smile symmetrically (Figure 3).

Other neurologic findings were normal. Magnetic resonance imaging of the head, with special focus on the right internal auditory canal, revealed no pathologic findings.

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

Figure 2.

A. Bell palsy.

B. Chronic inflammatory demyelinating polyneuropathy.

C. Melkersson-Rosenthal syndrome.

D. Parotid gland tumor.

E. Transient ischemic attack.

Figure 3.

DISCUSSION

Source: Adapted from Am Fam Physician. 2014;89(4):283-284.

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The correct answer is A: Bell palsy. Clinical characteristics of Bell palsy are caused by cranial nerve VII dysfunction and include sudden onset of unilateral paralysis, eyebrow droop, inability to close the eye, disappearance of the nasolabial fold, and mouth drawn to the unaffected side. It may be associated with loss of taste on the anterior two-thirds of the tongue, or with

AMERICAN FAMILY PHYSICIAN Summary Table Condition

Characteristics

Bell palsy

Sudden onset of unilateral paralysis; eyebrow droop, inability to close the eye, disappearance of the nasolabial fold, mouth drawn to the unaffected side; may be associated with loss of taste on the anterior two-thirds of the tongue, or with altered secretion of the lacrimal and salivary glands

Chronic inflammatory demyelinating polyneuropathy

Symmetric motor involvement is more pronounced than sensory; proximal and distal weakness; decrease in vibratory sensation, proprioception, pain/temperature sensation, and reflexes is possible

MelkerssonRosenthal syndrome

Facial edema and fissured tongue beginning in adolescence, with recurrent episodes of facial palsy; associated with tuberculoid granulomas in edematous tissue

Parotid gland tumor

Palpable parotid gland mass or swelling, or a unilateral facial palsy that does not improve

Transient ischemic attack

Transient episode of neurologic dysfunction lasting a few minutes to several hours; symptoms may be recurrent and are always reversible; wide range of areas are affected; presentations vary and can include dizziness, diplopia, dysarthria, hemianopia, numbness, focal hearing loss, and sometimes overwhelming stupor or coma

altered secretion of the lacrimal and salivary glands.

The forehead muscles are typically involved in patients with Bell palsy, whereas they are usually spared in patients with upper motor neuron lesions, as seen with transient ischemic attacks or cerebral stroke.

The onset of Bell palsy is often acute, and the course is progressive. Symptoms can peak up to three weeks after onset of facial nerve dysfunction, and may linger up to six months. Without treatment, symptoms usually resolve within three to four weeks. An estimated 75% of all facial paralyses are of unknown etiology.1 The role of herpes simplex virus in Bell palsy is controversial.2 Chronic inflammatory demyelinating polyneuropathy affects peripheral nerves and nerve roots,3 and leads to symmetric motor involvement that is more pronounced than sensory. Weakness is present in proximal and distal muscles, although cranial nerve involvement is possible. On physical examination, the patient may have a decrease in vibratory sensation, proprioception, pain/temperature sensation, and reflexes. MelkerssonRosenthal syndrome, or cheilitis granulomatosa, is rare. Symptoms begin in adolescence, with recurrent

facial palsy, facial edema, and lingua plicata.4 Facial palsy often occurs after facial swelling, but may appear months before. Facial palsy is intermittent; however, it may become permanent and can be unilateral, bilateral, partial, or complete. This condition can affect cranial nerves other than cranial nerve VII and is associated with tuberculoid granulomas in edematous tissue.

Most salivary gland tumors occur in the parotid gland.

Parotid gland tumors may cause facial paralysis. Partial or complete facial nerve paralysis occurs in up to 23% of patients with malignant parotid lesions at presentation and is associated with a worse prognosis.5 A palpable parotid gland mass or swelling, or a unilateral facial palsy that does not improve, should raise suspicion for parotid gland tumor.

Transient ischemic attacks are episodes of focal neurologic or retinal dysfunction provoked by impaired blood supply to a specific vascular territory of the central nervous system without acute infarction.

Symptoms may last from minutes to hours and are characterized by reversibility of the neurologic deficit.

Therefore, it is important to recognize transient ischemic attack as a warning of impending stroke.6 There are a wide array of clinical presentations because any vascular territories of the central nervous system may be affected. Distribution of symptoms is often not localized. Pure motor hemiparesis can occur and is characterized by weakness involving the face, arm, and/or leg of one side of the body in the absence of sensory deficits or cortical signs.

REFERENCES 1. Bauer CA, Coker NJ. Update on facial nerve disorders.

Otolaryngol Clin North Am. 1996;29(3):445-454.

2. Tiemstra JD, Khatkhate N. Bell’s palsy: diagnosis and management. Am Fam Physician. 2007;76(7):997-1002.

3. Rezania K, Gundogdu B, Soliven B. Pathogenesis of chronic inflammatory demyelinating polyradiculoneuropathy.

Front Biosci. 2004;9:939-945.

4. Levenson MJ, Ingerman M, Grimes C, Anand KV. Melkersson-Rosenthal syndrome. Arch Otolaryngol.

1984;110(8):540-542.

5. Sullivan MJ, Breslin K, McClatchey KD, Ho L, Farrior EH, Krause CJ. Malignant parotid gland tumors: a retrospective study. Otolaryngol Head Neck Surg.

1987;97(6):529-533.

6. Solenski NJ. Transient ischemic attacks: part I. Diagnosis and evaluation [published correction appears in Am Fam Physician. 2006;73(6):974]. Am Fam Physician.

2004;69(7):1665-1674.

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ANESTHESIOLOGY

To Evaluate the Effectiveness of Oral Tablet Clonidine as a Premedicant Drug: A Prospective Study of 100 Cases B BRINDA*, S CHAKRAVARTHY†, S MANJUNATHA PRASAD‡

ABSTRACT Introduction: Premedication is used to provide sedation and anxiolysis and to enhance the quality of induction; maintenance and recovery from anesthesia. The ideal premedicant should be orally effective, possess sedative; analgesic antianxiety, antisialogogue and antiemetic properties. It should maintain cardiovascular stability and normal respirations. No single drug has all the forementioned features. Hence search continues for an ideal premedicant. Recently emphasis has shifted to a2- adrenoceptor agonists, because of their properties, which are of potential benefit in anesthesia. Objectives: To evaluate the effectiveness of oral clonidine as a preanesthetic medicant and as a drug to attenuate the hemodynamic responses associated with laryngoscopy and endotracheal intubation. Material and methods: Study was performed on 100 patients of the age group 18-65 years in whom 4 µg/kg body weight of oral clonidine (max 0.2 mg) was administered 90 minutes prior to induction of anesthesia. Degree of sedation, anxiolysis, antisialagogue effect and changes in heart rate, systolic blood pressure (BP), diastolic BP, mean arterial pressure and ECG changes before and after premedication with oral clonidine were evaluated. Statistical methods: Descriptive statistical analysis has been carried out in the present study. Results on continuous measurements are presented on mean ± SD (Min-Max) and results on categorical measurements are presented in number (%). Statistical software: The statistical software namely SPSS 15.0, Stata 8.0, MedCalc 9.0.1 and Systat 11.0 were used for the analysis of the data and Microsoft word and Excel have been used to generate graphs, tables, etc. Results: Clonidine produced significant sedation with a p value of <0.05, before premedication 61% of patients had anxiety score of 1 and 27% had a score of 2 and after premedication 77% had a score of zero and 19% had score 1, which is significant anxiolysis. The association that is observed between clonidine as antisialogogue is mildly significant statistically. Premedication with clonidine produced decrease in pulse rate, decrease in systolic, diastolic and mean arterial pressure was highly significant statistically (p < 0.001). These values remained lower than the basal value after 1 minute up to 5 minutes after intubation. Conclusion: The premedication with oral clonidine produces significant sedation, anxiolysis, mild antisialagogue effect and hemodynamic stability during laryngoscopy and endotracheal intubation with no adverse effects. Thus oral clonidine may be used as an ideal preanesthetic medication.

Keywords: Premedication, oral clonidine, hemodynamic response

P

reanesthetic medication forms, an integral part of anesthetic management and is universally administered before any anesthesia. The ideal premedicant should be effective and pleasant to be

*Professor of Anesthesiology Dept. of Emergency Medicine KIMS, Bangalore, Karnataka †Registrar in Anesthesiology ‡Resident in Anesthesiology SSMC, Tumkur, Karnataka Address for correspondence Dr B Brinda Professor of Anesthesiology and Critical Care, Chief of ICU Dept. of Emergency Medicine KIMS Hospital, KR Road, VV Puram, Bangalore - 560 004, Karnataka E-mail: brindapaddu@rediffmail.com

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taken orally; have sedative, analgesic antiemetic, antisialagogue and antianxiety properties. Also it, should not impair cardiovascular stability or depress respiration.1 Clonidine is a mixed a1- and a2- adrenoceptor agonist with a predominant a2 action (a2:a1 = 220:1), which is mainly used as an antihypertensive agent, but has many properties of an ideal premedicant and also has beneficial effects by blunting hemodynamics response to laryngoscopy and intubation.2,3 Laryngoscopy and intubation is a noxious stimulus which provokes a sympathoadrenal response.

Characterized by rise in arterial blood pressure (BP) and pulse rate which is attenuated by clonidine. This study was undertaken to evaluate the effectiveness

ANESTHESIOLOGY of oral clonidine as a preanesthetic medicant and as also a drug to attenuate the hemodynamic responses associated with laryngoscopy and endotracheal intubation.4 MATERIAL AND METHODS One hundred patients of both sexes between 18-65 years scheduled for various elective surgeries under general anesthesia were taken in the study after ethical clearance and informed consent had been taken from the patients. Patients with central nervous system (CNS) disorders (UMN lesions, LMN lesions) and patients taking drug treatments known to affect heart rate, BP or hormonal stress responses were excluded.

All patients scheduled for the study are kept nil by mouth and neither premedicated the previous night nor on the morning of surgery. Tablet clonidine 4 µg/kg body weight (max. 0.2 mg) was given 90 minutes prior to induction of anesthesia with sips of water. No anticholinergic drug was given either before or at the time of induction of anesthesia. Assessment was done just before and 90 minutes after administration of the drug. Assessment of degree of sedation was evaluated by sedation score (0 - patient awake and talkative, 1 - patients awake but not communicative, 2 - patients drowsy, quiet and easily arousable, 3 - patient asleep).

Assessment of degree of anxiolysis and dryness of tongue was evaluated by anxiety scoring (0 - patient quiet and comfortable, 1 - patient uneasy, 2 - patient worried and anxious, 3 - patient very worried or very upset, 4 - patient frightened or terrified) status of tongue: moist/dry.

Baseline heart rate, BP (systolic and diastolic and mean arterial pressure) and ECG were recorded by noninvasive monitor (Datex) in preanesthetic room.

On arrival in OT, an IV line with appropriate fluid was started. General anesthesia was induced by injection of thiopentone 2.5%, 4-6 mg/kg body weight followed by injection succinylcholine 2 mg/kg body weight was given intravenously. Once there was cessation of fasiculation induced by succinylcholine, laryngoscopy was performed and appropriate size ETT was passed.

During laryngoscopy and intubation HR, BP (systolic, diastolic and mean arterial pressure) with continuous ECG recording done at a time interval of 1 minute continuously for 5 minutes there after. Any patient who strained or took >15 seconds for intubation or required second attempt to laryngoscopy and intubation were excluded from the study. Anesthesia was maintained with O2 and N2O only (without narcotic and inhalation agent) up to 5 minutes after endotracheal intubation.

After 5 minutes of monitoring, NDMR (injection atracurium) and inhalation anesthetic (halothane) were supplemented uniformly to all the cases. After completion of surgery, NDMR was antagonized by neostigmine and glycopyrolate. Once the patient satisfied extubation criteria – extubation done and shifted to recovery room, drugs like injection atropine and injection ephedrine diluted and loaded, kept ready in case of the patient developed complications like bradycardia or hypotension during the study.

Any complications like undesirable effect or rebound phenomenon or untoward hemodynamic event is noted and treated.

RESULTS In our study, maximum patients were in the age group of 31-40 years followed by 41-50 years (mean ± SD of 41.04 ± 12.61). Before premedication, all 100 patients were of sedation score 0 and after premedication

Moist (99%)

Dry (1%)

Before premedication

Dry (29%) Moist (71%)

After premedication

Figure 1. Percentage of patients having moist tongue before and after premedication.

Table 1. Sedation Score Before and After Premedication Sedation score Before premedication After premedication Inference

Mean ± SD

0

1

2

3

0

0

0

0

45%

50%

3%

2%

0.74 ± 0.58

Sedation score is significantly increased after premedications with p < 0.05

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ANESTHESIOLOGY Table 2. Anxiety Score Before and After Premedication Anxiety score

Mean ± SD

0

1

2

3

4

Before premedication

10%

60%

27%

2%

0

1.21 ± 0.64

After premedication

77%

19%

4%

0

0

0.27 ± 0.52

Inference

Anxiety score is significantly reduced after premedications with p < 0.001

Table 3. Hemodynamic Response Score Before and After Premedication Events

Heart rate

SBP (mmHg)

DBP (mmHg)

MAP (mmHg)

Before premed

80.29 ± 6.69

127.34 ± 9.27

81.04 ± 5.71

96.47 ± 6.37

After premed

74.39 ± 6.67

119.66 ± 9.07

73.82 ± 5.91

89.09 ± 6.43

Laryngoscopy and endotracheal intubation Ι0 min

87.58 ± 7.07

128.17 ± 7.79

82.12 ± 5.21

97.04 ± 6.28

Ι1 min

80.87 ± 6.44

125.47 ± 7.94

79.53 ± 5.07

94.46 ± 6.32

Ι2 min

79.03 ± 6.14

122.59 ± 7.79

77.13 ± 5.18

91.79 ± 6.16

Ι3 min

77.42 ± 6.29

119.33 ± 7.76

74.38 ± 5.21

88.97 ± 6.23

Ι4 min

75.76 ± 6.05

116.38 ± 7.59

71.52 ± 5.32

86.06 ± 6.15

Ι5 min

73.89 ± 6.11

113.26 ± 7.61

68.43 ± 5.27

83.07 ± 6.02

% change from basal value Before premed- after premed

-7.3%

-6.1%

-8.9%

-7.7%

Before premed- Ι0 min

+9.1%

+0.6%

+1.3%

+0.6%

Before premed- Ι1 min

+0.8%

-1.5%

-1.9%

-2.1%

Before premed- Ι2 min

-1.5%

-3.7%

-4.8%

-4.9%

Before premed- Ι3 min

-3.5%

-6.3%

-8.2%

-7.8%

Before premed- Ι4 min

-5.6%

-8.6%

11.7%

-10.8%

Before premed- Ι5 min

-7.9%

-11.1%

-15.6%

-13.9%

Table 4. Significance of Hemodynamic Response Score Before and After Premedication Significance Before premed- after premed

t = 18.02; p <0.001**

t = 22.88; p <0.001**

t = 26.52; p <0.001**

t = 28.89; p <0.001**

Before premed- Ι0 min

t = 34.47; p <0.001**

t = 1.25; p = 0.212

t = 1.52; p = 0.108

t = 0.86; p = 0.390

Before premed- Ι1 min

t = 2.80; p <0.001**

t = 2.74; p = 0.007

t = 2.46; p = 0.016*

t = 3.03; p = 0.003**

Before premed- Ι2 min

t = 5.68; p <0.001**

t = 6.68; p <0.001**

t = 6.16; p <0.001**

t = 7.27; p <0.001**

Before premed- Ι3 min

t = 10.57; p <0.001**

t = 11.90; p <0.001**

t = 10.50; p <0.001**

t = 11.391; p <0.001**

Before premed- Ι4 min

t = 16.13; p <0.001**

t = 15.70; p <0.001**

t = 14.95; p <0.001**

t = 15.79; p <0.001**

Before premed- Ι5 min

t = 21.13; p <0.001**

t = 19.47; p <0.001**

t = 20.37; p <0.001**

t = 20.50; p <0.001**

45% had score 0, 50% had score 1, 3% had score 2 and 2% had score 3, showing a statistically significant sedation with clonidine premedication, p < 0.05 (Table 1). Before premedication 61% of patients had anxiety score of 1 and 27% had a score of 2 and after premedication 77% had a score of 0 and 19% had score 1. P value was <0.001 thereby concluding that premedication with

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clonidine had very significant antianxiety effect (Table 2).

Before premedication 99% of patients had moist tongue and 1% had dry tongue. But after premedication with clonidine 71% remained to have moist tongue, which 29% had dry tongue (Fig. 1). This shows that though there is antisialagogue effect, it is not very significant.

From the above Tables 3 and 4, it can be concluded that

ANESTHESIOLOGY Age in years 15-30 31-50

100 95 90 85 80 75 70 65 60 55 50

Age in years 15-30 31-50

100 95 90 85 80 75

B pr efo em re ed pr Afte em r ed 10 m i 11 n m in 12 m in 13 m in 14 m in 15 m in

B pr efo em re ed pr Afte em r ed 10 m i 11 n m in 12 m in 13 m in 14 m in 15 m in

70

Heart rate (beats/min)

MAP (mmHg)

Figure 2. Mean values (beats/min) of pulse rate at various intervals.

Age in years 15-30 31-50 >50

130 125 120 115 110 105

B pr efo em re ed pr Afte em r ed 10 m i 11 n m in 12 m in 13 m in 14 m in 15 m in

100

Systolic BP (mmHg)

Figure 3. Mean values of systolic arterial pressure (mmHg) at various intervals.

Age in years 15-30 31-50

B pr efo em re ed pr Afte em r ed 10 m i 11 n m in 12 m in 13 m in 14 m in 15 m in

100 95 90 85 80 75 70 65 60 55 50

Diastolic BP (mmHg)

Figure 4. Mean values of diastolic arterial pressure (mmHg) at various intervals.

after premedication with clonidine, the decrease in the pulse rate is statistically highly significant. But, the rise in pulse rate during laryngoscopy and endotracheal intubation from basal value is not significant clinically

Figure 5. Mean values of mean arterial pressure (mmHg) at various intervals.

though some significance is seen statistically. After 1 minute of intubation pulse rate returned to basal value and remained lower than the basal value up to 5 minutes of intubation (Fig. 2).

After premedication with clonidine, there was decrease in systolic, diastolic and mean arterial pressure (Figs. 3-5). But, the rise in systolic, diastolic and mean arterial pressure during laryngoscopy and endotracheal intubation from basal value was not significant clinically though some significance is seen statistically.

These values remained lower than the basal value upto 5 minutes of intubation.

DISCUSSION The Îą2 agonists are assuming greater importance as anesthetic adjuvant and analgesics. Their primary effect is sympatholytic. They reduce peripheral noradrenaline release by stimulation of prejunctional Îą2 inhibitory adrenoceptors. They inhibit central neural transmission in the dorsal horn by presynaptic and postsynaptic mechanisms and directly in spinal preganglionic sympathetic nerves. Traditionally, they have been used as antihypertensive drugs, but doses based on sedative, anxiolytic and analgesic properties are being developed.

Clonidine hydrochloride is an imidazole derivative.

It was synthesized in early 1960â&#x20AC;&#x2122;s; as a derivative of the known alpha sympathomimetic drug naphazoline and talazonine. It was originally developed as a nasal vasoconstrictor. During clinical trials, it was found to cause hypotension; sedation and bradycardia. It was introduced as an antihypertensive first in Europe in 1966 and subsequently in the United States of America. It was the first antihypertensive known to act on the central nervous system. Clonidine is

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ANESTHESIOLOGY

H N

H N N

C I

CI

chemically 2([2-6 dichlorophenyl] Imino) Imidozoline monohydrochloride. a2 adrenergic receptors are G proteins, when activated to inhibit adenylate cyclase.

The result in decrease in accumulation of cyclic AMP attenuates the stimulation of cyclic AMP-dependent protein kinase. And hence the phosphorylation of target regulatory proteins. Efflux of potassium through an activated channel can hyperpolarise the excitable membrane and provide an effective means of suppressing neuronal firing. a2 adrenoreceptor stimulation also suppresses calcium entry into nerve terminals, which may be responsible for its inhibitory effect on secretion of neurotransmitters. a2 adrenergic agonists produce clinical effects by binding to a2 receptors of which there are 3 subtypes: a2a, a2b and a2c, a2a receptors mediate sedation, analgesia and sympatholysis. a2h receptors mediate vasoconstriction and possibly antishivering mechanisms. The startle response reflects activation of a2c recepetors.5 Clonidine is rapidly and almost completely absorbed from gastrointestinal tract. After oral intake, onset of action starts within 30-60 minutes and peak plasma concentration is reached within 60-90 min. The elimination half-life ranges from 6 to 24 hours with a mean of about 12 hours. Clonidine is metabolized mainly by the liver to produce P-hydroxy clonidine which subsequently undergoes glucuronidation to produce 0-glucuronide and is excreted in urine. Forty to 60% of an orally administered dose is excreted unchanged in urine within 24 hours.

Effects of clonidine on different systems: There is no prejunctional α2 receptor in the myocardium. Hence, a direct effect on heart is unlikely. It causes hypotension due to centrally-mediated reduction in sympathetic flow. Clonidine exerts vagomimetic effect on heart by stimulating nucleus tractus solitarious, which can be attenuated completely by highly selective muscarinic M2 receptor antagonists. It can cause bradycardia and reduction in cardiac output without affecting the cardiac contractility and peripheral vascular resistance.

Clonidine effectively inhibits the firing rate of locus ceruleus which mediates the normal response and exerts its hypotensive action by a net reduction in central sympathetic outflow. The α2 agonists hyperpolarize and

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depress the locus ceruleus through potassium channel and markedly reduce the nor adrenaline concentration.

Clonidine causes vasodilatation by the release of endothelium-derived relaxing factors (EDRF). a2 receptors are found densely in the pontine locus coeruleus which is an important source of sympathetic nervous system innervations. The sedative effects evoked by a2 agonists most likely reflect inhibition of this nucleus. Clonidine causes dose related sedation.

In small doses it causes anxiolysis almost comparable to that seen with benzodiazepines. It has a powerful analgesic action both at supra spinal and spinal levels.

Its potency is enhanced synergistically by opiods, acting through independent receptors. Clonidine by its action on α2 receptors reduces the anesthetic requirements.

It reduces the minimum alveolar concentration of halothane and isoflurane.

Clonidine is devoid of respiratory depressant action and lacks the negative effects on cognition, memory and behaviour as seen with midazolam. Thus it may be substituted for premedication.6,7 It does not potentiate the respiratory depression caused by opiods.

Clonidine inhibits the centrally-mediated sympathoadrenal outflow as seen by the decreased levels of catecholamines in circulation and decreased level of metabolities in urine.

Clonidine has a prominent antisialagogue effect by a direct action. Activation of prejunctional α2 adrenoreceptors inhibit the vagally-mediated release of gastric acid from the parietal cells and also reduces the gastric motility. It does not alter the gastric pH significantly.

The most commonly seen adverse effects are dry mouth, drowsiness, hypotension and bradycardia, if large doses are used. Withdrawal phenomenon is reported after chronic clonidine treatment. There is no evidence of sympathetic over reactivity after single dose therapy.

It probably takes about 6 days of continuous therapy to produce adaptive changes. In single dose preanesthetic therapy such rebound phenomenon are not seen. The hypertensive rebound, if occurs, is effectively treated with labetalol.8-12 Several studies have shown the efficacy of clonidine as a premedicant and also to suppress the hemodynamic responses to intubation.

Das AK, studied clinical efficacy of oral clonidine as preanesthetic medicant and found that the central action of clonidine reduces sympathetic outflow and produces sedation, anxiolysis and smooth induction of

ANESTHESIOLOGY anesthesia. It also reduces salivation, sleeping dose of IV anesthetics, requirements of inhalation anesthetics and postoperative shivering moreover it provides cardiovascular stability.13 Nishikawa T, studied the effects of oral clonidine on the hemodynamic changes associated with laryngoscopy and endotracheal intubation. They observed that when clonidine was given in a dose of 5 µg/kg orally, the increase in mean BP was significantly smaller as compared to that in the control group.3 Sympathoadrenal activation associated with laryngoscopy and endotracheal intubation cause rise in arterial BP and tachycardia.

Carabine et al suggested that cardiovascular responses by short lasting laryngoscopies can be attenuated with very low doses of oral clonidine.14 Study conducted by Orko et al, to evaluate the effect of clonidine on hemodynamic responses to endotracheal tube intubation and on gastric acidity found that the means of the systolic and diastolic arterial pressures just before and immediately after tracheal intubation were lower in the clonidine group (p < 0.001). The maximal increase in heart rate at intubation was lower in the clonidine group (p < 0.01).15 Study done to evaluate the effect of clonidine as preanesthetic medication by Weight et al16 found that clonidine produced a significant reduction in anxiety (p < 0.05) and caused sedation. Tachycardia in response to intubation was attenuated by clonidine (p < 0.05).

Study done to evaluate the low-dose oral clonidine as premedication before intraocular surgery in retrobulbar anesthesia by Weindler et al17 found that after clonidine 86% of the patients showed sedation. Clonidine produced effective anxiolysis before the operation (p < 0.01).

By the present study conducted, it can be concluded that Tab clonidine can be used as an effective premedicant drug as it produces good sedation, anxiolysis and also blunts the cardiovascular response to laryngoscopy and intubation significantly. However, the antisialagogue effect was not significant with the dosage we used.

REFERENCES 1. Raval DL, Mehta MK. Oral clonidine premedication for the attenuation of haemodynamic response to laryngoscopy and intubation. Indian J Anaesth 2002;46(2):124-9.

2. Ghignone M, Quintin L, Duke PC, Kehler CH, Calvillo O. Effects of clonidine on narcotic requirements and hemodynamic response during induction of fentanyl

anesthesia and endotracheal intubation. Anesthesiology 1986;64(1):36-42.

3. Nishikawa T, Taguchi M, Kimura T, Taguchi N, Sato Y, Dai M. Effects of clonidine premedication upon hemodynamic changes associated with laryngoscopy and tracheal intubation. Masui 1991;40(7):1083-8.

4. Corbett JL, Kerr JH, Prys-Roberts C. Cardiovascular responses to aspiration of secretions from the respiratory tract in man. J Physiol 1969;201(1):51P-52P. 5. Stoelting RK, Hillier SC (Eds.). Antihypertensive drugs.

In: Pharmacology and Physiology in Anesthetic Practice.

4th edition, Lippincott Williams& Wilkins: Philadelphia 2006:p.338-51.

6. Bergendahl H, Lönnqvist PA, Eksborg S. Clonidine: an alternative to benzodiazepines for premedication in children. Curr Opin Anaesthesiol 2005;18(6):608-13.

7. Bergendahl H, Lönnqvist PA, Eksborg S. Clonidine in paediatric anaesthesia: review of the literature and comparison with benzodiazepines for premedication.

Acta Anaesthesiol Scand 2006;50(2):135-43.

8. Morgan GE, Michael MS, Murray MJ. Adrenergic agonists and antagonists. In: Clinical Anesthesiology. 3rd edition, McGraw-Hill: New York 2002:p.216-7.

9. Collins VJ. Principles of preanesthetic medication. In: Principles of Anesthesiology. 3rd edition, Lea & Febiger: Malvern 1993:p.292.

10. Stoelting RK, Hillier SC. Antihypertensive drugs. In: Pharmacology and Physiology in Anesthetic Practice.

4th edition, Lippincott Williams & Wilkins: Philadelphia 2006:p.340-3.

11. Moss J, Glick D. The Autonomic nervous system. In: Miller’s Anesthesia. 6th edition, Miller RD (Ed.), Churchill Livingstone: Philadelphia 2005:p.650-1.

12. Maze M, Tranquilli W. Alpha-2 adrenoceptor agonists: defining the role in clinical anesthesia. Anesthesiology 1991;74(3):581-605.

13. Das AK, Rudra R. Clinical efficacy of oral clonidine as preanaesthetic medicant. Indian J Anaesth 1995;43: 133-9.

14. Carabine UA, Wright PM, Howe JP, Moore J. Cardiovascular effects of intravenous clonidine. Partial attenuation of the pressor response to intubation by clonidine. Anaesthesia 1991;46(8):634-7.

15. Orko R, Pouttu J, Ghignone M, Rosenberg PH. Effect of clonidine on haemodynamic responses to endotracheal intubation and on gastric acidity. Acta Anaesthesiol Scand 1987;31(4):325-9.

16. Wright PM, Carabine UA, McClune S, Orr DA, Moore J. Preanaesthetic medication with clonidine. Br J Anaesth 1990;65(5):628-32.

17. Weindler J, Kiefer RT, Rippa A, Wiech K, Ruprecht KW. Low-dose oral clonidine as premedication before intraocular surgery in retrobulbar anesthesia. Eur J Ophthalmol 2000;10(3):248-56.

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Study of Patient Satisfaction at a Super Specialty Tertiary Care Hospital PARAM HANS MISHRA*, TRIPTI MISHRA†

ABSTRACT Background: Hospitals have evolved from being an isolated sanatorium to a place with five star facilities. The patients and their relatives coming to the hospital not only expect world-class treatment, but also other facilities to make their stay comfortable in the hospital. This change in attitude and expectation has come due to tremendous growth of media and its exposure, as well as commercialization and improvement in the facilities. The aim of this study was to evaluate the level of patient/relatives’ satisfaction at tertiary care teaching hospital and feedback from them for improvement of the same. The study was conducted by distributing 100 structured questionnaires amongst patients and their relatives to find out the factors, which satisfy them in a tertiary care super specialty hospital. Methods: The study was conducted by: 1) Review of available national and international literature on the subject; carrying out a survey amongst 50 patients and their relatives at one of the surgical units by using structured questionnaire and by analyzing the data using appropriate statistical methods. Results: Eighty-two percent people were satisfied with the service at the admission counter while 81% were satisfied with room preparation at the time of admission.

The nursing services satisfied 80% of people while 92% were satisfied with explanation about disease and treatment by doctor.

The behavior of nurses, doctors and orderlies satisfied 92%, 92% and 83% of people, respectively. The cleanliness of toilets satisfied only 49%, while diet services satisfied 78% of people. Conclusion: The five major satisfiers were behavior of doctors, explanation about disease and treatment, courtesy of staff at admission counter, behavior and cooperation of nurses. The five major dissatisfiers were cleanliness of toilets, quality of food, explanation about rules and regulation, behavior of orderlies and sanitary attendant and room preparedness.

Keywords: Hospital, expectation, patient’s satisfaction, satisfiers, dissatisfiers

PATIENT SATISFACTION It can be defined as fulfillment or meeting of expectations of a person from a service or product. When a patient comes to a hospital, he has a preset image of the various aspects of the hospital as per the reputation and cost involved. Although, their main expectation is getting cured and going back to their work, but there are other factors, which affect their satisfaction. Sometimes, they might have rated a hospital very low on the basis of information, they have got from different sources,

*Medical Superintendent Indian Spinal Injuries Centre Vasant Kunj, New Delhi †Associate Professor Delhi Institute of Advanced Studies, Delhi Address for correspondence Dr Param Hans Mishra Medical Superintendent Indian Spinal Injuries Centre C-Block, Vasant Kunj, New Delhi -110 070 E-mail: drphmishra@rediffmail.com, drphmishra08@gmail.com, ms@isiconline.org

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

but they find it above their expectation and they are satisfied. Similarly, if they have got a very high expectation from a hospital, but if they find it below their expectation, they will not be satisfied.

Hospitals have expanded in terms of availability of specialties, improved technologies, facilities and increased competition and the expectations of patients and their relatives have increased manyfold. Consumer expectation in any medical experience influences whether how soon and how often they seek care from which medical facility. High expectation from a medical organization is a positive indicator of its reputation in the society and is very important for attracting patients, whereas low expectation deters patients from taking timely medical help, thus negatively affecting himself as well as the medical care provider. However, a very high and unrealistic expectation may lead to dissatisfaction despite reasonable good standards of medical practice.

Previously, there were very few government hospitals with no charge to the patients. Hence, the expectations were also very minimal. But now, the scenario has

COMMUNITY MEDICINE changed. The hospitals (even Govt.) have started charging the patient in the name of user charges.

Private hospital care cost has gone very high. With the advent of Consumer Protection Act (1986), the patient’s expectation has also gone very high. Now hospitals have to be very careful about patient dissatisfaction to avoid any unnecessary litigation.

Hospitals have evolved from being an isolated sanatorium to five star facilities. The patients and their relatives coming to the hospital not only expect world-class treatment, but also other facilities to make their stay comfortable in the hospital. This change in expectation has come due to tremendous growth of media and its exposure, as well as improvement in the facilities.

Knowledge of expectation and the factors affecting them, combined with knowledge of actual and perceived healthcare quality, provides the necessary information for designing and implementing programs to satisfy patients.

Human satisfaction is a very complex concept that is affected by a number of factors like lifestyle, past experience, future expectation and the values of individual and society in terms of ethical and economical standings.

Maslow in 1954 gave the hierarchy of needs for satisfaction and motivation of individuals. According to him, needs generally have priority in the following order: ÂÂ

Physiological

ÂÂ

Safety and security

ÂÂ

Sense of belonging

ÂÂ

Esteem

ÂÂ

Self-actualization.

PATIENT EXPECTATION AND SATISFACTION The satisfaction of patients coming to hospitals depends on the structure and function of the medical care system. The functioning of medical care system is based on the various social, technical and physical aspects. The structure of the medical care system is guided by the policies of the government and the type of government set-up prevailing in the country, whereas the functioning mainly depends on those who manage the system.

In a welfare state like India, where the government takes up the responsibility of providing free medical care to those who are unable to afford it, free consultation,

medicines and treatment facilities have to be provided.

Those receiving these kind of services may be satisfied with whatever services are being provided to them in the hospitals because they are free of cost.

But, as soon as they come to realize that it is their right to receive these services and it is the responsibility of government to look after their well-being, when they cannot afford, rise in their level of expectations is incontrollable.

PATIENT AS A CONSUMER Marketing experts are aware that consumers make their decision about utilization of services on the basis of their perception of the service rather than the reality and hence marketing and patient satisfaction have become of paramount importance as mouth-to-mouth publicity and personal referral is the most common and influential cause of using a particular health facility.

Healthcare facility is very difficult to measure; hence, it is a challenge to a healthcare provider to influence a patient’s perception of quality of care.

A patient’s satisfaction may not be totally influenced by the quality of care. A patient’s satisfaction may not be totally influenced by the quality of physician available, but it reflects how the medical care has been delivered.

To provide highest level of satisfaction that is profitable to both the patient and the provider, management must control both the perception of expectation and the quality of delivery of the healthcare services.

Knowledge of expectation and the factors affecting them, combined with knowledge of actual and perceived healthcare quality, provides the necessary information for designing and implementing programs to satisfy patients.

QUALITY It is defined as an inherent and distinctive attribute of a product or service. Common measures of quality are still structural measures - The condition of physical structure, floor space per bed, facilities for emergency power and lighting in operating rooms, inspection and cleaning of air intake sources, facilities for disposal of infectious waste, fire control and many more. Additional standards for facilities and equipment have been established by the Joint Commission on Accreditation of the Hospitals and by state licensing boards, etc.

These measures are concerned with personnel staffing pattern, educational background of the personnel, safety and cleanliness of facilities and equipment.

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625

COMMUNITY MEDICINE THE MEASUREMENT OF QUALITY

PATIENT SATISFACTION BENCHMARKING

Steps involved are:

People involved with a relatively large hospital may have already put into place a patient satisfaction tracking mechanism. If not, chances are that they have at least thought about such a survey. Regardless of whether they currently are monitoring their patients’ satisfaction, it is important to note that a patient satisfaction tracking program, by itself, will not give them a full picture of satisfaction in the marketplace.

ÂÂ

Specification of attributes to be measured

ÂÂ

Choice of an approach to measurement

ÂÂ

Choice of phenomenon to be measured

ÂÂ

Formulation of criteria and standards

ÂÂ

Obtaining information about care.

Patient satisfaction depends primarily on outcome of care; since it is ultimate well-being that results from acceptable care.

But satisfaction or dissatisfaction can also result from patient’s judgment on certain aspects of care, calibrating the degree of their acceptability. Satisfaction also contributes to the success of future care.

MEASURING THE QUALITY OF HEALTHCARE Attributes of Quality of Healthcare- Donabedin Avedis has described the key properties of healthcare that constitute quality as: Effectiveness, efficiency, optimality, acceptability, legitimacy and equity.

Effectiveness- is the degree to which the care proposed or received has achieved or can be expected to achieve, the greatest improvement in health possible now, given the patient’s condition and the current state of science and technology of healthcare.

Efficiency- is expressed as a ratio of actual or expected improvement in health to the cost of care responsible for these improvements. Thus, efficiency can be enhanced by either improving care, reducing cost or both.

Optimality- is a ratio of the effects of care on health or the financial benefits of these, or of the financial benefits of these effects to the cost of care.

Acceptability- depends on following factors: ÂÂ

Accessibility

ÂÂ

The patient-practitioner relationship

ÂÂ

Amenities

ÂÂ

Patient preference as to the effect of care

ÂÂ

Patient preference as to the cost of care.

Legitimacy- means conformity to social preference as expressed in ethical principles, values, norms, laws and regulations.

Equity- is the principle of fairness or justice in the distribution of care and of its benefit among the members of its population.

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The often- asked question is “how satisfied are my patients.” Framing the question a little differently, it becomes “how satisfied are all hospitals’ patients?” If you can answer this question, you know your hospital’s relative strengths and weaknesses at satisfying patients, and you are well positioned to exploit your knowledge.

One excellent way to benchmark is to periodically touch base with your competitors’ patients. A random survey of the market will reach these patients. Many people use their extensive network to find from people who recently have been in the hospital and to ask them about their experiences.

With the advancement in technology and stiff competition, hospitals are always striving for improvement in their services. Patient expectations are constantly changing, so what satisfies a patient at one point in time may not satisfy him at some later date. As you improve your service levels on some patient satisfaction ‘attributes,’ you will change patient expectations on the remaining attributes. This is akin to saying that when you fix something, something else that did not look too bad to start with, suddenly doesn’t look so good. You may need more detail on the ‘new’ items in need of improvement to properly measure progress toward improvement. If you offer new products, services or delivery channels, you will need to measure satisfaction with those areas. If you change your training program to encourage specific employee behaviors, you will want to consider adding questions to the tracking questionnaire to measure the extent to which patients perceive these desired behaviors. You may think of something you should have been measuring in the first place, but just forgot.

In establishing a patient satisfaction, some of the usual goals are to: ÂÂ

Measure patient satisfaction

ÂÂ

Monitor changes in satisfaction

ÂÂ

Measure performance on attributes (product and service characteristics ) that affect satisfaction

ÂÂ

Monitor changes in performance.

COMMUNITY MEDICINE Process of measure of quality of care in hospitals has become more common in recent years. Most common is Medical Audit approach, pioneered by Payane, University of Michigan Medical Centre. In the medical audit process, the hospital staff or a designated committee establishes criteria for the diagnosis, treatment, expected outcome, length of hospitalization of diagnostic categories. It then reviews cases, applying its own criteria.

Examples of other, more global process measures are the autopsy rate, the rate of surgical pathology reports and the completeness, accuracy and timeliness of medical records.

In 1989, the Robert Wood Johnson Foundation launched a project to test a consortium approach to quality improvement in which four hospitals consortia in various parts of the United States were sharing quality resources (e.g. Training) and collaborating on various improvement efforts. It was observed that collaborators in quality improvement gain important resources, such as better information, more relevant reference data base, colleagues and support for quality improvement specialists and economy in education programs, training materials and interaction with vendors.

Rationale for the study: Patient satisfaction is a very important aspect of medical care. We may have the most renowned medical professionals and infrastructure available, but there are many factors that affect patient satisfaction. We may not be aware of all of them. In modern times when expectation from healthcare institutions are increasing and level of satisfaction is decreasing, leading to increased number of legal suits and physical manhandling of medical professionals, it is very important to know the variables affecting patient satisfaction. Hence it was decided to take up the present study.

AIMS AND OBJECTIVES ÂÂ

To study the level of patient satisfaction at Indian Spinal Injuries Centre.

ÂÂ

To study the different factors affecting patient satisfaction.

ÂÂ

To suggest measures for improvement of services leading to better patient satisfaction.

RESEARCH METHODOLOGY The study was conducted by: ÂÂ

Study of currently available national international literature on the subject

and

ÂÂ

Carrying out survey amongst patients and their relatives at Indian Spinal Injuries Centre

ÂÂ

By analyzing the data using appropriate statistical methods.

REVIEW OF LITERATURE Currently available national and international literature was reviewed to understand the concept of patient satisfaction.

INTERNATIONAL STUDIES Codmans’ ‘Assessment of the outcomes of care’ investigated four aspects of care for each case received: 1) The physicians’ or surgeons’ input; 2) The hospital’s contribution; 3) The patients’ disease or condition’ and 4) The factors which deterred patient’s co-operation.

Pathology reports helped determine whether surgery was indicated in a case of appendectomy or not. They have had a wide application in the evaluation of quality of care. Ovariectomies and hysterectomies were examined by Doyle. Because many of these outcome measures do not assess the overall performance of the organization, Roemer had developed a method to adjust hospital death rates (which were calculated for all patients and all conditions), so that they could be used as an overall measure of the quality of care.

He called his index as ‘Surgery adjusted Death Rate’ (SADR). SADR tried to overcome the distortion when hospital death rates are compared which are not adjusted for patient mix and particularly severity of illness of the hospital’s patient population.

Hendrickson examined effects of implementing nursing information computer system in 17 Hospitals in New Jersey, USA. They observed that staff impression of the effects of system was positive; documentation was better (more readable). “Effects of a hospital-based managed care on the cost and quality of care” was studied by Bregan MA et al on women delivered by cesarean in the maternity unit at a tertiary level university hospital of Iowa, USA. They found decrease in average length of stay (ALS) by 13.5% and the average cost decreased by 13.1%; patients’ perception quality of care increased from 4.26 to 4.41 on a 1-5 scale.

Cock et al conducted a ‘continuous quality improvement study’ in their medicine department of McMaster University, Faculty of Health Sciences, Ontario by monitoring patterns in medical teaching ward. They found that in 68% of cases, oxygen therapy was initiated by house staff, nurse initiated therapy in 18% of cases, but discontinued it more often than any

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COMMUNITY MEDICINE other health worker. About 30% of patients on oxygen did not meet the criteria set by American College of Chest Physicians. This showed that practice guidelines based on best available evidence are needed to increase the efficiency of oxygen use.

Houston and Pasanen employed a patient satisfaction questionnaire with patients recently discharged after at least 2 days stay at a large hospital. Care was evaluated extremely favorable with the highest rating given to physician and nursing care. Most dissatisfaction was due to the fact that the physicians did not disclose details of their illness. Nearly 17.1% were reluctant to return to the medical care facility.

INDIAN STUDIES Khosla et al found in their study, emphasis by the patients of two Delhi hospitals on varying needs according to their income groups: ÂÂ

ÂÂ

Low Income Group- improved physical facilities, improved diet and relaxation of visiting hours, better service by Class IV staff, human and sympathetic behavior and transport facilities after discharge.

Middle and High Income group- personal and prompt attention of doctors, better behavior

by Class IV staff, improved physical facilities, relaxation of visiting hours.

Jain and Prasad, adopting interview techniques, studied the opinions of 400 patients admitted to medical wards of Gandhi Memorial College and associated hospitals and reported about patient satisfaction as shown in Table 1. Bhatia, in his study among orthopedic patients, found that the dissatisfaction was usually with food, entertainment, visiting hours and lack of proper interaction with the staff, i.e. doctors, nurses, etc. The patients also complained of lack of privacy.

Timmappaya et al, through a hypothesized model, studied the relationship between patient satisfaction, Table 1. Level of Patients Satisfaction as Reported in the Study by Jain and Prasad Factor Diet

Satisfied (%)

Unsatisfied (%)

66.4

33.6

Doctor-patient relationship

70

30

Nurse-patient relationship

78.3

21.7

Ward boys and sweeper

43

57

61.15

38.5

Reaction towards medical treatment

628

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

hospital status, employee satisfaction and service. This model assumes that the performance of the hospital will depend upon proper functioning of its social system, because practically every person working in the hospital depends upon some other person, since there is extensive diversion of labor and highly specialized work of each person. Doctors, nurses and others cannot function separately or independent of one another.

Their work is mutually supplementary, interlocking and interdependent.

If the system has to function properly and has to attain its objectives, its members and departments have to be highly co-ordinate. Job satisfaction is one of the conditions for better patient co-ordination and workers morale. Better co-ordination and job satisfaction of the employees will result into better patient care and satisfaction and consequently it will earn a better reputation for the hospital in the community. Good reputation of the hospital improves the status of its employees, which also contributes to their job satisfaction. Job satisfaction again, via services, leads to patient satisfaction to hospital reputation, etc.

As a part of their study, Chopra et al carried out participant’s observation in patient role in a hospital and confirmed through a flow chart that the aforesaid two factors led to better output i.e., recovery, which in turn led to patient satisfaction. In their report, hospital food, communication, discharge policy, use of influence, nursing orderly and sweepers were identified as dissatisfying factors. However, it was concluded that best possible hospital services might take care of patient dissatisfaction but to attain positive satisfaction, patients must have a good medical care.

OBSERVATION The study about patient satisfaction in Indian Spinal Injuries Centre was conducted by circulation of structured questionnaires amongst 100 patients and relatives of private and general wards.

The questions asked were about the process of patient getting admitted, their reception in the ward, room preparation, behavior of doctors, nurses, orderlies, food services, cleanliness of toilet, etc. The questions were given same scale from excellent to poor for uniformity of comparison. There were two open ended questions for their opinion about the problems and suggestions for improvement of services. ÂÂ

Admission and Reception: There is a procedure of issuing only one attendant’s pass. However, if a patient is sick or attendant is a lady and the

COMMUNITY MEDICINE attendant has to go out to get anything, etc. then he has problem. About 17% patients felt it was excellent, 25% patients felt it was very good, 40% felt good, 18% felt it was average. None of them said it to be poor. Overall, 82% people were satisfied with the services at admission counter. ÂÂ

Room preparation at the time of admission: About 17% patients felt it was excellent, 58% patients felt very good, 15% felt good, 9% felt it was average.

One percent of them said it to be poor. As a whole, 90% people were satisfied with the room preparation at the time of admission.

ÂÂ

Nursing services: About 27% patients felt it was excellent, 48% patients felt very good, 24% felt good, 10% felt it was average. One percent of them said it to be poor. So on a whole, 90% people were satisfied with the nursing services.

ÂÂ

Cleanliness of toilets: Nearly 10% of the patients felt it was excellent, 17% patients felt very good, 42% felt good, 22% felt it was average. About 9% of them said it to be poor. On a whole, only 69% people were satisfied with the cleanliness of the toilets.

ÂÂ

Briefing about policies, rules and regulations: About 3% patients felt it was excellent, 23% patients felt very good, 50% felt good, 14% felt it was average. About 10% of them said it to be poor.

So on a whole, 90% people were satisfied with the briefing about rules and regulations at the time of admission. It was observed that the briefing about the rules and regulations of hospital had got 10% average and 20% of poor response. It was the biggest dissatisfier.

ÂÂ

ÂÂ

ÂÂ

Quality of Doctors: Nearly 37% patients felt it was excellent, 40% patients felt very good, 17% felt good, 3% felt it was average. Three percent of them said it to be poor. In total, 94% people were satisfied with the explanation about disease and treatment by doctors.

Diet services: About 13% patients felt it was excellent, 35% patients felt very good, 40% felt good, 12% felt it was average. None of them said it to be poor. Food services got 12% average and 10% poor response. It was the second major dissatisfier.

Overall, only 78% people were satisfied with the quality of food served in the hospital.

Behavior of Nurses: About 10% patients/attendants felt it was excellent, 42% patients felt very good, 42% felt good, 6% felt it was average. None of them said it to be poor. On a whole, 92% people were satisfied with the behavior of Nurses.

ÂÂ

Behaviour of Doctors: Nearly 50% patients/ attendants felt it was excellent, 30% patients felt very good, 10% felt it was good. About 6% said it was average. Only 4% said it to be poor. Some people felt that the doctors have become less sensitive and empathetic to their problems. The new generations of doctors should be trained in soft skills and value of empathic care must be reemphasized. However, 90% people were satisfied with the behavior of Doctors.

ÂÂ

Behavior of Orderlies/Sweeper: About 13% patients/attendants felt it was excellent, 36% patients felt very good, 42% felt it was good, 9% felt it was average, 13% of them said it to be poor.

It was felt that there is less sensitivity about protocols to avoid cross infection amongst staff.

Some people complained about the bad behavior of hospital and houeskeeping attendants, although they did not give in writing. The shortage of hospital attendants for taking the patient for investigations and rehab (Physio) was also reported. On a whole, 78% people were satisfied with the behavior of Orderlies/Sweeper. This was a major dissatisfier.

The response to patient satisfaction questionnaries in the study conducted at Indian Spinal Injuries Centre is depicted in Table 2 and Figure 1.

RECOMMENDATIONS On interaction with patients and their attendants, following suggestions came out for improvement: ÂÂ

Admission: There is procedure of issuing only one attendant’s pass. However, if a patient is sick or attendant is a lady and the attendant has to go out to get any medicines, etc. then he has problem.

The policy of issuing two passes may have to be reconsidered.

ÂÂ

Room preparation: There were many complaints of cockroaches and rodents in the ward. The pest control department should do regular sprays and take effective measures for controlling them. Room preparation should be improved by more cleaning, anti-pest and anti-rodent measures.

ÂÂ

Nurses’ Behavior: Due to high demand, low supply and poor salary, there is always shortage of nurses. Hence, the working number of staff nurses has decreased. This has started showing in their efficiency and behavior. More number of staff nurses should be posted for patient care.

Management should devise methods and increase salary to attract and retain good nurses.

ÂÂ

Toilets: The cleanliness of toilets should be improved. It may be done twice a day. Frequent and

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

629

COMMUNITY MEDICINE Table 2. Response to Patient Satisfaction Questionnaries in the Study Conducted at Indian Spinal Injuries Centre Services

Excellent

Very good

Good

Average

Poor

Admission and Reception

17

25

40

18

-

Room preparation

17

58

15

9

1

Nursing

27

48

24

10

1

Cleanliness

10

17

42

22

9

Briefing about rules

3

23

50

14

10

Quality of Doctors

37

40

17

3

3

Diet services

13

35

30

12

10

Behavior of Nurses

10

42

42

6

0

Behavior of Doctors

50

30

10

6

4

Behavior of Orderlies

13

36

42

9

13

70

Excellent Very good Good Average Poor

60 50 40 30 20 10

lie

s

rs

er

Be

ha

vio

ha

ro

vio

fO

rd

ro

ur ro vio ha

Be

Be

fN

rv se et

ie Br

fD

se

ice

s

s

s Dr Di

of lity

ou ab g

ua

tr

nl ea Cl

fin

Q

in

ul

es

es

s

g in rs Nu

R ar oo at m io n ep pr

Ad

m

iss re ion ce a pt nd io n

0

Figure 1. Response to patient satisfaction questionnaries in the study conducted at Indian Spinal Injuries Centre.

of admission, which caused frequent delay in treatment and procedures and delay in payment.

Patients require more information about their disease and treatment. Patient should be explained in detail about the tests and procedures to be carried out and these should be pre planned and if possible may be done from the OPD itself. There were inadequate guidances for attendants about care of postoperative patients.

surprise checks by sanitary inspectors and administrators will instill a sense of responsibility and alertness in sanitary attendants. ÂÂ

ÂÂ

630

It was observed that the briefing about the rules and regulations of hospital had got 14% average and 10% of poor response. It was one of the biggest dissatisfiers. Although smoking is strictly prohibited in the hospital, still some people including staff are found openly smoking in the hospital. The patients and their relatives should be clearly informed in writing about the rules and regulations. This should be available in Hindi also.

Explanation about disease and treatment by doctors: All tests to be carried out and treatment options and costs were not told at the time

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

ÂÂ

Food services have got 12% average and 10% poor response. It was the second major dissatisfier. The quality and quantity of food, especially quality of chapattis and its presentation should be improved.

There were also some complaints of normal diet being given to diabetic patients and insects in food.

This needs careful monitoring.

COMMUNITY MEDICINE ÂÂ

ÂÂ

ÂÂ

ÂÂ

ÂÂ

Behavior of Nurses: Over the years, number of nurses have decreased due to high demand, low salary and hence low supply and number of working staff nurses have decreased. This is causing increased stress amongst them leading to some downfall in their services and behavior.

Behavior of Doctors: Although 90% of responses showed that the doctors at ISIC were above good level, yet 10% people felt that the doctors have become less sensitive and empathetic to their problems. The new generations of doctors should be trained and value of empathic care and soft skill must be re-emphasized Behavior of Orderlies/Sweeper: Twenty-two percent of the patients were disturbed by frequency of visits by different staff at different time. The timing for activities like nursing, cleaning, ward rounds should be fixed, so that the patient is mentally prepared for the same and can take rest at other time. Some people complained about the bad behavior of hospital and sanitary attendants. There is less sensitivity about avoiding cross infection in staff like washing of hands. There were also 2 complaints of theft (Mobile) by the attendants.

They should be trained about the importance of hand washing and other universal precautions, before and after touching any patient. They should be regularly trained and sensitized about how to improve their image and behavior.

With the introduction of consumer charges, the hospital services have become costly for poor people. Being a Not-for-profit hospital, people expect it to be cheap. Cost should be explained well to the patient before getting admitted in the hospital. However, this policy of revising rates may be looked into.

There should be package charges for some procedures to avoid running around by patient’s attendant for minor requirements. .

CONCLUSION It was found in the present study that most of the patients are satisfied with most of the services in the Indian Spinal Injuries Centre.

Five major satisfiers were: ÂÂ

Room preparation

ÂÂ

Quality and behavior of doctors

ÂÂ

Explanation about disease and treatment

ÂÂ

Courtesy of staff at admission counter

ÂÂ

Behavior of nurses.

Four major dissatisfiers were: ÂÂ

Cleanliness of the toilet

ÂÂ

Quality of the food and dietary services

ÂÂ

Explanation about rules and regulations

ÂÂ

Behavior of hospital and sanitary attendants.

BIBLIOGRAPHY 1. Codman EA. A Study of hospital efficiency: the first five years. Boston Thomas Todd Co, 1916.

2. Doyle JC. Unnecessary Ovariectomies. J Am Med Assoc 1952;148(13). Hysterectomies. J Am Med Assoc 1953;151(5):360-5.

3. Hendrickson G, Kovner CT, Knickman JR, Finkler SA. Implementation of a variety of computerized bedside nursing information systems in 17 New Jersey hospitals.

Comput Nurs 1995;13(3):96-102.

4. Blegen MA, Reiter RC, Goode CJ, Murphy RR. Outcomes of hospital-based managed care: a multivariate analysis of cost and quality. Obstet Gynecol 1995;86(5): 809-14.

5. Cock DJ. Continuous Quality Study, McMaster University, Faculty of Health Sciences, Ontario.

6. Houston CS, Pasanen WE. Patients’ perceptions of hospital care. Hospitals 1972;46(8):70-4.

7. Jain VC, Prasad BG. A study of hospitalised patients, attitude towards ward facilities and ward services in the general medical wards of a teaching hospital. Ind Med Gazette, Calcutta 1969;9(8):3-16.

8. Bhatia AK. Patient perception of needs and problems in the Hospital setup. Int J Health Educ 1971;14: 145-50.

9. Timmappaya et al. Patient satisfaction and Ward Social System, NIHFW Research Monograph, New Delhi; 1971.

10. Chopra V. Participant Observations in Patient’s Role in a Small Hospital, NIHFW Research Project Report No-5.

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631

COMMUNITY MEDICINE

In Patient Satisfaction and Suggestion Form

Dear Friend, Please spend few minutes to give your valuable feedback and suggestions. It will help us to improve the quality of services and serve you better.

Name:______________________________________________ Age:_____________________________________________ Address and Contact No.:_______________________________________________________________________________ ______________________________________________________________________________________________________ Ward and Bed No:_____________________________________________________________________________________ Date of admission:___________________________________ Date of discharge:_________________________________ Doctor in charge:______________________________________________________________________________________

Please rest assured that your name and identity will be kept confidential and it will not affect your treatment adversely.

Facilities and Staff

Excellent (10/10)

Front desk a. Ease of registration b. Front desk friendliness c. Front desk efficiency and service d. Front desk responsiveness to needs Medical care a. Quality of care b. Frequency of visits c. Explanation of procedures d. Rapport with your Doctor e. Empathy and understanding Nursing care a. Friendliness b. Professionalism c. Frequency of visits d. Knowledge of your treatment

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

Good (7/10)

Fair (5/10)

Poor (3/10)

COMMUNITY MEDICINE Facilities and Staff

Excellent (10/10)

Good (7/10)

Fair (5/10)

Poor (3/10)

Lab Investigations Courtesy Safety Efficiency Reporting Rehabilitation (This section is not applicable for patients who have not undergone rehabilitation) How will you rate their quality and performance a. Physiotherapist b. Occupational therapist c. Orthotist, prosthetist d. Social worker e. Peer counselor f. Clinical psychologist House keeping a. Cleanliness of room b. Cleanliness of bathroom c. Cleanliness of public areas d. Condition of linen e. Condition of TV In patient billing procedure a. Courtesy of staff b. Efficiency of staff c. Accuracy of Billing d. Timeliness of Billing General How would you rate their performance a. Kitchen - Quality of food - Temperature of food - Personalized attention of staff/ requirement - Cleanliness of staff b. Technical department like A/C, plumber/electrical, etc. c. Security- Behavior Helpfulness Corporate desk Courtesy Efficiency Reporting Overall rating a. Quality of care b. Quality of services

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

633

COMMUNITY MEDICINE Your additional comments and recommendations are appreciated: ______________________________________________________________________________________________________ ______________________________________________________________________________________________________ Would you recommend Indian Spinal Injuries Centre to other?

Yes

No

If No, give reasons ______________________________________________________________________________________________________ ______________________________________________________________________________________________________ Thanking you for taking time to fill out this survey.

You can be assured we will take corrective measures on your comments in the required areas to improve the services up to your expectation.

Wish you good health and good fortune.

Thank you very much for your cooperation.

Get well soon Sincerely yours Dr PH Mishra Medical Superintendent

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

庐

Capsules Syrup Ferric Ammonium Citrate: 160 mg

Keeps in the

ORANGE of Health

FRANCO路INDIAN PHARMACEUTICALS PVT. LTD.

20, Dr. E. MOHi Road, Mumb11400 011.

COMMUNITY MEDICINE

Prevalence and Pattern of Self-medication Practices in Rural Area of Barabanki SHYAM SUNDER KESHARI*, PRIYANKA KESARWANI†, MILI MISHRA‡

ABSTRACT Background: The use of self-medication is highly prevalent in the community. Self-medication can be defined as obtaining and consuming one (or more) drug(s) without the advice of a physician either for diagnosis, prescription or surveillance of treatment.

Aims and objectives: To study the prevalence and pattern of self-medication practices in rural area of Barabanki. Material and methods: A cross-sectional study was carried out in rural area of Barabanki to assess the knowledge, awareness and perception of self-medication practices by house-to-house survey during the period of October 2013 to March 2014. Results: Out of 235 participants enrolled, 168 responded (71.5%). A total of 67 (28.5%) participants were excluded in accordance with the exclusion criteria like incomplete information and not using self-medication. Out of 168 respondents, 117 (69.6%) reported self-medication within 1 year of recall period. Most common conditions/symptoms for self-medication in students were fever (72.6%), pain (64.3%) and respiratory symptoms (57.1%), followed by infections, headache and diarrhea, etc. Self-medication was the most common category of drugs used by all the participants except highly educated who used drugs prescribed by physician. Conclusion: Self-medication is an alarming sign for society.

Keywords: Self-medication, rural area, OTC drugs, highly educated

S

elf-medication can be defined as obtaining and consuming one (or more) drug(s) without the advice of a physician either for diagnosis, prescription or surveillance of treatment.1 In practice, it also includes use of the medication of family members, especially where the treatment of children or the elderly is involved.2 Pharmacists and pharmacy attendants play an important role in fostering self-medication among the public.3 Although, OTC (over-the-counter) drugs are meant for self-medication and are of proved efficacy and safety, their improper use due to lack of knowledge of correct dose, side-effects and interactions could have serious implications, especially in extremes of ages (children

*Professor and Head Dept. of Pharmacology †Associate Professor ‡Assistant Professor Dept. of Community Medicine Hind Institute of Medical Sciences, Barabanki, Uttar Pradesh Address for correspondence Dr Shyam Sunder Keshari Professor and Head Dept. of Pharmacology Hind Institute of Medical Sciences, Safedabad, Barabanki - 225 003, Uttar Pradesh E-mail: drsskeshari@gmail.com

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

and old age) and special physiological conditions like pregnancy and location.4,5 Use of self-medication is highly prevalent in both urban and rural community varying from 32.5% to 81.5%.6-8 There is always a risk of interaction between active ingredients of hidden preparations of OTC drugs and prescription medicines, as well as increased risk of worsening of existing disease pathology. Combination preparations containing ‘hidden’ classes of drugs and food supplements or tonics of doubtful value were commonly used in India.9 MATERIAL AND METHODS A cross-sectional study was carried out in rural area of Barabanki to assess the knowledge, awareness and perception of self-medication practices by house-tohouse survey during the period of October 2013 to March 2014. This study was a questionnaire-based survey approved by the Ethical Committee of Hind Institute of Medical Sciences (HIMS), Barabanki, Uttar Pradesh.

A self-developed, prevalidated questionnaire consisting of both open-ended and closed-ended items were used.

The study population comprised of inhabitants of rural area of Barabanki. All participants who were willing to participate in the study were enrolled. A briefing was given about the nature of study, and the procedure of

COMMUNITY MEDICINE completing the questionnaire was explained. Samples of 235 participants were selected randomly and written consent was taken. The inclusion criteria for the selection of participants was 15 years and above. A total of 67 participants were excluded in accordance with the exclusion criteria like incomplete information and not using self-medication. The questionnaire consisted of questions on type of medicine system, category of medicines and name of a particular medicine.

The results are based upon the data obtained from 168 participants. Data was analyzed using MS Excel 2007. The survey was descriptive and data was summarized as counts and percentages. The sum of percentage is not always 100% as some of the questions had multiple options to choose from.

RESULTS Out of 235 participants enrolled, 168 responded (71.5%).

A total of 67 (28.5%) participants were excluded in accordance with the exclusion criteria like incomplete information and not using self-medication. Out of 168 respondents, 117 (69.6%) reported self-medication within 1 year of recall period.

The prevalence of self-medication in the study population was more common in males (81%) as compared to females (19%) and it was more common in persons with 31-45 years of age (44.0%). Self-medication was more common in illiterate population (38.7%). Selfmedication was the most common category of drugs used by all the participants except highly educated (graduates and above) who used only prescribed drugs Table 1. Demographic Data of the Respondents (n = 168) Demography

No.

Percentage (%)

Sex Male

136

81.0

Female

32

19.0

Age

more frequently (Table 1). Majority of the respondents were taking Allopathic drugs (69.6%) followed by Ayurvedic drugs (13.1%) and Homeopathic drugs (10.7%) (Table 2). Most common conditions/symptoms for self-medication were fever (72.6%), pain (64.3%) and respiratory symptoms (57.1%), followed by infections, headache and diarrhea, etc. (Table 3).

The most commonly used drugs for self-medication were paracetamol (56.5%), drugs for gastrointestinal problems (40.5%), nonsteroidal anti-inflammatory drugs (NSAIDs) (39.9%) followed by cold remedies, antimicrobials, etc. (Table 4).

Table 2. Trust in Medical System (n = 168) Medical system

No.

Percentage (%)

Allopathic

117

69.6

Ayurvedic

22

13.1

Homeopathic

18

10.7

Unani

11

6.5

Table 3. Conditions/Symptoms for Self-medication (n = 168) Conditions/Symptoms

No.

Percentage (%)

Fever

122

72.6

Headache

68

40.5

Infections

76

45.2

Pain

108

64.3

Diarrhea

55

32.7

Respiratory symptoms

96

57.1

Table 4. Frequency of Drugs/Drug Groups Used by the Respondents for Self-medication (n = 168) Drugs/Drug group

Frequency of uses

Percentage (%)

Paracetamol

95

56.5

15-30

43

25.6

Other NSAIDs

67

39.9

31-45

74

44.0

Cold remedies

56

33.3

46-60

35

20.8

61-75

16

9.5

GIT drugs

68

40.5

Antimicrobials

55

32.7

Illiterate

65

38.7

Herbs/Ayurvedic drugs

27

16.1

Primary School

40

23.8

Homeopathic drugs

49

29.2

Secondary School

36

21.4

Unani drugs

16

9.5

Graduation and above

27

16.1

Education

NSAIDs: Nonsteroidal anti-inflammatory drugs; GIT: Gastrointestinal tract.

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

637

COMMUNITY MEDICINE Table 5. Source of Information about Drugs Used in Self-medication (n = 168) Source

No.

Percentage (%)

Previous prescription of Doctor

122

72.6

Chemists

64

38.1

Friends and neighbors

88

52.4

Advertisements

32

19.0

Table 6. Reasons for Self-medication (n = 168) Reason

No.

Percentage (%)

Time saving

76

45.2

Convenience

42

25.0

Minor illness (Doctor’s advice not needed)

67

39.9

High cost of consultation

71

42.3

The important sources of information for self-medication were previous prescription of doctors (72.6%), friends and neighbors (52.4%) and chemists (38.1%) (Table 5).

In present study, most common reasons for favoring self-medication were time saving (45.2%) followed by high cost of consultation (42.3%), minor illness (39.9%) followed by convenience (25.0%) (Table 6).

DISCUSSION Self-medication is widely practiced in many developing countries. The practice of self-medication is widespread all over the world especially urban and educated population.6,7 The extent and depth of knowledge regarding self-medication in community needs to be assessed. Previous studies have shown that the prevalence of self-medication as 37% in urban population and 17% in rural population in India,10 whereas 12.7-95% in other developing countries.11,12 Prevalence of self-medication has been found among 81.5% individuals in a rural area in Maharashtra.8 More male patients used self-medication compared to females, contrary to data from Western reports.12,13 Prevalence of self-medication could not be compared across different studies due to their varying nature of definitions used, recall period considered for definition, region selected and methodology adopted. Allopathic medicine was used by 69.6% respondents, which are consistent with studies carried out by Kumar (69%).14 Fever, pain, respiratory problems followed by headache were most common conditions for which people have used self-medications.

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

Paracetamol and analgesics were the most commonly used class of drugs, which is found to be similar to study carried out by Arrais et al.15 Previous doctor’s prescription (72.6%) was the major source of selfmedications information in this study. In the present study, doctors were found to be the most common source of drug information followed by chemists and advertisements. These are consistent with the earlier reports.16-18 Doctors are not available in time in rural areas, this might have tempted the rural population to use initial doctor’s prescription for self-medication. Most common reason for self-medication in present study was time saving (45.2%), which was consistent with the results reported by Pandya et al (41.2%).19 Most of the respondents had positive attitude in self-medication in minor illness. However, minor illness symptoms may cause major illness if not diagnosed properly.

CONCLUSION Self-medication is an alarming sign for society. Selfmedication with OTC drugs may lead to adverse drug reactions, drug-drug interactions, skin problems, hypersensitivity reactions, allergy and even death.

Several studies show that self-medication is a global phenomenon. Self-medication can be prevented or minimized by increased awareness and education in society.

REFERENCES 1. Montastruc JL, Bagheri H, Geraud T, Lapeyre-Mestre M. Pharmacovigilance of self-medication.

Therapie 1997;52(2):105-10.

2. World Health Organization: Guidelines for the regulatory assessment of medicinal products for use in self-medication. WHO/EDM/QSM/00.1,2000 (Cited 05 July 2014).

3. Kamat VR, Nichter M. Pharmacies, self-medication and pharmaceutical marketing in Bombay, India. Soc Sci Med 1998;47(6):779-94.

4. Murray MD, Callahan CM. Improving medication use for older adults: an integrated research agenda. Ann Intern Med 2003;139(5 Pt 2):425-9.

5. Choonara I, Gill A, Nunn A. Drug toxicity and surveillance in children. Br J Clin Pharmacol 1996;42(4):407-10.

6. Lam CL, Catarivas MG, Munro C, Lauder IJ. Selfmedication among Hong Kong Chinese. Soc Sci Med 1994;39(12):1641-7.

7. Sanghani S, Zaveri HG, Patel VJ. Self medication: Prevalence and pattern in urban community.

J Pharmacovigilance Drug Safety 2008;5:95-8.

COMMUNITY MEDICINE 8. Phalke VD, Phalke DB, Durgawale PM. Self-medication practices in rural Maharashtra. Indian J Commun Med 2006;31(1):34-5.

9. Greenhalgh T. Drug prescription and self-medication in India: an exploratory survey. Soc Sci Med 1987;25(3):307-18.

10. D

ineshkumar B, Raghuram TC, Radhaiah G, Krishnaswamy K. Profile of drug use in urban and rural India. Pharmacoeconomics 1995;7(4):332-46.

11. Shankar PR, Partha P, Shenoy N. Self-medication and nondoctor prescription practices in Pokhara valley, Western Nepal: a questionnaire-based study. BMC Fam Pract 2002;3:17.

12. Figueiras A, Caamaño F, Gestal-Otero JJ. Sociodemographic factors related to self-medication in Spain. Eur J Epidemiol 2000;16(1):19-26.

13. Habeeb GE Jr, Gearhart JG. Common patient symptoms: patterns of self-treatment and prevention. J Miss State Med Assoc 1993;34(6):179-81.

14. Kumar MT. Studies in drug utilization, Maharashtra.

Herald 1982 Jan 8.

15. Arrais PS, Coelho HL, Batista Mdo C, Carvalho ML, Righi RE, Arnau JM. Profile of self-medication in Brazil. Rev Saude Publica 1997;31(1):71-7.

16. Sharma R, Verma U, Sharma C L, Kapoor B. Selfmedication among urban population of Jammu city.

Indian J Pharmacol 2005;37(1):40-3.

17. Lefterova A, Getov I. Study on consumers’ preferences and habits for over-the-counter analgesics use. Cent Eur J Public Health 2004;12(1):43-5.

18. Krishnan HS, Schaefer M. Evaluation of the impact of pharmacist’s advice giving on the outcomes of selfmedication in patients suffering from dyspepsia. Pharm World Sci 2000;22(3):102-8.

19. Pandya RN, Jhaveri KS, Vyas FI, Patel VJ. Prevalence, pattern and perceptions of self-medication in medical students. Int J Basic Clin Pharmacol 2013; 2(3): 275-80.

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Exercise: A Prescription Reduces the chances of getting heart disease. For those who already have heart disease, exercise reduces the chances of dying from it. Lower the risk of developing hypertension and diabetes; reduce the risk for colon cancer and some other forms of cancer; improve mood and mental functioning; keeps the bones strong and joints healthy; helps you to maintain a healthy weight; help maintain independence into later years age is no bar; there is abundant evidence that exercise can enhance health and well-being. But, today for most watching TV, surfing the Internet or playing computer and video games is replacing the helpful exercises. The minimum threshold for good health is to burn at least 700-1,000 calories a week through physical pursuits. Exercise improves health and can extend life. Adding as little as half an hour of moderately intense daily physical activity can help one avoid a host of serious ailments, including heart disease, diabetes, depression and several types of cancer, particularly breast and colon cancers. Regular exercise can also help one sleep better, reduce stress, control weight, brighten mood, sharpen mental functioning and improve sex life. As per Harvard researchers a well-rounded exercise program must have all the four components: Aerobic activity; strength training; flexibility training, and balance exercises. ÂÂ

Aerobic activity: is the centrepiece of any fitness program. Most benefits of exercise revolve around aerobic cardiovascular activity, which includes walking, jogging, swimming and cycling. One should work out at moderate intensity when performing aerobic exercise—brisk walking that quickens the breathing is one example. This level of activity is safe.

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Strength training protects bone: Strength or resistance training, such as elastic-band workouts and the use of weight machines or free weights, are important for building muscle and protecting bone. Bones lose calcium and weaken with age, but strength training can help slow or sometimes even reverse this trend.

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Flexibility exercises ease back pains: Muscles tend to shorten and weaken with age. Shorter, stiffer muscle fibers make one vulnerable to injuries, back pain and stress. But, regularly performing exercises that isolate and stretch the elastic fibers surrounding the muscles and tendons can counteract this process. And stretching improves posture and balance.

ÂÂ

Balancing exercises prevents fall: Balance erode over time, and regularly performing balance exercises is one of the best ways to protect against falls that lead to temporary or permanent disability. Balance exercises take only a few minutes and often fit easily into the warm-up portion of a workout. Many strength-training exercises also serve as balance exercises. Or balance-enhancing movements may simply be woven into other forms of exercise, such as tai chi, yoga and Pilates.

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DERMATOLOGY

Degos’ Like Nonclear Cell Acanthoma: Could this be a New Entity?

ADITYA KUMAR BUBNA*, LEENA DENNIS JOSEPH†, MAHALAKSHMI VEERARAGHAVAN‡, SUDHA RANGARAJAN‡

ABSTRACT Degos’ acanthoma is a tumor that is clinically and histologically distinct. Typically, the lesions are solitary, sharply delineated red nodules or plaques 1-2 cm in diameter, usually covered by a thin wafer like crust. On microscopy, the striking presence of pale and slightly enlarged epidermal cells is essential to clinch the diagnosis. Here we present a case where the clinical picture was that of Degos’ acanthoma with the absence of glycogen rich clear cells on histology.

Keywords: Degos’ acanthoma, clear cells, psoriasiform histology

D

egos’ acanthoma or clear cell acanthoma (CCA) is an asymptomatic benign lesion of unknown etiology, which typically presents as a red brown, solitary nodule on the leg.1 A wafer like scale is often appreciated at the periphery.2 The hallmark feature of CCA on histology is the presence of clear cells in the epidermis that are rich in glycogen and show a positive periodic acid-schiff (PAS) reaction.3 Our patient though clinically presented as CCA, there was a characteristic absence of clear cells on microscopic examination of the biopsy specimen. However, other findings of CCA were strikingly evident. As clear cells are mandatory to diagnose CCA, we consider this as a new entity and would like to give the name Degos’ like nonclear cell acanthoma for this condition.

malleolus. He had noticed the lesion since the past 5 months. It was small initially and had progressively grown to attain the present size. Apart from occasional pain, there were no other symptoms. On examination, a solitary reddish nodule was seen over the above mentioned site, with a wafer like scale in the superior aspect (Fig. 1).

On palpation, the nodule was firm in consistency and nonfriable. Clinically, a differential diagnosis of eccrine poroma and CCA was made and an excision biopsy of the nodule performed. Histopathology revealed an acanthotic epidermis with psoriasiform hyperplasia and fusion of the rete ridges (Figs. 2 and 3).

The dermis showed a diffuse neutrophilic infiltrate and dilated blood vessels (Fig. 4). An aggregate of

CASE REPORT A 19-year-old boy from Bhutan presented to the Dept. of Dermatology with an elevated skin lesion over the lateral aspect of the right foot 2 cm anterior to the lateral

*Assistant Professor Dept. of Dermatology †Professor Dept. of Dermatology and Pathology ‡Professor Dept. of Dermatology Sri Ramachandra Medical College, Porur, Chennai Address for correspondence Dr Leena Dennis Joseph Dept. of Dermatology and Pathology Sri Ramachandra Medical College, Porur, Chennai - 600 116 E-mail: leenadj@gmail.com

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Figure 1. Solitary reddish nodule on lateral aspect of right foot.

DERMATOLOGY

Figure 4. Diffuse neutrophilic infiltrate and dilated blood vessels in the dermis.

Figure 2. Acanthotic epidermis with psoriasiform hyperplasia.

Figure 5. Aggregate of neutrophils in the crust overlying the epidermis.

Figure 3. Psoriasiform hyperplasia with fusion of the rete ridges.

neutrophils was also seen in the crust overlying the epidermis (Fig. 5). PAS reaction was negative (Fig. 6).

In none of the sections were clear cells appreciated.

Patient has come for follow-up with us with no recurrence of the lesion.

Figure 6. Negative PAS reaction.

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

641

DERMATOLOGY DISCUSSION

What is New?

Clear cell acanthoma (CCA) is a tumor that is clinically and histologically distinct. It was first described in 1962.4 Typically the lesions are solitary, sharply delineated red nodules or plaques 1-2 cm in size, usually covered by a thin wafer like peripheral crust.5 Clinically, various forms of CCA have been described in literature like the pigmented type,6,7 polypoidal type,8,9 pedunculated CCA,10 giant CCA,11 cystic CCA and eruptive CCA.12 A histopathologic examination of each of these variants also will show the hallmark finding of pale slightly enlarged cells in the epidermis. Apart from this psoriasiform epidermal hyperplasia with fusion of epidermal rete ridges and a clearly demarcated lateral border are other findings. Intralesional neutrophils are characteristic and are often evident within an overlying parakeratotic scale.13,14 The underlying dermis again shows a neutrophilic picture with enlarged blood vessels. The glycogen rich keratinocytes stain distinctively with PAS, which can be washed out with diastase that digests the glycogen. Our case showed the characteristic nodule of CCA.

Our patient presented with a lesion that clinically resembled Dego’s acanthoma with a striking absence of clear cells on histopathology. Other histologic features of the condition were however present. Though clear cells on histopathology are mandatory for a diagnosis of CCA, whether this could be a new histologic variant of Dego’s acanthoma or a new clinical entity altogether, further identification of new cases in the future would be decisive.

However, on histopathology, there were no clear cells and the PAS reaction was negative. Other findings on the other hand as seen in CCA were fulfilled in this case. As clear cells are mandatory for the diagnosis of CCA we consider this to be a new entity altogether and would like to propose the term Degos’ like non-CCA for this condition.

Key Message Degos’ acanthoma is not a rare dermatologic disorder as earlier thought. Clinically, apart from the classic description, there could be many other variants. The diagnosis can be arrived at only by a histopathology examination, which shows the presence of clear cells in the epidermis, excluding the basal layer, that are glycogen rich and show a positive PAS reaction. The absence of clear cells rules this diagnosis out. In such instances, a revision of the diagnosis is mandatory, mimicry being a common phenomenon in dermatology.

It is here where the ability of an astute clinician comes into play at coming to a precise conclusion.

What is Known?

Dego’s acanthoma is a clinically and histologically distinct tumor. The presence of clear cells in histopathology is a hallmark feature of this benign tumor.

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REFERENCES 1. Tempark T, Shwayder T. Clear cell acanthoma. Clin Exp Dermatol 2012;37(8):831-7.

2. Fine RM, Chernosky ME. Clinical recognition of clear-cell acanthoma (Degos’). Arch Dermatol 1969;100(5):559-63.

3. Wells GC, Wilson-Jones E. Degos’ acanthoma (acanthome à cellules claires). A report of five cases with particular reference to the histochemistry. Br J Dermatol 1967;79(5):249-58.

4. Degos R, Civatte J. Clear-cell acanthoma. Experience of 8 years. Br J Dermatol 1970;83(2):248-54.

5. Innocenzi D, Barduagni F, Cerio R, Wolter M. Disseminated eruptive clear cell acanthoma - a case report with review of the literature. Clin Exp Dermatol 1994;19(3):249-53.

6. Langer K, Wuketich S, Konrad K. Pigmented clear cell acanthoma. Am J Dermatopathol 1994;16(2):134-9.

7. Scheinfeld N. A glistening brown nodule. Pigmented clear cell acanthoma. Arch Dermatol 2007;143(2):255-60.

8. Kawaguchi H, Tatewaki S, Takeuchi M. A case of polypoid clear cell acanthoma on the scrotum. J Dermatol 2004;31(3):236-8.

9. Park SY, Jung JY, Na JI, Byun HJ, Cho KH. A case of polypoid clear cell acanthoma on the nipple. Ann Dermatol 2010;22(3):337-40.

10. Tanaka T, Arai T, Ishikawa T, Ohnishi T, Watanabe S. Pedunculated clear cell acanthoma. Report of a case with dermoscopic observation. Eur J Dermatol 2010;20(1): 132-3.

11. Kim CY, Kim NG, Oh CW. Multiple reddish weeping nodules on the genital area of a girl. Giant clear cell acanthoma (CCA). Clin Exp Dermatol 2010;35(3):e67-9.

12. Naeyaert JM, de Bersaques J, Geerts ML, Kint A. Multiple clear cell acanthomas. A clinical, histological, and ultrastructural report. Arch Dermatol 1987;123(12): 1670-3.

13. Brownstein MH, Fernando S, Shapiro L. Clear cell acanthoma: clinicopathologic analysis of 37 new cases.

Am J Clin Pathol 1973;59(3):306-11.

14. Hamaguchi T, Penneys N. Cystic clear cell acanthoma.

J Cutan Pathol 1995;22(2):188-90.

2014

2014

Rx

DIABETOLOGY

Macrovascular and Microvascular Complications in Newly Diagnosed Type 2 Diabetes Mellitus DEEPA DV*, KIRAN BR†, GADWALKAR SRIKANT R‡

ABSTRACT Objectives: To study the prevalence and clinical profile of microvascular and macrovascular complications in newly diagnosed type 2 diabetes mellitus patients in and around Bellary, Karnataka. Study design: The study was an observational cross-sectional study of 100 newly detected type 2 diabetics attending Dept. of Medicine (outpatient/inpatient), VIMS combined hospitals, Bellary, from October 2012 to June 2013 (9 months) who matched the inclusion criteria. Material and methods: Cases were screened for vascular complications as per ADA criteria, data tabulated and analyzed. Statistical analysis: SPSS software package was used for analysis. Statistical significance was defined as a p value <0.05. Results: The mean age of presentation was 54.05 ± 13.24 with male:female ratio of 1.6:1. The prevalence of diabetic retinopathy, nephropathy, neuropathy, cardiovascular, cerebrovascular and peripheral vascular disease was 20%, 37%, 16%, 26%, 8% and 11%, respectively; retinopathy, nephropathy and coronary artery disease screening being significant (p < 0.05). Conclusion: There was a significant correlation between prevalence of diabetes and increased waist circumference and body mass index. There was high prevalence of coronary artery disease, nephropathy and retinopathy in South Indian population at diagnosis. Screening for all cases of diabetes at diagnosis for complications is recommended.

Keywords: Type 2 diabetes mellitus, microvascular complications, macrovascular complications

D

iabetes mellitus is a common metabolic disorder and is associated with development of chronic complications leading to significant morbidity and mortality. The onset of type 2 diabetes (T2DM) is often silent and insidious. Pathogenic processes causing T2DM range from autoimmune destruction of cells of pancreas with consequent insulin deficiency to abnormalities that result in resistance to insulin action.

The asymptomatic phase of hyperglycemia accounts for the relatively high prevalence of complications at initial presentation.1 Majority of India’s population is in the villages and the rural population is ignorant about the disease and its complications. It is therefore, essential to device cost-effective and simple screening

*Senior Resident Bangalore Medical College and Research Institute, Bangalore, Karnataka †Senior Resident Rajarajeshwari Medical College, Bangalore, Karnataka ‡Professor and Head Dept. of General Medicine Vijayanagara Institute of Medical Sciences, Bellary, Karnataka Address for correspondence Dr Deepa DV No. 82, 5th Main, Maruthi HBCS, BTM I Stage, Bangalore - 560 029, Karnataka E-mail: drdeepa.dv@gmail.com, brkiranin@gmail.com

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tests to detect complications. The term ‘diabetes’ was first coined by Araetaeus of Cappodocia (81-133AD).

Mellitus (honey sweet) was added by Thomas Willis (Britain) in 1675, when he detected sweetness in urine.

It is said that it was first noticed by the ancient Indians; Shushrutha had named it as ‘Madhumeha’.2 According to Diabetes Atlas (5th edition) in 2011, the global prevalence of diabetes was estimated at 366 million; this figure is predicted to reach 552 million by 2030. Eighty percent people live in low and middle income countries. Diabetes caused 4.6 million deaths in 2011. China leads the world with largest number of diabetic subjects followed by India. According to the Diabetes Atlas 2011 published by the International Diabetes Federation, the number of people with diabetes in India currently around 61.3 million is expected to rise to 101.2 million by 2030.

MATERIAL AND METHODS

Source of Data Newly detected patients with T2DM attending Dept. of Medicine (outpatient/inpatient), Vijayanagara Institute of Medical Sciences (VIMS) combined hospital, Bellary, form the subjects.

DIABETOLOGY Design of the Study

Method of Data Collection

Cross-sectional observational study.

Patients newly detected of T2DM attending Dept. of Medicine (outpatient/inpatient), VIMS combined hospital, Bellary were included for the study.

Duration of Study October 2012 to June 2013 (9 months).

Inclusion Criteria Newly diagnosed T2DM adult patients >20 years of age were included in the study. (Laboratory diagnosis of diabetes mellitus was confirmed by latest criteria laid by the American Diabetes Association (ADA). Blood glucose levels were checked on two separate occasions before the diagnosis of diabetes mellitus was made.)

According to ADA,1 criteria for diagnosis are: Glycosylated hemoglobin (HbA1C) ≥6.5%. The test should be performed in a laboratory using a method that is NGSP (National Glycohemoglobin Standardization Program) certified and standardized to the DCCT (Diabetes Control and Complications Trial) assay.*

ÂÂ

Detailed history such as age and sex, family history of diabetes was recorded. Symptoms suggestive of diabetes or of related complications were noted. Past history of hypertension and complications of diabetes was documented. Any previous treatment for these complications taken was recorded. Smoking or alcohol history was noted.

General physical examination, vital parameters such as pulse, blood pressure (in sitting and standing position) temperature and respiratory rate were recorded.

Anthropometric measurements: ÂÂ

Weight (in kilograms) and height (in centimeters) was recorded.

ÂÂ

The body mass index (BMI) was determined by dividing the weight (in kilograms) by height (in meters2).

ÂÂ

Measurement of waist circumference (cm): It was measured just above the uppermost lateral border of the right iliac crest, a horizontal mark was drawn, and then crossed with a vertical mark on the midaxillary line. The measuring tape was placed in a horizontal plane around the abdomen at the level of this marked point on the right side of the trunk.

OR Fasting plasma glucose ≥126 mg/dL (7.0 mmol/L).

Fasting is defined as no caloric intake for at least 8 hours*

ÂÂ

OR 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an OGTT (oral glucose tolerance test)†

ÂÂ

OR ÂÂ

In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L).

*In the absence of unequivocal hyperglycemia, criteria 1-3 should be confirmed by repeat testing. †The

test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.

Exclusion Criteria ÂÂ

Type 1 diabetes mellitus

ÂÂ

Any other severe illness

ÂÂ

Patients already diagnosed of diabetes mellitus and on treatment

ÂÂ

Refusal to be a part of the study

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Pregnancy

Sample Size Hundred cases of newly diagnosed T2DM were included in this study.

Presence of skin infections, gangrene and ulcers was noted.

Systemic examination was carried out in all patients.

Presence of sensory neuropathy was defined4 by symptoms of tingling and numbness over the extremities (bilaterally symmetrical) with or without impaired touch, vibration sense or joint position sense.

Presence of motor neuropathy was noted. Autonomic dysfunction in the form of resting tachycardia, orthostatic hypotension, gastroparesis/diarrhea or abnormal sweating was noted. Ten gram monofilament was used to note any reduced sensation due to neuropathy. Dilated pupil fundoscopy was carried out in all patients by an ophthalmologist and retinopathy was defined and graded as nonproliferative diabetic retinopathy and proliferative retinopathy.5 Proliferative retinopathy was described by the presence of any retinal or optic disc neovascularization, or the presence of preretinal or vitreous hemorrhage, whereas the presence of microaneurysms, exudates (lipid exudates or ‘cotton-wool spots’) and/or retinal hemorrhages only

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

645

DIABETOLOGY t-test and Chi-square test was used to calculate the significance between the variables.

was defined as nonproliferative retinopathy. Fasting and postprandial blood sugars (venous blood samples drawn) on two separate occasions were determined using glucose oxidase-peroxidase method. Renal function tests included blood urea, serum creatinine and urine analysis. Urine was analyzed for glucose, ketone bodies and protein. Microalbuminuria was estimated by nephelometry. Microalbuminuria is defined as the mean urine albumin concentration of 30-300 mg/mL detected by nephelometry on three consecutive days. Macroalbuminuria is defined as urine albumin >300 mg/dL.6 Fasting lipid profile included serum cholesterol, serum triglycerides, serum high-density lipoprotein (HDL) and serum low-density lipoprotein (LDL).

Patient was termed to have dyslipidemia if LDL was >100 mg/dL, serum cholesterol >200 mg/dL, serum HDL <40 or serum triglycerides >150 mg/dL. A 12-lead electrocardiogram (ECG) and 2Dechocardiography was done to note the presence of ischemia or infarction to indicate coronary artery disease (CAD).6 Carotid Doppler was done to note for presence of stenosis. Ankle-brachial index (ABI) was determined using arterial Doppler. A value <0.9 was considered significant to have peripheral arterial disease.7

RESULTS In this study, 62 were males and 38 were females.

The mean age was 54.05 ± 13.24 years. The maximum incidence of diabetics was seen between 52-62 years.

Table 1 shows various metabolic parameters in the study population. The patients presenting with complaints correlated with diabetic complications of CAD, cerebrovascular disease, peripheral artery disease, retinopathy, nephropathy and neuropathy was 15%, 7%, 7%, 2%, 9% 7%, respectively. Fundus examination revealed that 19 cases had nonproliferative diabetic retinopathy and one case had proliferative retinopathy.

It was statistically significant. Microalbuminuria was seen in 30 cases, macroalbuminuria seen in four cases was statistically significant. ECG findings were normal in 74 cases, myocardial infarction (MI), left bundle branch block, left ventricular hypertrophy (LVH) in three cases each, old MI in seven cases, ischemic heart disease in six cases and arrhythmias in two cases. 2D-echocardiography showed regional wall motion abnormality in 23 cases, hypertensive heart disease in eight cases, concentric LVH and ischemic dilated cardiomyopathy in one case each. Carotid Doppler showed atherosclerosis in five cases and was statistically insignificant. ABI showed limb ischemia in 19 cases among which seven cases showed critical limb ischemia which was statistically insignificant. Twentyeight cases were detected on routine investigations,

Statistical Analysis SPSS software package was used for the analysis.

Statistical significance was defined as a p value <0.05 (two-sided). Mean standard deviation (SD) and confidence interval (CI) was calculated. Student’s

Table 1. Mean and Standard Deviation of the Metabolic Parameters Parameters Age

Diabetics (n = 100)

CAD (n = 25)

CVD (n = 8)

PVD (n = 11)

DR (n = 20)

DN (n = 34)

DNe (n = 16)

54.05 ± 13.24

57

61

55

55

56

59

Weight (kg)

74 ± 13

78

79

84.36

75.8

76.94

77.33

Height (cm)

165 ± 6.3

166

167.25

166

167

166

164

BMI

27.02 ± 12.8

28.04

30.10

30.6

27.28

27.85

28.81

Waist circumference

90.14 ± 9.43

93

96.25

95.54

88.75

90.6

93.73

208 ± 73.7

220

229

277

226

232

246

FBS PPBS

304 ± 95

326

344

426

334

344

338

Blood urea

29.6 ± 15.5

36.5

37.4

34.5

31.4

33.8

31.1

Serum creatinine

1.04 ± 0.39

1.24

1.275

1.9

1.24

1.203

1.129

HbA1C

8.65 ± 1.8

9.016

9.15

10.5

9.24

9.23

9.4

Total cholesterol

156 ± 49.9

170

183

196

168

160

176

BMI = Body mass index; CAD = Coronary artery disease; CVD = Cerebrovascular disease; DN = Diabetic nephropathy; DNe = Diabetic neuropathy; DR = Diabetic retinopathy; FBS = Fasting blood sugar; PPBS = Postprandial blood sugar; PVD = Peripheral vascular disease.

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

DIABETOLOGY 28 were incidentally detected when they attended the hospital for other illnesses and rest of the 44 cases presented with multiple complications due to diabetes.

The metabolic parameters are described in Table 1.

Common complications which they presented were CAD (15%), infection (12%), stroke (6%), ulcers (4%), neuropathy (4%) and diabetic ketoacidosis (1%). The prevalence of macrovascular complications CAD,

Table 3 shows correlation of HbA1C with diabetic complications. In our study, correlation coefficient of fasting blood sugar (FBS) and postprandial blood sugar (PPBS) in relation to HbA1C was 0.56 and 0.57, respectively.

Table 2. Prevalence of Complications at Diagnosis Complications

Percentage (%)

P value

CAD

26

0.011*

CVD

08

0.334

PVD

11

0.477

DR

20

0.018*

DN

34

0.003*

DN

16

0.368

cerebrovascular disease and peripheral arterial disease was 26.0%, 8.0% and 11.0%, respectively and microvascular complications retinopathy, nephropathy and neuropathy was 20.0%, 34.0% and 16.0%, respectively. Table 2 shows p values of the vascular complications. Smoking and hypertension are confounding factors which influence CAD. High incidence of complications especially microvascular and CAD occur with HbA1C of range >6.5.

DISCUSSION This is a study done over a period of 24 months in cases of newly detected T2DM attending the inpatient and outpatient department of VIMS combined

*Significant p <0.05.

Table 3. HbA1C in Correlation with Diabetic Complications HbA1C (%)

N

Mean ± SD

CAD

CVD

PVD

DR

DN

DNe

P value

<6.5

02

5.95 ± 0.77

P-01 A-01

P-01 A-01

P-00 A-02

P-00 A-02

P-01 A-01

P-00 A-02

0.8602*

6.51-7.5

37

7.16 ± 0.22

P-08 A-29

P-02 A-35

P-01 A-36

P-05 A-32

P-06 A-31

P-03 A-34

0.0301**

7.51-8.5

20

7.94 ± 0.31

P-03 A-17

P-01 A-19

P-02 A-18

P-04 A-16

P-07 A-13

P-04 A-16

0.0021**

8.51-9.5

13

9.16 ± 1.9

P-04 A-09

P-00 A-13

P-00 A-13

P-03 A-10

P-08 A-05

P-02 A-11

0.0040**

>9.51

38

11.16 ± 1.23

P-10 A-28

P-04 A-34

P-08 A-30

P-08 A-30

P-12 A-26

P-06 A-32

0.0026**

P-26 A-74

P-08 A-92

P-11 A-89

P-20 A-80

P-34 A-66

P-15 A-85

Pool *Nonsignificant; **Significant p <0.05.

A = Absent; N = Number; P = Present.

Table 4. Comparison of Prevalence of Complications with Other Studies Complications (%)

CAD

Mohan et al13 (n = 4,471)

Hoorn study12 (n = 255)

7.9

CVD PVD

2.3

DR

34.2

Weerasuriya et al9 (n = 597)

Drivsholm et al8 (n = 1,137)

Our study (n = 100)

M

F

26.9

28.4

27.9

26

5.1

3.4

2.4

08

4.6

16.1

17.5

11

1.9

15.2

5.4

4

20

DN

26.7

29

48.1

37.4

34

DN

48.3

25.2

19.1

19.1

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647

DIABETOLOGY hospital. In our study, 28 cases were detected on routine investigations out which 18 had symptoms of polydipsia, polyuria. Twenty-eight were incidentally detected when they attended the hospital for other illnesses and rest of the 44 cases presented with multiple complications due to diabetes.

REFERENCES

Total of about 43 cases had symptoms of polydipsia, polyuria. Present study correlates with findings seen in Drivsholm et al8 study. In T2DM, at diagnosis there is a high prevalence of complications. Our study showed similar results as Weerasuriya et al,9 which is a Sri Lankan study. In Western studies, there is low incidence of retinopathy. Drivsholm study8 showed higher prevalence of nephropathy in males. Table 4 shows prevalence of complications at diagnosis of various studies.

3. Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson JL, Loscalzo J. Harrison’s Principles of Internal Medicine.

18th edition, Vol. 2. McGraw-Hill: USA 2012;344: p. 2968-3002.

In our study, correlation coefficient of FBS and PPBS in relation to HbA1C was 0.56 and 0.57, respectively.

In DCCT10 it was 0.82 and in a study conducted by Nathan et al11 it was 0.89. The relative contribution of postprandial PG decreased progressively from the lowest to the highest quintile of HbA1C. By contrast, the relative contribution of fasting PG showed a gradual increase with increasing levels of HbA1C. CONCLUSION Large proportion of population presented because of complications occurring due to diabetes- a silent killer.

Screening for CAD, retinopathy and nephropathy at diagnosis was statistically significant. There is high prevalence of CAD (26%), retinopathy (20%) and nephropathy (34%) at diagnosis, which is statistically significant. Prevalence of cerebrovascular disease, peripheral vascular disease and neuropathy is 8%, 11% and 16%, which is statistically insignificant.

Nephropathy in our study defined by microalbuminuria has a high prevalence whereas overt kidney disease was negligible. This shows importance of screening at diagnosis and to treat and delay progression. HbA1C levels predict the prevalence of complications and there is moderate correlation between HbA1C and blood glucose levels. Screening with simple tests such as ECG, Echo, fundoscopy and urine microalbuminuria at diagnosis for all cases of diabetes is essential to identify the complications at an early reversible stage.

1. American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care 2006;29 Suppl 1:S43-8.

2. Ahmed AM. History of diabetes mellitus. Saudi Med J 2002;23(4):373-8.

4. American Diabetes Association American Academy of Neurology. Consensus statement: Report and recommendations of the San Antonio conference on diabetic neuropathy. Diabetes Care 1988;11(7):592-7.

5. Wilkinson CP, Ferris FL 3rd, Klein RE, Lee PP, Agardh CD, Davis M, et al; Global Diabetic Retinopathy Project Group.

Proposed international clinical diabetic retinopathy and diabetic macular edema disease severity scales.

Ophthalmology 2003;110(9):1677-82.

6. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care 2005;28 Suppl 1:S4-S36.

7. American Diabetes Association. Peripheral arterial disease in people with diabetes. Diabetes Care 2003;26(12): 3333-41.

8. Drivsholm T, de Fine Olivarius N, Nielsen AB, Siersma V. Symptoms, signs and complications in newly diagnosed type 2 diabetic patients, and their relationship to glycaemia, blood pressure and weight. Diabetologia 2005;48(2):210-4.

9. Weerasuriya N, Siribaddana S, Dissanayake A, Subasinghe Z, Wariyapola D, Fernando DJ. Long-term complications in newly diagnosed Sri Lankan patients with type 2 diabetes mellitus. QJM 1998;91(6):439-43.

10. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA(1c). Diabetes Care 2003;26(3):881-5.

11. Nathan DM, Turgeon H, Regan S. Relationship between glycated haemoglobin levels and mean glucose levels over time. Diabetologia 2007;50(11):2239-44.

12. Spijkerman AM, Dekker JM, Nijpels G, Adriaanse MC, Kostense PJ, Ruwaard D, et al. Microvascular complications at time of diagnosis of type 2 diabetes are similar among diabetic patients detected by targeted screening and patients newly diagnosed in general practice: the Hoorn screening study. Diabetes Care 2003;26(9):2604-8.

13. Premlatha G, Rema M, Mohan V. Complications of diabetes mellitus at diagnosis in South Indian type 2 diabetic patients. Int J Diab Dev Ctries 1998;18:1-4.

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Nocturnal Cough Productive Cough

Dry Cough Nocturnal Cough

Dry Cough

Productive Cough

Nocturnal Cough

Cough

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PHARMACEUTICALS PVT. LID. 20, Dr. E. MoaN IGlll, t.\Jn'Dll - 400 011

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

ENT

Non-Hodgkin’s Lymphoma Masquerading as Submandibular Sialadenitis KAPIL SONI*, VINEET PANCHAL†, BHUSHAN KATHURIA†, SPS YADAV‡, RAJIV SEN#

ABSTRACT Non-Hodgkin’s lymphoma often presents outside the lymphoid system. Among the salivary glands, parotid is exclusively involved and it is extremely rare in submandibular gland. We report a case of non-Hodgkin’s lymphoma in submandibular gland, which was initially managed as a case of chronic submandibular sialadenitis, but later on confirmed as non-Hodgkin’s lymphoma after surgical excision and histopathological examination.

Keywords: Non-Hodgkin’s lymphoma, parotid, submandibular, sialadenitis, histopathological examination

A

pproximately 25% of head and neck lymphomas are present in extranodal sites of pharynx, paranasal sinuses, nasal cavity, salivary glands, oral cavity, thyroid gland, central nervous system and larynx.1 Primary lymphomas arising in salivary glands are very uncommon. These lymphomas represent 1.7% of all reported salivary neoplasms.2 Majority of these lymphomas develop in the parotid glands (76%), but may also develop in submandibular gland (20%), sublingual glands (3%) and palatal glands (1%).1-3

Involvement of the salivary glands by Hodgkin’s lymphoma is very rare. Combining data from four large series on primary lymphomas of the salivary glands, Hodgkin’s lymphoma only accounted for 4% of all cases.4 Non-Hodgkin’s lymphoma is more common than Hodgkin’s lymphoma. Most cases of non-Hodgkin’s lymphoma arising in salivary glands are of B-cell lineage.

We report a similar case of non-Hodgkin’s lymphoma in submandibular gland in a 35-year-old female.

*Senior Resident †Resident ‡Senior Professor Dept. of Otolaryngology #Senior Professor and Head Dept. of Pathology Pt. BD Sharma University of Health Sciences, Rohtak, Haryana Address for correspondence Dr Kapil Soni Dept. of Otolaryngology Pt. BD Sharma University of Health Sciences, Rohtak - 124 001, Haryana E-mail: ksoni805@gmail.com

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

CASE REPORT A 35-year-old female presented with a 3 months history of swelling in left submandibular region, which was associated with mild intermittent pain especially, while chewing. Similar episodes of pain also occurred in the past, which settled spontaneously. No other complaint of dry mouth, variable tear production or joint symptoms were present. Patient was nonalcoholic and nonsmoker and was not a known case of any other chronic illness such as diabetes mellitus or hypertension.

Examination revealed patient to be in good general health with an obvious, isolated left submandibular gland enlargement of size around 3 × 3 cm, which was having smooth surface with welldefined margins, nontender to touch and bimanually palpable. Lacrimal glands, both parotid and sublingual glands and right-sided submandibular gland were normal. There was no significant lymphadenopathy or hepatosplenomegaly. Per oral examination was normal.

Systemic examination did not reveal any abnormal finding.

Investigations were as follows: Hemoglobin (Hb) 12 g/dL, white cell count - 5.2 × 109/L with a normal differential count and erythrocyte sedimentation rate (ESR) of 20 mm/hr. Electrolytes, liver function tests and chest X-ray were normal. Fine-needle aspiration cytology report came out to be of chronic sialadenitis. Patient was given a course of antibiotics without any perceptible relief. Hence, submandibular gland was excised. At the operation, the gland was found to be enlarged but not locally adherent and

ENT presence of lymphoma markers5 as was also observed in our case.

Figure 1. Photomicrograph showing diffuse infiltration of salivary gland by malignant lymphoid cells having large size, vesicular chromatin, prominent nucleoli with mitotic figures, which are destroying ductal epithelium (H&E 40x).

Figure 2. Photomicrograph showing CD-20 positivity in lymphoid cells (IHC CD-20, 400x).

was sent for histopathological examination, which revealed non-Hodgkin’s lymphoma of B-cell type (CD-20 positive) in the background of chronic lymphoepithelial sialadenitis (Figs. 1 and 2).

The sutures were removed after a week; however, patient had pain and discomfort at the local site, which was unusual and is generally not associated with submandibular gland excision.

DISCUSSION Batsakis and Regezi suggest three criteria for the diagnosis of salivary gland lymphomas: Extraglandular lymphoma must not be present; there is histological proof that the lymphoma involves the gland parenchyma and not the intraglandular lymph node; immunohistochemical screening must confirm the

Non-Hodgkin’s lymphoma of the salivary glands usually presents as a painless, progressive enlarging mass. Almost all primary lymphomas of the salivary glands affect the parotid and these form almost 5% of all extranodal lymphomas.5 In 10% of patients more than one gland is involved. This predilection for parotid gland may be due to presence of intraparotid lymph nodes and lymphoid follicles and their absence in submandibular and sublingual glands.2 Almost 40% of lymphomas of the head and neck are of the salivary glands and nearly all of these are nonHodgkin’s lymphomas and well-differentiated.6,7 These extranodal manifestations confuse the clinical diagnosis of masses presenting in the head and neck region. These tumors are initially seen by head and neck surgeons, who play an important role in initial diagnosis. B-cell immunophenotype can be confirmed by immunopositivity for CD-20.4 This disease can remain localized to the salivary glands or be a part of Sjogren’s syndrome. The association between Sjogren’s syndrome and lymphoma have been recognized since 1964,8 which was also present in our case. The risk of developing lymphoma in this syndrome is said to be 40 times that of normal population.9 The prognosis of salivary gland lymphoma is usually favorable; however, it depends upon the histological subtype and clinical stage. Tumors that are localized (stage IE) at the time of presentation and demonstrate low-grade histology have an excellent prognosis as was also observed in present case. With lymph node involvement (stage IIE), prognosis is usually similar to primary nodal low-grade b-cell lymphoma. Most salivary gland non-Hodgkin’s lymphomas tend to remain localized and relapse locally. Therapeutically complete tumor resection and irradiation constitutes a suitable treatment modality for early stage tumors, with the addition of chemotherapy in advanced disease. This may be supported by findings that highgrade transformed mucosa-associated with lymphoid tissue (MALT) lymphomas recurred only after local therapy (surgery and irradiation), thus affecting patient survival. Salivary gland non-Hodgkin’s lymphomas of other histological types are generally considered a systemic disease, suggesting that chemotherapy should be administered.10 Recently, the use of rituximab, an anti-CD20 antibody has emerged as treatment option in patients with B-cell lymphomas.11-13 Dunn et al described that the overall survival and relapse-free survival rates at 5 years were 95% and 51%, respectively;

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ENT thus salivary gland lymphoma is an indolent disease.14 We would like to conclude that though submandibular gland lymphoma is very rare; however, it’s possibility should be kept in mind whenever dealing with the swellings of submandibular glands.

Unusual postoperative pain and discomfort at the surgical site should alert the surgeon towards unusual pathology and surgical excision should always be followed by histopathological examination in every case.

REFERENCES 1. Shidnia H, Hornback NB, Lingeman R, Barlow P. Extranodal lymphoma of the head and neck area. Am J Clin Oncol 1985;8(3):235-43.

2. Gleeson MJ, Bennett MH, Cawson RA. Lymphomas of salivary glands. Cancer 1986;58(3):699-704.

3. Schusterman MA, Granick MS, Erickson ER, Newton ED, Hanna DC, Bragdon RW. Lymphoma presenting as a salivary gland mass. Head Neck Surg 198810(6):411-5.

4. Batsakis JG. Primary lymphomas of the major salivary glands. Ann Otol Rhinol Laryngol 1986;95(1 Pt 1):107-8.

5. Batsakis JG, Regezi JA. Selected controversial lesions of salivary tissues. Otolaryngol Clin North Am 1977;10(2):309-28.

6. Rowley H, McRae RD, Cook JA, Helliwell TR, Husband D, Jones AS. Lymphoma presenting to a head and neck clinic.

Clin Otolaryngol Allied Sci 1995;20(2):139-44.

7. Freeman C, Berg JW, Cutler SJ. Occurrence and prognosis of extranodal lymphomas. Cancer 1972;29(1):252-60.

8. Talal N, Bunim JJ. The development of malignant lymphoma in the course of Sjoegren’s syndrome. Am J Med 1964;36:529-40.

9. Batsakis JG, Pinkston GR, Luna MA, Byers RM, Sciubba JJ, Tillery GW. Adenocarcinomas of the oral cavity: a clinicopathologic study of terminal duct carcinomas.

J Laryngol Otol 1983;97(9):825-35.

10. Roh JL, Huh J, Suh C. Primary non-Hodgkin’s lymphomas of the major salivary glands. J Surg Oncol 2008;97(1): 35-9.

11. Ross JS, Gray K, Gray GS, Worland PJ, Rolfe M. Anticancer antibodies. Am J Clin Pathol 2003;119(4):472-85.

12. Fanale MA, Younes A. Monoclonal antibodies in the treatment of non-Hodgkin’s lymphoma. Drugs 2007;67(3):333-50.

13. Marcus R, Hagenbeek A. The therapeutic use of rituximab in non-Hodgkin’s lymphoma. Eur J Haematol Suppl 2007;(67):5-14.

14. Dunn P, Kuo TT, Shih LY, Lin TL, Wang PN, Kuo MC, et al.

Primary salivary gland lymphoma: a clinicopathologic study of 23 cases in Taiwan. Acta Haematol 2004;112(4): 203-8.

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Tinnitus: Turning Down the Volume The drug D-cycloserine was no more effective than placebo when used with a computer-based cognitive training program for relieving persistent ear ringing in patients with tinnitus in a small clinical study, but patients did report fewer cognitive difficulties.

Sixteen study participants with tinnitus were treated with D-cycloserine - the dextrorotatory form of the antibiotic cycloserine, which has been widely studied in conjunction with cognitive behavioral therapy for the treatment of anxiety and stress-related psychiatric disorders. Another 14 patients were treated with placebo and all 30 study participants took part in cognitive training sessions, conducted twice weekly for 5 weeks.

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

GASTROENTEROLOGY

An Unusual Case of Massive Splenomegaly in Cirrhotic Portal Hypertension MONIKA MAHESHWARI*, RAJENDRA KUMAR VERMA†, RAVI‡

ABSTRACT Splenomegaly is a common finding in a wide-spectrum of diseases. It is usually reported in myeloproliferative disorders, lymphoma, leukemia, visceral leishmaniasis, tropical malaria and extrahepatic (noncirrhotic) portal hypertension. We describe herein recently encountered one unusual case of massive splenomegaly in a patient of hepatic cirrhosis with portal hypertension.

This case report highlights that cirrhotic portal hypertension may be added in the differential diagnosis of massive splenomegaly to facilitate timely diagnosis and treatment.

Keywords: Massive splenomegaly, portal hypertension, hepatic cirrhosis

M

assive splenomegaly is defined as weight of spleen >1,000 g or largest dimension >20 cm.

It is usually reported in myeloproliferative disorders, lymphoma, leukemia, visceral leishmaniasis, tropical malaria and extrahepatic (noncirrhotic) portal hypertension. We describe herein one unusual case of massive splenomegaly in a patient of hepatic cirrhosis with portal hypertension.

CASE REPORT A 45-year-old female, diagnosed to have chronic liver disease 3 years back, presented with fever and dragging sensation in the abdomen along with abdominal distension and difficulty in breathing since 15 days. On physical examination, she looked pale, mild icteric and toxic. Abdomen was nontender with massive splenomegaly and moderate ascites. There was reduced air entry in left hemithorax. Laboratory investigation revealed hemoglobin (Hb) - 8 g/dL, total leukocyte count (TLC) - 2,100/mm3, neutrophils - 59%; lymphocytes - 28% and platelets at 38,000/mm3. Stool was positive for occult blood. Bilirubin was 2.5 mg/dL,

*Associate Professor †Senior Resident ‡1st Year Resident JLN Medical College, Ajmer, Rajasthan Address for correspondence Dr Monika Maheshwari Naveen Niwas, 434/10, Bapu Nagar, Ajmer, Rajasthan E-mail: opm11@rediffmail.com

with direct bilirubin at 0.46 mg/dL, alanine aminotransferase (ALT) at 94 U/L, alkaline phosphatase (ALP) at 112 U/L and albumin at 2.5 g/dL. This case was investigated for other causes of massive splenomegaly including tropical splenomegaly, malaria, noncirrhotic portal hypertension and leishmaniasis.

Her anti-HCV (hepatitis C virus), anti-HDV (hepatitis D virus), antinuclear antibodies, malarial parasite and Coomb’s test was negative. Bone marrow aspirate and trephine revealed hypercellular marrow with all cell lines normal. Serum ceruloplasmin and iron

Liver

Spleen

Figure 1. CT scan abdomen (longitudinal view) showing massive splenomegaly and shrunken liver.

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GASTROENTEROLOGY

Spleen

Figure 2. CT scan abdomen (cross-sectional view) showing massive splenomegaly.

studies were normal. Ultrasound of the abdomen demonstrated massive splenomegaly of size 24 cm, increased portal vein diameter (>20 mm), contracted gallbladder and liver and left pleural effusion with gross ascites. Computed tomography (CT) scan of abdomen also confirmed massive splenomegaly with dilated splenic and superior mesenteric vein shrunken liver with irregular borders and porcelain gallbladder with cholelithiasis (Figs. 1 and 2). Patient was referred to higher center for hybrid management of massive splenomegaly and pancytopenia.

DISCUSSION

problem of heaviness/distension on the left side of the abdomen along with pancytopenia. The exact relationship between the enlarged spleen and the decrease in cellular elements of the blood is unknown but two interesting theories have been proposed.

Doan3 suggests that with stagnation of the blood in the spleen, there is a change in the cells which makes them more susceptible to hemolysis. Dameshek4 on the other hand, believes that the spleen elaborates a hormone, which acts on the marrow to suppress it so that the cells do not mature and hence do not reach the general circulation. Although systemic therapies are usually the primary modality of treatment for most disorders causing massive splenomegaly, splenectomy may be helpful. Studies have shown that laparoscopic splenectomy can sometimes be performed even for massive spleens, with a resultant decrease in blood loss, a shorter postoperative hospital stay and a decrease in postoperative morbidity and mortality.5 However, overwhelming postsplenectomy septicemia risk should be reduced with the administration of preoperative polysaccharide vaccines against Streptococcus pneumoniae, Haemophilus influenzae and Neisseria meningitides.

CONCLUSION This case report highlights that cirrhotic portal hypertension may be added in the differential diagnosis of massive splenomegaly to facilitate timely diagnosis and treatment as we did in our patient.

REFERENCES

Splenomegaly is a common finding in a wide-spectrum of diseases. In a retrospective study, evaluating massive splenomegaly in 2,056 patients who presented to a large university medical center from 1913 to 1995, 31% had a hematologic disorder (lymphoma, leukemia), 17% had hepatic disease (noncirrhotic portal hypertension) and 8% had infectious disease (visceral leishmaniasis, tropical malaria).1 Massive splenomegaly is a rarely described feature of hepatic cirrhosis.2 In this case report, we shared our experience with recently encountered one case of hepatic cirrhosis who presented with massive splenomegaly crossing the midline. Massive splenomegaly caused mechanical

1. O’Reilly RA. Splenomegaly in 2,505 patients at a large university medical center from 1913 to 1995. 1963 to 1995: 449 patients. West J Med 1998;169(2):88-97.

2. Mirza R, Z A, Z A, Nh L. Massive splenomegaly with pancytopenia in children and adolescents with hepatitis B cirrhosis. J Coll Physicians Surg Pak 2006;16(9):629-30.

3. Doan CA. Ibid 1949;25:625-7 4. Dameshek W. Hypersplenism. Bull N Y Acad Med 1955;31(2):113-36.

5. Owera A, Hamade AM, Bani Hani OI, Ammori BJ. Laparoscopic versus open splenectomy for massive splenomegaly: a comparative study. J Laparoendosc Adv Surg Tech A 2006;16(3):241-6.

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INTERNAL MEDICINE

An Incidental Finding of Polysplenia Syndrome in a Geriatric Patient: A Case Report PRAVEEN KUMAR*, KALPANA CHANDRA†, NEERAJ PRAJAPATI‡

ABSTRACT Polysplenia syndrome is a rare congenital disease characterized by presence of two or more spleens and affection of other asymmetric organs. It is often recognized in childhood and rarely in adulthood. Here we report a case of polysplenia syndrome in an elderly female having multiple accessory spleens, stomach and aorta on right side of abdomen and liver, gallbladder, inferior vena cava and common bile duct on left side of abdomen. She was also having congestive cardiac failure with atrial fibrillation and lumbar vertebra collapse.

Keywords: Polysplenia, polysplenia syndrome

P

olysplenia syndrome is a heterogeneous disease characterized by presence of two or more spleens and affection of other asymmetric organs including heart, lungs, liver and intestines.1 It is a rare congenital disease often recognized in childhood and rarely in adulthood. Here we report a case of polysplenia syndrome in a geriatric patient, as an incidental finding.

A 75-year-old female patient was admitted in our hospital with a history of lower backache of 1 month duration. On enquiry, patient gave history of nonproductive cough, dyspnea, swelling of lower limbs and intermittent, colicky and vaguely located abdominal pain. On examination, she was having pulse rate of 80/min with irregularly irregular rhythm. Her blood pressure (BP) was 140/90 mmHg. Edema was present in lower limbs and neck veins were engorged

with raised jugular venous pressure. Cardiovascular system showed systolic murmur in mitral and tricuspid area. Respiratory system showed scattered bilateral crepitations. On palpation, there was tenderness over lumbar vertebra. Per abdomen and central nervous system were within normal limit. Investigations revealed hemoglobin - 11.9 g/dL, total leukocyte count (TLC) - 5,200/mm3, differential leukocyte count (DLC) N65L30E5, erythrocyte sedimentation rate (ESR) - 36 mm 1st/hour, platelet count - 1.96 lacs/mm3, blood sugar random (BS[R]) - 80 mg/dL, urea - 25 mg/dL, creatinine 0.6 mg/dL, Na - 140 mmol/L, K - 3.5 mmol/L liver function tests (LFTs) - normal and renal function tests (RFTs) - normal. Electrocardiography (ECG) showed atrial fibrillation with left ventricular hypertrophy (LVH). Ultrasonography (USG) showed liver in midline and more towards left side, hilum leftward, but inferior vena cava (IVC) and hepatic veins on right side and were normal.

*Associate Professor Dept. of Medicine †Associate Professor Dept. of Pathology ‡Assistant Professor Dept. of Radiodiagnosis Shri Ram Murti Smarak Institute of Medical Sciences Bhojipura, Bareilly, Uttar Pradesh Address for correspondence Dr Praveen Kumar A-1, Doctor’s Residence Shri Ram Murti Smark Institute of Medical Sciences Bhojipura, Bareilly - 243 202, Uttar Pradesh E-mail: praveen_kmr_23@yahoo.co.in

No spleen on left side was identified with an impression of situs ambiguous abdominis. Echo showed dilated right (R) atrium and R ventricle, LVH, mild mitral regurgitation, mild aortic regurgitation, mild tricuspid regurgitation with mild pulmonary arterial hypertension and normal left ventricular ejection fraction. High-resolution computed tomography (HRCT) thorax showed evidence of focal fibrosis in left lung, predominantly in peripheral aspect with suggestion of volume loss. Mild honeycombing with septal thickening in anterior segment of right lobe medially and a small emphysematous bulla in apical segment of left (L) upper lobe medially was seen.

CASE REPORT

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INTERNAL MEDICINE Contrast-enhanced computed tomography (CECT) abdomen was performed on a 128 slice dual source dual energy scanner and it showed evidence of liver, gallbladder, IVC and common bile duct on left side of abdomen. Stomach, aorta and spleen with evidence of multiple accessory spleens (at least 3) were on right

side of abdomen (Figs. 1-3). A final impression of situs inversus with polysplenia syndrome was made on CECT abdomen.

DISCUSSION Polysplenia is a presence of two or more spleens in a patient and polysplenia syndrome refers to its association with multiple congenital abnormalities in abdomen and chest. It is a rare congenital disease with incidence of 1/2,50,000 live births and was initially described by Helwig in 1929.2,3 The exact cause of polysplenia has not been defined.

The probable hypotheses are embryonic such as accelerated curvature of the embryonic body, genetic causes and teratogenic factors.2 There is slight female preponderance and rare familial association has also been found.2

Figure 1. Axial CECT image demonstrating liver and IVC on left side, stomach and spleen on right side.

Figure 2. Axial CECT-gallbladder in midline, portal vein on left side.

The splenic mass is usually divided into fairly equalsized masses, varying in number from 2 to 6 and ranging from 1 to 6 cm in diameter, which together equal the mass of a normal spleen. The location of the spleens is in either the left or right upper quadrant, along the greater curvature of the stomach.4 More than 40% cases of polysplenia syndrome have cardiac anomalies and majority of such children do not survive beyond 5th year of life.5 The various cardiovascular anomalies that may be encountered are atrial septal defect (ASD) (78%), azygous continuation of the IVC (65%), ventricular septal defect (VSD) (63%), bilateral superior vena cava (SVC) (47%), right-sided aortic arch (44%), partial anomalous pulmonary venous return (39%), transposition of the great arteries (31%), pulmonary valvular stenosis (23%) and subaortic stenosis (8%). The abdominal findings include midline liver (57%), situs inversus (21%), short pancreas, semiannular pancreas, preduodenal portal vein and malrotation. Renal agenesis or hypoplasia may also be seen. The pulmonary manifestations include bilateral bilobed lungs and hyparterial bronchi (58%).2,6,7 The presentation of polysplenia syndrome depends upon the presence and severity of the associated anomalies. About 10% of polysplenia cases reach adulthood and are commonly detected on diagnostic work-up of other associated disease.5

Figure 3. Coronal reformatted image-PV confluence on left side of abdomen with reverse relation of aorta and IVC and stomach on right side of abdomen.

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Plain chest X-ray and abdomen can give clue about abnormality in chest and abdomen. CT scan, magnetic resonance imaging (MRI), angiography and echocardiography are important tools for ascertaining the location and number of spleens, location of other

INTERNAL MEDICINE organs in the chest and abdomen, and identification of other associated anomalies.

We report a case of elderly female of polysplenia syndrome with lumbar vertebra collapse, congestive cardiac failure and atrial fibrillation. On evaluation, she was found to have liver, gallbladder, IVC and common bile duct on left side of abdomen and stomach, aorta and spleen with evidence of multiple accessory spleen on right side of abdomen, as evidenced on CECT abdomen.

Peoples et al conducted a study on 146 cases of polysplenia, which showed both lungs with two lobes in 55% of patients, abdominal heterotaxy in 56% cases and cardiac anomalies occurring in at least half of the patients, which included bilateral SVC, interruption of the IVC with azygous continuation, VSD, ostium primum defect and morphologic left ventricular outflow tract obstruction. Fifty percent patient died by 4-month of the age and 75% before 5 years of age.7 Choh et al reported a case of polysplenia syndrome in a 40-year-old male patient. He was having multiple splenic masses, midline liver and stomach on right upper quadrant and also VSD with congenital lobar emphysema.6 Rasool and Mirza reported a case of polysplenia syndrome associated with situs inversus abdominis and jejunal atresia in a 2-day-old female baby.5

spleens with affection of other asymmetric organs and usually diagnosed incidentally in adult.

Acknowledgment 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 Medicine, Pathology, Biochemistry and Radiodiagnosis for providing me adequate facility, which helped me to carry out this study. I owe great sense of indebtedness to Dean SRMS-IMS, Bhojipura, Bareilly, Uttar Pradesh for permitting me to carry out this study.

REFERENCES 1. Abell I. Wandering spleen with torsion of pedicle. Ann Surg 1938;98(4):722-35.

2. Applegate KE, Goske MJ, Pierce G, Murphy D. Situs revisited: imaging of the heterotaxy syndrome.

Radiographics 1999;19(4):837-52; discussion 853-4.

3. Chen SJ, Li YW, Wang JK, Wu MH, Chiu IS, Chang CI, et al. Usefulness of electron beam computed tomography in children with heterotaxy syndrome. Am J Cardiol 1998;81(2):188-94.

4. Gayer G, Zissin R, Apter S, Atar E, Portnoy O, Itzchak Y. CT findings in congenital anomalies of the spleen. Br J Radiol 2001;74(884):767-72.

5. Rasool F, Mirza B. Polysplenia syndrome associated with situs inversus abdominus and type 1 jejunal atresia. APSP J Case Rep 2011;2(2):18.

CONCLUSIONS

6. Choh NA, Choh SA, Jehangir M, Naikoo BA. Congenital lobar emphysema associated with polysplenia syndrome.

Ann Saudi Med 2010;30(6):482-4.

Polysplenia syndrome is a rare congenital disorder of childhood characterized by presence of two or more

7. Peoples WM, Moller JH, Edwards JE. Polysplenia: a review of 146 cases. Pediatr Cardiol 1983;4(2):129-37.

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Basic vs Advanced Life Support Outcomes after Out-of-Hospital Cardiac Arrest Patients who had cardiac arrest at home or elsewhere outside of a hospital had greater survival to hospital discharge and to 90 days beyond if they received basic life support (BLS) vs. advanced life support (ALS) from ambulance personnel, according to a report published online by JAMA Internal Medicine.

Emergency medical services (EMS) respond to an estimated 3,80,000 cardiac arrests that happen annually out of the hospital. ALS providers, or paramedics, are trained to use sophisticated, invasive interventions (such as intubation - the placement of a breathing tube) to treat cardiac arrest before the patient arrives at the hospital. BLS providers, or emergency medical technicians, use simpler devices such as bag valve masks (hand-operated mask that helps breathe for the patient) and automated external defibrillators. Consequently, ALS paramedics tend to spend more time at the location of a cardiac arrest than BLS personnel.

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INTERNAL MEDICINE

Super Vasmol Hair Dye: An Emerging Fatal Poison RAMMURTHY P*, NETTO GEORGE MUNDADAN†, SUNILKUMAR N†, SURESH C†

ABSTRACT Hair dye poisoning is not rare, but is an emerging poisoning in India. The main component of super vasmol hair dye causing toxicity is paraphenylenediamine (PPD) and can cause rhabdomyolysis, laryngeal edema, severe metabolic acidosis, acute renal failure (ARF) and myocarditis. There is no specific antidote for hair dye poisoning and treatment is mainly supportive.

We report a case of suicidal ingestion of hair dye that presented with angioneurotic edema, rhabdomyolysis and ARF. Our patient improved completely with dialysis and symptomatic management. Various pathogenesis of its complications are also explained in this case report.

Keywords: Super vasmol, paraphenylenediamine, acute renal failure, rhabdomyolysis

A

cute, deliberate self-poisoning with agricultural pesticides is a global public health problem and accounts for as many as 3,00,000 deaths worldwide every year. Super vasmol, a cheap, freelyavailable, hair dye in rural areas is emerging as a major cause of suicidal poisoning in India.1 The active ingredients include paraphenylenediamine (PPD), propylene glycol, liquid paraffin, cetostearyl alcohol, sodium lauryl sulfate and resorcinol.1 PPD is the major toxin amongst these and produces both local as well as systemic toxic effects. Systemic features of PPD poisoning occur in three phases. Phase 1 is an acute presentation with edema of neck, airway obstruction, gastritis and severe vomiting. Phase 2 is a subacute presentation with acute renal failure (ARF), rhabdomyolysis and hemolysis.

Phase 3 progresses to multiorgan failure. Mainstay of management is early recognition and supportive measures as there is no specific antidote. We hereby report a young male who presented to us with features of angioedema and renal dysfunction after ingesting super vasmol, which was treated successfully.

*Associate Professor †Postgraduate Student Dept. of General Medicine Vijayanagara Institute of Medical Sciences (VIMS), Bellary, Karnataka Address for correspondence Dr Netto George Mundadan Postgraduate Student Dept. of General Medicine VIMS, Cantonment, Bellary - 583 104, Karnataka E-mail: nettomundadan@gmail.com

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CASE REPORT A 21-year-old male presented with history of suicidal consumption of super vasmol hair dye to our casualty in the evening. He had mild puffiness of face, edema of lips, stridor and difficulty in speaking. There was no history of dark colored urine, decreased urine output, breathlessness or seizures at presentation.

On examination, pulse rate was 90/min, blood pressure was 120/80 mmHg and SpO2 was 96% at room air. His systemic examination was normal. Gastric lavage was given to the patient and in view of stridor and facial puffiness he was treated with injection hydrocortisone 100 mg t.i.d. and antihistamines for angioneurotic edema, which resolved completely within next 4 hours.

On next day morning, he complained of passing dark-colored urine with a decreased urine output.

His complete hemogram with peripheral smear, liver and renal function tests, ECG and chest X-ray were within normal range. However, blood urea and serum creatinine raised to 79 mg/dL and 2.8 mg/dL, respectively on Day 2 of admission. His serum electrolytes were normal and urine myoglobin came to be positive.

Nephrology opinion was taken immediately and he was treated with forced alkaline diuresis. His ultrasonography (USG) abdomen was normal in size and echotexture. By next day, his urine output came down to 300 mL over 24 hours and serum creatinine raised to 5.3 mg/dL. He was then hemodialyzed for three sittings on Days 3, 4 and 6 till urine output improved. His renal parameters and urine output are shown in Table 1.

INTERNAL MEDICINE Table 1. Renal Parameters and Urine Output of our Patient During Hospital Stay Day of admission

2

3*

4*

5

6*

7

8

Blood urea (mg/dL)

79

148

161

160

144

112

66

Serum creatinine (mg/dL)

2.8

5.3

7.1

6.2

6.0

4.5

2.6

Urine output

800

300

250

300

750

1100

1700

*Days on which he was dialyzed.

His ARF slowly resolved over 7 days and he was discharged on Day 10 of hospital admission.

DISCUSSION Hair dye ingestion leading to a wide variety of complications has been described in literature. Super vasmol 33 is one of the widely used hair dyes in India.

It has a potent nephrotoxic cocktail-containing PPD, propylene glycol and resorcinol. The extent of renal involvement in poisoning varies between transient proteinuria and oliguric ARF. PPD is a coal-tar derivative, which on oxidation produces Bondrowskiâ&#x20AC;&#x2122;s base, which is allergenic, mutagenic and highly toxic. Poisoning with PPD presents with the characteristic features of severe angioneurotic edema, rhabdomyolysis and intravascular hemolysis with hemoglobinuria culminating in ARF.2 The mechanism of rhabdomyolysis is due to leakage of calcium ions from the smooth endoplasmic reticulum, followed by continuous contraction and irreversible change in the muscleâ&#x20AC;&#x2122;s structure. Rhabdomyolysis is the main cause of ARF and the morbidity and mortality are high once renal failure develops.

Hypovolemia and the direct toxic effects of PPD or its metabolites on the kidneys also contribute.

The respiratory syndrome following the ingestion of PPD is represented by asphyxia and respiratory failure secondary to inflammatory edema involving cricopharynx and larynx.3 Myoglobinuric ARF is observed in the tropics after a variety of conditions, such as crush syndrome, burns, heat stroke, electrical injury, eclampsia, prolonged labor, poisoning with mercuric chloride, zinc or aluminium phosphide, status epilepticus, viral myositis and status asthmaticus.4 The diagnosis is established by the demonstration of myoglobin in urine and elevated levels of creatine phosphokinase and aldolase in the serum. Since, myoglobin is a small molecule with a molecular weight of 17 kDa and binds only lightly to the plasma proteins, it escapes easily in the urine. Therefore, the

urine may not contain myoglobin if the patient presents late in the course of the disease and the true incidence of myoglobinuric ARF will be underestimated.

Early recognition of rhabdomyolysis is crucial, since intravenous bicarbonate and saline have been shown to ameliorate the development of ARF and prevent requirement of dialysis.

Propylene glycol is associated with hyperosmolality, raised anion gap metabolic acidosis, central nervous system depression, arrhythmias and renal dysfunction.

Resorcinol found in hair dyes is a phenol derivative, which may also contribute to renal toxicity. In addition, a few hair dyes also contain lead acetate and Bismuth sulfate, which can cause chronic kidney disease or acute interstitial nephritis, respectively.5 Our patient presented with angioedema of upper airway and on Day 2 of poisoning developed rhabdomyolysis and ARF. Antihistamines and steroids are commonly used in the management of airway edema because of the possibility of a hypersensitivity reaction to PPD. ARF in our patient was managed with forced alkaline diuresis and hemodialysis. The toxin is not dialyzable and there is no specific antidote for PPD.6 The patient responded well to treatment and was discharged on Day 10 of hospital admission.

In conclusion, hair dye poisoning is a life-threatening emergency which requires emergency resuscitation and aggressive management of anaphylaxis. Early forced alkaline diuresis prevents ARF minimizing the need for dialysis. And also the time of development of renal failure following PPD intoxication is uncertain and hence all patients should be monitored in hospital for development of renal complications.

Acknowledgment We thank Dr Gadwalkar Srikant R, Professor and Head, Dept. of Medicine and Dr Anwar MI, Nephrologist, VIMS, Bellary for supporting in treating and preparing this manuscript.

REFERENCES 1. Chrispal A, Begum A, Ramya I, Zachariah A. Hair dye poisoning - an emerging problem in the tropics: an

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INTERNAL MEDICINE experience from a tertiary care hospital in South India.

Trop Doct 2010;40(2):100-3.

2. Anuradha S, Arora S, Mehrotra S, Arora A, Kar P. Acute renal failure following para-phenylenediamine (PPD) poisoning: a case report and review. Ren Fail 2004;26(3):329-32.

3. Yabe K. The effect of a p-phenylenediamine containing hair dye on the Ca2+ mobilization in the chemically skinned skeletal muscle of the rat. Nihon Hoigaku Zasshi 1992;46(2):132-40.

4. Chugh KS, Malik GH, Singhal PC. Acute renal failure following paraphenylene diamine [hair dye] poisoning: report of two cases. J Med 1982;13(1-2):131-7.

5. Hayman M, Seidl EC, Ali M, Malik K. Acute tubular necrosis associated with propylene glycol from concomitant administration of intravenous lorazepam and trimethoprim-sulfamethoxazole. Pharmacotherapy 2003;23(9):1190-4.

6. Singla S, Miglani S, Lal AK, Gupta P, Agarwal AK. Paraphenylenediamine (PPD) poisoning. JIACM 2005;6(3):236-8.

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Constipation may be Improved by Self-applied Acupressure Applying external pressure to the perineum in conjunction with standard constipation treatment can improve bowel function and quality of life for people suffering from the common digestive condition, a study has shown.

In a randomized trial of 91 patients, the self-acupressure technique improved constipation symptoms at 4 weeks in 72% of the patients randomly assigned to the treatment, Ryan Abbott, MD, MTOM, from the Division of General Internal Medicine and Health Services Research at the David Geffen School of Medicine at the University of California, Los Angeles, and colleagues report in an article published online November 18 in the Journal of General Internal Medicine.

USPSTF: No Evidence for Routine Vitamin D Screening The US Preventive Services Task Force (USPSTF) has issued its first-ever guidance on the routine screening of asymptomatic patients for vitamin D deficiency. The recommendation is now final following the issue of draft guidance in June. There simply is no evidence on the specific pros and cons of screening for vitamin D deficiency, so routine screening cannot be advised at the current time, say the authors of the recommendation statement, led by Dr Michael L LeFevre (University of Missouri, Columbia) and colleagues. The statement and a review of the data on screening and treatment with vitamin D in asymptomatic individuals, by Dr Erin S LeBlanc (Kaiser Permanente Center for Health Research, Portland, Oregon) and colleagues, are published today in the Annals of Internal Medicine.

CABG may be Preferred for Revascularization in Diabetics Bypass surgery may be the preferred option for coronary revascularization in patients with diabetes, especially when long-term survival is anticipated, according to results of a systematic review and meta-analysis.“There is good external evidence favoring coronary artery bypass grafting (CABG) overall that we have accurately summarized in the article, but the best decision making involves clinicians tailoring this information to their specific patients and healthcare environments,” Dr. James M. Brophy from McGill University Medical Center and the Royal Victoria Hospital in Montreal, Quebec, Canada told Reuters Health by email. Several studies have suggested the superiority of CABG over percutaneous coronary intervention (PCI) with stenting for diabetics with multivessel disease or left main coronary artery disease, but the optimal revascularization technique in diabetic patients remains uncertain. Dr. Brophy’s team used a systematic review and network meta-analysis of 40 published trials to compare CABG with PCI using bare-metal stents (BMS) or drug-eluting stents (DES). The analysis included seven trials of PCI-DES vs CABG, six trials of PCI-BMS vs CABG, and 27 trials of PCI-BMS vs PCI-DES. (Reuters Health)

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

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8

OBSTETRICS AND GYNECOLOGY

A Rare Case of Cor Triloculare Biventriculare Detected in a Postpartum Female PARNEET KAUR*, KHUSHPREET KAUR†, RAMA GARG‡, ISHA GUPTA#

ABSTRACT Maternal heart disease complicates at least 1% of pregnancies and is one of the most important cause of maternal death. This is a case report of postpartum female incidentally diagnosed with cor triloculare biventriculare. Recognizing heart disease during pregnancy is challenging as physiological changes during pregnancy can cause signs and symptoms mimicking cardiac disease, e.g., fatigue, shortness of breath, edema and systolic ejection murmur. Early diagnosis, prompt and effective management is important in decreasing maternal and fetal mortality and morbidity.

Keywords: Cor triloculare biventriculare, pregnancy, congenital heart disease

M

aternal heart disease complicates at least 1% of pregnancies and is one of the most important cause of maternal death.1 In developing countries, rheumatic heart disease remain the major cause, while in developed countries congenital heart diseases (CHD) are more prevalent due to improved survival of children with CHDs. Hemodynamic burden of pregnancy can unmask previously asymptomatic heart disease. Women with pre-existing but yet undiagnosed heart diseases are likely to present primarily to obstetrician and not to cardiologist. The prevalence of heart disease in pregnant women and its potentially life-threatening consequences justify a careful cardiac history, family history and physical examination in all pregnant women. Recognizing heart disease during pregnancy is challenging as physiological changes during pregnancy can cause signs and symptoms mimicking cardiac disease, e.g., fatigue, shortness of breath, edema and systolic ejection murmur.

*Associate Professor †Professor ‡Assistant Professor #Junior Resident Dept. of Obstetrics and Gynecology Government Medical College and Rajindra Hospital, Patiala, Punjab Address for correspondence Dr Parneet Kaur House No.: 151, Punjabi Bagh Near Klair Orthopedic Centre, Patiala - 147 001, Punjab E-mail: parneetkd@yahoo.co.in

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

CASE REPORT A 19-year-old G2P1L0 female, married for 3 years with 7-month period of amenorrhea reported in labor room of Government Medical College and Rajindra Hospital, Patiala on 18/4/2014 (vide CR No. 3325) with complaints of pain abdomen and slight bleeding per vaginum (BPV) for the last 12 hours with no proper antinatal care. Ultrasonography (USG) already done on 1/4/14 showed single live intrauterine fetus with 20-21 weeks of gestation with intrauterine growth restriction (IUGR) and oligohydramnios, amniotic fluid index (AFI) 0.6 cm, placenta posterior showing 13 × 6.0 cm heterogeneous mass suggestive of retroplacental hemorrhage. Patient did not consult any doctor after this USG. Her first pregnancy was home conducted preterm delivery at 7½ months of gestation and baby died after 22 days (1 year back).

On admission, her vitals were: pulse rate 99/min, blood pressure (BP) 100/60 mmHg, respiratory rate 20/min, afebrile, chest was clear on auscultation. On per abdomen height of uterus was 28 weeks, abdomen was tense and uterine contractions were present. Fetal heart sound could not be localized. On per vaginum examination, cervix was 3 cm dilated, fully effaced.

Her routine investigations were within normal limits.

She delivered a dead male baby (macerated) with birth weight of 500 g after 3 hours of admission.

After about 1 hour of delivery patient had palpitations.

On examination, uterus was well-retracted and BPV was within normal limits. Vitals at that time were pulse rate 130/min irregularly irregular, BP 110/70 mmHg;

OBSTETRICS AND GYNECOLOGY tachypnea was present. Her O2 saturation was 85%, cyanosis and clubbing were present. But no pallor, icterus, enema or lymphadenopathy (LAP) was present. Jugular venous pressure (JVP) was normal.

On auscultation chest was clear with bilateral air entry equal. On cardiovascular examination, apex beat was present in left 5th intercostal space in midclavicular line, parasternal heave present, P2 palpable, S1 loud, ejection systolic murmur was present in pulmonary area. Central nervous system examination was normal.

Provisional diagnosis of atrial fibrillation with cyanotic heart disease was made.

Patient was shifted to intensive coronary care unit (ICCU) and put on treatment in form of O2 inhalation, injection furosemide, tablet metoprolol 25 mg along with antibiotics. Her fluids intake was restricted and she was put on cardiac monitoring. Electrocardiography (ECG), chest radiography and echocardiogram was done.

Chest X-ray was normal. ECG depicted RSR’ pattern in lead V1 suggestive of right bundle branch block (RBBB).

Echocardiogram revealed congenital cyanotic heart disease with single common atrium (intra-atrial septum deficient), large perimembranous VSD (ventricular septal defect 22 mm), moderate pulmonary arterial hypertension (PAH), moderate mitral regurgitation and moderate tricuspid regurgitation. She was managed conservatively and responded well to the treatment.

Patient was discharged on 7th postpartum day with stable vitals and advised to continue tablet metoprolol 25 mg b.i.d. and regular follow-up in Cardiology Department.

DISCUSSION Cor triloculare biventriculare (single common atrium) is a very rare congenital disorder in adults with very few reports among adults.2 It is similar to a very large septal defect. This defect occurs as a result of lack of septum primum and septum secundum formation.

Clinical presentation includes mild tachypnea, cyanosis and clubbing of fingers and toes. Our patient was incidentally diagnosed because of the thrill discovered on routine physical examination. The patient presented here was essentially asymptomatic until the second stage of labor. Hemodynamic changes of labor had altered the haemodynamic balance with resultant decompensation.

Major hemodynamic changes occur during late pregnancy, labor, delivery and postpartum period.

In patients with pre-existing cardiovascular disease (CVD), cardiac decompensation often coincides with

this peak. Few cases have been reported among the whites, since the early twentieth century. The few reported cases of cor triloculare biventriculare include Abott’s in 1936, who reported five cases in her analysis of 1,000 CHD cases in United State.3 Brown et al also reported isolated case series with few surviving beyond middle age.4 Cunningham in 1948, reported a case of a man with cor triloculare biventriculare, pulmonary dilatation and membranous VSD who lived till 51 years of age.5 Ellis et al, Dubost and Blondaeu described similar patients who were between ages 3 and 31 years.6 Ellis-van Creveld syndrome is a rare combination of cor triloculare biventriculare, chordra and ectodermal dysplasia, polydactyly and most patients die in infancy.7 Baron also reported another case from Spain in 1962.8 Peachey and Robertson reported a case of cor triloculare biventriculare with hypoplasia of the tricuspid valve surviving to the age of 65 years in United Kingdom.9 Sangam et al recently reported a case of a stillborn male fetus of 35 weeks gestation with cor triloculare biventriculare and persistent left superior vena cava in India.10 Akintunde et al reported a similar case of cor triloculare biventriculare and pulmonary stenosis in Nigerian primigravid woman.11 Contraindications of pregnancy in cardiac diseases are: ÂÂ

Severe hypertension of any etiology

ÂÂ

Severe fixed obstructive cardiac lesion

ÂÂ

New York Heart Association (NYHA) Class III and IV heart failure

ÂÂ

Left ventricular ejection fraction <40%

ÂÂ

Prior peripartum cardiomyopathy (PPCM)

ÂÂ

Dilated unstable aorta of 40-45 mm or above or severe cyanosis.

Cardiac diseases in pregnancy score (CARPREG) risk score has been shown to predict the adverse cardiac complications during pregnancy (Table 1): ÂÂ

It is composed of four clinical features

ÂÂ

Each risk factor is associated with 1 point

ÂÂ

Maternal cardiac event rate associated with 0, 1, >1 points is 5%, 27% and 75%, respectively.

Maternal mortality in women with this syndrome ranges from 30% to 50% with a 50% risk to fetus if mother survives. Mortality is frequently caused by thromboembolic events. Fetal risk due to maternal hypoxemia is substantial with a high incidence of fetal loss, premature delivery, IUGR and perinatal death.

Because of considerable risk to fetus and mother,

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665

OBSTETRICS AND GYNECOLOGY volume and prevention of sudden increasing pulmonary vascular resistance.

Table 1. CARPREG Risk Score Criteria

Examples

Point

Prior cardiac events

Heart failure, TIA, stroke before pregnancy, arrhythmia

NYHA III or IV or cyanosis

1

REFERENCES 1. Weiss BM, von Segesser LK, Alon E, Seifert B, Turina MI. Outcome of cardiovascular surgery and pregnancy: a systematic review of the period 1984-1996. Am J Obstet Gynecol 1998;179(6 Pt 1):1643-53.

1

Valvular and outflow tract obstruction

Aortic valve <1.5 cm2, mitral valve <2 cm2

1

Myocardial dysfunction

LVEF <40% or restrictive or obstructive cardiomyopathy

1

2. Shaher RM, Johnson AM. The haemodynamics of common atrium. Guys Hosp Rep 1963;112:166-70.

3. Abbott ME. Atlas of congenital cardiac diseases.

American Heart Association, New York, 1936.

TIA = Transient ischemic attacks; NYHA = New York Heart Association; LVEF = Left ventricular ejection fraction.

4. Brown JW. Congenital Heart Disease. 2nd edition, Staples Press: London, 1950.

pregnancy is contraindicated. If pregnancy occurs therapeutic abortion is recommmended. Studies show that a low maternal oxygen saturation (<85%) is associated with a very low rate of live born infants (12%).

Women who choose to continue pregnancy are advised to restrict physical activity, use continuous oxygen at least for third trimester and consider use of pulmonary vasodilating drugs such as iloprost and prostacyclin.

Anticoagulation is recommended during the third trimester and for 4 weeks after delivery.

The most vulnerable period for mother is labor, delivery and first week postpartum. Vaginal delivery, facilitated by vacuum or low forceps extraction is the method of choice. Cesarean delivery is associated with substantially higher mortality than the vaginal route.

Anesthetic management includes central venous and arterial pressure monitoring, with maintenance of adequate systemic vascular resistance and intravenous

5. Dexter L. Atrial septal defect. Br Heart J 1956;18(2): 209-25.

6. Ellis FH Jr, Kirklin JW, Swan HJ, Dushane JW, Edwards JE. Diagnosis and surgical treatment of common atrium (cor triloculare-biventriculare). Surgery 1959;45(1): 160-72.

7. Giknis FL. Single atrium and the Ellis-van Creveld syndrome. J Pediatr 1963;62:558-64.

8. Baron Lis De Vijnovich E. Congenital heart defect; cor triloculare biventriculare. Rev Asoc Med Argent 1962;76:313-6.

9. Peachey RD, Robertson PG. Cor trilocularebiventriculare with hypoplasia of the tricuspid valve: survival to the age of 65 years. Br Heart J 1965;27(5): 786-90.

10. Sangam MR, Devi SS, Krupadanam K, Anasuya K. Cor triloculare biventriculare with left superior vena cava.

Folia Morphol (Warsz) 2011;70(2):135-8.

11. Akintunde AA, Aremu AA, Akinboro AO, Akinlade MA. Cor triloculare biventriculare and pulmonary stenosis in a Nigerian primigravid woman: a case report. Int J Cardiovasc Res 2013;2:3.

■■■■

Botox Ok for Some Patients With OAB, but Not All Onabotulinumtoxin A, approved by the US Food and Drug Administration (FDA) in 2013 to treat overactive bladder (OAB), may be an appropriate second-line treatment option for select patients with OAB, according to a joint committee opinion by the American College of Obstetricians and Gynecologists and the American Urogynecologic Society. The committee opinion was published in the June issue of Obstetrics & Gynecology.

The key symptoms of OAB include the bladder squeezing out urine at the wrong time, resulting in urination 8 or more times a day or 2 or more times at night. The committee notes that OAB is accompanied by frequency and nocturia, sometimes accompanied by urge urinary incontinence and in the absence of urinary tract infection.

Remedies include medicines that relax the muscles and nerves. Onabotulinumtoxin A, marketed as Botox A, is a neurotoxin that paralyzes muscles and blunts nerve response and that has been found to significantly improve symptoms of OAB up to 1 year after injection.

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OBSTETRICS AND GYNECOLOGY

Cervical Molar Pregnancy and Its Future Fertility BABITA RAMANI*, RAJAT MOHANTY†, SUDIPTA PATNAIK‡

ABSTRACT Background: Cervical complete molar pregnancy is very rare and fatal and surgical intervention makes it lethal. Case report: A 37 years G2P1L1 with previous cesarean section 4 years back, had presented with brisk vaginal bleeding after evacuation at private hospital 2 days back. She was admitted in labor room,VSS Medical College, Burla at 9 pm on 22.04.2012 as an emergency case. USG report which was done at our institute, showed cervical invasive mole with right ovarian cyst. She was managed with methotrexate and no other intervention was required, as her serum b-hCG was declining. Now, she is having a normal pregnancy. Conclusion: Surgical intervention in such situations is very fatal. We propose her to go for a fertility sparing medical management.

Keywords: Cervical molar pregnancy, vaginal bleeding, injection methotrexate, serum b-hCG

C

ervical pregnancy is a rare variety of ectopic pregnancy. Incidence of cervical pregnancy is <1% of all ectopic pregnancies.1 Molar changes in the cervical pregnancy are very rare occurrence.

To preserve uterus and cervix in such a situation is really a challenge to the obstetrician.

CASE REPORT

On examination, her pulse rate was 90/min and blood pressure (BP) 110/70 mmHg with moderate degree of pallor. Abdomen was soft with normal findings. No bleeding was present on inspection of vulva.

On per speculum examination, external os was open, no bleeding through os was seen. On bimanual examination cervix was distended, os was 2 cm

A 37-year-old lady G2P1L1 came to the labor room, VSS Medical College, Burla, at 9 pm on 22.04.2012 in emergency with complaint of bleeding per vaginum for 2 days at 6 weeks of pregnancy for which suction and evacuation was tried at a local hospital, but she landed up with brisk hemorrhage and was referred to higher center, where sonography revealed an enlarged uterus and distended cervix with multiple tiny anechoic structures filling the dilated cervical canal (Fig. 1). Internal os was closed and there was a cervical pregnancy, so she was referred to a tertiary center.

*Senior Resident Dept. of Obstetrics and Gynecology VSS Medical College, Burla, Sambalpur, Odisha †Senior Specialist and Consultant Dept. of Obstetrics and Gynecology ‡Assistant Professor Dept. of Physiology SCB Medical College, Cuttack, Odisha Address for correspondence Dr Babita Ramani Qtr No: 3R/10, Doctor’s Colony VSS Medical College Campus, Burla - 768 017, Sambalpur, Odisha E-mail: babitaramani@gmail.com

Figure 1. Enlarged uterus and distended cervix with multiple tiny anechoic structures filling the dilated cervical canal.

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OBSTETRICS AND GYNECOLOGY dilated and soft structure felt through os. Uterus was bulky, anteverted, soft, mobile, fornices were free and nontender.

Figure 2. Multiple cystic lesions in the cervix.

Her hemoglobin was 9.8 g/dL and serum b-hCG (human chorionic gonadotropin) was 19,714.74 mIU/mL. Her liver function tests, renal function tests and thyroid-stimulating hormone were within normal limits. USG, revealed an enlarged uterus (115 × 65 × 49 mm) with complex lesion adherent to the anterior cervical wall of size 43 × 40 × 32 mm, volume 21.6 cc, mostly cystic with peripheral hypervascularity, a right ovarian cyst of size 43 × 29 × 30 mm; no identifiable gestational sac was seen (Figs. 2 and 3). Left ovary was normal. Endometrial thickness was 12 mm, with signs of invasive cervical mole. Histopathology report revealed hydropic villi with irregular scalloped outline (Fig. 4).

As she was not bleeding was managed her conservatively with 1 unit of blood transfusion and injection methotrexate 1 mg/kg on D 1, 3, 5, 7 alternating with folinic acid 0.1 mg/kg. Injectable broad-spectrum antibiotic was also given, which was continued till 29.04.12 and was discharged on 01.05.12 with advice for barrier contraception.

Serial serum b-hCG gradually decreased to undetectable levels within a span of 6 weeks. She used calender method, instead of barrier contraception and conceived after 14 months in June 2013 and this time it was an intrauterine pregnancy. During this pregnancy at 6 weeks, she terminated the same by medical method.

Figure 3. Right ovarian cyst (theca lutein).

DISCUSSION Four cases of cervical molar pregnancy have reported in literature till now, two of them were partial cervical moles and two were complete cervical mole. Beless et al2 have given cervical cerclage like stay sutures to control the bleeding after surgical procedure. Schorge and associates3 evaluated that fertility was not impaired and pregnancy outcomes were usually normal following successful treatment of cervical molar pregnancy.

Schwentner et al4 revealed the cause of cervical molar pregnancy, which was traumatic holding of the cervix during evacuation of a missed abortion. It has also been suggested that a previous cesarean section may play a role in the etiology of cervical pregnancy and molar changes are related to the older age group i.e., >35 years.5

Figure 4. Hydropic villi with irregular scalloped outline.

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

These two factors may be the main cause of the present case. Aytan et al6 terminated the partial cervical molar

OBSTETRICS AND GYNECOLOGY pregnancy by suction and evacuation followed by serial serum b-hCG evaluation. The present case was managed successfully by injection methotrexate in multiple doses alternating with folinic acid. She was also counseled about the future risk of choriocarcinoma.

2. Beless DJ. Cervical hydatidiform mole causing severe vaginal hemorrhage: a case report. J Reprod Med 1995;40(12):855-8.

CONCLUSION

4. Schwentner L, Schmitt W, Bartusek G, Kreienberg R, Herr D. Cervical hydatidiform mole pregnancy after missed abortion presenting with severe vaginal bleeding: case report and review of the literature.

Eur J Obstet Gynecol Reprod Biol 2011;156(1):9-11.

Surgical intervention in such a situation is very fatal.

We propose to go for a fertility sparing medical management.

REFERENCES 1. Ushakov FB, Elchalal U, Aceman PJ, Schenker JG. Cervical pregnancy: past and future. Obstet Gynecol Surv 1997;52(1):45-59.

3. Schorge JO, Goldstein DP, Bernstein MR, Berkowitz RS. Recent advances in gestational trophoblastic disease.

J Reprod Med 2000;45(9):692-700.

5. Parazzini F, La Vecchia C, Pampallona S. Parental age and risk of complete and partial hydatidiform mole.

Br J Obstet Gynaecol 1986;93(6):582-5.

6. Aytan H, Caliskan AC, Demirturk F, Koseoglu RD, Acu B. Cervical partial hydatidiform molar pregnancy.

Gynecol Obstet Invest 2008;66(2):142-4.

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IBD may Increase Risk for Adverse Perinatal Outcomes Pregnancies complicated by inflammatory bowel disease (IBD) may carry significantly increased risk for adverse perinatal outcomes, according to an article published online March 20 in the Journal of Perinatology. Darios Getahun, MD, PhD, MPH, from the Department of Research and Evaluation, Kaiser Permanente Southern California Medical Group, Pasadena, California, and Department of Obstetrics and Gynecology, Rutgers-Robert Wood Johnson Medical School, New Brunswick, New Jersey, and colleagues conducted a retrospective cohort study of almost 400,000 maternally linked medical records in the Kaiser Permanente Southern California system between 2000 and 2012.

The prevalence of both subtypes of IBD has been increasing in industrialized nations during the last several decades. The Kaiser Permanente researchers found that prevalence of IBD came to 130 of every 1,00,000 singleton pregnancies during the study period but varied by subtype. Prevalence for ulcerative colitis came to 100/1,00,000, and prevalence for Crohn’s disease came to 30/1,00,000. Women with IBD tended to be older, white, and have more education than women without IBD.

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OBSTETRICS AND GYNECOLOGY

Randomized Controlled Study Comparing Sublingual to Vaginal Misoprostol for Cervical Priming Prior to Surgical Termination of Pregnancy in First Trimester NALINI SHARMA*, JK GOEL*

ABSTRACT Background: To compares the effectiveness and acceptability of sublingual versus vaginal route of misoprostol for cervical priming prior to vacuum aspiration. Material and methods: In this prospective clinical study, a total of 70 women with period of gestation between 6 and 12 weeks selected randomly for day surgery abortion were sequentially allocated into two groups of 36 and 34. All selected women received 400 mg of misoprostol 3 hours prior to vacuum aspiration either by sublingual or by vaginal route in the hospital. Results: For all periods of gestation, sublingual misoprostol significantly improved cervical dilatation. Duration of the procedure and amount of blood loss were comparable in both the groups. Patient acceptability was higher in the sublingual group. Conclusion: Cervical priming with sublingual misoprostol is effective and convenient route with high patient acceptability rate.

Keywords: Vaginal, sublingual, misoprostol, cervical priming, first trimester, abortion

V

acuum aspiration is currently one of the standard management for the termination of pregnancy in first trimester with success rate of >95%,1 but it is associated with cervical injury, uterine perforation, hemorrhage and incomplete uterine evacuation.

Cervical priming prior to surgical termination of pregnancy reduces the risk of various complications.

Previously Laminaria tent, Dilapan have been used, but pharmacological cervical priming is preferred to mechanical dilatation. Various prostaglandins like gemeprost (prostaglandin E1 [PGE1] analog) have been found to be more beneficial, because they are easy to administer and very effective but they are expensive and require refrigeration storage and are associated with high gastrointestinal effects like nausea, vomiting and diarrhea. Misoprostol is a synthetic analog of PGE1.

Misoprostol has the advantage of easy availability ease of administration by various routes, lower cost and

*Dept. of Obstetrics and Gynecology Shri Ram Murti Smarak Institute of Medical Sciences and Medical College, Bareilly, Uttar Pradesh Address for correspondence Dr Nalini Sharma B1D, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong, Meghalaya E-mail: nalinisharma100@rediffmail.com

stability of room temperature with few systemic side effects. Various studies established the efficacy and safety of oral and vaginal route.2-7 Oral misoprostal has the advantage that patient can take the medicine at home prior to hospital admission, but oral misoprostol needs to be administered 12 hours prior to surgery for cervic ripening. Vaginal route has been found to be more effective than oral8 because of slower, but more constant absorption through the vaginal mucosa.

Vaginal route is associated with less gastrointestinal side effects. It was found that 400 mg misoprostol given 3-hour before the procedure was the optimal dose for vaginal application.5 Vaginal route is most preferred route inspite of having inconvenience and lack of privacy. There are studies that showed the efficacy of sublingual route8,9 for cervical priming in first trimester abortion. Sublingual route has been proven to be more effective than oral.8 There are limited number of studies comparing the effect of sublingual misoprostol with vaginal misoprostol for cervical ripening prior to first trimester abortion9-11 Ngai et al reported oral administration of misoprostol 3-hour prior to vacuum aspiration was as effective vaginal misoprostol for cervical priming7,12 but administration of oral misoprostol 3-hour before the operation may causes if problems, if the patient undergoes the operation under general anesthesia. Misoprostol is absorbed through

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OBSTETRICS AND GYNECOLOGY vaginal mucosa in vaginal administration. The buccal mucosa being very vascular is able to serve the same purpose. The misoprostol is very soluble in water and dissolves within 10-15 minutes when administered under the tongue. Sublingual administration of misoprostol avoids the first pass effect via the liver as in oral administration.

Sublingual misoprostol is convenient to use, avoids painful vaginal administration and avoids the ingestion of water before anesthesia with less gastrointestinal side effect. It is the aim of this randomized study to assess the efficacy and patients acceptability of sublingual misoprostol and compare it with vaginal misoprostol for preoperative cervical priming before surgical termination of pregnancy in first trimester.

MATERIAL AND METHODS It is a prospective randomized controlled study.

A total of 70 pregnant women with gestational age between 6 and 12 weeks were recruited from among women requesting legal termination of pregnancy from April 2009 to March 2010 in Shri Ram Murti Smarak Institute of Medical Sciences, Bareilly, Uttar Pradesh; a medical college hospital for this prospective study. The local Ethical Committee approved the study protocol.

A written informed consent was obtained after explaining the study. Women aged over 18 years with period of gestation between 6-12 weeks were included in the study. Criteria for inclusion were a normal general and gynecological history and physical examination. Gestational age was calculated by last menstrual periods (LMP) and was confirmed by clinical examination or ultrasonographic examination. Women suffering from chronic diseases like hypertension, diabetes, asthma, hemoglobin (Hb) <9 g/dL, allergic to prostaglandins, had an intrauterine contraceptive device (IUCD) and previous lower-segment cesarean section (LSCS) were excluded. Routine investigations included Hb, blood group and Rh typing.

The patients in each treatment group were sequentially allocated to receive 400 mg of misoprostol 3-hour prior to vacuum aspiration either by sublingual or by vaginal route (after wetting the tablet with water in order to increase the absorption through vaginal mucosa).

Before the surgical evacuation the patients were asked about the side effects like abdominal pain graded from 0 to 3 (0 for no pain, 1 for mild pain, 2 for moderate pain that did not require treatment with analgesic, 3 for severe pain), nausea, vomiting, shivering, hyperthermia and vaginal bleeding noted. Vacuum aspiration was done by either of the two senior persons (NS or JBK)

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to reduce individual variation. The operation was done under sedation. All subjects were given to midazolam 2 g before the operation. Intraoperatively, cervical dilatation before performing vacuum aspiration was measured using Hegar dilators.

The dilators were passed through the cervix in descending order starting with size 12. The largest Hegarâ&#x20AC;&#x2122;s dilator passing through the internal os without resistance was regarded as the dilatation achieved.

No further dilatation was performed, if the cervix had gestation appropriate dilatation. In patients with insufficient dilatation, paracervical block was given to reduce pain perception. Suction evacuation was done

by Karmanâ&#x20AC;&#x2122;s cannula. At the end of this procedure, the uterus was gently curetted by a curette.

Duration of surgery was measured from the start of dilatation until the end of curettage. Intraoperative blood loss was measured as the volume of the uterine aspirate after sieving away the products of conception.

Intraoperative pain score was based on a numerical scale 0-10 with 0-3 mild, 4-6 as moderate and 7-10 as severe pain requiring injectable analgesics. Any cervical or uterine injury was noted. The women were observed for 3 hours before discharge from the hospital. Followup was done twice, first after 7 days and subsequently after 1 month. No major complaints were noted. The main study outcome measures were cervical dilatation prior to suction evacuation, amount of blood loss during surgery and time duration of surgery. Other evaluation factors were pain intensity, complications during surgery, side effects of misoprostol and acceptability of route of administration.

RESULTS Age and obstetric profile is summarized in Table 1.

Preoperatively, of the 70 patients who were given sublingual (n = 36) or vaginal (n = 34) misoprostol.

Fifteen (41.66%) in the sublingual group versus 9 (26.47%) in the vaginal group had mild bleeding after 3-hour of administration of misoprostol. Mild spasmodic pain was experienced by 25 (69.44%) and 20 (58.62%) in sublingual and vaginal group, respectively. Four patients in sublingual group and one patients in vaginal group had nausea. One patient had hyperthermia in sublingual group (Table 2).

There was a significant difference in average internal os diameter between two groups. Value of t-test is 0.00005627, which is significant. Three (8.33%) women in sublingual group as compared to 8 (23.52%) women in vaginal group were given paracervical block for the mechanical cervical dilatation, as these women had not

OBSTETRICS AND GYNECOLOGY Table 1. Demographic Characteristic of the 70 Women Who Underwent Surgical Abortion Sublingual (n = 36)

Vaginal (n = 34)

Age year (mean) 18-40 year

29.4 years (mean)

28.2 (mean)

Gestation (weeks) (6-12 weeks)

8.7 weeks (mean)

8.5 weeks (mean)

Parity (Po-P6)

3.4 (mean)

3.6 (mean)

Women with history of surgical abortion

10 (27.77%)

8 (23.52%)

Table 2. Preoperative Side Effects

Nausea

Sublingual (n = 36)

Vaginal (n = 34)

4 (11.11%)

1 (2.94%)

Vomiting Vaginal bleeding scanty

Nil

Nil

15 (41.66%)

9 (26.47%)

Nil

Nil

25 (69.44%)

20 (58.82%)

1 (2.77%)

Nil

Nil

Nil

Diarrhea Pain (mild-to-moderate) Hyperthermia Passage of product of conception before operation

Table 3. Intraoperative Parameters Sublingual (n = 36)

Vaginal (n = 34)

t-value

8.9

7.7

0.00005627 (Significant)

Mean blood loss (CC)

19.01

18.58

0.331 (Not Significant)

Mean time (mins)

7.96

9.03

0.2627 (Not Significant)

Paracervical block

n=3

n=9 (26.47%)

Baseline dilatation (mm)

desired cervical dilatation. In 6 (17.64%) women out of 34 in vaginal group tablet was partially absorbed while in 2, it was intact after 3 hours of administration. In sublingual group, tablet was absorbed in all women within 10-50 minutes. The findings at operation are summarized in Table 3. A higher patient acceptability of sublingual (90%) route as compared to the vaginal (40%) route was noted. Reasons were that the vaginal route requires the patients to report to the hospital 3-hour prior to vacuum aspiration, while sublingual route was convenient and time saving.

DISCUSSION This study suggest the feasibility of the sublingual route of misoprostol administration for cervical priming prior to first trimester surgical abortion using vacuum aspiration as the commonly used method for first trimester abortion. Cervical dilatation is the crucial step in vacuum aspiration as most of the cervical and uterine injuries are due to forceful cervical dilatation of the cervix.13 Cervical priming has been shown to result in shorter operation time, less blood loss and easier mechanical dilatation.7 The beneficial effects of pharmacological agents for cervical priming have been established. It does not require a trained medical personnel to administer and not painful for the patient.

Mifepristone and PGE1 analogs are effective cervical priming agents,12,14 but mifepristone is expensive and it has the disadvantage of requiring 36-48 hours for cervical priming. PGE1 analog is drug of choice.

Misoprostol is preferred, since it is cheap and stable at room temperature and it is associated with less gastrointestinal side effect than gemeprost.15 Various routes of administration of misoprostol have been used for cervical priming in the first trimester. Both oral and vaginal routes were shown to be equally effective when given 3 hours before the vacuum aspiration.8,12 In one of the studies (Zieman et al 1997), the systemic bioavailability of vaginally administered misoprostol was three times higher than that of orally administered misoprostol and effect was prolonged,10 but there is wide variation in absorption of vaginal misoprostol2 and sometimes remnants of vaginal tablet may be found in the vagina after hours just like in this study in eight women. Both oral and vaginal routes have drawbacks. Some women found vaginal administration of drug inconvenient and unacceptable12 and it was more convenient to give a drug by mouth. In a day surgery setting at the same time it was better to avoid oral intake of fluid before operation especially if this was done under general anesthesia.

Sublingual misoprostol can avoid the uncomfortable vaginal application and oral intake of fluid before operation. Patient can take sublingual tablet at home thus reducing the time of hospital admission. Its clinical effectiveness in cervical priming was proven to be same as vaginal misoprostol in this study. Pilot studies3 reported the successful use of repeated doses of sublingual misoprostol for medical abortion. The sublingual route allows the use of most vascular area in the buccal cavity and the reported dissolving time is about 10-15 minutes. In this study, it was 10-50 minutes.

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OBSTETRICS AND GYNECOLOGY This provides a promising route of administering misoprostol avoiding first pass effect with oral route and inconvenience and discomfort to women with vaginal administration. The present study observed that cervical ripening effect and mean time taken by misoprostol were favorable among the sublingual group. Our result were consistent with the observation by various other studies.9,11,16 The mean intraoperative blood loss was less in the vaginal group though statically, it was not significant (value of t-test 0.331).

The total duration of surgery was less in the sublingual group that can be explained on the basis of more cervical ripening and dilatation achieved in this group.

This finding was consistent with other observations.11 Intraoperative pain score was found to be significantly lower in sublingual group. Saxena et al, Parveen et al and Tang et al also found significant difference with regard to this parameter.9,11,16 Vaginal bleeding and abdominal pain were the commonest side effects after misoprostol. In this study, very few women complained of severe abdominal pain. In most of the women, bleeding amount was scanty. In this study, there were few shortcomings: ÂÂ

We did not use tonometer to measure the actual force applied for dilatation

ÂÂ

Surgeon and patient were not blinded to the route of administration

ÂÂ

Number of patients was relatively less.

CONCLUSION It can be concluded that sublingual misoprostol is an effective and favorable cervical priming agent for first trimester abortion as compared to vaginal route. It can be conveniently self-administered at home thereby decreasing hospital stay and cost. It also has a good patient acceptability rate.

REFERENCES 1. Child TJ, Thomas J, Rees M, MacKenzie IZ. Morbidity of first trimester aspiration termination and the seniority of the surgeon. Hum Reprod 2001;16(5):875-8.

2. Tang OS, Schweer H, Seyberth HW, Lee SW, Ho PC. Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod 2002;17(2):332-6.

3. Tang OS, Miao BY, Lee SW, Ho PC. Pilot study on the use of repeated doses of sublingual misoprostol in termination of pregnancy up to 12 weeks gestation: efficacy and acceptability. Hum Reprod 2002;17(3): 654-8.

4. Fong YF, Singh K, Prasad RN. A comparative study using two dose regimens (200 microg or 400 microg)

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

of vaginal misoprostol for pre-operative cervical dilatation in first trimester nulliparae. Br J Obstet Gynaecol 1998;105(4):413-7.

5. Singh K, Fong YF, Prasad RN, Dong F. Vaginal misoprostol for pre-abortion cervical priming: is there an optimal evacuation time interval? Br J Obstet Gynaecol 1999;106(3):266-9.

6. Lawrie A, Penney G, Templeton A. A randomised comparison of oral and vaginal misoprostol for cervical priming before suction termination of pregnancy. Br J Obstet Gynaecol 1996;103(11):1117-9.

7. Ngai SW, Chan YM, Tang OS, Ho PC. The use of misoprostol for pre-operative cervical dilatation prior to vacuum aspiration: a randomized trial. Hum Reprod 1999;14(8):2139-42.

8. Ashok PW, Hamoda H, Nathani F, Flett GM, Templeton A. Randomised controlled study comparing oral and vaginal misoprostol for cervical priming prior to surgical termination of pregnancy. BJOG 2003;110(12):1057-61.

9. Saxena P, Salhan S, Sarda N. Sublingual versus vaginal route of misoprostol for cervical ripening prior to surgical termination of first trimester abortions. Eur J Obstet Gynecol Reprod Biol 2006;125(1):109-13.

10. Danielsson KG, Marions L, Rodriguez A, Spur BW, Wong PY, Bygdeman M. Comparison between oral and vaginal administration of misoprostol on uterine contractility. Obstet Gynecol 1999;93(2):275-80.

11. Parveen S, Khateeb ZA, Mufti SM, Shah MA, Tandon VR, Hakak S, et al. Comparison of sublingual, vaginal, and oral misoprostol in cervical ripening for first trimester abortion. Indian J Pharmacol 2011;43(2):172-5.

12. Ho PC, Ngai SW, Liu KL, Wong GC, Lee SW. Vaginal misoprostol compared with oral misoprostol in termination of second-trimester pregnancy. Obstet Gynecol 1997;90(5):735-8.

13. Hakim-Elahi E, Tovell HM, Burnhill MS. Complications of first-trimester abortion: a report of 170,000 cases.

Obstet Gynecol 1990;76(1):129-35.

14. el-Refaey H, Calder L, Wheatley DN, Templeton A. Cervical priming with prostaglandin E1 analogues, misoprostol and gemeprost. Lancet 1994;343(8907):1207-9.

15. Henry AM, Haukkamaa M. Comparison of vaginal misoprostol and gemeprost as pre-treatment in first trimester pregnancy interruption. Br J Obstet Gynaecol 1999;106(6):540-3.

16. Tang OS, Mok KH, Ho PC. A randomized study comparing the use of sublingual to vaginal misoprostol for pre-operative cervical priming prior to surgical termination of pregnancy in the first trimester. Hum Reprod 2004;19(5):1101-4.

OBSTETRICS AND GYNECOLOGY

Effectiveness on Knowledge of Necklace Method as a Natural Family Planning Among Reproductive Age Group Mothers LATHA VENKATESAN*, DHANALAKSHMI†

ABSTRACT It is estimated that human population will increase by 1 billion people in the next decade. Millions of Indian women are at risk of an unwanted pregnancy. About 70% of the women who want to space their next birth are using no family planning. The necklace method, a new, natural method of family planning, is 95% effective when used correctly. It is most appropriate for women with menstrual cycles between 26 and 32 days; couples must avoid unprotected intercourse during a woman’s fertile period i.e., Days 8 through 19 of the woman’s menstrual cycle.

Keywords: Unwanted pregnancy, family planning, necklace method, unprotected intercourse

“Natural family planning is a life saver for millions of women and children every year” The rapid growth of the world’s population over the past one hundred years results from a difference between the rate of birth and the rate of death. The human population will increase by 1 billion people in the next decade. Millions of Indian women are at risk of an unwanted pregnancy; 70% of the women who want to space their next birth are using no family planning.

The necklace method is a new, natural method of family planning developed by the Institute for Reproductive Health at Georgetown University, USA. The method is 95% effective when used correctly (Arevalo, et al, 2002). The necklace method is most appropriate for women with menstrual cycles between 26 and 32 days.

To use the method, couples must avoid unprotected intercourse during a woman’s fertile period i.e., Days 8 through 19 of the woman’s menstrual cycle. During this period, couples using the SDM may abstain or use a barrier method.

Statement of the problem “A study to assess the effectiveness on knowledge of necklace method as a natural family planning among reproductive age group mothers at selected communities, Chennai” OBJECTIVES ÂÂ

To assess the existing knowledge of necklace method as a temporary family planning among reproductive age group mothers.

ÂÂ

To evaluate the change in knowledge of necklace method as a temporary family planning among reproductive age group mothers after 5 days of specific intervention.

ÂÂ

To compare the knowledge of necklace method as a temporary family planning among reproductive age group mothers before and after specific intervention.

ÂÂ

To associate the pre-intervention knowledge of necklace method as a temporary family planning among reproductive age group mothers with the selected demographic variables.

Need for the Study *Principal and Head †Reader Dept. of Obstetrics and Gynecology Apollo College of Nursing, Chennai, Tamil Nadu Address for correspondence Dr Dhanalakshmi E-mail: dhanalakshmi_vn@yahoo.co.in

The world population has grown tremendously over past two thousand years in 1999. The world population passed the six billion mark. Latest official current population of world 1,270,567,080 (world population clock) and current population of India is estimated to be 1.22 billion people (www.populationmedia.org/).

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

675

OBSTETRICS AND GYNECOLOGY The current population of Chennai is 4,792,949. Going by the census of India in 2011, population of Chennai city was 4,681,087 (4.6 million). Currently Chennai is the sixth largest city of India.

The aim of family planning is to bring down population growth, so as to ensure a better standard of living.

Among all type of family planning, natural family planning has no cost and there are no side effects (DC Dutta).

According to ACCORD (2005), it is totally natural, does not involve chemicals. It can be used to assist or prevent pregnancy, encourages shared responsibility by the woman and her spouse, which can enhance the relationship, enables a couple to be independent and in control of their fertility, can be used at all stages of reproductive life.

Is upto 98% effective against pregnancy, when used by motivated couples and taught by experienced teachers (FPA 1995). It is inexpensive, convenient and is free of all side effects.

Hypothesis ÂÂ

H1: The post-test score of mothers exposed to demonstration were greater than the pre-test score as measured by structured knowledge questionnaire.

ÂÂ

H2: There was a significant association of the pretest knowledge of mothers with selected demographic variables.

MATERIAL AND METHODS Evaluatory research approach and quasi-experimental research design. One group pre-test post-test design were used. Sixty reproductive age group mothers (15-45 years) were involved with the following criteria.

Mother who were having only one child and the age of the child is below 2 years.

Mothers did not use any other family planning method and mothers who were having regular periods (28-32) days. Nonprobability convenience sampling were used for the selection of mothers.

Instruments used for data collection were sociodemographic data which include age, religion, education, working status, age at marriage, age of children, regular periods and menstrual cycle, any previous experience of necklace method, structured knowledge questionnaire and open ended questions were utilized for quantitative approach.

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

14 11.566

12 10 8 6 4

3.416

2 0

Pre-test score

Post-test score

Figure 1. Comparison of overall pre-test score and post-test score of necklace method as a temporary family planning among reproductive age group mothers.

RESULTS AND DISCUSSION Totally 60 reproductive mothers were involved.

The majority of 50 (83%) mothers were in the age group between 21-30 years, whereas remaining 10 (17%) mothers were in the age group between 3145 years. Among 60 mothers, 45 (75%) mothers were belonging to Hindu religion, 12 (20%) were Christian and 03 (05%) were Muslim. Among 60 mothers, 22 (36%) mothers were secondary education, whereas 38 (64%) mothers were graduates. Out of 60 mothers, 48 (80%) mothers got married between 20-25 years, whereas remaining 12 (20%) mothers at the age group between 25-30 years. Forty-eight (80%) mothers are having children below 1 year and 12 (20%) mothers are having children below 11/2 years. All mothers are having regular periods and it is between 28-32 days cycle. None of the mothers had previous exposure of necklace method.

Major Findings The paired t-test was found to be 8.77 whereas the table value is 1.67. The calculated value is more than the table value which shows that, there is a significant change between pre-test and post-test.

Statistical analysis shows that there is no association of pre-intervention knowledge of necklace method as a temporary family planning with the selected demographic variables.

CONCLUSION The study findings show increased knowledge after demonstration of necklace method as evidenced by post-test score, usefulness and performance, which shows best result after demonstration of necklace

OBSTETRICS AND GYNECOLOGY method. Also researchers confirm that necklace method is not only effective for contraception but also for conception for reproductive age mothers.

SUGGESTED READING 1. A Standard Days Method: A Natural Family Planning Option for Couples, A Guide for local government units, Management sciences for Health, Philippins Program Manamen Technical Assistant Team Services (PMTAT).

2. http://www.nim.nih.gov/bsd/uniform requirements.html 3. http://www.lib.monash.edu.au/tutorials/citing/ Vancouver.html 4. http://wwwlib.murdoch.edu.au/find/citation/Vancouver. html#world%20wide%web%20Documents 5. htp://www.ncbi.nlm.nih.gov/books/bv.fogi?call=bv.View. showTOC&ind=citmed.TOC&depth=2 6. http://library.curtin.edu.au

■■■■

Don’t Ignore Women’ Health Women are not diagnosed or treated as aggressively as men. Even though more women than men die of heart disease each year, women receive only 33% of all angioplasties, stents and bypass surgeries; 28% of implantable defibrillators and 36% of open-heart surgeries, according to the National Coalition for Women with Heart Disease.

Although the traditional risk factors for coronary artery disease — such as high cholesterol, high blood pressure and obesity — have a detrimental impact in men and women, certain factors play a bigger role in the development of heart disease in women. ÂÂ

Metabolic syndrome — a combination of increased blood pressure, elevated blood glucose and triglycerides — has a greater impact on women than men.

ÂÂ

Mental stress and depression affect women’s hearts more than they do men’s.

ÂÂ

Smoking is much worse for women than men.

ÂÂ

A low level of estrogen before menopause is a significant risk factor for developing microvascular disease.

ÂÂ

Though women will often have some chest pain or discomfort, it may not be the most prominent symptom.

Diffuse plaques build–up and diseased smaller arteries are two reasons why symptoms can be different in women.

ÂÂ

In addition to chest pain, pressure or discomfort, signs and symptoms of heart attack in women include: Neck, shoulder, upper back or abdominal discomfort, Shortness of breath, Nausea or vomiting, Sweating, Light-headedness or dizziness and unusual fatigue.

ÂÂ

Endothelial dysfunction is more common in women. In this the lining of the artery does not expand (dilate) properly to boost blood flow during activity, which increases the risk of coronary artery spasm and sudden death.

ÂÂ

Results of the WISE study suggest that the commonly used treatments for coronary artery disease — angioplasty and stenting — are not the best options for women with more diffuse plaques.

ÂÂ

Typical tests for coronary artery disease — angiogram, treadmill testing and others — are not reliable in women.

ÂÂ

The WISE study showed that in some women, plaques accumulate as an evenly spread layer along artery walls, which is not visible using traditional testing methods.

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

677

ONCOLOGY

Lesson Learnt in Anal Melanoma: A Case Report LANKA PRAVEEN*, VIPON KUMAR†, ASWINI KUMAR PUJAHARI‡

ABSTRACT A 54-year-old lady had presented with perineal pain. Clinically, she had pallor and inspection of the perineum showed black mapping of the skin. She was diagnosed to be a case of melanoma on transanal biopsy. There were no liver and pulmonary metastasis. She underwent abdomino-perineal resection and adjuvant chemoradiotherapy. However, she threw a convulsion after 6 months and later died of cerebral metastasis. Complete metastatic work-up is mandatory before undertaking cancer therapy in a case of malignant melanoma.

Keywords: Melanoma, transanal biopsy, chemoradiotherapy, cerebral metastasis

M

elanoma of anal canal is so rare that the treatment guidelines are not yet standardized.

It metastasizes early and thus has a poor prognosis in spite of aggressive multimodality approach. Wide local excision (if the lesion is localized) and abdominoperineal resection (if sphincter cannot be preserved) remain the standard surgical procedures.1,2

CASE REPORT A 54-year-old lady reported with history of bleeding per rectum and pain in the perineal region of 1-year duration. She also had unquantified weight loss. On examination, she had pallor. There was no inguinal lymphadenopathy. Inspection of the perianal area showed black mapping of the skin (Fig. 1).

Proctoscopy and colonoscopy revealed a hyperpigmented polypoidal lesion 3 cm from anal verge at 3-5 ‘O’ clock position and rest of the colon was normal.

Biopsy of the lesion revealed melanoma. Contrastenhanced computerized tomography (CECT) chest and abdomen had no evidence of metastatic disease.

Whole body positron emission tomography computed

*Assistant Professor †Associate Professor ‡Professor Armed Force Medical College, Pune, Maharashtra Address for correspondence Dr Aswini Kumar Pujahari Professor Armed Force Medical College, Pune - 411 040, Maharashtra E-mail: ajpuja@rediffmail.com

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Figure 1. Dark pigmentation indicating anal melanoma.

Submucosal spread

Tumor

Figure 2. The resected specimen showing the tumor and submucosal and subcutaneous spread.

ONCOLOGY tomography (PET-CT) was not done due to financial constraints. As a case of localized disease, she was taken up for abdominoperineal resection. At surgery, there were no liver or peritoneal metastasis and the surgery went uneventful.

The resected specimen of the tumor revealed submucosal and subcutaneous spread (Fig. 2).

Pathological staging was T2 N1 M0. She was given adjuvant external pelvic radiation and peginterferon2Îą as immunotherapy; however, she had an episode of seizure after 2 months of pelvic irradiation, which on evaluation revealed multiple brain metastasis. She was further referred for palliative whole brain radiotherapy.

She succumbed to her illness a month later.

DISCUSSION Anal melanoma presents with nonspecific symptoms making it difficult to differentiate this condition from benign anorectal disorders leading to delayed diagnosis.3 The common symptoms include bleeding, perineal pain, tenesmus and changes in bowel habits.

Metastatic disease presents with weight loss, anemia and fatigue. Our case had all the above features.

Weyandt et al reported that 32% of patients have metastatic disease at the time of diagnosis.4 Metastatic disease is likely to occur in the liver, lung, pelvis or brain and imaging should focus on metastatic work-up with a CECT chest, abdomen and pelvis. PET is useful for staging of anorectal melanoma. In published series, the sensitivity was 74-100% and specificity 67-100%.5 Owing to the inherent aggressive tumor biology, distant metastasis must be ruled out in the preoperative setting. The primary modality of treatment remains surgical excision, the choice of procedure being abdominoperineal resection or wide local excision depending upon whether sphincters can be preserved.6 Endoscopic ultrasound assesses the depth of penetration of the tumor and may render the patient suitable for a limited procedure. The overall prognosis for patients with anal melanoma is poor; the 5-year survival rate depends on the extent of disease and is 32%, 17% and 0%, for local, regional and distant disease, respectively.7 The prognosis of primary malignant anorectal melanoma is poor, irrespective of surgical treatment.

Neither age at diagnosis, surgery performed, nor use of radiation significantly affects survival.

In a series from Memorial Sloan-Kettering Cancer Center, Yeh et al8 reported a change in practice patterns with a paradigm shift in the treatment strategy, with

local excision trumping radical resection. Prophylactic bilateral inguinal lymphadenectomy in N0 patients has increased complication rate with no survival benefit.

For N1 disease, elective inguinal lymph node dissection should be considered. Adjuvant chemotherapy in the form of dacarbazine/temozolomide is associated with a response rate of approximately 20%. The vast majority of responses, however, are partial, with median response duration of only 4-6 months. Radiation is now more commonly included as a component in the treatment armamentarium.

In a study from MD Anderson Cancer Centre, 23 patients with anorectal melanoma underwent local excision (including lymph node dissection of documented N1 disease) followed by adjuvant radiation therapy. The actuarial 5-year local control rate was 74%, with an actuarial 5-year disease-specific survival of only 36%.9 Melanoma shows a greater susceptibility to immune assault than most other tumor types, and has therefore been the most widely studied target for immunotherapy.

A minority of patients with metastatic disease demonstrate a response to immune mediators such as interferon-2Îą and interleukin-2, suggesting that metastatic melanoma is also susceptible to immunotherapy. Multicenter randomized control studies are required before the adjuvant therapy is used as a routine.

CONCLUSION Whole body imaging including PET scan is mandatory to rule out distant metastasis before considering radical resection in primary anorectal melanomas. Surgery remains the mainstay of treatment with the ultimate aim of minimizing the morbidity and improving the quality-of-life.

REFERENCES 1. Belli F, Gallino GF, Lo Vullo S, Mariani L, Poiasina E, Leo E. Melanoma of the anorectal region: the experience of the National Cancer Institute of Milano. Eur J Surg Oncol 2009;35(7):757-62.

2. Chang AE, Karnell LH, Menck HR. The National Cancer Data Base report on cutaneous and noncutaneous melanoma: a summary of 84,836 cases from the past decade. The American College of Surgeons Commission on Cancer and the American Cancer Society. Cancer 1998;83(8):1664-78.

3. Roviello F, Cioppa T, Marrelli D, Nastri G, De Stefano A, Hako L, Pinto E. Primary ano-rectal melanoma: considerations on a clinical case and review of the literature. Chir Ital 2003;55(4):575-80.

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PEDIATRICS

Apert Syndrome with Epibulbar Dermoid Cyst in the Eye - Coincidence or an Additional Clinical Finding: A Case Report DILLIP KUMAR DAS*, SOUMYASHREE HOTA†, SAMARENDRA MAHAPATRO‡

ABSTRACT Craniosynostosis are heterogeneous group of syndromes characterized by premature fusion of suture that may occur alone or together with other anomalies. Apert syndrome, an autosomal dominant disorder, first described by Baumgartner in 1842, accounts for 4.5% of all children with craniosynostosis. We report a case of a 5-year-old female child who presented with complaints of inability to speak, facial dysmorphism and symmetric syndactyly of both hands and feet.

Keywords: Apert syndrome, craniosynostosis, autosomal dominant disorder, epibulbar dermoid cyst

A

pert syndrome (AS) was described on 1842

by Baumgartner and on 1894 by Wheaton.1 According to Cohen, incidence of AS is 15 in 10,00,000 live births and accounts for 4.5% of all children with craniosynostosis.2,3 Few cases have been reported from India till now.

CASE REPORT A 5-year-old female child was admitted with complaints of inability to speak, facial dysmorphism and symmetric syndactyly of both hands and feet. She was born to nonconsanguineous parents without any antenatal, natal and postnatal complications. Both parents were normal and in the third decade of life. Other family members were normal.

On examination, she had facial dysmorphism in form of craniosynostosis, microbrachycephaly, flat occiput, protuberant frontal region, low-set ear, ocular proptosis, antimongoloid slant, hypertelorism, depressed nasal bridge, thick nose with bulbous tip, cleft palate and dermoid cyst in left eye (Figs. 1-3). Child had bilateral

*Assistant Professor †Postgraduate ‡Professor Dept. of Pediatrics, Hi-Tech Medical College, Bhubaneswar, Odisha Address for correspondence Dr Dillip Kumar Das C/o: Bijay Mohan Biswal, House No. - 14, Malha Sahi, Mangalabag, Cuttack, Odisha E-mail: dr.dillipdas@gmail.com

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Figure 1. Apert facies.

Figure 2. Cleft palate.

PEDIATRICS

Figure 3. Epidermoid cyst in the eye.

a

Figure 5. Syndactyly of foot.

b

Figure 4. Syndactyly of right (a) and left hand (b).

Figure 6. X-ray showing bones are not united.

symmetrical syndactyly with complete fusion of all the five digits of both the hands with inwardly placed thumb and syndactyly of left foot (Figs. 4 and 5) mildto-moderate mental disability.

Apert syndrome is an autosomal dominant disorder caused due to mutation of either Ser252Trp, Ser252Phe or Pro253Arg in fibroblast growth factor receptor FGFR-2 gene on chromosome 10q25.3-26. The various hypotheses have been proposed as eitiology of AS: Virus embryopathy following maternal infection; antenatal drug consumption; an inflammatory process at the base of the skull and maldevelopment of the skull and increasing paternal age.6 As per Cohen et al (2005), sutural agenesis in the midline region is characteristic of AS. This midline defect normally obliterates during 2nd-4th year of life. The head is not able to grow normally, which leads to a sunken appearance in the middle of the face, bulging and wide set eyes, beaked nose, underdeveloped jaw and crowded teeth with normal to mild or moderate intellectual disability.7

Other system examinations were normal. Radiograph of both hands and feet showed soft tissue syndactyly of all digits and synostosis of two phalanges (Fig. 6).

Hemogram, liver function test, renal function test, echocardiography and ultrasound of abdomen and pelvis, vision and hearing were normal.

DISCUSSION Craniosynostosis are heterogeneous group of syndromes characterized by premature fusion of suture that may occur alone or together with other anomalies.4,5 More than 70 craniosynostosis syndromes are described in the literature. Apert syndrome is classified as branchial arch syndrome, affecting the first branchial arch.5

Our patient had the classical clinical triad that characterizes AS like brachycephalic skull, midfacehypolasia and syndactyly of hands and feet.7 The child had fused coronal suture and agenesis of sagittal and

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PEDIATRICS metopic suture, which resulted in wide defect extending from glabella to the posterior fontanelle. The sphenooccipital, sphenoethmoidal, frontoethmoidal sutures were also fused early,3,6 resulting in turribrachycephalic skull. The typical appearance includes a flat, elongated forehead with bitemporal widening and occipital flattening.7 In our patient, a rare finding in form of posterior epibulbar dermoid cyst in the left eye without causing interference in vision was noted. Posterior epibulbar dermoid is usually not attached to the eyeball and are attached to the conjunctiva that covers the eye. They often extend posteriorly into the eye socket and usually cannot be entirely removed. It can be found in persons with Goldenhar syndrome, linear nevus sebaceous syndrome and encephalocraniocutaneous lipomatosis.

The cyst usually does not require any treatment apart from cosmetic reasons. We have not come across with this finding in any available literature. It may be a coincidence or may be one additional feature of AS. Osseous and or cutaneous syndactyly of hands and feet are most common with complete fusion of second to fourth digits. Cutaneous syndactyly of all toes with or without osseous syndactyly may also be seen. Wilkie et al8 scored the severity of the syndactyly in AS according to modified version of classification of Upton (1991): ÂÂ

Type I: Thumb and part of fifth finger are separate from syndactylous mass

ÂÂ

Type II: Little fingers are not separate

ÂÂ

Type III: Thumb and all fingers are included.

Syndactyly in foot may involve mainly three digits (type I) or digits 2-5 with a separate toe (type II) or be continuous (type III). Our case had type II syndactyly in the hands and type III syndactyly in foot.

The palate is high arched and narrows transversely.

Pseudo cleft-palate along with an anteriorly tipped palatal plane is common. Cleft palate is observed in 30% cases.8 Apert syndrome and Crouzon syndrome share most of the similar clinical features. The important difference between the two are syndactyly of hands and feet, and

cleft or pseudo cleft-palate, which is seen in AS and extremely rare in Crouzon syndrome.6,9 Prenatal detection of the syndrome is possible with prenatal ultrasound screening for fetal anomalies.10 Three-dimensional computed tomography (CT) reconstruction scans of skull have added advantage in those cases planning for surgery. Treatment is usually multidisciplinary.

REFERENCES 1. Paravatty RP, Ahsan A, Sebastian BT, Pai KM, Dayal PK. Apert syndrome: a case report with discussion of craniofacial features. Quintessence Int 1999;30(6): 423-6.

2. Athanasiadis AP, Zafrakas M, Polychronou P, FlorentinArar L, Papasozomenou P, Norbury G, et al. Apert syndrome: the current role of prenatal ultrasound and genetic analysis in diagnosis and counselling. Fetal Diagn Ther 2008;24(4):495-8.

3. Batra P, Duggal R, Parkash H. Dentofacial characteristics in Apert syndrome: a case report. J Indian Soc Pedod Prev Dent 2002;20(3):118-23.

4. Martelli H Jr, Paranaíba LM, de Miranda RT, Orsi J Jr, Coletta RD. Apert syndrome: report of a case with emphasis on craniofacial and genetic features. Pediatr Dent 2008;30(6):464-8.

5. Dalal M Soni NC. Apert’s syndrome: a rare case report.

J Indian Acad Oral Med Radiol 2010;22(4):232-5.

6. Carinci F, Pezzetti F, Locci P, Becchetti E, Carls F, Avantaggiato A, et al. Apert and Crouzon syndromes: clinical findings, genes and extracellular matrix.

J Craniofac Surg 2005;16(3):361-8.

7. Cohen MM Jr, Kreiborg S. Skeletal abnormalities in the Apert syndrome. Am J Med Genet 1993;47(5):624-32.

8. Wilkie AO, Slaney SF, Oldridge M, Poole MD, Ashworth GJ, Hockley AD, et al. Apert syndrome results from localized mutations of FGFR2 and is allelic with Crouzon syndrome. Nat Genet 1995;9(2):165-72.

9. Taksande A, Vilhekar K, Khangare S. Apert syndrome: a rare presentation. J Ind Acad Clin Med 2007;8(3):245-6.

10. Sannomiya EK, Reis SA, Asaumi J, Silva JV, Barbara AS, Kishi K. Clinical and radiographic presentation and preparation of the prototyping model for pre-surgical planning in Apert’s syndrome. Dentomaxillofac Radiol 2006;35(2):119-24.

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EXPERT VIEW

What Health Problems are Associated with Hypertension?

RAJIV GARG

H

ypertension is the most important modifiable risk factor for coronary heart disease, stroke, congestive heart failure (CHF), end-stage renal disease (ESRD) and peripheral vascular disease.

Hypertension, if left untreated, is associated with an increased risk of mortality and is often described as a silent killer. Mild-to-moderate hypertension may lead to atherosclerotic disease in 30% of people and organ damage in 50% of people within 8-10 years after onset. It has been demonstrated that for every 20 mmHg systolic or 10 mmHg diastolic increase in blood pressure (BP) above 115/75 mmHg, the mortality rate for both ischemic heart disease and stroke doubles.

Uncontrolled and prolonged hypertension can lead to detrimental changes in the myocardial structure, coronary vasculature and conduction system of the heart. These changes in turn can lead to the development of left ventricular hypertrophy (LVH), coronary artery disease (CAD), various conduction system diseases and systolic and diastolic dysfunction of the myocardium. Clinically, these changes present as angina or myocardial infarction, cardiac arrhythmias (especially atrial fibrillation) and CHF. Thus, hypertensive heart disease is a term applied generally to heart diseasesâ&#x20AC;&#x201D;such as LVH, CAD, cardiac arrhythmias and CHFâ&#x20AC;&#x201D;that are caused by direct or indirect effects of raised BP. Although these diseases generally develop in response to chronically elevated BP, marked and acute elevation of BP can also lead to accentuation of an underlying predisposition to any of the symptoms traditionally associated with chronic hypertension.

In the Framingham Heart Study, it was seen that the age-adjusted risk of CHF was 2.3 times higher in men and three times higher in women when the highest BP was compared to the lowest BP.

Senior Medical Specialist and Head Dept. of Medicine ESI Hospital, Noida, Uttar Pradesh

Data from multiple risk factor intervention trial (MRFIT) revealed that the relative risk for CAD mortality was 2.3-6.9 times higher for persons with mild-to-severe hypertension than it was for persons with normal BP. The relative risk for stroke ranged from 3.6-19.2. The population attributable risk percentage for CAD varied from 2.3% to 25.6%, whereas the population attributable risk for stroke ranged from 6.8% to 40%.

Nephrosclerosis is one of the possible complications of long-standing hypertension.

The risk of hypertension-induced ESRD is higher in black patients, even when BP is under good control.

Furthermore, patients with diabetic nephropathy who are hypertensive are also at high-risk for developing ESRD. The Framingham Heart Study found a 72% increase in the risk of all cause death and a 57% increase in the risk of any cardiovascular event in patients with hypertension who were also diagnosed with diabetes mellitus. BP is also a powerful determinant of risk for ischemic stroke and intracranial hemorrhage; in fact, long-standing hypertension may manifest as hemorrhagic and atheroembolic stroke or encephalopathy. Both the high systolic and diastolic pressures are harmful; a diastolic pressure of >100 mmHg and a systolic pressure of >160 mmHg are associated with a significant incidence of strokes.

The American Heart Association notes that individuals whose BP level is <120/80 mmHg have about 50% the lifetime stroke risk of that of hypertensive individuals.

Marked and acute elevation of BP can also lead to accentuation of an underlying predisposition to any of the symptoms traditionally associated with chronic hypertension. The most common clinical presentations of hypertensive emergencies are cerebral infarction (24.5%), pulmonary edema (22.5%), hypertensive encephalopathy (16.3%) and CHF (12%). Other clinical presentations associated with hypertensive emergencies include intracranial hemorrhage, aortic dissection and eclampsia, as well as acute myocardial infarction.

Hypertension is also one of the several conditions that have been increasingly recognized as having an

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EXPERT VIEW association with posterior reversible encephalopathy syndrome (PRES), a condition characterized by headache, altered mental status, visual disturbances and seizures. Clinical trials have demonstrated the following benefits with antihypertensive therapy. ÂÂ Average 35-40% reduction in stroke incidence. ÂÂ Average 20-25% reduction in myocardial infarction. ÂÂ Average >50%reduction in heart failure

Moreover, it is estimated that one death is prevented per 11 patients treated for Stage 1 hypertension and other cardiovascular risk factors when a sustained eduction of 12 mmHg in systolic BP over 10 years is achieved. However, for the same reduction is systolic BP reduction, it is estimated that one death is prevented

per nine patients treated when cardiovascular disease or end-organ damage is present.

SUGGESTED READING 1. Chobanian AV, Bakris GL, Black HR, et al; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003;42(6):1206-52.

2. Culleton BF, Larson MG, Kannel WB, et al. Serum uric acid and risk for cardiovascular disease and death: the Framingham Heart Study. Ann Intern Med 1999;131:7-13.

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...Cont’d from page 679

4. Weyandt GH, Eggert AO, Houf M, Raulf F, Bröcker EB, Becker JC. Anorectal melanoma: surgical management guidelines according to tumour thickness. Br J Cancer 2003;89(11):2019-22.

5. Prichard RS, Hill AD, Skehan SJ, O’Higgins NJ. Positron emission tomography for staging and management of malignant melanoma. Br J Surg 2002;89(4):389-96.

6. Pessaux P, Pocard M, Elias D, Duvillard P, Avril MF, Zimmerman P, et al. Surgical management of primary anorectal melanoma. Br J Surg 2004;91(9):1183-7.

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7. Podnos YD, Tsai NC, Smith D, Ellenhorn JD. Factors affecting survival in patients with anal melanoma. Am Surg 2006;72(10):917-20.

8. Yeh JJ, Shia J, Hwu WJ, Busam KJ, Paty PB, Guillem JG, et al. The role of abdominoperineal resection as surgical therapy for anorectal melanoma. Ann Surg 2006;244(6):1012-7.

9. Row D, Weiser MR. Anorectal melanoma. Clin Colon Rectal Surg 2009;22(2):120-6.

AROUND THE GLOBE

News and Views ÂÂ Probiotics should be consumed by pregnant and

lactating women and their breast-fed infants in order to prevent the development of atopic dermatitis, suggest recommendations that will soon be issued by the World Allergy Organization. The announcement was made at the American College of Allergy, Asthma & Immunology (ACAAI) 2014.

ÂÂ A study looking at intermediate-term outcomes

following sleeve gastrectomy among obese patients with type 2 diabetes has concluded that the procedure may be best at an early stage of diabetes.

The impact of sleeve gastrectomy on diabetes was significant in the first year, a trend that continued over 5 years but to varying effect depending on disease severity. The findings were presented at Obesity Week 2014.

ÂÂ Mortality among patients with epilepsy is 3-fold

higher than in the general population and the excess mortality seems to be highly related to the etiology of epilepsy, suggests a new systematic review published in Neurology.

ÂÂ Tumor immunity signatures differ significantly

between Asian and non-Asian gastric adenocarcinomas, particularly regarding T-cell function, points a new meta-analysis, thereby suggesting that gastric cancers in Asian and nonAsian patients may be molecularly different. The findings are published online in Gut.

ÂÂ Golimumab, given every 4 weeks, improves long-

term clinical outcomes in patients with ankylosing spondylitis (AS), according to results from the GO-RAISE phase 3 clinical trial. The findings are published online in Annals of the Rheumatic Diseases.

ÂÂ Optimal secondary stroke prevention therapy,

including a combination of antihypertensive, antithrombotic, and/or lipid modifying drugs, appears to be associated with a significantly lower risk of second stroke, major vascular events and death among stroke survivors reports an analysis of data from an international randomized, controlled trial published online in Neurology.

ÂÂ Patients who had cardiac arrest at home or

elsewhere outside of a hospital had greater survival to hospital discharge and to 90 days

beyond if they received basic life support (BLS) vs advanced life support (ALS) from ambulance personnel, suggested a report published online in JAMA Internal Medicine. ÂÂ The majority of preschoolers may not be getting the

amount of sleep they need each night, putting them at higher risk of being overweight or obese within a year, suggests a new study. The study found an association between mothers’ employment status and their children’s weight over time that was mediated by how much sleep the child was getting each night. The findings are published in Sleep Medicine.

ÂÂ Almost one third of male adolescents inaccurately

perceive their weight which influences their eating habits and, consequently, their health, suggests a new study. Researchers noted that 8% of the boys were inaccurate on estimating their weight status. Among those with a low weight status, 43% overestimated their weight level, while 86% of those who were obese underestimated their real weight status.

ÂÂ An experimental drug showed promising results

and potential problems in treating a common liver disease. More research will be needed to determine the drug’s long-term safety and effectiveness.

Currently, there are no specific therapies for NASH. Management typically includes losing weight; eating a healthy diet, increasing physical activity and avoiding alcohol. NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) launched a large clinical trial to test the effectiveness of a modified bile acid called obeticholic acid (OCA) for treating NASH. Natural bile acids affect metabolism and insulin sensitivity and are used by the body to help with digestion. The study enrolled 283 adults diagnosed with NASH at 8 medical centers across the country.

Participants were randomly assigned to take 25 milligrams of OCA daily or a placebo pill. Results appeared online on November 6, 2014, in the Lancet.

ÂÂ Being overweight or obese is associated with

poorer brain health in cognitively healthy adults in their 60s, according to new data from the longrunning Australian PATH Through Life Study.

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AROUND THE GLOBE ÂÂ A report published online November 19 in Neurology

suggests that people who have complex jobs that require working with data, such as architects and engineers, or with other people, such as social workers and lawyers, may have better memory and thinking abilities in later life than their peers in less complex jobs.

ÂÂ Applying external pressure to the perineum in

conjunction with standard constipation treatment can improve bowel function and quality of life for people suffering from the common digestive condition. In a randomized trial of 91 patients published online November 18 in the Journal of General Internal Medicine, the self-acupressure technique improved constipation symptoms at 4 weeks in 72% of the patients randomly assigned to the treatment.

ÂÂ According to the new recommendations from the

US Preventive Services Task Force (USPSTF), there simply is no evidence on the specific pros and cons of screening for vitamin D deficiency, so routine screening cannot be advised at the current time.

The USPSTF has issued its first-ever guidance on the routine screening of asymptomatic patients for vitamin D deficiency. The recommendation is now final following the issue of draft guidance in June.

ÂÂ Results

of the investigator-initiated BASKET PROspective Validation Examination II (BASKETPROVE II) showed that, in an intention-to-treat analysis, the biolimus-eluting stent was as effective as second-generation durable-polymer stents and was superior to bare metal stents, said Christoph Kaiser, MD, professor of medicine at University Hospital Basel, Switzerland.

ÂÂ When the hypertension treatment recommendations

from panel members appointed to the Eight Joint National Committee (commonly but unofficially known as JNC 8) controversially shifted the blood pressure treatment goal from 140/90 mmHg to 150/90 mmHg for patients ages 60 and older without diabetes or chronic kidney disease, it reclassified one in seven people seen at cardiology clinics for hypertension into being “at goal.”

However, among those 14.6%, nearly a quarter had a prior stroke or transient ischemic attack and 65% had coronary artery disease, found William B. Borden, MD, of George Washington University, Washington, D.C., and colleagues.

ÂÂ Results of the Air vs oxygen in ST-elevation

myocardial

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infarction

(AVOID)

trial

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supplemental oxygen therapy in patients with STelevation MI (STEMI) may actually be harmful for patients who are not hypoxic. The trial compared supplemental oxygen vs no oxygen unless O2 fell below 94%. Dr Dion Stub (St Paul’s Hospital, Vancouver, BC, and the Baker IDI Heart and Diabetes Institute, Melbourne, Australia, said, “The AVOID study found that in patients with ST-elevation myocardial infarction who were not hypoxic, there was this suggestion that, potentially, oxygen is increasing myocardial injury, recurrent myocardial infarction and major cardiac arrhythmia and may be associated with greater infarct size at 6 months.” Infarct size estimated by creatinine kinase levels was greater with oxygen than with none for patients with normal oxygen saturation (ratio of geometric mean peaks 1.26, P = 0.01). The findings of their research were presented at the American Heart Association meeting (MedPage). ÂÂ Infant exposure to peanut traces in house dust may

double the risk for peanut allergy, researchers have found. In a new study, published online November 18 in the Journal of Allergy and Clinical Immunology, environmental peanut exposure increased likely peanut allergy 2.10-fold (95% confidence interval (CI), 1.20-fold to 3.67-fold; P < .01). It also increased the odds of peanut skin prick test (SPT) sensitization (1.71-fold; 95% CI, 1.13-fold to 2.59-fold; P = .01).

ÂÂ Children between the ages of 6 and 18 years with

immune deficiency disorders and other highrisk conditions should receive a single dose of PCV13, according to a new recommendation from the American Association of Pediatrics (AAP) published in the December issue of Pediatrics.

The AAP recommends that children in this age group with HIV, sickle-cell disease, cerebrospinal fluid leaks, or cochlear implants receive the pneumococcal conjugate vaccine PCV13 if they have not previously received it. They should receive this dose of PCV13 regardless of whether they have received PCV7 or PPSV23 in the past. In addition, if these children have not previously been vaccinated with the pneumococcal polysaccharide vaccine PPSV23, they should receive a dose of this vaccine no <8 weeks after their dose of PCV13.

ÂÂ Between 2001 and 2009 the number of geriatric

patient visits to U.S. emergency departments (EDs) increased 24.5%, which outpaced the growth in outpatient geriatric visits.

CSI 2014

Proceedings of 66th Annual Conference of Cardiological Society of India Conversations with Giants and Legends in Cardiology

Dr HK Chopra in conversation with Dr Navin C Nanda, USA PLEASE SHARE THE RECIPE OF SUCCESS TOWARDS ATTAINING THE TITLE OF “WORLD FATHER OF ECHO” WITH OUR AUDIENCE First of all, I am most humbled that on behalf of the CSI you have included me in the Giants and Legends in Cardiology in the world and have called me the World Father of Echocardiography. To answer your first question, hard work, dedication and innovation are the three most important aspects for success in any field including echocardiography. To master a technique and attain thoroughness, it is most important to pick up some research projects because this will make you search the internet and digest all the information published in the world on the subjects concerned and will spur your mind to develop innovative strategies. You will have a very clear concept of what is lacking and what needs to be worked on. Humility is also important. I remember once at a farewell dinner for a young Fellow who had worked with me for a long time, he mentioned to my wife Kanta that “after having worked with Dr Nanda for a long time and learning everything from him I have become an expert in the technique and now I know everything about echocardiography” to which my wife replied “that is really fantastic because your teacher Dr Nanda complains all the time he is still learning echocardiography and there is so much more to imbibe and grasp!”

I also remember a Fellow who worked very hard on a project involving 2- and 3-D echo assessment of LV noncompaction and when he went for an interview for a Residency position he was queried on any research he

had done. At that time not too many people knew about LV noncompaction and the Fellow began explaining the lesion. The Program Director was so impressed with his knowledge that he asked him to give a lecture to all physicians and residents that afternoon on the subject.

Having learnt and fully grasped the subject because he had done research on it, the Fellow was able to give a masterly presentation and was immediately selected for the position. He is now a fully fledged cardiologist.

HOW DID YOU CHOOSE ECHOCARDIOGRAPHY AS YOUR CAREER? I learnt cardiology from Dr KK Datey and Dr Ivan Pinto and their team at Seth GS Medical College and King Edward Memorial Hospital in Mumbai, then relearnt it at the Institute of Cardiology and National Heart Hospital in London where I was selected as a Fellow and again had to relearn when I went to Rochester, New York.

Having thus gained some knowledge of conventional cardiology, I began to look for newer techniques which I could learn. At that time, I came across a 4-6 page paper which contained all the information available on the newly developed technique of echocardiography and found that it could noninvasively image the mitral, aortic and tricuspid valves but not the pulmonary valve because it was believed to be located under the left lung.

As a cardiology fellow, I had to attend some autopsies and talking with pathologists found the pulmonary valve was not located under the lung, especially in patients with a dilated pulmonary artery. This spurred me to make efforts to use echocardiography to find the pulmonary valve and together with Dr Raymond Gramiak, a radiologist, we succeeded in finding it. With this innovative landmark development, all the four cardiac valves could now be studied by echocardiography and this tremendously helped in the further growth of echocardiography. It also spurred the development of pediatric echocardiography since now potentially fatal conditions such as transposition of the great vessels could be diagnosed by this modality. The first papers on the subject were published from our Lab and I remember often being called at night to make the

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CSI 2014 diagnosis or exclude transposition in newborn cyanotic infants. Once the pulmonary valve was found, it became important to publish the findings as quickly as possible.

Dr Gramiak, being a radiologist had some connection with a Radiology Journal and thought he might be able to publish it in that journal very quickly especially if he put his name and not my name as the first author.

I agreed to this and that is the reason the paper was published in a radiology and not a cardiology journal.

After publication of this paper, I had to travel to many centers in USA and other countries to teach cardiologists the echo technique of imaging the pulmonary valve and also had many cardiologists spend time with me in our Laboratory from many centers including the Mayo clinic. These developments encouraged me to devote my career to echocardiography and contribute to its further growth and it is heartening to know it is currently the most cost-effective noninvasive technique in the field of cardiology.

HOW MANY BOOKS AND ORIGINAL PAPERS OF ECHOCARDIOGRAPHY HAVE YOU PUBLISHED TILL DATE? The number of publications exceeds >1000, of which over 500 are original research papers. The number of books and video-textbooks exceed 20 including the latest one titled “Comprehensive Textbook of Echocardiography” which is in 2 volumes with 2,000 pages, over 3,000 illustrations and 8 DVDs containing 1,800 movie clips. This is probably the largest and most comprehensive manual on echocardiography to-date covering all aspects and is published under the aegis of the Indian Academy of Echocardiography and the International Society of Cardiovascular Ultrasound.

Some of the research done by me: ÂÂ First

to discover the pulmonary valve by echo. This led to the development of pediatric echocardiography.

ÂÂ First to diagnose a bicuspid aortic valve by echo. ÂÂ First

to characterize echocardiography.

myocardial

texture

by

ÂÂ Invented treadmill exercise echocardiography.

Pioneered the use of echocardiography in cardiac pacing and electrophysiology.

First to study and show high incidence of MI in young adults in India and also relationship of DM to MI.

WHAT IS THE IMPORTANCE OF RESEARCH? Echocardiography is still a relatively young technique and there is considerable room for further developments and innovations in many areas including three- and four -dimensional echocardiography, speckle tracking imaging, contrast echocardiography and newer aspects of LV and RV function assessment including twist and torsion measurements.

Further innovations on the horizon include plane wave ultrafast imaging with up to 20,000 frames per second, elastography and tissue characterization, miniaturization of transducers and other equipment, therapeutic ultrasound, acoustic-optical imaging and vortex and particle imaging. These will undoubtedly enhance patient care throughout the world.

Young and budding physicians in India should devote a part of their time to research which will not only broaden their general outlook but also ensure in depth mastery of the subject and technique they are trying to learn rather than acquiring only superficial ‘get by’ knowledge. The government as well as other institutions should institute scientific research as part of the curriculum for both undergraduate and postgraduate medical education.

It is also important to make it financially rewarding and competitive for those who choose a career entirely in cardiac research or those who opt to go for both cardiology practice and research as happens in academic institutions realizing this will pave the way for creativity, innovation and progress in cardiology.

If this were to happen, India with its huge population base of young individuals could find itself in the forefront of medical progress in the world.

HOW MANY DOCTORS HAVE BEEN TRAINED BY YOU IN ECHO ACROSS THE GLOBE?

Invented the technique of transpharyngeal and transgastric ultrasound.

It is very difficult to ascertain how many individuals have been trained by me over the past four or five decades or have been influenced in their clinical cardiology practice by the research, publications and books that I have written but their numbers, I am sure, run into thousands.

Developed the technique of 3- and 4-D transesophageal echocardiography.

Thank you Dr Nanda, for sparing your valuable time to be with us at this conference.

ÂÂ Introduced color Doppler to the USA. Developed

currently used criteria for semi-quantitation of mitral, aortic and tricuspid valve regurgitation.

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

MEDILAW

High Risk Consent and Other Issue Related to Consent KK AGGARWAL

Is it necessary to take high-risk consent for an angiography procedure?

best in an ST-elevation myocardial infarction (STEMI).

Not giving this option may amount to malpractice.

Yes, it is necessary to take high-risk consent for an angiography procedure.

Study: Second-generation cobalt-chromium everolimuseluting stents are the best stents for patients with STEMI, according to a new meta-analysis published in J Am Coll Cardiol 2013;62(6):496-504. These stents represent a substantial advance in terms of both patient safety and efficacy compared to both bare-metal stents (BMS) and first-generation (drug-eluting stents).

“The MCI Ethics Committee considered the appeal against the order dt. 14.09.2011 passed by Orissa Medical Council and treating doctors who appeared before the Ethics Committee on 17.03.2012.

The Ethics Committee after hearing both the parties and going through the available records, decided that the treating Cardiologist had not given the highrisk informed form to the patient/attendant of the patient, which was a necessary procedure in this case (angiography). The Consent Form was also found not in order, since it did not carry the signature of the patient who was conscious throughout this procedure. It was felt that such a high-risk patient deserved to be kept in ICCU with intensive care unit facilities for cardiac patient. It was decided that treating cardiologist was negligent as a treating physician and his name should be removed from the Medical Register for a period of 03 (three) months starting from the date of issue of the letter.” Appeal against order dated 14.09.2011 passed

by Orissa Medical Council filed by the complainant.

(F.No.466/2011).

Can the hospital management decide the type of stent to be put in a patient?

No, the hospital management cannot decide the type of stent to be put in a patient. Informed consent is the rule for any procedure and it includes consent about the procedure, implant or devise and risk vs benefits. The doctor’s job is to enlist the options along with risk and benefits and let the patient be a part of the decisionmaking. For example, a recent meta-analysis has shown that cobalt-chromium everolimus-eluting stents are the

Senior Physician and Cardiologist, Moolchand Medcity, New Delhi Member, Ethics Committee, Medical Council of India

The meta-analysis included 22 trials with 12,453 randomized patients who received sirolimuseluting stents, paclitaxel-eluting stents, the Endeavor phosphorylcholine-based zotarolimus-eluting stent or the Xience cobalt-chromium everolimus-eluting stent (the only second-generation drug-eluting stent evaluated).

At 1 year, compared to bare-metal stents, the cobaltchromium everolimus-eluting stent was associated with significantly lower rates of cardiac death/myocardial infarction (odds ratio [OR] 0.65), myocardial infarction (OR 0.55), definite stent thrombosis (OR 0.32) and definite/probable stent thrombosis (OR 0.36) and the sirolimus-eluting stents were associated with significantly lower rates of cardiac death/myocardial infarction (OR 0.70).

Can a PCI be done after taking consent only for angiography?

A percutaneous coronary intervention (PCI) cannot be done after taking consent only for angiography, unless it is a life-saving procedure. In a case decided

by Supreme Court of India, SCI, Civil Appeal No. 1949 of 2004, 16.01.2008, Samira Kohli vs Dr. Prabha Manchanda and Anr, B.N. Agrawal, P.P. Naolekar and R.V. Raveendran, JJ, the following was observed: “Further a consent for hysterectomy, is not a consent for bilateral salpingo-oophorectomy.” “(A) It is customary, except in emergency or extraordinary circumstances, that no substantial procedures are performed upon a patient unless and until he or she has had an opportunity to

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

689

MEDILAW discuss them with the physician or other health professional to the patient’s satisfaction.

ÂÂ

My doctors has supported all his plan with scientific literature

(B) Each patient has right to consent, or to refuse consent, to any proposed procedure of therapeutic course.”

ÂÂ

All the data in the form has been filled up in my presence

ÂÂ

I have not hidden any information from my doctors.

One must anticipate a complication or need for a procedure and take advanced consent or take it on the table before proceeding further.

What things should be checked in case of a dispute regarding consent? ÂÂ Medical consent ÂÂ High-risk medical consent ÂÂ

Surgical consent

ÂÂ

High-risk surgical consent

ÂÂ

Implied consent

ÂÂ

Informed consent: Whether all components are present or not

ÂÂ

Overwriting in consent

ÂÂ

Role of witness

ÂÂ

Who has given consent: Patient/Spouse/Guardian if minor

ÂÂ

Signature on each page

ÂÂ

Extended consent

ÂÂ

Negative consent

What are the model contents of a consent form?

The contents of a consent form include the following: ÂÂ

Name of the patient/Age/Sex/Bed number/Hospital number

ÂÂ

Day and time

ÂÂ

Consent given by Patient/Spouse/Parents, if minor

ÂÂ

Witnesses present.

ÂÂ

Following issues have been addressed: Diagnosis, proposed treatment with its risks and benefits, alternative treatments with its risk and benefits.

ÂÂ

I have been told specific risks and benefits as under:

ÂÂ

I have been communicated in my own language.

ÂÂ

I agree with the explained plan and give my consent.

ÂÂ

All my queries have been answered.

ÂÂ

I am giving my extended consent for the following …………

ÂÂ

If I develop any complications I hereby authorize ………. to take all decisions on my behalf.

690

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

What is a model medical (nonsurgical) consent form?

I ……………………S/o, D/o, W/o ………………………….. hereby give my consent for the following: I will be treated by a team of ………………and ………………….. along with a team of doctors assigned by the hospital including a critical care team from the hospital and I have been explained in my own language about the following by the treating doctors: 1. Plan about the disease, investigations, treatment and discharge plan.

2. I have been explained about the cost incurred at each level.

3. I have been explained about the credit and/or Mediclaim bills in which many ancillary items may not be reimbursed (like cost of consumables), for which I may be billed directly.

4. I have been explained that my doctors will not be responsible if any faulty information has been provided by me, while filling Mediclaim or credit bill case forms.

5. I have been explained that any test done for illness for which I am not admitted may not be covered

by Mediclaim or credit bill establishment.

6. Kindly communicate about my illness to me or ……….……….……….…......……. in my absence.

7. In case I become serious, I assign Mr./Mrs .……….……….………...........………. to give consent on my behalf.

8. In case I am not satisfied by any service, I will inform/complain to my primary treating doctor on the same day.

9. I understand that my primary doctors are honorary doctors/ paid hospital doctors.

10. During emergency and in the odd hours a team of hospital doctors will look after me including a team of ICCU or critical care consultants on call.

MEDILAW 11. It may be possible that in emergency my primary doctor/s may not be available in the hospital premises.

12. That all decisions regarding my treatment are taken or informed to my primary doctors but emergency decisions may be taken by the hospital provided doctors and/or consultants.

13. That the fee charged by the hospital doctors or critical care doctors will be separate.

14. That my primary doctors may call other specialists and other consultants for more opinions, cross opinions or management help depending upon the need.

15. That all the investigative facilities may not be available in the hospital and for some, the patient

after informing the relatives, may need to be shifted to some other diagnosis facility.

16. That normally my primary doctors will charge for two visits but in serious cases, ICU cases, diabetics on sugar monitoring, uncontrolled hypertension, etc. the charges may be for one extra emergency visit.

17. You can contact on phone your primary doctors in case of any emergency situation. For regular query you can contact room no ………. from 9 am to 4 pm.

Witness 1:………………

Witness 2:……………….

■■■■

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

691

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INSPIRATIONAL STORY

Small Victories

S

tanding in the noisy cafeteria of the old school, I was watching the students line up for lunch.

Having wearied of trying to “cut” in line on each other, they were intently moving toward the food. As I continued to watch their progress, I began to remember scenes from my own grade school days. This old school building was somewhat similar to mine.

anger. As I moved through the room, I stopped by each child to check on progress and to help with work. Lee was working with educational coloring sheets and I let him work on his pictures in sequence rather than finishing one at a time. Doing a part of each until all were completed seemed to suit his temperament. He began to smile as if he and I shared a huge joke.

I could still remember coming into the warm building with the funny smells of furnace heat and cleaning liquids. I visualized the rooms, heated with oldfashioned steam pipe radiators and the hand-turn heat regulators. I could picture the Spartan desks in long straight rows, with scratched and scared surfaces and the small cloak closets with wood doors folding in along the back of the room.

This time, I did not have lunch duty, so I lined the children up and led them to the cafeteria where another teacher took charge of their progress through the line.

I went back to the room to check each child’s work again and eat a quick sandwich. In fifteen minutes, Lee was back in the room, unable to eat lunch again, having left the cafeteria without permission. I gave him some money, the cost of an alternate lunch and walked him down to the cafeteria. At the end of lunch, Lee was back in the room with the young man assigned to the room as psychological counselor. Evidently, a cafeteria supervisor sent him to be counseled about his difficulties with eating.

“Teacher,” a small hand tugged my wrist, “I can’t eat my lunch,” complained a small Asian American boy, standing behind me. My thoughts abruptly returned to the present in the cafeteria of the old school where I was substitute teaching.

“What’s wrong?” I replied as I watched the last of the lunch line disappear into the kitchen. “Why not?” I asked as I turned to face the cafeteria at large.

“Jamal and Anthony keep poking at my food. I don’t want to eat it!”

Making my way to his lunch table, I took up Lee’s cause. I admonished the children, “Keep your hands to yourselves and eat properly!” My repeated warnings went unheeded, and I began to move the children to different spots at the table. To no avail--as soon as Lee sat down, the pestering began again. As the hearty children began finishing their food, I urged Lee to go back to the kitchen to get a second lunch, promising I would speak to the cooks for him. When I went out to playground duty, he was still sitting in front of his second tray, picking at the food. I tried not to worry about the thin child because I remembered that I had not always eaten my cafeteria lunches and I survived.

I substituted frequently at this school, and in a few weeks, I was back in Lee’s small class. Both the teacher and the assistant were absent. The children in this room had some learning difficulties and each child had different instructions and activities. I soon realized that Lee had a problem with staying on task and with

Slowly, with shyness and pride, he handed me my money back and told me what he and the counselor had rehearsed. “Thank you, Mrs. Grishan (his pronunciation), but my mom and dad will not let me accept money. They provide my food.”

I smiled, accepted the money and watched Lee go with the counselor for further discussion. When he returned, the counselor stayed with him to keep him sweet and on task.

Later in the year, I was back at the same school to substitute with a large fourth grade class for a week.

The day I had lunch duty, I noticed as I glanced quickly around the cafeteria that Lee’s table was at peace. They were eating quietly and were not teasing each other.

Lee was eating too and as he looked at me intensely, I glanced away because I did not want to interfere with his concentration on his food. I know, though, that I was smiling and my heart was singing. I thought of the phrase, “all the little children of the world, brown and yellow, black and white,” and these precious children were all getting along just fine. I knew that major work by persistent teachers, a dedicated counselor, fine administrators, and parents willing to partner with the school had wrought a change in the life of these troubled children.

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

693

LIGHTER READING

LAUGH-A-WHILE

Lighter Side of Medicine But the boy was not to be stopped and carried the detergent to the counter and paid for it, even as the grocer still tried to talk him out of washing his dog.

TROUBLE ON THE ROOF Mike and Rob were laying tiles on a roof when a sudden gust of wind came and knocked down their ladder.

About a week later the boy was back in the store to buy some candy. The grocer asked the boy how his dog was doing.

“I have an idea,” said Mike. “We’ll throw you down, and then you can pick up the ladder.”

“What, do you think I’m stupid?” Rob replied.”

I have an idea. I’ll shine my flashlight, and you can climb down on the beam of light.”

“Oh, he died,” the boy said.

The grocer, trying not to be an I-told-you-so, said he was sorry the dog died but added, “I tried to tell you not to use that detergent on your dog.”

“What, do you think I’m stupid?” Mike answers.

“You’ll just turn off the flashlight when I’m halfway there.”

“Well,” the boy replied, “I don’t think it was the detergent that killed him.”

“Oh? What was it then?”

Santa calls up the doc at 2 AM. “Doc, my wife is having severe abdomen pain. I think it’s her appendix.”

“I took out your wife’s appendix 2 years ago. Go back to sleep.”

Five minutes later, the phone rings and it’s Santa again.

“Doc, I’m sure it’s her appendix.”

“Oh God!” the doctor groaned.

“Did you ever hear of anyone having a second appendix?”

QUOTES

“What nonsense!” says the doc sleepily.

“I think it was the spin cycle!”

“Happiness is the meaning and the purpose of life, the whole aim and end of human existence” –Aristotle

Dr. Good and Dr. Bad SITUATION: A patient with acute pulmonary edema had a blood pressure of 240/140.

“No...,” says Santa. “But I’m sure you must have heard of someone having a second wife!!!!”

DOG WASHING

It is due to heart damage

It is due to diastolic heart failure

©IJCP Academy

A young boy, about 8 years old, was at the corner Mom & Pop grocery picking out a pretty good size box of laundry detergent. The grocer walked over and trying to be friendly, asked the boy if he had a lot of laundry to do.

“Oh, no laundry,” the boy said, “I’m going to wash my dog.”

“But you shouldn’t use this to wash your dog.

It’s very powerful and if you wash your dog in this, he’ll get sick. In fact, it might even kill him.”

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Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

LESSON: Patients with significant elevation of blood pressure have mostly preserved left ventricular systolic function.

KK Aggarwal

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. 25, No. 7, December 2014

695

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.

–

696

The legend must include enough information to permit interpretation of the figure without reference to the text.

Indian Journal of Clinical Practice, Vol. 25, No. 7, December 2014

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

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Their world awaits CONFIRM-HF

Ferric CarboxymaltOse evaluatioN on perFormance in patients with IRon Deficiency in coMbination with chronic Heart Failure

Ferinject® improves 6MWT distance at week 243 LSM change in 6MWT distance from baseline (m)

30

P=0.002

20 10 0 -10 -20 -30

week 24

Ferinject (N=150) Placebo (N=151)

Ferinject® consistently and significantly improves (33 +11 m) 6MWT distance compared to placebo Improvement in the 6MWT distance was observed across all subgroups, including patients with and without anaemia Ref: 1. Ferinject Summary of Product Characteristics. 2. Kulnigg S et al. Am J Gastroenterol 2008; 103:1182-92.

3. Ponikowski P, et al. Eur Heart J 2014 Aug 31. pii: ehu385 [Epub ahead of print]

ferric carboxymaltose

Abridged Prescribing Information: Indications: For treatment of iron deficiency in adults when oral ironpreparations are ineffective or cannot be used.

Dosage & Administration: The cumulative dose for repletion of iron using Ferinject is determined based on the patient's body weight and haemoglobin level and must not be exceeded. A single dose should not exceed 1000 mg of iron/day. Do not administer 1000 mg of iron more than once a week. Ferinject may be administered by IV injection using undiluted solution up to 1000 mg iron (up to a maximum of 15 mg/kg body weight). Ferinject may also be administered by IV infusion up to a maximum single dose of 1000 mg of iron (up to a maximum of 20 mg/kg body weight). Before administering, diagnosis of iron deficiency must be done based on laboratory test, must be administered only by the IV route: by bolus injection, or during a haemodialysis session undiluted directly into the venous limb of the dialyser, or by drip infusion. In case of drip infusion Ferinject must be diluted only in sterile 0.9% m/V NaCl. Contraindications: Hypersensitivity to Ferinject or any of its excipients, anaemia not attributed to iron deficiency. Warnings & Precautions: Parenterally administered iron preparations can cause hypersensitivity reactions including anaphylactoid reactions, facilities for cardio-pulmonary resuscitation must be available; If allergic reactions or signs of intolerance occur during administration, the treatment must be stopped immediately; In patients with liver dysfunction, should only be administered after careful risk/benefit assessment; should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda (PCT); Careful monitoring of iron status is recommended to avoid iron overload; must be used with caution in case of acute or chronic infection, asthma, eczema or atopic allergies; should be stopped in patients with ongoing bacteraemia; In patients with chronic infection a risk/benefit evaluation has to be performed, taking into account the suppression of erythropoiesis; Caution should be exercised to avoid paravenous leakage when administering Ferinject. One ml of undiluted Ferinject contains up to 5.5 mg (0.24 mmol) of sodium, to be taken into account in patients on a sodium-controlled diet. One ml of undiluted Ferinject contains maximally 75 ì g aluminium, should be considered in the treatment of patients undergoing dialysis.

Pregnancy: Iron st deficiency occurring in the 1 trimester can in many cases be treated with oral iron. If the benefit of Ferinject treatment is nd rd judged to outweigh the potential risk to the fetus, it is recommended that treatment should be confined to the 2 and 3 trimester. Lactation: It is unlikely that Ferinject represents a risk to the nursing child. Pediatric Use: Not recommended. Geriatric Use: The dosing schedule not associated with any significant concerns. Undesirable effects: Common: Headache, dizziness, nausea, abdominal pain, constipation, diarrhoea, rash, injection site reaction, transient blood phosphorus decreased, alanine aminotransferase increased.

Full Prescribing Information is available on request.