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Indian Journal of

CLINICAL PRACTICE 1-52 Pages

June 2011

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Volume 22, Number 1

Extensive Osteolytic Bone Lesion and Progressive Renal Failure in Multiple Myeloma: An Unusual Presentation

Dr KK Aggarwal

Group Editor-in-Chief

Head Office: E - 219, Greater Kailash, Part - 1, New Delhi - 48, India. e-Mail: emedinews@gmail.com, Website: www.ijcpgroup.com

emedinews is now available online on www.emedinews.in or www.emedinews.org From the Desk of Editor in Chief Padma Shri and Dr BC Roy National Awardee

Dr KK Aggarwal

President, Heart Care Foundation of India; Sr Consultant and Dean Medical Education, Moolchand Medcity; Member, Delhi Medical Council; Past President, Delhi Medical Association; Past President, IMA New Delhi Branch; Past Hony Director. IMA AKN Sinha Institute, Chairman IMA Academy of Medical Specialities & Hony Finance Secretary National IMA; Editor in Chief IJCP Group of Publications & Hony Visiting Professor (Clinical Research) DIPSAR

9th June 2011, Thursday Surprising findings on omega-3 fats, trans fats, and prostate cancer risk For men who are concerned about their prostate health, one consistent recommendation over the years has been to add to their diets healthy fats, like the omega-3 fats found in fatty fish, and to cut back on unhealthy fats, like trans and saturated fats. A report in the American Journal of Epidemiology muddies the waters on this.

A study of men taking part in the nationwide Prostate Cancer Prevention Trial found a link between high intake of heart-healthy omega-3 fats and increased risk of developing aggressive, high-grade prostate cancer, while high intake of artery-damaging trans fats was linked to a lower risk. Should these results prompt men to scale back on fish and eat more processed food? No. Experts I talked with recommend staying the course when it comes to dietary fats (Suzanne Rose, Editor, www.HarvardProstateKnowlege.org ).

Dr KK Aggarwal Editor in Chief ———————————————————————————— Radiation levels will now be displayed on handsets: Sachin Pilot The Indian government has announced new guidelines for handset makers and telecom tower manufacturers in light of health concerns related to radiation from cell phone towers and devices. This follows a World Health Organisation (WHO) report stating radiation from cell phone towers and devices may lead to cancer. The inter–ministerial group set up by the Department of Telecommunications (DoT) in August 2010 has submitted its final report on the new regulations.

According to the group, mobile handsets have to now mandatorily declare the radiation levels. It has also proposed revising the limit of 2 watts per kilogram averaged over 10 grams tissue to 1.6 watts per kilogram averaged over 1 gram tissue. For mobile towers, the group has suggested strict radiation norms, shifting from the current range of ‘safe power density’ of f/200 watts per square meter (ICNIRP guidelines) to f/2000 watts per square meter. In a press release, the Union Minister of State for Communications and Information Technology Sachin Pilot said that while telecom is a huge success story in India, any possible health related effects of radiation emitted by mobile phones and towers are to be reflected and ensured in the guidelines.

—Source: http://techcircle.vccircle.com/500/radiationlevels-will-now-be-displayed-on-handsets-sachin-pilot/, June 6, 2011)

Waist size is a better predictor of health, especially in heart patients Research studies and health experts have long predicted that waist size is a better way to estimate heart disease and mortality risk than BMI. Now a new review article published in the Journal of the American College of Cardiology adds to the list of evidence in favor of measuring waist size. The article, which reviews and analyzes results from several major studies, declares that waist size provides a far more accurate way to predict a heart patient’s chances of dying at an early age from a heart attack or other causes. Researchers from the Mayo Clinic analyzed data from just under 16,000 heart patients who had participated in previous studies. More than one-third of the patients died during the studies, which lasted from six months to eight years. The researchers found that heart patients with a high ratio of waist-to-hip circumference or a large waist size (greater than 35 inches for women or greater than 40 inches for men) were 70 percent more likely to die during the study period than those with smaller waists. The combination of a large waist and a high BMI upped the risk of death even more, indicating that overall body weight does play

a part, although it’s to a lesser extent. In order to keep your waistline down, aim to exercise or be active on most days of the week. −Contributed by Rajat Bhatnagar, International Sports & Fitness Distribution, LLC, http://www.isfdistribution.com

Spiritual Update Hanuman Chalisa?

IJo Sat Baar Paath Kar Koi Chhutahi Bandi Maha Sukh Hoi Meaning: By repeating this mantra one hundred times, one is liberated by all problems and obtains unlimited happiness.

Spiritual Significance: By repeating this process of meditative pranayama with the bija sound one hundred times one gets liberated of all reversible sicknesses and acquires unlimited happiness..

Infertility Update What is a typical IVF calendar?

The sequence of events depends on the treatment protocol that has been planned for you. Usually OPD-based injections are started on Day 20 of previous menses, further gonadotrophins with follicular monitoring and blood tests start from 2nd day of menses for about 10 days. You may need daycare admission for oocyte retrieval as you will be administered anesthesia. Two days later you will come back for Embryo transfer which is an OPD USG-guided procedure.

In a different protocol, stimulation starts from Day 2/3 of period and collection is done around day 15 after 10-12 days of stimulation.

—Dr. Kaberi Banerjee, Infertility and IVF Specialist Max Hospital; Director Precious Baby Foundation

SMS of the Day Always keep hoping for good, as a famous Japanese thought says.

“Keep a green tree in your heart, the singing birds will automatically come.”

—Dr GM Singh

Medi Finance Update There is no tax return for salary and interest income up to Rs 5 lakh. In India, as many as 85 lakh salaried tax payers whose taxable income, including salary and interest income, is up to Rs 5 lakh, are not required to file income–tax return from now onwards.

Laugh a While Lovely Girl An Army driver was chauffeur to a Major who was a notorious womanizer. One day, the major saw a lovely girl. “Turn the car around,” he ordered. The driver promptly stalled the car. By the time he had re–started it the girl had vanished. “Driver,” said the major, “you’d be a total loss in an emergency.” “I thought I did pretty well,” the driver said. “That was my girl.”

—Dr GM Singh

IMSA Update International Medical Science Academy (IMSA) Update Safety guidelines for atypical antipsychotic medications in children With exception of using risperidone (i.e., for the management of irritability associated with Autism, manic and mixed episodes associated with Bipolar I Disorder, and Schizophrenia) and aripiprazole (i.e., for manic and mixed episodes associated with Bipolar I Disorder and Schizophrenia), the Food and Drug Administration (FDA) has not approved the use of AAMs in children and adolescents.

(Ref: McKinney C, Renk K. Atypical antipsychotic medications in the management of disruptive behaviors in children: Safety guidelines and recommendations. Clin Psychol Rev 2010 Nov 18. Epub ahead of print)

Indian Journal of

Online Submission

Clinical Practice

Volume 22, Number 1, June 2011

Contents

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

Dr KK Aggarwal CMD, Publisher and Group Editor-in-Chief

From the Desk of Group Editor-in-Chief

Bottle-to-scalpel Time: A New Surgical Parameter for Laparoscopic Surgeons KK Aggarwal

Dr Veena Aggarwal Joint MD & Group Executive Editor Anand Gopal Bhatnagar Editorial Anchor IJCP Editorial Board Dr Alka Kriplani Asian Journal of Obs & Gynae Practice

INFECTIOUS DISEASE

Prevalence of HIV Cases in a Tertiary Care Hospital in North India

Dr Swati Y Bhave Asian Journal of Paediatric Practice Dr Vijay Viswanathan The Asian Journal of Diabetology Dr KMK Masthan Indian Journal of Multidisciplinary Dentistry Dr M Paul Anand, Dr SK Parashar Cardiology Dr CR Anand Moses, Dr Sidhartha Das Dr A Ramachandran, Dr Samith A Shetty Diabetology Dr Ajay Kumar Gastroenterology Dr Koushik Lahiri Dermatology Dr Georgi Abraham Nephrology Dr Sidharth Kumar Das Rheumatology Dr V Nagarajan Neurology Dr Thankam Verma, Dr Kamala Selvaraj Obs and Gyne Advisory Bodies Heart Care Foundation of India Non-Resident Indians Chamber of Commerce & Industry World Fellowship of Religions

7

Pooja Gupta, Deepak Arora, Kashish Gupta, Pooja Arora, Rajiv Chawla

Dr VP Sood Asian Journal of Ear, Nose and Throat Dr Praveen Chandra Asian Journal of Clinical Cardiology

5

Review article

Acute Otitis Media: Role of Cefaclor

11

VP Sood

original study

Efficacy of Turmeric Capsules on Metabolic Management in Type 2 Diabetes Mellitus

17

Prabir Kumar Kundu, Madhuchhanda Mandal, Rajyasree De, Ujjwal Bhattacharya, Ramaprasad Goswami

clinical review

Role of Prebiotics and Probiotics in the Treatment of Gastroenteritis

23

Pravin M Rathi, Sandeep B Bhete

Clinical Study

A Case-control Study of Pelvic Inflammatory Disease and Its Association with Multiparity SV Patel, RK Baxi, PV Kotecha, VS Mazumdar, HN Bakshi, KG Mehta

28

Indian Journal of

Clinical Practice

Volume 22, Number 1, June 2011

Contents

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

Case Study

BMIs and Self-perception of Weight and Height among Adolescent Students in Rural Area of Vadodara

Printed at Pavitra Printers, New Delhi E-mail: pavitraprint86@gmail.com

32

PV Kotecha, Sangita V Patel, VS Mazumdar, RK Baxi, Shobha Misra, Harsh Bakshi, Mansi Diwanji, Ekta Modi, Kedar Mehta

Š Copyright 2011 IJCP Publications Pvt. Ltd. All rights reserved.

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 Pvt. Ltd. No part of this publication may be published in any form whatsoever without the prior written permission of the publisher.

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.

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.

case report

Extensive Osteolytic Bone Lesion and Progressive Renal Failure in Multiple Myeloma: An Unusual Presentation

40

K Gantait, I Nayak, CL Bhunia

emedinews section

From eMedinewS

42 Photo quiz

Linear Lesions in a Neonate

45

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From the Desk of Group Editor-in-Chief Clinical Practice

Bottle-to-scalpel Time: A New Surgical Parameter for Laparoscopic Surgeons

Dr KK Aggarwal

Padma Shri and Dr BC Roy National Awardee Sr. Physician and Cardiologist, Moolchand Medcity President, Heart Care Foundation of India Group Editor-in-Chief, IJCP Group Editor-in-Chief, eMedinewS Chairman Ethical 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)

A

new study published in April issue of Archives of Surgery has shown that experienced laparoscopic surgeons’ operating skills remain impaired as late as 4 p.m. the day after a drinking binge. The study was conducted by Anthony G. Gallagher, PhD, of the National Surgical Training Center, Royal College of Surgeons in Dublin, Ireland.

There are no rules or guidelines to govern consumption of alcohol the night before operative duties or to permit clear-cut recommendations for a ‘bottle-to-scalpel’ interval to be made. Alcohol consumption has acute effects on performance, but little information is available on persistence of the effects. Both acute and late effects of alcohol consumption have particular relevance to laparoscopic surgery, because the technique places considerable demands on cognitive, perceptual and visuospatial abilities - all known to be vulnerable to the effects of alcohol.

The authors conducted two small studies involving use of a virtual reality training system for minimally invasive surgery, recruiting 16 science students and eight experienced laparoscopic surgeons. The effects of alcohol on nextday performance were observed in both surgical novices and experienced surgeons.  In the first study, the 16 students (laparoscopic novices) were randomized to abstain from alcohol or to consume alcohol until subjectively intoxicated.  In the second study, the eight expert laparoscopic surgeons had dinner and drank until they felt intoxicated.  Participants in both studies completed a baseline test in the surgical simulator prior to their night out. The test consisted of six increasingly complex tasks commonly performed by laparoscopic surgeons. The eight surgeons’ blood alcohol levels were assessed by a breathalyzer immediately prior to beginning the performance phase of the study. One surgeon still had a blood alcohol level that exceeded the legal limit for driving.  The primary outcomes of both studies were the time to complete the tasks, mean number of errors per task and efficiency of diathermy (mean burn time divided by optimal burn time). All participants completed the performance test three times: 9 a.m., 1 p.m. and 4 p.m.

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

from the desk of group editor-in-chief 







In the first study, the students who abstained from alcohol and those who drank until they felt intoxicated had similar time scores. However, the alcohol group had significantly worse performance on diathermy (p = 0.03) and made significantly more errors (p = 0.003). An analysis of performance by time of day showed that the alcohol group required more time to complete the tasks at all test times, but the differences reached statistical significance only at 9 a.m. The authors attributed that finding to wide variability in the drinkers’ performance.

In the second study, the surgeons completed the tasks faster during the second assessment than during the baseline assessment. Their performance time was significantly worse at 1 p.m. (p < 0.01) and returned to baseline levels by 4 p.m. The surgeons’ economy-of-diathermy scores deteriorated as the day progressed (p < 0.001), and they performed significantly worse at all three test times compared with baseline (p < 0.05 to p < 0.01). Error scores also differed significantly from baseline (p < 0.001). The surgeons made more errors at all three test times compared with the baseline test results, but the difference reached statistical significance only a 1 p.m. (p < 0.001).

The amount of alcohol consumed by each individual and actual blood alcohol levels were not measured in either study.

Given the considerable cognitive, perceptual, visuospatial and psychomotor challenges posed by modern image-guided surgical techniques, abstinence from alcohol the night before operating may be a sensible consideration for practicing surgeons. n

n

n

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

INFECTIOUS DISEASE

Prevalence of HIV Cases in a Tertiary Care Hospital in North India Pooja Gupta*, Deepak Arora**, Kashish Gupta†, Pooja Arora‡, Rajiv Chawla#

Abstract The most common cause of human immunodeficiency virus (HIV) disease throughout the world is HIV-1, first identified in West Africa. This disease is now a leading cause of death among men and women under 45 years old and of children under five years. The HIV/acquired immunodeficiency syndrome (AIDS) epidemic has devastated many individuals, families and communities. Our aim was to study the groups of people who are most affected and also the ongoing trend of HIV affection in relation to sex and age and also the symptomatology in patients. Results showed that HIV still continues to affect sexually active and economically productive age group; there seems to be an increase of HIV in females and gap between male and female is narrowing. As far as mode of spread is concerned, visit to commercial sex workers i.e., heterosexual sex and IV drug usage top the list. Fever and cough are the commonest symptoms of AIDS presentation. HIV has spread from high-risk groups to low-risk ones and has affected all segments of population.

Key words: Human immunodeficiency virus, injecting drug users

I

ndia is one of the largest and most populated countries in the world, with over one billion inhabitants. Of this number, it’s estimated that around 2.3 million people are currently living with HIV.1 Human immunodeficiency virus (HIV) emerged later in India than it did in many other countries.

Infection rates soared throughout the 1990s, and today the epidemic affects all sectors of Indian Society, not just the groups - such as sex workers and truck drivers - with which it was originally associated.

At the beginning of 1986, despite over 20,000 reported acquired immunodeficiency syndrome (AIDS) cases worldwide,2 India had no reported cases of HIV or AIDS but later in the year, India’s first cases of HIV were diagnosed among sex workers in Chennai, Tamil Nadu.3 It was noted that contact with foreign visitors had played a role in initial infections among sex workers. Most of the initial cases had occurred through heterosexual sex, but at the end of the 1980s a rapid spread of HIV was observed among injecting drug users (IDU) in Manipur, Mizoram and Nagaland - three northeastern states of India bordering Myanmar (Burma).4 *Assistant Professor **Associate Professor †Eye Surgeon ‡Dental Surgeon #Immunologist Dept. of Microbiology, Adesh Medical College, Bathinda Address for correspondence Dr Pooja Gupta Assistant Professor, Dept. of Microbiology, Adesh Medical College, Bathinda E-mail: dr_poo1953@sify.com

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

In later years the trend changed. Throughout the 1990s, it was clear that although individual states and cities had separate epidemics, HIV had spread to the general population. Increasingly, cases of infection were observed among people that had previously been seen as ‘low-risk’, such as housewives and richer members of society.5 In 2008, the figure was confirmed to be 2.5 million,6 which equates to a prevalence of 0.3%. While this may seem a low rate, because India’s population is so large, it is third in the world in terms of greatest number of people living with HIV. With a population of around a billion, a mere 0.1% increase in HIV prevalence would increase the estimated number of people living with HIV by over half a million.

As the epidemic evolves further, rates will continue to rise in communities and nations where poverty, social inequalities and weak health infrastructures facilitate spread of the virus. The estimate of 5.7 million HIVinfected people in India (in year 2006), as compared with 5.5 million in South Africa, has captured wide attention. However, it remains uncertain if India has more infected people than any other country. National AIDS Control Organization (NACO) and Ministry of Health and Family Welfare, Government of India in 2005 declared six states (Andhra Pradesh, Karnataka, Maharashtra, Manipur, Nagaland and Tamil Nadu) as high prevalence areas (defined by a rate of HIV positivity of >1% among women visiting prenatal clinics and a rate of >5% among patients visiting clinics for sexually transmitted disease (STD).1 The present

Infectious disease study was conducted in Dept. of Microbiology, Adesh Institute of Medical Sciences and Research, Bathinda.

As this Institute is the only apex hospital in the region, the information gathered from attendees of this center may throw light on the epidemiology of HIV.

Table 1. Distribution of HIV as per Sex

Material and Methods

Table 2. Distribution of HIV as per Age

All the suspected patients were screened by enzymelinked immunosorbent assay (ELISA) technique using enzyme immunoassay (EIA) Kit provided by Ortho Diagnostics. The present study was conducted in the Dept. of Microbiology, Adesh Institute of Medical Sciences and Research, Bathinda. The study was performed over a period of two years from May 2007 to May 2009. All the HIV positive patients who presented to the hospital and susceptible family members of the HIV positive patients were screened and if found symptomatic and seropositive were included in the study. Fully automatic EIA reader from Johnson and Johnson was used. Two milliliters blood sample was collected under aseptic technique for the same and assayed for HIV status. Cut-off values for labeling HIV patients more than or equal to 0.250 absorbance value for HIV positive patient and less than 0.250 absorbance value for HIV negative patient.

If the first ELISA was positive, second time ELISA was done with the same method but with different kit, J Mitra. Cut-off values more than or equal to 0.240 absorbance in HIV positive, less than 0.240 absorbance was HIV negative. Information regarding the patients was recorded as per the Proforma.

Result and Observations

No. of HIV infected males (%)

No. of HIV Infected females (%)

Total number of cases

18 (36)

50 (100)

32 (64)

Age groups (in years)

No. of HIV infected males (%)

No. of HIV infected females (%)

0-10

1 (3.12)

0 (0.00)

11-20

2 (6.25)

1 (5.56)

21-30

8 (25)

11 (61.1)

31-40

16 (50)

5 (27.8)

41-50

4 (12.5)

1 (5.56)

51-60

1 (3.12)

0 (0.00)

Table 3. Distribution of HIV as per Occupation in Males Occupation

Number of HIV infected males (%)

Truck drivers

11 (34.2)

Farmers

8 (25)

Laborers

7 (20.8)

Students

3 (10)

Govt. employees

3 (10)

Table 4. Distribution of HIV as per Occupation in Females Occupation

No. of HIV infected females (%)

Housewives

10 (55.6)

Working

7 (38.9)

Students

1 (5.5)

Age and Sex Distribution

Disease is affecting mainly the people in sexually active age group 15-44 years. Out of the total 50 patients who met the inclusion criteria, there were 32 (64%) males and 18 (36%) females. The age range varied from four to 60 years, amongst the males, with the mean age being 36.48 Âą 12.38 years. The maximum incidence (decade-wise) was seen in the age range of 31-40 years. In the females, the age range varied from six and half years to 60 years with the mean age being 36.50 Âą 14.81 years. The maximum incidence (decade-wise) was seen in the age range of 21-30 years.

(Table 1 and 2).

laborers, three (10%) were government employee and four were students. Out of these four students three were males (10%). Out of 18 female patients, one was student, seven were working and 10 were housewives (Table 3 and 4).

Occupation-wise Distribution

Symptomatology and Its Analysis

Out of 50 patients, 11 (34.2%) were truck drivers, eight (25%) were farmers, seven (20.8%) were

The most common symptoms observed in the study group were fever, cough, anorexia, diarrhea, headache

Mode of Spread

The maximum incidence was through exposure to commercial sex workers (45%), parenteral injections (25%) and unprotected sex with spouse (15%).

Transmission could not be ascertained in 15% of the subjects.

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

Infectious disease and fatigue. Fever was the most common symptom seen in 28 (56%).

Discussion The present study was conducted in the Dept. of Microbiology at Adesh Institute of Medical Sciences and Research, Bathinda, with an aim to evaluate the clinical profile and the latest trends of HIV prevalence in relation to age, sex and mode of spread in HIV infected patients presenting to a teaching hospital in Punjab. All HIV positive individuals who met the inclusion criteria were included. Detailed history, clinical examination and investigative work-up was done. The epidemiological analysis of the case data shows that the disease is affecting mainly the people in the sexually active age group of 15-44 years (NACO, 2003). In the present study, the age range varied from four to 60 years, amongst the males, with the mean age being 36.48 ± 12.38 years. The maximum incidence (decade-wise) was seen in the age range of 31-40 years which correlates with a fact sheet that most of people getting infected are in sexually active and economically productive 15-44 years age group.7 Similarly, in the females the age range varied from six and half to 60 years with the mean age being 38.50 ± 14.81 years.

The maximum incidence (decade-wise) was seen in the age range of 21-30 years. Hence, it was observed that female patients were involved at younger age group (decade-wise) which is almost consistent with the NACO analysis. Over the years HIV infection has increased sharply among commercial sex workers, rapidly increasing among STD clinic attendants and steadily progressing among low-risk population. This is how HIV has spread among the general population in India, because epidemic has followed type 4 pattern.8 The present study has shown that now HIV infection is not only limited to commercial sex workers and truck drivers, but it has spread to the farmers, laborers and other low-risk population. Interestingly no commercial sex worker was seen in the study group. This could be due to social taboo associated with the labeling of commercial sex worker. In our study 36% of the patients were females while rest were males.

This finding is in accordance with statistical finding that women now account for 39% of affected adult population.9 Epidemiological analysis of the AIDS

by NACO, 2003 (India)10,11 showed that maximum transmission is through heterosexual contact, (85.27%), through blood and blood products (2.69%), through injection drug users (2.35%) and the history was not Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

available in 7.01%. In the present study the maximum incidence was through exposure to commercial sex workers (45%), parenteral injections (25%) and unprotected sex with spouse (15%). The mode of transmission could not be ascertained in 15% of the subjects. Transmission through IDU has increased recently as in 2006, new sites of high prevalence among IDUs were identified in Punjab, Tamil Nadu, West Bengal and Maharashtra.12 Our findings of prevalence of AIDS being higher in commercial sex workers, IDUs correlates with the fact that HIV prevalence among certain groups (CSW, IDUs) is higher and is currently around 6-8 times that of general population. In the present study fever was the most common symptom seen in 28 (56%) patients. The finding correlates with study done by Mayo Clinic.13 Conclusion Though, there is an increasing trend in the cases of HIV, the real data is very difficult to be obtained due to the social taboo. Cases presenting actually is just the tip of an iceberg. So, our study has contributed baseline data and provided insights in HIV infection in India. This would undoubtedly serve as a basis for further studies on this topic.

Bibliography 1. NACO. ‘HIV sentinel surveillance and HIV estimation in India 2007; A technical brief ’.

2. Bureau of Hygiene and Tropical Diseases. AIDS Newsletter’ Issue 1 January 30 1986.

3. Simoes EA, Babu PG, John TJ, et al. Evidence for HTLV-III infection in prostitutes in Tamil Nadu (India).

Indian J Med Res 1987;85:335-8.

4. Panda S. The HIV/AIDS epidemic in India: an overview.

In: ‘Living with the AIDS Virus. Panda S, Chatterjee, Abdul-Quader AS. (Eds.), The Epidemic and the Response in India 2002:20.

5. Baria F, et al. India Today (15th March 1997), AIDS Striking Home.

6. UNAIDS (2008) ‘India: Country Situation’.

7. Overview of HIV and AIDS in India. Avert. Feb. 3, 2010.

8. UNGASS (2008) ‘India - Country progress report.

9. UNAIDS (2008) ‘Epidemiological fact sheet on HIV and AIDS. 10. Sengupta D, Rewari BB, Shankat M, Misra SN. HIV in India, Ed. Das, Ashok Kumar, Post graduate Medicine.

The Association of Physicians of India 2001: Vol. 15.

11. Medicine update 1999. Vol. 9 (Part I).

12. UNGASS (2008) ‘India - Country progress report.

13. HIV/AIDS symptoms. Mayo Clinic. August 2008.

AD/24/JUNE/2011

Review article

Acute Otitis Media: Role of Cefaclor VP Sood

Abstract Acute otitis media (AOM) is the rapid onset of signs and symptoms of acute infection, viral or bacterial, within the middle-ear. High-dosage amoxicillin is recommended as first-line antibiotic therapy in children with AOM. The recent increase in the prevalence of antibiotic-resistant Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis has important implications for the treatment of AOM and poses a challenge to clinicians. Another antimicrobial effective against all the common pathogens causing acute middle-ear disease would be desirable. Cefaclor, a semi-synthetic second-generation oral cephalosporin is highly active against pathogens which are most frequently responsible for AOM in children. It is particularly active against S. pneumoniae, H. influenzae, S. aureus, Branhamella spp. and Streptococcus pyogenes.

Moreover, significantly fewer patients treated with cefaclor report gastrointestinal disturbances especially diarrhea which is the most frequently reported adverse event in children treated with antibiotics for this disease.

Key words: Acute otitis media, eustachian tube dysfunction, antibiotic

A

cute otitis media (AOM) is the rapid onset of signs and symptoms of acute infection, viral or bacterial, within the middle-ear.1 It is the most common infection for which antibiotics are prescribed for children.2 By the age of one year, 60% of children will have had at least one such episode and 17% will have had ≥3 episodes. A second peak occurs at about five years of age attributed to school admission.3 Adults make up <20% of patients presenting with AOM.2 The acute and chronic manifestations of AOM may have long-term sequelae: Hearing loss, impaired cognitive development, perforation of tympanic membrane (TM), facial paralysis, meningitis and brain abscess.3 Hence, there is a need for correct and early diagnosis of AOM so that appropriate and timely treatment is initiated.

Pathophysiology Genetic, infectious, immunologic and environmental factors predispose children to ear infections.4,5 In most cases, an allergy or upper respiratory tract infection causes congestion and swelling of the nasal mucosa, nasopharynx and eustachian tube. Obstruction at the eustachian tube isthmus results in accumulation of middle-ear secretions; secondary bacterial or viral infection of the effusion causes suppuration and Secretary-cum-Managing Trustee Dr Sood Nasal Research Foundation, New Delhi E-mail: vpsood@drsoodnasalfoundation.com

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

features of AOM.6 In younger children, presence of a shorter, more horizontal and more flexible eustachian tube is an important contributory factor.

The effusion may persist for weeks or months after the infection resolves.4 Otitis media with effusion may occur spontaneously as a result of eustachian tube dysfunction or as an inflammatory response after AOM.7 Risk Factors1,2  Age: Maximal incidence between six and 24 months of age (peak incidence in the first two years)  Fall and winter season  Breastfeeding (breastfeeding for at least three months is protective)  Day care attendance: Contact with multiple children  Exposure to cigarette smoke (increased incidence, especially if parents smoke)  Male sex  More than one sibling living at home  Pacifier use  Previous antibiotic use  Previous otitis media  Underlying pathology such as allergic rhinitis, cleft palate Down syndrome  Miscellaneous: Birth weight <1,500 g, prone sleeping position 11

Review ARticle Causative Organisms The most common viral pathogen is the respiratory syncytial virus; other viruses like parainfluenza, rhinovirus, coronavirus and adenovirus have also been isolated in children with AOM.3 Viruses may be responsible for many cases of apparent failure of antibiotic treatment.8 Streptococcus pneumoniae, nontypeable Haemophilus influenzae, Moraxella catarrhalis and Group A streptococcus are the most common bacterial isolates from the middle-ear fluid of children with AOM.9 Bacterial infection is often preceded by a viral infection. Viruses can cause AOM without coinfection with bacteria.10 With the routine use of the heptavalent pneumococcal vaccine the microbiology of AOM has changed considerably.8 It is noticed that the rates of pneumococcal AOM decreased by 37%, and the rates of b-lactamase-producing organisms increased by 56%, with H. influenzae and M. catarrhalis accounting for more than half of the isolates.3 Previously, S. pneumoniae and H. influenzae were the common isolates, but in the present scenario gram-negative bacilli are the forerunners in cases of AOM. The commonest isolate in a 1-year study was Pseudomonas aeruginosa (28.3%).11 The most notable development in the bacteriology of AOM is rise in drug-resistant S. pneumoniae, b-lactamase producing H. influenzae and M. catarrhalis.1 Grubb et al noted an increase in penicillin resistance from 13% to 61% among S. pneumoniae isolates.12 Management of AOM Treatment goals in AOM include symptom resolution and reduction of recurrence.13 Most children with AOM (70-90%) have spontaneous resolution within 7-14 days; therefore, antibiotics should not routinely be prescribed initially for all children.14,15 Delaying antibiotic therapy in selected patients reduces treatment-related costs and side effects and minimizes emergence of resistant strains.16 Symptomatic Treatment

Pain management is important in the first two days after diagnosis. Options include acetaminophen (15 mg/kg every 4-6 hours) and ibuprofen (10 mg/kg every six hours).17 Antipyrine/benzocaine otic suspension can be used for local analgesia.7,8,18 Antibiotics

The goal of antibiotics in the treatment of AOM is eradication of the causative organism from the 12

middle-ear fluid. In order to reach this goal, two conditions must be met: i) The drug should be active against the causative organisms and ii) the drug should reach the middle-ear fluid and maintain a sufficient concentration long enough to allow bacterial inhibition and eventual killing.19 The ultimate challenge is the eradication of the pathogens from humans and, more specifically, from infants and young children, since they constitute the majority of patients with AOM. A meta-analysis of randomized trials found that antibiotics are most beneficial in children younger than two years with bilateral AOM and in children with AOM and otorrhea.20 Antibiotics are recommended for all children younger than six months, for those six months to two years of age when the diagnosis is certain, and for all children older than two years with severe infection (defined as moderate-to-severe otalgia or temperature >102.2ÂşF.8 Choice of Antibiotic

High-dosage amoxicillin (80-90 mg/kg/day, divided into twice-daily doses for 10 days) is recommended as first-line antibiotic therapy in children with AOM.8,17 In children older than six years with mild-to-moderate disease, a five- to seven-day course is adequate. But, amoxicillin has drawbacks. It has limited efficacy when β-lactamase producing bacteria are the causative organisms. Due to the increasing incidence of β-lactamase producing bacteria, more and more children may fail to respond to this initial therapy and may possibly require a second course of antibiotics. Also, first-line treatment with amoxicillin is not recommended in children with concurrent purulent conjunctivitis, after antibiotic therapy within the preceding month, in children taking amoxicillin as chemoprophylaxis for recurrent AOM or urinary tract infection, and in children with penicillin allergy. The recent increase in the prevalence of antibiotic-resistant S. pneumoniae, H. influenzae and M. catarrhalis has important implications for the treatment of AOM and poses a challenge to clinicians.21-23 Another antimicrobial effective against all the common pathogens causing acute middle-ear disease would be desirable.

Role of Cefaclor in Acute Otitis Media Cefaclor, a semi-synthetic second-generation oral cephalosporin with a broad antibacterial spectrum is highly active against pathogens which are most Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

Review ARticle frequently responsible for AOM in children.24 It is particularly active against S. pneumoniae, H. influenzae, S. aureus, Branhamella spp. and Streptococcus pyogenes.

Moreover, its ability to achieve adequate concentrations in the middle-ear fluid when given in a dose of 20 mg/kg twice-daily25 and proven tolerability suggest that it is a good alternative to agents like amoxicillin which are traditionally used in AOM. It has been shown to be more cost-effective than amoxicillin in the treatment of AOM.26 In another study, cefaclor was found to be superior to amoxicillin in chemoprophylaxis of recurrent AOM. In randomized controlled trials in children with AOM, oral cefaclor 40 mg/kg/day (usually administered in two divided doses for 5-10 days) was well-tolerated and at least as effective as standard regimens of amoxicillin/clavulanic acid, cefuroxime axetil, cefixime or clarithromycin as assessed by either clinical or bacteriological criteria.27-30 Cefaclor vs Amoxicillin-clavulanate

One hundred thirty-three infants and children with documented AOM were randomized to receive the oral suspension of either amoxicillin-clavulanate potassium or cefaclor. Cefaclor was found to have equivalent clinical efficacy to that of amoxicillin-clavulanate but it had fewer side effects.27 Another multicentric prospective study compared the efficacy and safety of cefaclor versus amoxicillin + clavulanate in children with AOM.31 One hundred sixty-seven patients were evaluated for efficacy endpoints in the cefaclor arm comprised of 104 males and 63 females with a mean age of 5.74 ± 2.80 years and 185 patients in the amoxicillin-clavulanate group comprised of 118 males and 67 females with a mean age of 4.93 ± 2.92 years. Both cefaclor and amoxicillinclavulanate caused a significant improvement in all the signs and symptoms after a 10-day treatment period.

However, between-the-group comparisons showed that the reduction in most of the symptoms was significantly more in cefaclor arm as compared to amoxicillinclavulanate arm. The clinical success (clinical cure + improvement) at the end of therapy was significantly more in cefaclor arm: 98% with cefaclor versus 85% with amoxicillin + clavulanate, p < 0.05. Failure cases were prescribed other antibiotics according to the culture sensitivity reports, as rescue medication.

Bacterial eradication rates were largely consistent Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

with clinical responses. Bacteriological eradication was seen in 95% of patients in cefaclor group and 78% of patients in amoxicillin + clavulanate group. It was concluded that cefaclor was a well-tolerated and effective antibacterial option for AOM in children and it was superior to the combination of amoxicillin + clavulanate in efficacy and tolerability in AOM. Cefaclor vs Cefuroxime Axetil

A study was undertaken to compare the efficacy and safety of a 10-day treatment course of cefaclor and cefuroxime axetil in the treatment of AOM with effusion in children who failed therapy with amoxicillin.28 Cefaclor and cefuroxime axetil suspensions were administered twice-daily for a total daily dose of 40 mg/kg and 30 mg/kg, respectively.

Physical examination, pneumatic otoscopy and tympanogram were performed to evaluate efficacy to therapy. Therapeutic equivalence was established by ruling out a difference (cefaclor minus cefuroxime axetil) of 15% in percentages of clinical success (cure plus improvement). Safety evaluation was performed by assessment of clinical adverse events. In the intent-totreat analysis post-therapy (1-6 days after completion of therapy), 96 of 104 (92.3%) cefaclor-treated patients had clinical success compared to 90 of 101 (89.1%) cefuroxime axetil patients. The 95% confidence limits on the difference between proportions of favorable outcomes (cefaclor minus cefuroxime axetil) was from –4.8% to +11.2%. At termination of the study (Day 10-16 after completion of therapy), 86 of 104 (82.7%) cefaclor patients and 84 of 101 (83.2%) cefuroxime axetil patients had favorable clinical outcomes (95% confidence interval: –10.8% to +9.9%). Thirty-two (30.8%) of the 104 patients in the cefaclor treatment group reported at least one adverse event, with rhinitis reported in nine (8.7%) patients and cough increased in seven (6.7%) patients. Thirty-six (35.6%) of the 101 patients in the cefuroxime axetil treatment group reported at least one event, with diarrhea reported in 11 (10.9%) of patients and rhinitis in 10 (9.9%) patients. Cefaclor and cefuroxime axetil were equally effective in the treatment of patients with AOM with effusion who had failed therapy with amoxicillin.

Significantly fewer patients treated with cefaclor reported diarrhea, which is the most frequently reported adverse event in children-treated with antibiotics for this disease.

13

Review ARticle Cefaclor vs Clarithromycin

The safety and efficacy of a new oral suspension formulation of clarithromycin were evaluated in a multicenter, Phase III, single-blind, comparative trial in 379 children ages six months to 12 years with signs or symptoms of AOM.30 Children were randomized to receive a 10-day course of clarithromycin oral suspension (7.5 mg/kg; maximum, 500 mg) or cefaclor oral suspension (20 mg/kg; maximum, 500 mg) twice-daily. Specific clinical response criteria were developed based on pre-treatment signs and symptoms and results of tympanometry. Of the 379 enrolled patients 281 (74%) were evaluable (clarithromycin, 150; cefaclor, 131). There were no demographic differences between the two groups. Fifty percent of the patients had 2-4 episodes of otitis media (including the current episode) in the past 12 months; 63% of the patients had an infection of moderate severity. Clarithromycin and cefaclor suspensions were similarly effective for the treatment of AOM. Clinical success (cure, cure with effusion or improvement) was achieved in 86% of clarithromycin-treated patients and 90% of cefaclor-treated patients. The majority of bacterial isolates for which susceptibility results were available were fully or moderately susceptible to the study drugs (96% clarithromycin, 92% cefaclor). Both drugs were well-tolerated; adverse events considered probably study drug-related were reported by 30 (15%) of clarithromycin recipients and 31 (17%) of cefaclor recipients. There were no significant differences between the groups in the numbers of patients reporting events that were thought to be related to study medication.

Palatability and Compliance

Palatability of oral antibiotic suspensions is important and may be a substantial factor in determining compliance in young pediatric patients. A study was undertaken to assess the acceptance of and compliance with oral antibiotic suspensions commonly used in Israel.32 In the study 546 children received one of the following drugs: Amoxicillin (n = 222); cefaclor (n = 142); cefuroxime axetil (n = 107); trimethoprim/ sulfamethoxazole (n = 75). No major differences in background data were noted; >50% of each group had AOM. Seventy-three percent of the cefaclor group reported acceptance of the drug with ‘pleasure’ or ‘without problems’ versus 60, 55 and 20% for amoxicillin, trimethoprim/sulfamethoxazole and cefuroxime axetil, respectively, whereas ‘resentment’ or ‘refusal’ was reported in 11, 16, 26 and 56%, 14

respectively (p < 0.0001). Mothers reported to be generally ‘satisfied’ or ‘extremely satisfied’ with the drug in 89, 81, 74 and 67% with cefaclor, amoxicillin, trimethoprim/sulfamethoxazole and cefuroxime axetil, respectively, and 85, 77, 73 and 67% of the children, respectively, received the drug for the entire prescribed course (p < 0.001). Data from the study suggest that cefaclor suspension was the most palatable and thus better patient compliance could be expected.

Conclusion Acute otitis media is the rapid onset of signs and symptoms of acute infection, viral or bacterial, within the middle-ear. The acute and chronic manifestations of AOM may have long-term sequelae: Hearing loss, impaired cognitive development, perforation of TM, facial paralysis, meningitis and brain abscess. Hence, there is a need for appropriate and timely treatment for AOM. The goal of antibiotics in the treatment of AOM is eradication of the causative organism from the middle-ear fluid. High-dosage amoxicillin is recommended as first-line antibiotic therapy in children with AOM. But, amoxicillin has drawbacks. It has limited efficacy when β-lactamase producing bacteria are the causative organisms. The recent increase in the prevalence of antibiotic-resistant S. pneumoniae, H. influenzae and M. catarrhalis has important implications for the treatment of AOM and poses a challenge to clinicians. A new antimicrobial effective against all the common pathogens causing acute middle-ear disease would be desirable. Cefaclor, a semi-synthetic second-generation oral cephalosporin with a broad antibacterial spectrum is highly active against pathogens which are most frequently responsible for AOM in children. Its ability to achieve adequate concentrations in the middle-ear fluid when given in a dose of 20 mg/kg twice-daily suggest that it is a good alternative to agents like amoxicillin which are traditionally used in AOM. Moreover, significantly fewer patients treated with cefaclor report gastrointestinal disturbances especially diarrhea which is the most frequently reported adverse event in children-treated with antibiotics for this disease.

References 1.

Li WC, Chiu NC, Hsu CH, Lee KS, Hwang HK, Huang FY. Pathogens in the middle ear effusion of children with persistent otitis media: implications of drug resistance and complications. J Microbiol Immunol Infect 2001;34(3): 190-4.

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Ramakrishnan K, Sparks RA, Berryhill WE. Diagnosis and treatment of otitis media. Am Fam Physician 2007;76(11):1650-8.

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Bhetwal N, McConaghy JR. The evaluation and treatment of children with acute otitis media. Prim Care 2007; 34(1):59-70.

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Klein JO, Pelton S. Epidemiology, pathogenesis, clinical manifestations, and complications of acute otitis media.

Accessed May 15, 2007, at: http://patients.uptodate.com/ topic.asp?file=pedi_id/2870&title=Acute+Otitis+media

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Arrieta A, Singh J. Management of recurrent and persistent acute otitis media: new options with familiar antibiotics. Pediatr Infect Dis J 2004;23(2 Suppl): S115-24.

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Rovers MM, Schilder AG, Zielhuis GA, Rosenfeld RM. Otitis media [Published correction appears in Lancet 2004;363:1080]. Lancet 2004;363:465-73.

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American Academy of Family Physicians, American Academy of Otolaryngology-Head and Neck Surgery, American Academy of Pediatrics Subcommittee on Otitis Media with Effusion. Otitis media with effusion. Pediatrics 2004;113:1412-29.

24.

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American Academy of Pediatrics Subcommittee on Management of Acute Otitis Media. Diagnosis and management of acute otitis media. Pediatrics 2004;113(5): 1451-65.

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Leibovitz E, Broides A, Greenberg D, et al. Current management of pediatric acute otitis media. Expert Rev Anti Infect Ther 2010;8(2):151-61.

10. Morris PS, Leach AJ. Acute and chronic otitis media.

Pediatr Clin North Am 2009;56(6):1383-99.

11. De A, Varaiya A, Tainwala S, Mathur M. Bacteriology of acute otitis media in children. Indian J Med Microbiol 2002;20(1):54-5.

12. Grubb MS, Spaugh DC. Microbiology of acute otitis media, Puget Sound region, 2005-2009. Clin Pediatr (Phila) 2010;49(8):727-30.

13. Darrow DH, Dash N, Derkay CS. Otitis media: concepts and controversies. Curr Opin Otolaryngol Head Neck Surg 2003;11(6):416-23.

14. Rosenfeld RM, Kay D. Natural history of untreated otitis media. Laryngoscope 2003;113(10):1645-57.

15. Scottish Intercollegiate Guidelines Network. Diagnosis and management of childhood otitis media in primary care.

A national clinical guideline. Accessed May 15, 2007, at: http://www.sign.ac.uk/pdf/sign66.pdf.

16. Eskin B. Evidence-based emergency medicine/systematic review abstract. Should children with otitis media be treated with antibiotics? Ann Emerg Med 2004;44(5): 537-9.

17. Bell LM. The new clinical practice guidelines for acute otitis media: an editorial. Ann Emerg Med 2005;45(5): 514-6.

18. Hoberman A, Paradise JL, Reynolds EA, Urkin J. Efficacy of Auralgan for treating ear pain in children with acute

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otitis media. Arch Pediatr Adolesc Med 1997;151(7): 675-8.

Craig WA, Andes D. Pharmacokinetics and pharmacodynamics of antibiotics in otitis media. Pediatr Infect Dis J 1996;15(3):255-9.

Rovers MM, Glasziou P, Appelman CL, Burke P, McCormick DP, Damoiseaux RA, et al. Antibiotics for acute otitis media: a meta-analysis with individual patient data. Lancet 2006;368:1429-35.

Barnett ED, Klein JO. The problem of resistant bacteria for the management of acute otitis media. Pediatr Clin North Am 1995;42(3):509-17.

Centers for Disease Control and Prevention (CDC).

Drug-resistant Streptococcus pneumoniae - Kentucky and Tennessee, 1993. MMWR Morb Mortal Wkly Rep 1994;43(2):23-6, 31.

Dagan R, Abramson O, Leibovitz E, Lang R, Goshen S, Greenberg D, et al. Impaired bacteriologic response to oral cephalosporins in acute otitis media caused by pneumococci with intermediate resistance to penicillin.

Pediatr Infect Dis J 1996;15(11):980-5.

MacLoughlin GJ, Barreto DG, de la Torre C, Pinetta EA, del Castivo F, Palma L. Cefpodoxime proxetil suspension compared with cefaclor suspension for treatment of acute otitis media in paediatric patients.

J Antimicrob Chemother 1996;37(3):565-73.

Eden T, Anari M, Ernstson S, Sundberg L. Penetration of cefaclor to adenoid tissue and middle ear fluid in secretory otitis media. Scand J Infect Dis Suppl 1983;39:48-52.

Callahan CW Jr. Cost effectiveness of antibiotic therapy for otitis media in a military pediatric clinic. Pediatr Infect Dis J 1988;7(9):622-5.

Kaleida PH, Bluestone CD, Rockette HE, Bass LW, Wolfson JH, Breck JM, et al. Amoxicillin-clavulanate potassium compared with cefaclor for acute otitis media in infants and children. Pediatr Infect Dis J 1987;6(3): 265-71.

Turik MA, Johns D Jr. Comparison of cefaclor and cefuroxime axetil in the treatment of acute otitis media with effusion in children who failed amoxicillin therapy. J Chemother 1998;10(4):306-12.

Rodriguez WJ, Khan W, Sait T, Chhabra OP, Bell TA, Akram S, et al. Cefixime vs. cefaclor in the treatment of acute otitis media in children: a randomized, comparative study. Pediatr Infect Dis J 1993;12(1):70-4.

Gooch WM 3rd, Gan VN, Corder WT, Khurana CM, Andrews WP Jr. Clarithromycin and cefaclor suspensions in the treatment of acute otitis media in children. Pediatr Infect Dis J 1993;12(12 Suppl 3) S128-33.

Aggarwal M, Sinha R, Murali MV, Trihan P, Singhal PK. Comparative efficacy and safety evaluation of cefaclor vs amoxycillin + clavulanate in children with acute otitis media (AOM). Indian J Pediatr 2005;72(3):233-8.

Dagan R, Shvartzman P, Liss Z. Variation in acceptance of common oral antibiotic suspensions. Pediatr Infect Dis J 1994;13(8):686-90.

15

original study

Efficacy of Turmeric Capsules on Metabolic Management in Type 2 Diabetes Mellitus Prabir Kumar Kundu*, Madhuchhanda Mandal**, Rajyasree De†, Ujjwal Bhattacharya‡, Ramaprasad Goswami¶

Abstract Diabetes mellitus is a group of metabolic diseases characterized by hyperglycemia and abnormal lipid and protein metabolism resulting from defects of insulin secretion and/or increased cellular resistance to insulin. An open labelled randomized comparative controlled study was conducted to evaluate the efficacy of turmeric therapy on glycemic and other metabolic control in type 2 diabetic subjects with comparison to standard allopathic therapy, in the year 2008 at Calcutta School of Tropical Medicine (CSTM), Kolkata. One group (control group) was given allopathic antidiabetic medicines and the second group (study group) was treated with Turmeric capsules at a dose of one capsule per day for the period of six months. The results showed significant reduction in postprandial blood glucose, glycosylated hemoglobin (HbA1C), triglyceride and body mass index (BMI) and better elevation in high-density lipoprotein cholesterol (HDLC) in turmeric-treated type 2 diabetics as compared to treatment with allopathic drugs. No adverse effects, were either reported or observed in the clinical trial, which establishes the safety of the product. So, it can be concluded that Turmeric capsules are safe and effective in the management of type 2 diabetes mellitus.

Key words: Turmeric, type 2 diabetes

D

iabetes mellitus is the commonest metabolic disorder characterized by onset of microvascular and macrovascular complications.1 Though microvascular complications depend mainly on glycemic control and duration of diabetes, the onset of macrovascular complications is long before the onset of hyperglycemia indicating coexistence of other risk factors like obesity, dyslipidemia, hypertension, smoking, family history of premature cardiovascular disease (CVD) death, etc., beyond control of hyperglycemia.2 Studies have shown significant decrease in microvascular complications like retinopathy, nephropathy and polyneuropathy with decrease in glycosylated hemoglobin (HbA1C) to ≤7% in type 2 diabetics irrespective of drugs used for treatment.3 Recent trials like ADVANCE4 and ACCORD5 revealed a small but incremental benefit in microvascular outcomes with HbA1C value closer to *Assistant Professor **RMO cum Clinical Tutor ¶Associate Professor Dept. of Tropical Medicine, Calcutta School of Tropical Medicine (CSTM), Chittaranjan Avenue, Kolkata †HIV Research Fellow (Non Medical), Centre of Excellence, CSTM, Kolkata ‡Postgraduate Trainee, Dept. of Kayachikitsa, Institute of Post Graduate Ayurvedic Education and Research, Shyamdas Vaidya Shastra Pith, Kolkata Address for correspondence Dr Prabir Kumar Kundu BJ-368, Sector-II, Salt Lake City, Kolkata - 700 091 E-mail: drpkkundu@rediff.mail.com

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

normal i.e. <6.5%. In day-to-day clinical practice, it is difficult to achieve good glycemic control and avoiding hypoglycemia or other adverse effects of treatment.

Regarding macrovascular outcomes, randomized controlled trials of intensive versus standard glycemic control have not shown a significant reduction in CVD outcomes during the randomized portion of the trials.2 Type 2 diabetes, also called adult-onset diabetes, is the most common form. It is characterized by two major pathophysiologic defects: Insulin resistance, which results in increased hepatic glucose production and decreased glucose disposal, and impaired β-cell secretory function (both basal and glucosestimulated).6 Loss of the acute insulin response to a carbohydrate load is a prototypical defect that occurs early in the natural course of the disease; when fasting plasma glucose (FPG) levels reach 115 mg/dl,7 this leads to postprandial hyperglycemia (PPHG). Diabetes mellitus presents with characteristic symptoms such as thirst, polyuria, blurring of vision and weight loss. In its most severe forms, ketoacidosis or a nonketotic hyperosmolar state may develop and lead to stupor, coma and, in absence of effective treatment, death. Often symptoms are not severe, or may be absent and consequently hyperglycemia 17

original study sufficient to cause pathological and functional changes may be present for a long time before the diagnosis is made. The long-term effects of diabetes mellitus include progressive development of the specific complications of retinopathy with potential blindness, nephropathy that may lead to renal failure, and/or neuropathy with risk of foot ulcers, amputation, Charcot joints and features of autonomic dysfunction, including sexual dysfunction. People with diabetes are at increased risk of cardiovascular, peripheral vascular and cerebrovascular disease.

In the absence of a more specific biological marker to define diabetes, plasma glucose estimation remains the basis of diagnostic criteria. The 2006 WHO recommendations for the diagnostic criteria for diabetes are FPG â&#x2030;Ľ7.0 mmol/l (126 mg/dl) and/or two-hour plasma glucose â&#x2030;Ľ11.1 mmol/l (200 mg/dl). The FPG cut-point for impaired fasting glucose (IFG) is 6.1 mmol/l.8 HbA1C reflects average plasma glucose over the previous 2-3 months in a single measure, which can be performed at any time of the day. It does not require any special preparation such as fasting.

Management of diabetes mellitus includes diet restrictions, oral hypoglycemic agents (OHAs), insulin and lifestyle modification. Though OHAs and insulin have been effective in the management of diabetes mellitus, they are not without side effects.9 Therapy with sulfonylureas may cause chronic hypoglycemia, which reduces adrenergic counter-regulatory responses.

Gastrointestinal side effects like dyspepsia, anorexia, nonspecific abdominal discomfort and skin rash have been reported with sulfonylurea therapy.10 Lactic acidosis is a major side effect of metformin.11 Profound hypoglycemia may occur due to the accumulation of these drugs, which possess a long half-life, more so, if their elimination is impaired. In type 2 diabetes mellitus, insulin resistance is a major pathophysiologic factor influencing glucose hemostasis and eventually causes a relative or absolute deficiency in insulin secretion.12 An intensive search in Ayurvedic literature for a multipotent agent possessing antihyperglycemic efficacy as well as the ability to reduce other defined risk factors without major adverse events was done by the authors to find out a specific agent for the present study. In Ayurveda, Haridra has been widely used in health and disease.13 It has also been used successfully as 18

hypoglycemic agent in the past. Recently, attention has been drawn to its active principle curcumin14 and its derivatives. The basic chemical structure of curcumin is diferuloylmethane (C21H20O6). Its hypoglycemic effect is attributed to p-tolylmethyl carbinol and the antioxidant property, to phenolic character.

Aim of the Study To evaluate the efficacy and safety of Turmeric capsules in patients suffering from type 2 diabetes mellitus.

Material and Methods From 1st May to 31st October 2008, 100 diagnosed type 2 diabetic subjects, whose plasma glucose were not controlled on diet and exercise, were recruited to two groups of 50 diabetic subjects each, after matching with age, sex and duration of diabetes. One group (control group) was given allopathic antidiabetic medicines and the second group (study group) was treated with Turmeric capsules at a dose of one capsule per day for the period of six months. The composition of Turmeric capsule is given in table 1. The control group was also given atorvastatin at a fixed dose of 10 mg daily throughout the study period. All these cases were selected from Diabetic Clinic, Calcutta School of Tropical Medicine (CSTM), Kolkata and OPD of Shyamdas Vaidya Shastra Pith Hospital of the Institute of Post Graduate Ayurvedic Education and Research (IPGAER), Kolkata. Type 2 diabetics with pregnancy, acute infection and illness, advanced liver disease, nephropathy, features of acute coronary syndrome, cerebral stokes and in coma were excluded from the study.

Detailed history, physical examination, anthropometry and laboratory investigations along with special tests like Doppler flow study of limb arteries, echocardiogram, vibration perception threshold test and HbA1C estimation were performed in the diabetic subjects under study. The duration of the study was Table 1. Composition of Turmeric Capsule Sanskrit Botanical name name

Part Used

Quantity per capsule (on dry basis)

Extract

Haridra

Curcuma Rhizome longa

230 mg

Powder

Haridra

Curcuma Rhizome longa

370 mg

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

original study 180 days (six months) with follow-ups at an interval of one month. Clinical examination was done at each follow-up visit. Laboratory investigations were done at the point of entry into the study, at the final visit and as and when required. Special tests were performed only at the entry and exit of the study.

All the adverse events, either reported or observed by the patients, were recorded with information about severity, date of onset, duration and action taken regarding the study drug. Relation of adverse events to study medication was predefined as ‘Unrelated’ (a reaction that does not follow a reasonable temporal sequence from the administration of the drug), ‘Possible’ (follows a known response pattern to the suspected drug, but could have been produced by the patient’s clinical state or other modes of therapy administered to the patient) and ‘Probable’ (follows a known response pattern to the suspected drug that could not be reasonably explained by the known characteristics of the patient’s clinical state). Patients were allowed to voluntarily withdraw from the study, if they had experienced serious discomfort during the study or sustained serious clinical events requiring specific treatment. For patients withdrawing from the study, efforts were made to ascertain the reason for dropout. Noncompliance (defined as failure to take <80% of the medication) was not regarded as treatment failure, and reasons for noncompliance were noted.

Primary and Secondary Endpoints

The predefined primary efficacy endpoint were improvement in glycemic and lipid profile parameters.

The predefined secondary safety endpoints were acute and chronic safety, as assessed by the incidence of adverse events and patient compliance to therapy.

Statistical Analysis

The values are expressed as mean ± SD. Statistical analysis was carried out using Fisher’s exact test using GraphPad Prism, Version 4.03 for windows, Graphpad Software, San Diego, California, USA. www.graphpad.com. The changes in various parameters from baseline values to after treatment values were evaluated by ‘paired t-test’.

Results Age- and sex-matched 100 diabetic subjects with nearly similar duration of diabetes and glycemic Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

Table 2. Baseline Characteristic of the Two Groups Characteristics

Control group

Study group

Age

45 ± 1.5 years

45 ± 1 years

Male:Female

2:1

1.8:1.2

Middle income:Low income

3:1

1:1

1.5 years ± 6 months

1.5 years ± 8 months

Duration of diabetes mellitus

control were selectively divided into control and study groups, with 50 patients in each group (Table 2). The results were obtained after six months of treatment with Turmeric capsule in 50 type 2 diabetic subjects in the study group viz-a-viz allopathic drugs in the control group (glimepiride and metformin, either as a single agents or in combination, along with other drugs like atorvastatin with titration of doses as and when required) with regular monthly follow-up in both groups. FPG was significantly reduced in both the groups, but more in control group; p < 0.02 vs p < 0.05 in study group. PPG was reduced significantly in study group; p < 0.01 vs p < 0.05 in control group. Reduction of plasma HbA1C was significant in study group; p < 0.05 vs p < 0.1 in control group. Reduction in serum low-density lipoprotein cholesterol (LDLC) was nearly equal in both the groups. Reduction of serum triglyceride was marginally better in study group; p < 0.05 vs p < 0.02 in control group. Serum high-density lipoprotein cholesterol (HDLC) was better elevated in study group (p < 0.01) than control group (p < 0.1).

Systolic blood pressure (SBP) as well as diastolic blood pressure (DBP) reduced at greater magnitude in the control group as compared to study group.

Body weight was gained in the control group whereas it was reduced in the study group as evidenced by body mass index (BMI) (Table 3).

Discussion In the present study, all the diagnosed type 2 diabetic subjects were interrogated and examined in detail, and routinely investigated along with sophisticated investigations (as required) at monthly interval for six months. Middle-aged male patients predominated in the study, which can be explained by the male dominance in attendance pattern in the OPD of tertiary care hospital. After matching with age, sex and glycemic status, patients were randomly assigned to the Turmeric 19

original study Table 3. Results after the End of Study at Six Months Characteristics

Control group At entry

At the end of the study

At entry

At the end of the study

FPG (mg/dl)

170 ± 16.02

119 ± 13.04 (p < 0.02)

174 ± 24.3

128 ± 17.28 (p < 0.05)

PPG (mg/dl)

170 ± 20.33

140 ± 15.74 (p < 0.05)

188 ± 30.46

148 ± 12.05 (p < 0.01)

7.9 ± 0.36

7.0 ± 0.45 (p < 0.01)

8.3 ± 0.58

7.2 ± 0.6 (p < 0.05)

HbA1C (%) BMI

(kg/m2)

27.3

28.6

27.8

26.3

LDLC (mg/dl)

111 ± 19.05

95 ± 9.01

118 ± 16.68

105 ± 7.38

Triglyceride (mg/dl)

158 ± 21.0

140 ± 23.06 (p < 0.02)

169 ± 25.46

153 ± 15.74 (p < 0.05)

HDLC (mg/dl)

49 ± 14.54

50 ± 6.94 (p < 0.1)

46 ± 7.43

52 ± 6.51 (p < 0.01)

Systolic blood pressure

150 ± 10

126 ± 9.4

144 ± 5

136 ± 10.2

Diastolic blood pressure

100 ± 6

80 ± 3.6

96 ± 4

88 ± 5.6

group (study group) and allopathic group (control group). Existing diet and exercise were continued in all diabetics as lifestyle therapy. In the control group, patients were given glimepiride and metformin either singly or in combination as antidiabetic regimen. The selection of drugs and their doses were based on body weight, BMI, glycemic status, renal status, hepatic status, presence or absence of comorbidities like CVD, diabetic foot, etc. and previous history of treatment.

The doses of antidiabetic agents were titrated as and when required at follow-up. Atorvastatin (10 mg) oncedaily after dinner was also given to all diabetics in this group as fixed dose. Telmisartan, hydrochlorothiazide and amlodipine were used as antihypertensive either as single agent or in combination in both groups as and when required, with titration of dose at each follow-up if needed. Aspirin 75 mg extended-release aspirin was given to all the diabetic subjects for the duration of the study. In the study group, Turmeric capsule was given at a dose of one capsule per day for the period of six months.

At entry of the study, all type 2 diabetics had poor control with average FPG 180 mg/dl, average PPG 192 mg/dl and, average HbA1C 8.1%. Plasma glucose along with HbA1C was reduced significantly in both control and study group, after six months of treatment as per protocol with marginally better response in study group in respect of reduction of PPG (p < 0.01 vs p < 0.05) and HbA1C (p < 0.05 vs p < 0.1). Lowering of PPG depends on some important factors, like glycemic excursions in blood carbohydrate load, glycemic index and carbohydrate count in a mixed meal, motility of gastrointestinal tract and action of incretin hormones and their metabolism by Dipeptidyl peptidase IV 20

Study group

inhibitor. Curcuminoids might have gastrointestinal effects whereas in control group no prandial glucose regulator was used. According to Ayurveda, Haridra has katu (spicy) and tiktarasa (bitter), laghu (light) and ruksha guna (drying property), usna virya (hot in potency) and katu vipak (spicy metabolite). So, it may be the reason for reduction of madhur rasa (decreases glucose), virya and vipak as reflected by reduction of PPG15 in the present study. Better reduction in HbA1C in study group, can be explained by the fact that higher the baseline value, better was the response.

Regarding blood lipid control, LDLC was better controlled by using atorvastatin in the control group than curcuminoids since atorvastatin was not used in the study group accepting the fact that atorvastatin is a potent cholesterol-lowering drug, whereas the reverse was observed in case of serum triglyceride as its reduction is in direct proportion to that of plasma glucose in addition to the gastrointestinal effect of curcuminoids. HDLC increase significantly in the study group as compared to the control group in spite of nearly similar glycemic control. This can be explained by the fact that HDLC is inversely related to serum triglyceride in blood. According to Ayurvedic view, it can be said that due to medo dusti (fat vitiation), the blood lipid levels are increased in madhumeha (diabetes). In medo dusti, the kshiti and apa (panchamahabootha concept) are increased, which are counteracted by Haridra, as its property is just opposite to that of meda dhatu (lipids).

Regarding blood pressure control, SBP reduced from 156 to 122 mmHg in the study group and from Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

original study 146 to 122 mmHg in the control group. Response in DBP reduction in study group was from 98 to 90 mmHg as compared to reduction from 102 to 82 mmHg in the control group. Hence, the reduction in DBP was nearly equal in both the groups, whereas SBP reduction in SBP was more in the study group. This can be explained by the favorable effect of Haridra on endothelial function which was found in Ayurvedic literature.

The response regarding BMI was favorable in the study group as reflected by reduction of BMI from 27.8 to 26.3 kg/m2, whereas it increased from 27.3 to 28.6 kg/m2 in the control group. This can be explained by the fact that glimepiride (sulfonylurea) had the potential to cause gain in body weight in the control group. Curcuminoids may have antiobesity activity, which was found by the authors in a previous randomized control trial by using NCB-02 containing curcumin as one of its component.

Conclusion The outcomes in the present study as regards lowering of plasma glucose as well as HbA1C, achieving target in lowering of blood pressure and lipid profile was considerable in the curcuminoid group (study group) as compared to the control group treated with standard allopathic drugs. Though reduction in body weight in the curcuminoid group was marginal, but would add significant benefit to type 2 diabetic patients in cardiovascular outcomes in the long run. There were no adverse effects reported or observed, which establish the safety of the product. So, it can be concluded that Turmeric capsules are safe and effective in the metabolic management of type 2 diabetes mellitus.

References 1. Genuth S, Alberti KG, Bennett P, Buse J, Defronzo R, Kahn R, et al; Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Follow-up report on the diagnosis of diabetes mellitus. Diabetes Care 2003;26(11):3160-7.

with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000;321(7258):405-12.

4. Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, et al; ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008;358(24):2560-72.

5. Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, et al; Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358(24):2545-59.

6. Kahn SE, Porte D Jr. The pathophysiology of type II (noninsulin-dependent) diabetes mellitus: implications for treatment. In: Ellenberg & Rifkin’s Diabetes Mellitus.

5th edition, Porte D Jr, Sherwin RS (Eds.), Appleton & Lange: Stamford, Conn 1997:p487-512.

7. Porte D Jr. Banting lecture 1990. Beta-cells in type II diabetes mellitus. Diabetes 1991;40(2):166-80.

8. Definition, diagnosis and classification of diabetes mellitus and its complications. Report of a WHO Consultation Part 1: Diagnosis and classification of diabetes mellitus.

WHO/NCD/NCS/99.2, World Health Organization 1999.

9. Holman RR, Turner RC. Oral agents and insulin in the treatment of NIDDM. In: Textbook of Diabetes.

Pickup J, Williams G (Eds.), Blackwell: Oxford 1991:9467-9.

10. Jackson JE, Bressler R. Clinical pharmacology of sulphonylurea hypoglycaemic agents: part 1. Drugs 1981;22(3):211-45.

11. Berger W. Incidence of severe side effects during therapy with sulfonylureas and biguanides. Horm Metab Res Suppl 1985;15:111-5.

12. Eriksson J, Franssila-Kallunki A, Ekstrand A, Saloranta C, Widén E, Schalin C, et al. Early metabolic defects in persons at increased risk for non-insulin-dependent diabetes mellitus. N Engl J Med 1989;321(6):337-43.

13. Chopra’s Indigenous drugs of India 1932, Academy Publishers, Kolkata.

2. ADA Standards of Medical Care in Diabetes - 2009.

Diabetes Care 2009;32(Suppl 1):S13-S61.

14. Kuroda M, Mimaki Y, Nishiyama T, Mae T, Kishida H, Tsukagawa M, et al. Hypoglycemic effects of turmeric (Curcuma longa L. rhizomes) on genetically diabetic KK-Ay mice. Biol Pharm Bull 2005;28(5):937-9.

3. Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, et al. Association of glycaemia

15. Shastri AD. Susruta Samhita (all volumes), 13th edition, Chaukhamba Sanskrit Sansthan, 2002.

n

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

n

n

21

clinical review

Role of Prebiotics and Probiotics in the Treatment of Gastroenteritis Pravin M Rathi*, Sandeep B Bhete**

Abstract Gastrointestinal infections are a major cause of morbidity and mortality worldwide. There are many causes of diarrhea like bacterial, viral and protozoal infections, radiation and antibiotic therapy. Different studies have found that probiotics are useful in gastroenteritis. Various mechanisms have been proposed for its usefulness in gastroenteritis such as improving intestinal barrier function, by altering the ability of pathogens to adhere to or invade colonic epithelial cells and by inhibiting the growth of pathogen. In this review, randomized control trials were selected in which patients of diarrhea were treated either with probiotics or placebo. Preliminary results are promising. As evidenced by current studies, probiotics are safe and well-tolerated.

Key words: Probiotics, gastroenteritis

G

astrointestinal infections are a major cause of morbidity and mortality worldwide. Infectious diarrhea occurs more commonly in developing countries than developed countries.1 In developing countries, deaths due to diarrhea and dehydration are most common in children younger than five years2 while in developed nations the elderly are mainly affected.3 Enteric pathogens include viruses (rotaviruses, noroviruses) and bacteria such as different strains of pathogenic Escherichia coli, toxigenic Clostridium difficile, Vibrio cholerae and Campylobacter jejuni. These pathogens produce different types of toxins that can cause severe dehydration and diarrhea. In addition to the typical pattern of acute gastroenteritis, infectious agents such as enteropathogenic E. coli (EPEC) may cause persistent, chronic diarrhea in children lasting more than 1-week.4 Such persistent infections may increase the risk of dehydration and long-term morbidities. Recent studies have shown long-term morbidities associated with gastroenteritis.

Early childhood diarrhea predisposes children to lasting disabilities, including impaired fitness, impaired cognition, stunted growth and school performance.5 Therefore, preventing or treating acute gastroenteritis before long-term sequelae develop would definitely reduce hospitalizations, disability-adjusted life years and medical costs.

Enteric viruses are the predominant etiologic agents in acute gastroenteritis in children less than three years of age, and bacteria caused the majority of cases of acute gastroenteritis in children older than three years of age.6

*Professor and Head, Dept. of Gastroenterology TNMC and BYL Nair Ch Hospital Consultant Gastroenterologist, Bombay Hospital, Mumbai **Assistant Professor, Dept. of Pharmacology TNMC and BYL Nair Ch Hospital, Mumbai

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

In addition, approximately 15-25% of cases of antimicrobialassociated diarrhea (AAD) are caused by C. difficile.

In general antibiotics have limited utility for the treatment of gastroenteritis and are not generally recommended as prevention strategies because of the problems of antibiotic resistance and AAD. Thus, instead of suppressing bacterial populations with antibiotics, probiotics can be used to shift microbial communities to a healthy state. The aim of treatment of gastroenteritis is to prevent or reverse dehydration, shorten the duration of the illness and to reduce the period that a person is infectious. Treatment options available are oral rehydration solution, antibiotics and gut motility suppressing agents such as loperamide, codeine and probiotics.

Probiotics are living microorganisms (bacteria or yeasts), which have potential beneficial effects in the prevention or in the treatment of gastroenteritis and other disorders.

Prebiotics are poorly absorbed dietary oligosaccharides which stimulate growth of gut-beneficial microbes.7 This review gives brief overview of probiotics and prebiotics and their role in the treatment of gastroenteritis. The evidences from randomized, placebo-controlled trials are also reviewed.

Probiotics and Prebiotics The term ‘probiotic’ was first used in 1965, by Lilly and Stillwell for describing substances secreted by one organism which stimulate the growth of another.8 The term probiotic was derived from the Greek, meaning ‘for life’. Probiotics are defined as ‘live microbial food supplements or components of bacteria which have been shown to have beneficial effects on human health’.9 Probiotics consist of either bacteria or yeasts. The microorganisms most commonly used as probiotics are Bifidobacteria and Lactobacilli.

23

Clinical Review Prebiotic is also described as ‘nonabsorbable food components that beneficially stimulate one or more of the gut-beneficial microbe groups and thus have a positive effect on human health’.10 The most commonly used prebiotic is fructooligosaccharides.

For organisms to be considered as probiotics, the following criteria need to be fulfilled: 

They should be nonpathogenic



They should be isolated from the same species as its intended host



They should be able to survive transit through the gastrointestinal tract

Bacteria 

 

    



They should have a demonstrable beneficial effect on the host





On storage, large number of viable bacteria must be able to survive for longer duration.



Single or mixed cultures of live microorganisms are used in probiotic preparations (Table 1).11 These probiotics may be useful in various conditions. Indications, where probiotics can be used, are shown in Table 2.12 Probiotics should be used cautiously in patients taking immunosuppressants such as cyclosporine, azathioprine and chemotherapeutic agents, since probiotics could cause an infection in immunocompromised patients.13 Safety Profile Probiotics are generally considered safe and well-tolerated.

As evidenced by epidemiologic studies, bacteremia or sepsis from lactobacilli is extremely rare. Numerous probiotics have a long history of safe use and no health hazards have been observed.14 Proposed Mechanism of Action of Probiotics in Diarrhea The disruption of epithelial barrier function and loss of tight junction formation in the intestinal epithelium may contribute to pathophysiology and diarrheal symptoms observed during infection with certain pathogens.15,16 Loss of tight junctions can lead to increased paracellular transport that can result in fluid loss and pathogen invasion of the submucosa. Pathogens may secrete factors such as enterotoxins that may promote excessive apoptosis or necrosis of intestinal epithelial cells, thereby disrupting the intestinal barrier. Enteric pathogens may also cause lesions at the mucosal surface due to direct adherence with intestinal epithelial cells. In contrast, probiotics have been reported to promote tight junction formation and intestinal barrier function.17,18 Although, the mechanisms of promoting barrier integrity are not well-understood, probiotics may counteract the disruption of the intestinal epithelial barrier

24

Table 1. Microorganisms used as Probiotics Lactobacillus: acidophilus, rhamnosus, sporogenes, plantarum, delbrueckii, reuteri, fermentum, lactis, cellobiosus, brevis Bifidobacterium: bifidum, infantis, longum, animalis Streptococcus: thermophilus, lactis, cremoris, salivarius, intermedius Propionibacterium Pediococcus Leuconostoc Enterococcus faecium Enterococcus Bacillus

Yeast and moulds 

Saccharomyces: boulardii, cerevisiae, niger, oryzae Pintolopesii

Table 2. Indications for use of Probiotics12 Rotavirus diarrhea Reduction of antibiotic-associated side effects Traveler’s diarrhea Prevention of vaginitis Urogenital infections Atopic eczema Inflammatory bowel disease Helicobacter pylori infection Irritable bowel syndrome Cystic fibrosis Dental caries Various cancers

despite the presence of pathogens. Probiotics may also inhibit toxin production or interfere with the abilities of specific pathogens to adhere directly to the intestinal surface. As a result, pathogens may have a diminished ability to disrupt intestinal barrier function.

Probiotics sometimes rather than directly inhibiting the growth or viability of the pathogen, may compete for an ecological niche or, otherwise, create conditions that are unfavorable for the pathogen to take hold in the intestinal tract. There are many possible mechanisms for how pathogen exclusion may take place. First, several probiotics have been demonstrated to alter the ability of pathogens to adhere to or invade colonic epithelial cells in vitro.19,20 Second, probiotics could sequester essential nutrients from invading pathogens and impair their colonization ability. Third, probiotics may alter the gene expression program of pathogens in such a way as to inhibit the expression of virulence functions.21 Prebiotics and probiotics are useful in the management of gastroenteritis. The benefits of using prebiotics and probiotics in the treatment of gastroenteritis are shown in Table 3.

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

Clinical Review Table 3. Benefits of using Pre- and Probiotics in Gastroenteritis 

Help in preventing diarrhea during antibiotic therapy



Reduce incidence, duration and severity of acute diarrhea



Reduce abdominal pain and stabilize intestinal microflora



Useful adjuncts to rehydration therapy in diarrhea

Current Evidence from Randomized Placebocontrolled Clinical Studies To evaluate the evidence for usefulness of probiotics in diarrhea, we chose to focus only on data from randomized placebo-controlled clinical trials. Probiotics have preventive as well as curative effects on several types of diarrhea of different etiologies like infection, radiation and antibiotic therapy.

Infective Diarrhea Probiotics have been best researched as a form of management for acute infantile diarrhea. Rotavirus is the leading cause of this condition worldwide. The primary treatment for this is rapid oral rehydration.22 The study conducted by Shamir et al involved 65 children aged 6-12 months were randomized to receive probiotics mixture of Streptococcus thermophilus, Bifidobacterium lactis, Lactobacillus acidophilus, 0.3 grams of fructooligosaccharides and 10 mg of zinc/day in the supplemented group (n = 33) or placebo (n = 32), given in a soy protein-based rice cereal. Diarrhea resolution occurred after 1.43 ± 0.71 days in the supplemented group versus 1.96 ± 1.24 in the control group (p = 0.017). The feeding of a cereal containing S. thermophilus, B. lactis, L. acidophilus and zinc, reduced the severity and duration of acute gastroenteritis in young children.23 In one study, 100 children between six and 60 months of age were selected and randomly allocated into two groups. Study group (n = 50) was given probiotic mixture which contained L. acidophilus and Bifidobacterium infantis, one capsule thrice-daily for four days and control group (n = 50) received parenteral rehydration only without any medication. All children were evaluated for the degree of dehydration before rehydration.

The clinical course of diarrhea was followed during the treatment period. Features on admission were similar between the study group and control group in age, duration of diarrhea at home, serum sodium and potassium and dehydration degree. There was no difference between the study group and control group in the frequency of diarrhea stools on the day before admission (p > 0.05). However, the frequency of diarrhea for study group improved on the first and second day of hospitalization with statistical difference (p < 0.01). The duration of diarrhea during hospitalization in study group also decreased (3.1 vs 3.6 days, p < 0.01).

Probiotic therapy is an effective adjuvant therapy in rotavirus positive and negative children with diarrhea

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

and can be safely administered during an episode of acute diarrhea.24 Oberhelman et al conducted a study administering Lactobacillus rhamnosus GG (LGG) or a placebo to 204 malnourished children age ranging from six to 24 months.

There was significantly lower incidence of diarrhea in the patients treated with probiotic compared with the placebo group (5.2 vs 6.0 episodes per child per year).25 At least three systematic reviews have shown that use of probiotics achieves overall reductions in the duration of diarrhea ranging from 17 to 30 hours.26-28 The data on the use of probiotics to manage adults with infective diarrhea are limited and mixed. Allen et al reviewed 23 papers on the treatment of infectious diarrhea with probiotics and concluded that they appear to be a useful adjunct to rehydration therapy when managing both adults and children.26 In one metaanalysis, for the treatment of pediatric diarrhea, trials that measured duration of diarrhea, 18 trials were analyzed. In the pooled estimate, probiotics were found to significantly reduce the duration of diarrhea compared to controls (SMD = –0.56 days, 95% CI –0.73, –0.38, z = 6.20, p < 0.001) in the pooled standardized mean difference random effect model (Fig. 1).29 Antibiotic-associated Diarrhea The antibiotics that cause diarrhea are clindamycin, cephalosporins, ampicillin and amoxicillin. Kotowska et al enrolled 269 children who were taking antibiotics for ear Standardized mean difference (95% Cl) –0.46 (–0.69, –0.22) –0.43 (–0.79, –0.08) –0.91 (–1.32, –0.50) –1.10 (–1.62, –0.57) –1.06 (–1.71, –0.42) –0.44 (–0.92, 0.05) 0.00 (–0.35, 0.35) –0.84 (–1.50, –0.19) –0.60 (–1.24, 0.03) –0.47 (–1.07, 0.12) –0.75 (–1.35, –0.15) –0.46 (–0.92, 0.01) –0.67 (–1.07, –0.26) –0.61 (–1.23, 0.00) –1.37 (–2.07, –0.66) –0.30 (–0.84, 0.24) 0.28 (–0.13, 0.69) –0.61 (–1.11, –0.12) –0.56 (–0.73, –0.38)

Study Guandalini 2000 LGG Shornikova 1997 LGG Guarino 1997 LGG Isolauri 1991 LGG Isolauri 1994 LGG Rosenfeldt 2002 LRLR Costa Ribeiro 2003 LGG Pant 1996 LGG Shornikova 1997 high LR Shornikova 1997 low LR Shornikova 1997 high LR Simakachorn 2000 LA Lee 2001 LABI Rosenfeldt 2002 LRLR Kaila 1992 LGG Chicoine 1973 LALBSL Pearce 1974 LALBST Shamir 2005 Synbio1 Overall –2.0702

0 Standardized mean difference

Favors Probiotic

2.07023

Favors Control

Figure 1. Forest plot of 18 randomized controlled trials for the treatment of pediatric diarrhea by probiotics using duration of diarrhea as the outcome. Random effect model.

LGG = Lactobacillus rhamnosus GG; LR = Lactobacillus reuteri; LA = Lactobacillus acidophilus; LABI = L. acidophilus and Bifidobacterium infantis; LRLR = L. rhamnosus and L. reuteri; LALBSL= L. acidophilus + L. bulgaricus + S. lactis; LALBST = L. acidophilus + L. bulgaricus + S. thermophilus; Synbiotic 1 = Streptococcus thermophilus + Bifidobacterium lactis + L. acidophilus + Zinc + fructooligosaccharide.

25

Clinical Review or respiratory infections and randomized them to either Saccharomyces boulardii (500 mg/d) or placebo for the duration of the antibiotic treatment. Even though the follow-up time was short (two weeks postantibiotic), the frequency of diarrhea in the probiotic group was significantly less (3.4%) compared to 17.3% in the placebo group.30 One recent trial tested a fermented drink with a mixture of Lactobacillus casei DN-114001, S. thermophilus and L. bulgaricus against a control milkshake. The study treatment was given randomly to hospitalized adults over 50 years old on antibiotics for the duration of the antibiotic and an additional week. Patients were followed for an additional four weeks for the development of AAD. The patients given the probiotic mixture reported significantly less AAD (12.3%, p < 0.05) than those given the control (33.9%).

No adverse reactions were reported.31 Most metaanalyses have concluded that probiotics are effective for preventing AAD.32,33

A limited number of randomized controlled trials have been conducted to test probiotics for the treatment of CDI as their primary outcome (Table 4).35-39 In one randomized, controlled trial, patients with CDI were prescribed either one of two doses of vancomycin (2 g/d or 500 mg/d) or metronidazole (1 g/d) then randomized to either S. boulardii or placebo (1 g/d for 4 weeks).36 Patients treated with high-dose vancomycin and the probiotic had significantly decreased recurrence rates (16.7%) compared to vancomycin and placebo (50%). The probiotic given with the low-dose vancomycin or metronidazole was not significantly protective against CDI. This finding was in contrast to a prior trial of the same probiotic strain that showed significant effectiveness of S. boulardii as an adjunct to standard vancomycin or metronidazole therapy.35 Several other trials for CDI were terminated early due to slow enrollment rates and the resulting small study sizes (15-25) precluded any statistical conclusions.37-39

Clostridium difficile-associated Diarrhea

Radiation-induced Diarrhea

Probiotics may offer promise as an adjunctive therapy (given along with standard antibiotics vancomycin or metronidazole) for C. difficile infection (CDI), as several strains produce proteases that directly degrade C. difficile toxins or increase the immune response to C. difficile toxins A and B.34 A metaanalysis of six randomized controlled trials using probiotics combined with one of the two standard antibiotics to treat CDI found probiotics, in general, significantly reduced the risk of CDIs (p = 0.005).35

Diarrhea is a nearly constant adverse effect of irradiation of the pelvis. A double-blind, placebo-controlled trial was done to investigate the efficacy of a high potency probiotic preparation on prevention of radiation-induced diarrhea in cancer patients. About 490 patients, who underwent adjuvant postoperative radiation therapy, were given either high potency probiotic mixture of Lactobacilli, Bifidobacteria and S. thermophilus or placebo. Efficacy endpoints were incidence and severity of radiation-induced diarrhea and daily number

Table 4. Randomized, Controlled Clinical Trials of Probiotics for the Treatment of Clostridium difficile Infections Probiotic

Population

Duration (days)

Frequency of CDI relapses in probiotic

Saccharomyces boulardii

124 adult patients on varied doses of vancomycin or metronidazole; recurrent and initial CDAD cases

28, followed for another 4 weeks

15/57 (26.3%)

Saccharomyces boulardii

National, 1993-1996, 170 adult patients recurrent CDAD; on vancomycin (500 mg/d, n = 83) or (2 g/d, n = 32) or metronidazole (1 g/d, n = 53)

28, followed for another 4 weeks

Vancomycin (2 g/d) 3 (17%), vancomycin (500 mg/d) 23 (51%), metronidazole (1 g/d) 13 (48.1%)

7 (50%), 17 (44.7%), 13 (50%)

Surawicz36 2000

Lactobacillus rhamnosus GG

25 adults on vancomycin or metronidazole, recurrent and initial CDAD

21

4/11 (36.4%)

5/14 35.7%

Pochapin37 2000

Lactobacillus plantarum 299v

29 enrolled, 20 adults finished, 9 sites, 1-5 prior episodes, over 2 years

38 days, followed until Day 70

4/11 (36%)

Metronidazole only, 6/9 (67%)

Wullt38 2003

3/8 (37.5%)

1/7 (14.3%)

Lawrence39 2005

Lactobacillus rhamnosus GG and 64 mg inulin

26

15 adults on vancomycin or Duration 21 days metronidazole with CDAD, enrolled over 9 months

Frequency of CDI relapses in controls 30/67 (44.8%)

References

McFarland35 1994

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

Clinical Review of bowel movements. Results were as follows: More placebo patients had radiation-induced diarrhea than probiotic mixture patients and more patients given placebo suffered Grade 3 or 4 diarrhea compared with probiotic mixture recipients. So, it was concluded that probiotic lactic acid producing bacteria are an easy, safe and feasible approach to protect cancer patients against the risk of radiation.40 Traveler’s Diarrhea Traveler’s diarrhea is a common health complaint among travelers. Acute diarrhea occurs in about half of travelers who visit high-risk areas. Although, most cases are mild and self-limiting, there is a considerable morbidity. Antibiotics are effective prophylaxis but are not recommended for widespread use and there is thus a need for cost-effective alternative treatments. Several studies were performed with the use of probiotics. A meta-analysis was done on published randomized controlled clinical trials of traveler’s diarrhea cases. It was concluded that probiotics significantly prevent traveler’s diarrhea. S. boulardii and a mixture of L. acidophilus and B. bifidum had significant efficacy.41 Other Conditions with Diarrhea Irritable bowel syndrome (IBS) is precipitated by an episode of acute gastroenteritis in upto 30% of cases.42 Various probiotic species have shown promise in the treatment of ulcerative colitis. In one study, Sood et al enrolled 147 patients of ulcerative colitis either receiving probiotic mixture of Lactobacilli, Bifidobacteria and S. thermophilus or placebo. At Week 6, the percentage of patients with an improvement in symptoms was significantly higher in the group given probiotic mixture (32.5%) than the group given placebo (10%).43

Conclusion In summary, probiotics have a beneficial effect in the treatment of gastroenteritis by improving intestinal barrier function, by altering the ability of pathogen to adhere to or invade colonic epithelial cells and by inhibiting the growth of pathogen. Evidences from current clinical trials suggest that probiotics are safe and well-tolerated. In most of the placebocontrolled clinical trials, probiotics showed promising results in the management of diarrhea. This review suggests that probiotics are useful in the treatment of diarrhea.

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Savarino SJ, Bourgeois AL. Trans R Soc Trop Med Hyg 1993;87(Suppl 3):7‑11.

Nguyen RN, et al. Emerg Infect Dis 2006;12(4):597-603.

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Guerrant RL, et al. Arch Med Res 2002;33(4):351-5.

Klein EJ, et al. Clin Infect Dis 2006;43(7):807‑13.

Sartor RB. Gastroenterology 2004;126(6):1620-33.

Lilly DM, Stillwell RH. Science 1965;147:747-8.

Salminen S, et al. Br J Nutr 1998;80:S147-71.

Gibson GR, Roberfroid MB. J Nutr 1995;125(6): 1401-12.

D’Souza AL, et al. BMJ 2002;324:1361.

Gorbach SL. Dig Liver Dis 2002;34(Suppl 2):S2-7.

Natural Medicines Comprehensive Database. Lactobacillus monograph. www.naturaldatabase.com. Accessed 2011 March 30.

Reid G. Clin Infect Dis 2002;35(3):349-50.

Guttman JA, et al. Cell Microbiol 2006;8(4):634‑45.

Hecht G. Am J Physiol Gastrointest Liver Physiol 2001;281(1):G1-7.

Johnson-Henry KC, et al. Infect Immun 2008;76(4): 1340-8.

Klingberg TD, et al. Appl Environ Microbiol 2005;71(11): 7528-30.

Johnson-Henry KC, et al. Cell Microbiol 2007;9(2): 356-67.

Spurbeck RR, Arvidson CG. Infect Immun 2008;76(7): 3124-30.

Medellin-Peňa MJ, et al. Appl Environ Microbiol 2007;73(13):4259-67.

Harish K, Varghese T. Calicut Med J 2006;4(4):e3.

Shamir R, et al. J Am Coll Nutr 2005;24(5):370‑5.

Lee MC, et al. Acta Paediatr Taiwan 2001;42(5):301-5.

Oberhelman RA, et al. J Pediatr 1999;134(1):15-20.

Allen SJ, et al. Cochrane Database Syst Rev 2004;(2): CD003048.

Szajewska H, et al. J Pediatr Gastroenterol Nutr 2001;33 (Suppl 2):S17-S25.

Van Neil CW, et al. Pediatrics 2002;109(4):678‑84.

McFarland LV, et al. Int J Probiot Prebiot 2006;1(1): 63-76.

Kotowska M, et al. Aliment Pharmacol Ther 2005;21(5): 583-90.

Hickson M, et al. BMJ 2007;335(7610):80.

McFarland LV. Am J Gastroenterol 2006;101(4):812‑22.

Meerpohl JJ, Timmer A. Z Gastroenterol 2007;45(8): 715-7.

Kekkonen RA, et al. World J Gastroenterol 2008;14(20): 3188-94.

McFarland LV, et al. JAMA 1994;271(24):1913-8.

Surawicz CM, et al. Clin Infect Dis 2000;31(4):1012-7.

Pochapin M. Am J Gastroenterol 2000;95(1 Suppl):S11‑3.

Wullt M, et al. Scand J Infect Dis 2003;35(5):365-7.

Lawrence SJ, et al. J Med Microbiol 2005;54(Pt 9):905-6.

Delia P, et al. World J Gastroenterol 2007;13(6):912-5.

McFarland LV. Travel Med Infect Dis 2007;5(1):97-105.

Spiller R, Campbell E. Curr Opin Gastroenterol 2006; 22(1):13-7.

Sood A, et al. Clin Gastroenterol Hepatol 2009;7(11): 1202-9.

27

Clinical Study

A Case-control Study of Pelvic Inflammatory Disease and Its Association with Multiparity SV Patel*, RK Baxi**, PV Kotecha†, VS Mazumdar**, HN Bakshi‡, KG Mehta§

Abstract Research question: Do multiparity lead to pelvic inflammatory disease (PID)? Object: To known the association between PID and multiparity. Study design: Case-control study. Setting: Shree Sayaji General Hospital (SSGH), Government Medical College, Vadodara. Participants: Women attending Gyne Clinics and Curative Practice and General Practice (CPGP) OPD. Sample side: 150 cases and 150 controls. Statistical analysis: Chi-square test. Results: The odds ratio (OR) for, PID with multiparity as risk factor was 0.69 with 95% confidence interval (CI) being 0.42-1.09. Among 143 cases, multiparity was present in 63 cases (44.05) while in 150 controls it was in 80 (53.33%). The difference was not statistically significant (p = 0.141). But, the OR with untrained person as a risk factor for PID was 2.41 with 95% CI being 1.78-3.27.

This suggests etiological fraction of 58.5% (CI 43.9-69.4%) among untrained persons. The delivery by untrained person was significantly higher in cases than in controls. Conclusions: Present study did not show multiparity as risk factor but delivery conducted by untrained persons emerged as a risk factor.

Key words: Pelvic inflammatory disease, multiparity, case-control study

P

elvic inflammatory disease (PID) is one of the most serious infections faced by women today.

It is a common problem encountered in gynecologic infertility, family planning, legal abortions, postnatal and sterilization clinics in India and abroad.1 PID, as described by the Centers for Disease Control and Prevention (CDC), is a general term that refers to infection of the uterus, fallopian tubes and other reproductive organs. It is a common and serious complication of some sexually transmitted diseases (STDs), especially chlamydia and gonorrhea. PID can damage the fallopian tubes and tissues in and near the uterus and ovaries. Untreated PID can lead to serious consequences, including infertility, ectopic pregnancy, abscess formation and chronic pelvic pain.2 PID is one or the most widespread and debilitating disease affecting women today. Present case-control

*Associate Professor **Professor Dept. of Preventive and Social Medicine †Country Representative, Academy for Educational Development ‡Tutor §Junior Lecturer Dept. of Preventive and Social Medicine, Govt. Medical College, Vadodara Address for correspondence Dr Sangita Patel Associate Professor Dept. of Preventive and Social Medicine Govt. Medical College Baroda, Vadodara - 390 001, Gujarat E-mail: sangita_psm@yahoo.co.in

28

study undertaken to know the association between PID and multiparity.

Objective To know the multiparity.

association

between

PID

and

Methodology This study was conducted at Shree Sayaji General Hospital (SSGH) which is a regional referral hospital attached to Government Medical College, Vadodara.

Selection of Cases and Sources of Cases

The Obstetric and Gynecology Department of SSGH has daily outpatients service. Average daily outpatient at this OPD is 100 gynecological cases, of which 8-10% have PID. In present study, 150 patients of PID who attended Gynecology OPD of SSGH over a period of one-year were selected with uniformly accepted criteria for PID as given under: Complaints of lower abdominal pain, vaginal discharge and adnexal tenderness leading to pain. All cases meeting with the above diagnostic criteria were labeled as clinical cases of PID. Exclusion Criteria

Those who have extramarital history were excluded from both cases and controls. After taking consent, Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

Clinical study we obtained information by conducting in-depth interviews for two or three sessions with each patient.

Selection of Controls and Sources of Controls

Table 1. Comparison Age Group in both Cases and Control Age group

Cases

Control

16-20

02

06

For each case, a control was selected from women attending SSGH outdoor for any complaints, health problems other than obstetrics and gynecology. One hundred fifty controls were selected from Curative, Preventive and General Practice (CPGP) unit of SSGH Hospital. CPGP has adequately comfortable offices which provided necessary privacy for interviews of the control group. For the purpose of present study definition of the term multiparity was considered from available literature.

21-25

28

24

26-30

38

41

31-35

42

38

36-40

21

20

>40

19

21

Multiparity

Total

Those women who have more than three living children born are labeled as multiparous women. In order to evaluate the role of multiparity as risk factor which might influence the pathogenesis of PID, each patient was matched with a patient in the concurrent group with respect to age (by five years age group) (Table 1). The mean age in cases was 32.56 Âą 7.31 and in controls was mean 32.58 Âą 8.05. The difference was statistically not significant.

Data Processing and Statistical Analysis

The entire information from the questionnaire of cases and controls was coded and data fed into computer by using statistical software EPI-Info. Data was analyzed by Epi-Info.3 Significance of difference in the prevalence of PID patients (cases) and control due to multiparity was analyzed by using Chi-square test.

Results Among 143 cases multiparity was present in 63 cases (44.05%) while in 150 controls it was in 80 (53.33%).

The difference was not statistically significant (p = 0.141). The odds ratio (OR) for PID with multiparity as a risk factor was 0.69 with 95% confidence interval (CI) being 0.42-1.09 (Table 2).

Delivery in itself is not a risk factor for PID but delivery by untrained person is a risk factor. The OR for delivery by an untrained person as a risk factor for PID was 2.41 with 95% CI being 1.78-3.27. This suggests etiological fraction of 58.5% (CI 43.9-69.4%) Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

Table 2. Association between Multiparity and PID Cases

Controls

Total

Multiparity +

63 (44.05%)

80 (53.33%)

143

Multiparity -

80 (55.94%)

70 (46.66%)

150

143

150

293

Table 3. Comparison of Delivery Assistance in Total No. of Deliveries in both Groups Total deliveries among cases

Total deliveries among controls

Total

Trained persons

193 (52.44%)

282 (72.69%)

475

Untrained persons

175 (47.56%)

106 (27.31%)

281

368

385

756

Total

Table 4. Comparison of Place of Delivery in Total No. of Deliveries in both the Groups Total deliveries among cases

Total deliveries among controls

Total

Hospital deliveries

165 (45.96%)

254 (64.96%)

419

Home deliveries

194 (54.04%)

137 (35.04%)

331

359

391

750

Total

among untrained persons. The delivery by untrained person was significantly higher in cases than in controls (Table 3).

Discussion A standard proforma was used to collect delivery history. The present study is a hospital-based study. The cases as well as controls were drawn from a hospital so other factors like occupation, income, socioeconomic status, personal hygiene, etc. are similar because both cases and controls represent the same group of patients 29

Clinical study presenting to the hospital. In seven cases information on multiparity was not available.

Multiparity initially was thought to be a risk factor because:  Repeated births cause infection in the birth passage.  Patient’s general immunity is decreased due to repeated delivery, so increasing chances of infection.  Repeated blood loss due to repeated deliveries, leads to anemia and chances of infections are much more in anemic women.

The OR for PID with multiparity as a risk factor was 0.69 with 95% CI being 0.42-1.09. Among 143 cases multiparity was present in 63 cases (44.05%) while in 150 controls it was in 80 (53.33%). The difference was not statistically significant (p = 0.141).

The possible explanation for the same could be:  High estrogen and progesterone hormones levels like in pregnant state give protective effect against PID; similar to protective effect observed due to oral contraceptive use.  The frequency of sexual intercourse is decreased during pregnancy and sexual intercourse is as a risk factor for PID. So less chances of PID in multiparity.4-6  Repeated deliveries may mean repeated contacts with doctors; if infection was present then it would have been treated.  PID in the fallopian tubes (salpingitis) can cause adhesions or complete tubal obstruction. Thus, ectopic pregnancy or infertility may occur even after only one episode. For example, in a Swedish study of 415 women with a history of salpingitis 21% were infertile compared with 3% in a comparison group with no history of salpingitis.7 One study conducted by Beerthuizen found that nulliparous women with stable monogamous relationships are not at higher risk of PID than parous women.8 One longitudinal study done by Wright demonstrated that there was no relationship between the parity of the patients and the development of PID.9 Delivery in itself is not a risk factor for PID but delivery by untrained person is a risk factor.

Although the data between hospital delivery and home delivery is separated, the importance of conduction of delivery by trained person can not be ignored. So, we 30

analyzed the data comparing delivery by trained and untrained persons. The OR with untrained person as a risk factor for PID was 2.41 with 95% CI being 1.78-3.27. This suggests etiological fraction of 58.5% (CI 43.9-69.4%) among untrained persons. The delivery by untrained person was significantly higher in cases than in controls.

Conclusions Present study did not show multiparity as risk factor but delivery conducted by untrained persons emerged as a risk factor for PID. Recommendation Training of dais is important. The Government of India has already started a training program for dais in aseptic techniques which should be strengthened to ensure aseptic delivery.

References 1. Pachauri S. Defining A Reproductive Health Package for India: A proposed Framework. Regional Working Paper No 4. 1995.

2. Tolu Oyelowo DC. Pelvic Inflammatory Disease.

Mosby’s Guide to Women’s Health. 2007:168-71.

3. Epi_Info VdAwp, Database, and Statistical Programme for Public Health on IBM-compatible Microcomputers.

Centers for Disease Control and Prevention. Atlanta, Georgia, USA Developed by Dean AG, Coulombier D, Brendel KA, Smith DC, Burton AG, Dicker RC, et al.

2001.

4. Duncan ME, Tibaux G, Pelzer A, Reimann K, Peutherer JF, Simonds P, et al. First coitus before menarche and risk of sexually transmitted disease. Lancet.

1990;355(8685):338-40.

5. Eschenbach DA. Prospective study of pelvic inflammatory by clinical criteria. Obstet Gynecol 1950;55: 1485-525.

6. Lee NC, Rubin GL, Grimes DA. Measures of sexual behavior and the risk of pelvic inflammatory disease.

Obstet Gynecol 1991;77(3):425-30.

7. Sweet RL, Draper DL, Hadley WK. Etiology of Acute Salpingitis: influence of episode number and duration on symptoms. Obstet Gynaecol 1981;58(3):62-8.

8. Beerthuizen RJ. Pelvic inflammatory disease in intrauterine device users. Eur J Contracept Reprod Health Care 1996;1(3):237‑43.

9. Wright EA, Aisiena AO. Pelvic inflammatory disease and the intrauterine contraceptive device. Int J Gynecol Obstet 1989;28(2):133-6.

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

Case Study

BMIs and Self-perception of Weight and Height among Adolescent Students in Rural Area of Vadodara PV Kotecha*, Sangita V Patel**, VS Mazumdar†, RK Baxi‡, Shobha Misra**, Harsh Bakshi§, Mansi Diwanji¶, Ekta Modi¶, Kedar Mehta¥

Abstract Objectives: To know the perceptions about height and weight of adolescents and to compare it with their actual body mass index (BMI) status. Methodology: A quantitative survey was carried out using a self-administered semi-structured questionnaire among 768 (428 boys and 340 girls) students by systematic random sampling from 20 schools out of total 121 schools in five talukas (4 schools from each taluka). Results and Discussion: Regarding their perception about the appropriateness of their height and weight, nearly half (50.2%) of the boys and girls felt that their height was appropriate.

When adolescents’ perception of the appropriateness of their weight was compared with their actual BMI, it was found that, 51.6% of the boys who were classified as below normal by their BMI status perceived that they had normal weight for their age. When BMI was calculated, it was found that 55.2% of the adolescents covered under the survey were underweight.

Among those, having normal BMI, 70.3% of boys and 54.9% of girls felt that their weight was normal. Recommendations: The present study has shown the need for addressing physical growth. Issues relating to height and weight need to be dealt with more scientifically and in depth.

Key words: Adolescent, body mass index, self-perception

T

he adolescent experiences not only physical growth and change but also emotional, psychological, social and mental change, and growth. Physiological changes lead to sexual maturity and usually occur during the first several years of this period. This process of physical changes is known as puberty, and it generally takes place in girls between the ages of 8 and 14, and boys between the ages of 9 and 16.1 Adolescence represents a window of opportunity to prepare for a healthy adult life. The world’s adolescent population (10-19 years of age) - 1,200 million persons, or about 19% of the total population - faces a series of serious nutritional challenges not only affecting their growth and development but also their livelihood as *Technical Advisor Academy for Educational Development **Associate Professor †Professor and Head ‡Professor §Lecturer ¶Research Associate ¥Junior Lecturer Dept. of Preventive and Social Medicine (PSM) Govt. Medical College Baroda, Vadodara, Gujarat Address for correspondence Dr Sangita Patel Associate Professor Dept. of Preventive and Social Medicine Govt. Medical College Baroda, Vadodara - 390 001, Gujarat E-mail: sangita_psm@yahoo.co.in

32

adults.2 Yet adolescents remain a largely neglected, difficult-to-measure and hard-to-reach population, in which the needs of adolescent girls in particular are often ignored.

Adolescence is a particularly unique period in life because it is a time of intense physical, psychosocial, and cognitive development. Increased nutritional needs at this juncture relate to the fact that adolescents gain upto 50% of their adult weight, >20% of their adult height and 50% of their adult skeletal mass during this period.3 Caloric and protein requirements are maximal.

Increased physical activity, combined with poor eating habits and other considerations, e.g., menstruation and pregnancy, contribute to accentuating the potential risk for adolescents of poor nutrition.

Adolescents are particularly concerned about their appearance because dating begins at this age and many will choose marital partners.4 In addition to physical complications, negative social and emotional associations of overweight and obesity such as low self-esteem, being bullied, depression, behavioral and learning problems have been well-studied.5,6 Underweight or normal weight adolescents who perceive themselves to be overweight are at an increased Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

case study risk for eating disorders such as anorexia nervosa.7 Little is known about the relationship between actual weight and weight perception among adolescents in India. Hence, the present study was conducted to know the association between assessing their perceptions about their height and weight and then comparing them to their actual BMI status.

Material and Methods The study was carried out among selected school children and the assessment was done in the rural areas of Vadodara district. A quantitative survey was carried out using a self-administered semi-structured questionnaire among 768 (428 boys and 340 girls) students from Classes 8-12 in 15 Gujarati medium schools in rural Vadodara, selected for the study by systematic random sampling from a total of 121 school in five talukas (4 schools from each talukas), while the remaining five schools were reserved as replacement for eventual dropouts. A self-administered questionnaire was used to collect quantitative data on weight and height perceptions and their BMI, after passing Institutional Ethical Clearance. The study was conducted during the years 2004-2006.

Data Collection

Considering the WHO definition of adolescents as persons in the age group of 10-19 years and the ability of school students to respond to the self-administered questionnaire, it was decided to include students of Classes 8-12 in the study.

Body mass index (BMI) relates a personâ&#x20AC;&#x2122;s weight to his/her height. BMI can be used to assess both thinness and obesity. The BMI is defined as the weight in kilograms, divided by the height in meters squared.

BMI of less than 5th percentile indicates chronic energy deficiency, which indicates nutritional deficiencies. BMI between 5th and 85th percentile is normal for that age. BMI above 85th percentile indicates overweight. On this basis adolescents were classified as normal, below normal (underweight) and above normal (overweight) based on the BMI calculated with help of their actual height and weight by using appropriate standard measurements.8 The schools were informed on phone and a convenient time and date were fixed. The team, accompanied by a Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

teaching staff member from the Preventive and Social Medicine Department, Baroda Medical College reached the schools at the appointed time. The identified classes were explained the purpose of the study. Participation in the study was voluntary. Due consent was taken from each student. To ensure that they understood the questions; the students were led question by question while answering the questions in the study instrument.

To ensure confidentiality, the writing of the names was optional. The instruments were collected after checking for completeness and the students and teachers were thanked for their participation in the study.

The quantitative data so collected was entered into computer using Epi Info (Version 6.04d) software.

(Epi Info) Data cleaning was carried out, checked for discrepancies and rectified.9 Results The age distribution of the adolescent boys and girls, shows that half of them belonged to the early adolescence category - the age group of 13-15 years, about one-third were in the mid adolescence group (age 16-18 years) and the rest belonged to the late adolescence group of 17-20 years. A few boys and girls were unaware of their age. The median age of boys and girls was 15 years.

Regarding their perception about the appropriateness of their height and weight, nearly half (50.2%) of the boys and girls felt they had appropriate weight, while 46.6% felt that they had appropriate height (Tables 1 and 2). Nearly a third (27.8%) perceived themselves to be underweight, while 18.2% thought they were obese.

Similarly, 46.6% of boys and girls perceived that they had normal height and a small percentage (11.1%) thought they were taller than they ought to be, whereas nearly 34% thought they were shorter. The agreement between actual BMI and perceived weight was 0.4 in females (kappa) and 0.5 in males (kappa). Over half (55.2%) of the adolescents covered under the survey were underweight, while only a very small percentage of adolescents were either overweight or obese. It was however very surprising to find that under nutrition was more common in boys as compared to girls. The overall prevalence of obesity though less, was found to be more in boys. When adolescentsâ&#x20AC;&#x2122; perception of the appropriateness of their weight was compared with their actual BMI, it was found that, 51.6% of 33

case study Table 1. Weight as Perceived by the Participating Students Perception

Boys

Girls

Total

N = 428

%

N = 340

%

N = 768

%

Normal

238

55.6

148

43.5

386

50.2

Less than required

126

29.4

88

25.8

214

27.8

More than required

56

13.0

84

24.7

140

18.2

No response

8

1.8

20

5.8

28

3.64

Chi-square 28.77; p value <0.0001

Table 2. Height as Perceived by the Participating Students Perception

Boys

Girls

Total

N = 428

%

N = 340

%

N = 768

%

Normal

217

50.7

141

41.4

358

46.6

Less than required

146

34.1

115

33.8

261

33.9

More than required

41

9.5

45

13.2

86

11.1

No response

24

5.6

39

11.4

63

8.2

Chi-square 13.67; p value <0.001

Table 3. Sex-wise Comparison of BMI Status of the Students BMI Status

Sex Boys (N = 417)

Girls (N = 339)

Total (N = 756)

No.

%

No.

%

No.

%

Normal

119

28.5

207

61.1

326

43.1

Below normal

290

69.5

127

37.5

417

55.2

Above normal

8

1.9

5

1.5

13

1.7

Chi-square 80.98; p value <0.0001

Table 4. Relationship between Weight Perceived and BMI Status of the Students BMI status

Weight perceived by the students Boys

Girls

Normal

Less than required

More than required

Total

Normal

Less than required

More than required

Total

Normal

83 (70.3%)

15 (12.7%)

20 (16.9%)

118 (28.9%)

106 (54.9%)

33 (17.1%)

54 (28.0%)

193 (60.5%)

Below normal

146 (51.6%)

107 (37.8%)

30 (10.6%)

283 (69.2%)

41 (33.9%)

54 (44.6%)

26 (21.5%)

121 (37.9%)

Above normal

3 (37.5%)

1 (12.5%)

4 (50.0%)

8 (2.0%)

1 (20.0%)

0 (0.0%)

4 (80.0%)

5 (1.6%)

the boys who were classified as below normal as per their BMI status perceived themselves having normal weight for their age, while 37.5% of them thought that they had more weight than required. Less than a fifth (16.9%) of the boys who were normal as per their BMI status thought that they had more weight than 34

what is required. In case of girls who were classified as below normal by their BMI status, 33.9% thought that they were normal while 20% thought that they had weight more than required. However, 70.3% and 54.9% of boys and girls respectively, having normal BMI felt that they were normal (Table 4).

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

case study Table 5. Relationship between Height Perceived and BMI Status of the Students BMI status

Height perceived by the students Boys

Normal Below normal Above normal

Girls

Normal

Less than required

More than required

Total

Normal

Less than required

More than required

Total

62

45

8

115

86

70

25

181

(53.9%)

(39.1%)

(7.0%)

(53.9%)

(47.5%)

(38.7%)

(13.8%)

(60.3%)

150

94

32

276

52

43

20

115

(54.3%)

(34.1%)

(11.6%)

(53.9%)

(45.2%)

(37.4%)

(17.4%)

(38.3%)

2

4

0

6

2

2

0

4

(33.3%)

(66.7%)

(0.0%)

(1.5%)

(50.0%)

(50.0%)

(0.0%)

(1.3%)

*Must et al. Cut offs for BMI grades for adolescents: < 5th percentile - Underweight, 5th-85th percentile - normal, 85th-95th percentile - Overweight, above 95th percentile - Obese.

A comparison between adolescentsâ&#x20AC;&#x2122; perception of their height and BMI status revealed that, out of those students who were classified as below normal by their BMI status, 54.3% of the boys thought that they had normal height for their age while 11.6% thought that their height was more than required. In the case of girls who were classified as below normal by their BMI status, 45.2% thought that they had normal height for their age, while 17.4% thought that their height was more than required. About half of the adolescents, 53.9% of boys and 47.5% of girls, with normal BMI thought that they had normal height (Table 5).

Discussion The number of students in the late adolescence age group was very less, perhaps because by that age adolescents are withdrawn from schools and made to work to support the family in agricultural activities and most of the girls get married after they pass X standard. Body image refers to a personâ&#x20AC;&#x2122;s perceptions, attitudes and experiences about his/her body. Weight and height perception is an important part of this concept. Findings from this study state that body weight perceptions tend to be inaccurate when compared with BMI calculated from measured height and weight. We further demonstrated a gender difference in the extent of this disagreement in our local adolescent population.

Specifically, the agreement between actual (estimated) BMI and perceived weight was poor in females and fair in males. More girls than boys considered themselves to be overweight when they are normal and more boys than girls considered themselves to be underweight Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

when they are normal. Understanding the reasons for these gender differences may help health professionals assist adolescents to make appropriate decisions about adopting weight control or weight gain strategies.

Considering the magnitude of the problem of malnutrition we believe that health promotion programs should take into account the importance of cultivating a realistic and healthy body image, especially for adolescents. Healthy behaviors need to be promoted whereas health-compromising behaviors should be discouraged. The media often blend thinness and beauty. Adolescents are particularly vulnerable because of their developing cognition. Therefore, promotion of healthy body perception by schools and health organizations is particularly important to counteract such influences.

One rural study among adolescents conducted by Deshmukh et al found that the prevalence of thinness was observed to be 53.8%.10 Another study by Kapil et al among well to do adolescent school children found that overall prevalence of obesity was higher in male (8.3%) than female (5.5%) children.11 As compared to this in our study the prevalence of obesity was 1.9% in boys and 1.5% in girls. The observed difference may be due to geographical variation as our study was conducted in rural area and also because of socioeconomic differences.

Brener et al reported that half the normal weight high school students had weight misperception.12 About 30% of normal weight Hong Kong adolescents misperceive themselves as fat,13 and more girls than boys overestimate their weight.14 35

case study The comparison of BMI with perceived height has not been done here as it is less important than the comparison of BMI and perceived weight because there is a strong genetic factor in determining height.

However, in the prevention of chronic malnutrition diet and exercise play an important role to some extent.

The lack of knowledge about and access to growth charts has probably made it difficult for adolescents to evaluate their weight status objectively. Frequent exposure to the media’s thin ideal for females15-17 and muscular physique for males18 may therefore predispose adolescents to weight misperception.19 Teasing about weight is common among adolescents.

Adolescents are sensitive to weight-related influences, and may experience tremendous pressure from weight teasing. Weight teasing about thinness would be more relevant in developing countries such as China and India, where underweight is common.

To solve the problems of malnutrition is beyond the capacity of a single profession. A successful strategy is likely to involve developing skills for behavioral change, building a positive self-image, addressing psychosocial difficulties and tackling harmful societal norms. Education on what constitutes healthy weight, healthy growth and development is as important as balancing caloric input and output.

Our findings have several important implications for future primary and secondary prevention efforts. First, students and their parents need to be better informed regarding the definition of healthy body weight, and frequent assessments and professional evaluation of their growth and weight status are needed. The gender differences suggest the need for gender-tailored intervention programs. Second, adolescents who are concerned about their weight and those who have the desire to modify their weight should be provided with more appropriate and effective guidance and support to make desirable behavior changes in order to achieve their goals. The rising obesity epidemic among young people may be controlled by appropriate selfinitiated weight control practices if they are supported by families, schools, healthcare providers and society.

As shown by our study, more than two-fifths of the students were already trying to lose weight. Public health professionals should capitalize on this. Because body weight status perception is a key determinant of 36

adolescents’ weight management intention, nutrition and physical activity habits, students who are overweight or obese but fail to perceive themselves so are unlikely to engage in appropriate weight control practices. In light of the high prevalence of malnutrition, adolescents and their parents should be empowered to recognize the importance of maintaining a healthy weight and choosing healthy lifestyles following national recommendations and guidelines.

Different definitions or classifications are used for assessing under nutrition by different authors so, it may at times be a bit confusing to health managers and planners, who are not always the subject matter specialists. Otherwise also, it is always better to follow one single criteria of assessment for comparison of priority areas in developmental planning and intervention.

Compared to previous studies, our study has several strengths: a) We studied an underserved population group, and b) both boys and girls were included.

Previous studies in the literature on body image have been predominately conducted among girls. The present study also has several limitations. First, we studied a selective population group. Thus, the results cannot be generalized to other groups, secondly, because of the cross-sectional nature of this study, causality could not be inferred between perceived weight and actual (estimated) BMI. Future studies could examine this by using a prospective design. In addition, although diet and exercise are the most common means to control weight, other factors including genetics, family history of obesity and stress could have influenced the results.

Conclusions and Recommendations It was found that many of the adolescents were not aware of their correct age. Their perception of height, weight and their BMI is incomplete and incorrect. It was surprising to see that majority of the adolescents were underweight; boys forming a larger percentage.

Physical growth particularly height and weight being a ‘body image issue’ needs to be explained more scientifically and, in greater detail. Early records of height and weight, and simple explanations of ‘range of normal growth’ should be the desirable first step at the school.

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

case study Acknowledgements

I express my sincere thanks to Government of Gujarat for funding this study and to Dr Arvind Mathur in particular for providing technical guidance.

References 1. Goldenring J. A Review provided by VeriMed Healthcare Network. Medline Plus 2004.

2. Census of India. New Delhi: Office of the Registrar General 2001.

3. World Health Organization. Adolescent nutrition: a neglected dimension. 2005.

4. Pritchard ME, King SL, Czajka-Narins DM. Adolescent body mass indices and self-perception. Adolescence 1997;32:863-80.

5. Pesa JA, Syre TR, Jones E. Psychosocial differences associated with body weight among female adolescents: the importance of body image. J Adolesc Health 2000;26(5):330-7.

6. Rierdan J, Koff E. Weight, weight-related aspects of body image, and depression in early adolescent girls.

Adolescence 1997;32:615-24.

7. Cash TF, Pruzinsky T. Body image: development, deviance, and change. Guilford Press: New York 1990:20-4.

10. Deshmukh PR, Gupta SS, Bharambe MS, Dongre AR, Maliye C, Kaur S, et al. Nutritional status of adolescents in rural Wardha. Indian J Pediatr 2006;73(2):139-41.

11. Kapil U, Singh P, Pathak P, Dwivedi SN, Bhasin S. Prevalence of obesity amongst affluent school children in Delhi. Indian Pediatr 2002;39(5):449-52.

12. Brener ND, Eaton DK, Lowry R, McManus T. The association between weight perception and BMI among high school students. Obes Res 2004;12: 1866-74.

13. Cheung PC, Ip PL, Lam ST, Bibby H. A study on body weight perception and weight control behaviours among adolescents in Hong Kong. Hong Kong Med J 2007;13(1):16-21.

14. Wardle J, Haase AM, Steptoe A. Body image and weight control in young adults: international comparisons in university students from 22 countries. Int J Obes (Lond) 2006;30(1):644-51.

15. Falkner NH, Neumark-Sztainer D, Story M, Jeffery RW, Beuhring T, Resnick MD. Social, educational, and psychological correlates of weight status in adolescents. Obes Res 2001;9(1):32-42.

16. Pinhas-Hamiel O, Singer S, Pilpel N, Fradkin A, Modan D, Reichman B. Health-related quality of life among children and adolescents: associations with obesity. Int J Obes (Lond) 2006;30(2):267-72.

8. Must A, Dallal GE, Dietz WH. Reference data for obesity: 85th and 95th percentile of body mass index (wt/ht2) and triceps and skin-fold thickness. Am J Clin Nutr 1991;53(4):839-46.

17. Richardson LP, Garrison MM, Drangsholt M, Mancl L, LeResche L. Associations between depressive symptoms and obesity during puberty. Gen Hosp Psychiatry 2006;28(4):313-20.

9. Epi_Info Version 6.04_d. A word processing database and statistical programme for public health on IBMcompatible Microcomputers. Centers for Disease Control and Prevention. Atlanta, Georgia, USA Developed by Dean AG, Coulombier D, Brendel KA, Smith DC, Dicker RC, et al. 2001.

19. Latner JD, Stunkard AJ. Getting worse: the stigmatization of obese children. Obes Res 2003;11(3):452-6.

18. Zhang HB, Tao FB, Zeng GY, Cao XQ, Gao M, Shao FQ. Effects of depression symptoms and other psychological factors on unhealthy weight reducing behaviors of adolescents. Chinese J School Health 2000;21:348-9.

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case report

Extensive Osteolytic Bone Lesion and Progressive Renal Failure in Multiple Myeloma: An Unusual Presentation K Gantait*, I Nayak**, CL Bhuniaâ&#x20AC;

Abstract Multiple myeloma (MM) is a malignant disorder of monoclonal plasma cells. The classic triad of MM is marrow plasmacytosis (>10%), lytic bone lesions, and a serum and/or urine M component. We present a case of a 32-year-old young male presented with severe pain more in skull and the pelvic region, who presented on examination, he had severe pallor with hemoglobin level of 4.7 g/dl mild pedal edema and no generalized lymphadenopathy. X-ray of skull revealed extensive multiple radiolucent areas (moth eaten lesion). Serum protein electrophoresis report revealed a band in the gamma-globulin region. Examination of bone marrow aspiration revealed a hypercellular marrow.

Key words: Multiple myeloma, plasma cells, extramedullary, osteolytic

M

ultiple myeloma (MM) is a malignant proliferation of plasma cells that accounts for about 1% of malignant disorders. Growing older increases the chances of developing MM, peaking at about 60-70 years. In United States, the median age of onset is 68 years for men and 70 years for women. MM is rare in children, teens and young adults >30 years of age. The frequency of MM in patients >40 and 30 years was 2.2% and 0.3%, respectively.1 Very young adults may have an atypical presentation and an indolent course with prolonged survival.

However, an aggressive clinical course has also been reported in very few young patients.2 Case Report A 32-year-old young male presented with severe bone pain more in skull and pelvic region. He gave history of decrease in appetite and urine output, weakness and mild respiratory distress. He had lost 8 kg of weight over 30 days. He had no history of prior hospitalization. On examination, he had severe pallor with hemoglobin level of 4.7 g/dl, (reference range, *Consultant Physician Bishnupur SD Hospital, Bankura, West Bengal **Medical Officer, SD Hospital, Kharagpur â&#x20AC; Consultant Pathologist Spandan Hospital, Midnapore, West Bengal Address for correspondence Dr K Gantait Ballavpur, Midnapore Paschim Medinipur - 721 101, West Bengal E-mail: gkripasindhu@yahoo.in

40

14-16 g/dl), mild pedal edema and no generalized lymphadenopathy. The peripheral smear revealed a normocytic normochromic blood picture with occasional myelocytes seen. Erythrocyte sedimentation rate (Westergren method) was 160 mm/1st hour.

Other laboratory investigations revealed total leukocyte count was within normal limit and normal DC. Blood urea and serum creatinine level were 114 mg/dl and 3.64 mg/dl, respectively. Uric acid level was 7.9 mg/dl, serum calcium level was 10.8 mg/dl. Serum alkaline phosphatase (ALP) was within normal limit. Urine and stool examination and chest X-ray did not reveal any abnormalities.

He underwent radiological investigations (Fig. 1 [a and b]) X-ray of skull revealed extensive multiple radiolucent areas (moth eaten lesion). Ultrasound of the abdomen was normal. Serum protein electrophoresis report revealed a band in the gamma-globulin region.

Examination of bone marrow aspiration revealed a hypercellular marrow. There is proliferation of plasma cells infiltrating the marrow. Both mature and immature forms seen; few binucleate forms were present. Plasma cell population was >40% of marrow cell population.

Discussion Multiple myeloma (MM) is a malignant disorder of monoclonal plasma cells. The classic triad of MM is marrow plasmacytosis (>10%), lytic bone lesions and a serum and/or urine M component. It has been mentioned that approximately 2% of patients with Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

Case Report a

b

Figure 1 (a and b). X-ray of skull revealed extensive multiple radiolucent areas (moth eaten lesion)

MM are >40 years and it is still rarer in patients >30 years.1 In the study by National Cancer Institute, the frequency of such occurrence was 7/3,815 (0.18%).3 Hewell et al have reported a frequency of 1%.4 We have reviewed that MM is unusual in young patients.

Lazarus reported two cases of plasma cell myeloma in patients >25 years.5 Bence-Jones protein (BJP) in urine showed negative in our case. This is consistent with most of the cases reported in literature, which have rarely reported BJP. Only the report by Blade et al found BJP in five out of 10 patients.1 Renal function impairment is a common phenomenon in MM. Mayo Clinic analysis revealed renal function impairment and hypercalcemia in 20% and 30% of the 72 patients, respectively. Kapoor et al6 did not find any evidence of renal impairment, hypercalcemia or any other electrolyte imbalance. In our subject, we found progressive renal impairment but serum calcium levels were within normal limits.

Both Blade et al,1 and Geetha et al7 from India described MM in young patients who showed involvement of extramedullary component. In our subject we found extensive osteolytic bone lesions.

The median duration of survival of patients with MM ranges between 2-3 years. In the study from Mayo Clinic the median duration of survival was 87 months.

The survival of the younger patients was considerably

longer than that of older patients with MM. Thus, the occurrence of myeloma in the younger individual does not appear to impart a bad prognosis or survival.

But in our subject, prognosis was bad and duration of survival was <6 months, which was unusual.

References 1. BladĂŠ J, Kyle RA, Greipp PR. Presenting features and prognosis in 72 patients with multiple myeloma who were younger than 40 years. Br J Haematol 1996;93(2): 345-51.

2. Clough V, Delamore IW, Whittaker JA. Multiple myeloma in a young woman. Ann Intern Med 1977;86(1):117-8.

3. Young JL, Percy CL, Asire AJ. Surveillance, epidemiology and end results. Bethesda, MD. US Department of Health and Human Services. National Cancer Institute Monograph 1981:57.

4. Hewell GM, Alexanian R. Multiple myeloma in young persons. Ann Intern Med 1976;84(4):441-3.

5. Lazarus HM, Kellermeyer RW, Aikawa M, Herzig RH. Multiple myeloma in young men. Clinical course and electron microscopic studies of bone marrow plasma cells. Cancer 1980;46(6):1397-400.

6. Kapoor R, Bansal M. Clinical spectrum and prognosis of multiple myeloma in patients younger than 30 years: is it different from the elderly? JK Science 2006;8(4): 225-8.

7. Geetha N, Jayaprakash M, Rekhanair A, Ramachandran K, Rajan B. Plasma cell neoplasms in the young. Br J Radiol 1999;72(862):1012-5.

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emedinews section

From eMedinewS

FDA Panel Endorses another HCV Drug On 28th April 2011, an FDA panel unanimously endorsed the investigational drug telaprevir for treatment of hepatitis C, making it the second HCV drug in two days to receive passing marks from the panel.

Anti-VEGF Drug Trial Results Released Early Bevacizumab (Avastin) and ranibizumab (Lucentis) were equally effective in preserving visual acuity in patients with ‘wet’ age-related macular degeneration, according to results of a large randomized trial published on 28th April 2011 in the New England Journal of Medicine.

Treating Depression may Augment Diabetes Patients’ Overall Health Treating diabetes patients’ depression boosts their overall health, according to a study in the journal Medical Care, which included 145 people with type 2 diabetes and depression who received a yearlong depression intervention that included 12 weeks of cognitive behavioral therapy over the phone, followed by nine monthly booster sessions, which included a walking program.

Medifinance Update

—Dr Maninder Ahuja, Secretary General IMS

Pediatric Update GERD: Clinical Presentation

The diagnosis of gastroesophageal reflux disease (GERD) is often made clinically as the bothersome symptoms or signs that may be associated with GER symptom descriptions are unreliable in infants and children younger than 8-12 years of age, and many of the purported symptoms of GERD in infants and children are nonspecific. There is a continuum between GER and GERD with no cutoff separation between the physiological reflux (GER) and pathological reflux (GERD). A third type of GER exists which is secondary to pyloric stenosis, neurological impairment, nasogastric tubes and food allergy.

—Dr Neelam Mohan, Director Pediatric Gastroenterology, Hepatology and Liver Transplantation, Medanta – The Medicity

What are Gilt-edged Securities?

Gilt-edged securities are government securities and bonds usually with a low interest rate. They are considered safest investments, as the government security is free from default risk. Originally such certificates were edged with gold and hence the name.

—Dr GM Singh

Gyne Update Definition of Menopause

Menopause is defined as cessation of menstruation for one year. That is why it is a retrospective diagnosis.

Menopause which occurs because of depletion of 42

ovarian follicles is mainly genetically programed. The average age of menopause is about 46.5 years in India and about 51-52 years for our western counterparts.

When menopause occurs before 40 years of age it is termed as premature menopause. Perimenopause is the period of 4-5 years around menopause when hormonal irregularities begin leading to irregular periods or AUB (abnormal uterine bleeding) and other symptoms.

Health – Important Tips  Do not drink coffee TWICE a day.  Do not take pills with COOL water.  Do not have HUGE meals after 5 p.m.  Reduce the amount of OILY food you consume.  Drink more WATER in the morning, less at night.  Keep your distance from hand phone CHARGERS.  Best sleeping time is from 10 p.m. at night to 6 a.m. in the morning.

—Dr Monica and Brahm Vasudev

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

2011

Photo quiz

Linear Lesions in a Neonate

A

male infant was born via uncomplicated vaginal delivery at 42 weeksâ&#x20AC;&#x2122; gestation after a normal pregnancy. Linear, skin-colored plaques were n o t e d at birth (Figures 1 and 2). The plaques followed the embryologic clonal expansion lines (Blaschko lines) and were most prominent on the left hand, arm, axilla, and trunk.

The child was large for gestational age, but physical examination findings were otherwise normal. Two days after birth, a vesicular component developed more diffusely. Results of a Tzanck smear and complete blood count with differential were normal. The vesicles resolved by one week of age, with the lesions returning to their original state.

Question Based on the patientâ&#x20AC;&#x2122;s history and physical examination, which one of the following is the most likely diagnosis?

A. Epidermal nevi.

B. Incontinentia pigmenti.

C. Infantile acropustulosis.

D. Neonatal herpes simplex virus infection.

Discussion The correct answer is A: epidermal nevi.

Epidermal nevi are hamartomatous proliferations of the epidermis and papillary dermis, thought to originate from pluripotent cells in the basal layer of the embryonic epidermis. The condition includes verrucous, sebaceous, pilosebaceous, and eccrine subtypes. Epidermal nevi occur in one out of 1,000 live births, and 80 percent of cases appear in the first year of life.1,2 The nevi are generally unilateral, following Blaschko lines in linear configurations on the limbs.

The condition can be associated with syndromes that manifest with developmental abnormalities of Source: Adapted from Am Fam Physician. 2011;83(6):755-756.

Indian Journal of Clinical Practice, Vol. 22, No. 1, June 2011

Figure 1.

Figure 2.

the nervous, cardiovascular, urogenital, or skeletal systems. Children born with more extensive lesions should be monitored closely early in life. Treatment consists of full-thickness surgical excision or ablation.

Topical treatments, such as steroids, retinoids, tars, and fluorouracil, have only limited benefit.

Incontinentia pigmenti is an X-linked dominant disease and is often fatal in male fetuses. It almost always occurs in female infants and is associated with cutaneous lesions that appear in four phases: vesicular, verrucous, hyperpigmented, and atrophic.3 Lesions appear in the first three weeks of life and follow Blaschko lines. During the vesicular phase, the rash is predominantly located on the lower extremities, and histology demonstrates eosinophilic spongiosis.

The condition is often associated with extracutaneous findings, including dental, central nervous system, and ocular abnormalities. Infants with incontinentia pigmenti require baseline ophthalmologic examination, and periodic dental and neurodevelopmental evaluation.

Infantile acropustulosis typically occurs between three and six months of age, and occasionally at birth. It is associated with recurrent crops of pruritic vesicopustular lesions, primarily on the palms and soles. The condition can be misdiagnosed as scabies infection. The lesions begin as pinpoint papules, progressing into vesicles over the course of a day, and then disappear in a variable amount of time. Recurrences usually stop around three or four years of age.

45

Photo Quiz Selected Differential Diagnosis of Rash in a Neonate Condition

Characteristics

Epidermal nevi

Lesions are generally unilateral, following Blaschko lines in a linear configuration; may be related to developmental abnormalities

Incontinentia pigmenti

X-linked dominant disease almost always occurring in female infants, usually in the first three weeks of life; lesions follow Blaschko lines; associated with dental, central nervous system, and ocular abnormalities

Infantile acropustulosis

Recurrent crops of pruritic vesicopustular lesions that usually resolve by three or four years of age; lesions primarily appear on the palms and soles and look similar to scabies

Lichen striatus

Rare, idiopathic linear eruption on the extremities that are self-limited and sometimes pruritic; lesions appear between four months and 15 years of age, usually in girls; associated with atopic dermatitis

Linear psoriasis

Erythematous, scaly papules and plaques; linear distribution; typically occur on the extremities

Neonatal herpes simplex virus infection

Vesicular rash often appears on the face or scalp in first seven to 10 days of life; usually transmitted during vaginal birth; risk of disseminated infection

Neonatal herpes simplex virus (HSV) is usually transmitted during vaginal birth, presenting as a vesicular rash on the face or scalp in the first seven to 10 days of life.4 Lesions that appear in the first 24 hours of life suggest an in utero infection, which more often causes erosions than vesicles. Tzanck smear has 79 percent sensitivity and 100 percent specificity for the diagnosis of HSV infection.5 Cultures of skin lesions, nasopharynx, eyes, and cerebrospinal fluid should be obtained, as well as polymerase chain reaction testing if available. Disseminated neonatal HSV infection may not lead to skin lesions and has a 57 percent mortality rate.6 References 1. Solomon LM, Esterly NB. Epidermal and other congenital organoid nevi. Curr Probl Pediatr. 1975;6(1):1-56.

2. Cockerell CL, Larsen F. Benign epidermal tumors

and proliferations. In: Bolognia JL, Jorizzo JL, Rapini RP, eds. Dermatology. 2nd ed. St. Louis, Mo.: Mosby; 2008:1671-1672.

3. Gilliam AE, PauportĂŠ M, Frieden I. Vesiculobullous and erosive diseases in the newborn. In: Bolognia JL, Jorizzo JL, Rapini RP, eds. Dermatology. 2nd ed. St. Louis, Mo.: Mosby; 2008:484-485.

4. Drolet BA, Esterly NB. The skin. In: Fanaroff AA, ed.

Neonatal-Perinatal Medicine: Diseases of the Fetus and Infant. 7th ed. St. Louis, Mo.: Mosby; 2002:1537.

5. Ozcan A, Senol M, Saglam H, et al. Comparison of the Tzanck test and polymerase chain reaction in the diagnosis of cutaneous herpes simplex and varicella zoster virus infections. Int J Dermatol. 2007;46(11): 1177-1179.

6. Whitley R, Arvin A, Prober C, et al. Predictors of morbidity and mortality in neonates with herpes simplex virus infections. N Engl J Med. 1991;324(7):450-454.

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June 2010

Jo urn w ie ev R er Pe

Vol. 10, No. 6, June 2010

ISSN 0971-880X

Single Copy Rs. 85/-

www.ijcpgroup.com

RNI NO. - 71334/99

DR KK AGGARWAL Gr. Editor-in-Chief, IJCP Group

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D I T O R I A L

Padma Shri and Dr BC Roy Awardee Sr Physician and Cardiologist, Moolchand Medcity President, Heart Care Foundation of India Group Editor-in-Chief, IJCP Group Chief Editor, eMedinewS Member, 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) drkk@ijcp.com

Member The Indian Newspaper Society

VOLUME 12, NUMBER 2

Official Voice of Doctors of India

igh doses or long-term use of PPIs or proton-pump inhibitors can lead to an increased risk of bone fractures. This holds especially true for those over the age of 50, and for people on the high dose. The latest warning is based on a FDA review of several studies of the treatment.

These epidemiologic studies revealed an elevated fracture risk at the hip, wrist and spine. But the studies do not, definitively prove that PPIs are the cause of the fractures.

FDA has instructed the manufacturers of the drugs to change the labels for both the prescription and the over-the-counter versions of the PPIs. The FDA said they should only be taken for 14 days to help ease frequent heartburn and under no circumstances should over-the-counter PPIs be taken for more than three 14-day periods in a year.

Asian Journal of

Ear, Nose Throat

Visceral fat is a hot topic because of metabolic syndrome, which predisposes people to disease.

Intra-abdominal fat, or the fat that wraps around the organs in the abdomen and chest, tends to accumulate at midlife and can contribute to developing diabetes, hypertension and heart disease. The fat around the organs is known to be more related to heart disease and diabetes.

A woman does not need to appear outwardly heavy to have a potentially troublesome extra ‘tire’ around her organs.

Exercise for long has been known to reduce the amount of intra-abdominal fat.

“ Always aim at complete harmony of thought and word and deed. Always aim at purifying your thoughts and everything will be well.

”

– Mahatama Gandhi

MAKE SURE

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DURING MEDICAL PRACTICE A terminally ill patient who develops bed sores, is given only systemic antibiotics.

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S

I

Evidence-based Medicine

Please change the position of the patient frequently and keep the skin clean and dry.

IJCP Academy

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iddle-aged women who move around more in their daily life have lower levels of intra-abdominal fat, a risk factor for heart disease. Minor modifications in daily routine such as reducing the time watching TV or increasing the walk time to work, can make a difference in the long-term health.

Make sure that good nursing care and maintenance of skin hygiene is advised first to patients with bed sores, along with topical antibiotics.

KK Aggarwal

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CD I

CD II

CD III

CD IV

8.0 cm W x 6.5 H

17.0 cm W x 6.5 cm H

17.0 cm W x10.0 H

Dr KK Aggarwal Group Editor-in-Chief

Dr Praveen Chandra

Guest Editor

January-March 2010

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3

Preparing for Commonwealth Games Illnesses

9

News & Views

10

Expert’s Opinion

11

FDA Update

13

Dr Vijay Viswanathan Editor

Classified Display Rate Card 5.5 cm W x 6.5 cm H

April - June 2010

www.ijcpgroup.com

Most researchers believe that more fractures are due to decreased calcium absorption from the diet because of the reduced stomach acid. But, it’s also possible that these drugs interfere with bone maintenance.

Notably, PPIs have previously been linked to an increased risk of contracting pneumonia and the troublesome bacterium Clostridium difficile, as well as to an increased risk of dementia.

Minor Changes in Lifestyle are All That is Required for Good Health

Category Dimensions

IJCP

PPIs may Cause Bone Fractures When Used for More Than One-year or at Higher Doses: FDA

H Group Editor-in-Chief Dr KK Aggarwal

ISSN 0972-7043

DIABETOLOGY

Pages 16

Dr KK Aggarwal

Single Copy Rs. 250/-

Volume 13, Number 2, June 2010, Pages 29-56

The Asian Journal of

Current Concepts in the Management of Congenital Fibrinogen Deficiency

ISSN 0972-70035

www.ijcpgroup.com

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Volume 21, Number 1

Peer Review Journal

IJCP

No. of Insertions Amount (Rs.)/Advt.

1

3,575.00

2-5

3,200.00

6+

3,000.00

1

5,200.00

2-5

4,500.00

6+

4,000.00

1

11,050.00

2-5

10,500.00

6+

9,500.00

1

17,000.00

2-5

16,150.00

6+

15,300.00

Dr VP Sood

Dr KK Aggarwal

Editor

Group Editor-in-Chief

Dr KK Aggarwal

Group Editor-in-Chief

IJCP Group has been on the

forefront of Medical Journalism in India. Today, with over two decades of existence and a host of Medical Journals, our Group has more than two lac avid readers. We are reaching core specialty doctors with a wide range of journals and offer you an opportunity to advertise your products/services in our new classified display section.

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