IJCP_October_2011

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Indian Journal of

CLINICAL PRACTICE 209-260 Pages

October 2011

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Volume 22, Number 5

CD117-negative Colonic GIST A Rare Diagnosis

Dr KK Aggarwal

Group Editor-in-Chief

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Indian Journal of

Online Submission

Clinical Practice

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

Volume 22, Number 5, October 2011

FROM THE DESK OF GROUP EDITOR IN &+ IEF

Do not Ignore Yellow Plaques on the Eyelids

213

KK Aggarwal

Dr KK Aggarwal &0' 3XEOLVKHU DQG *URXS (GLWRU LQ &KLHI DRUG REVIEW 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 Dr VP Sood Asian Journal of Ear, Nose and Throat Dr Praveen Chandra Asian Journal of Clinical Cardiology 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 Hasmukh J Shroff Dermatology Dr Georgi Abraham Nephrology Dr Sidharth Kumar Das Rheumatology Dr V Nagarajan Neurology Dr Thankam Verma, Dr Kamala Selvaraj Obs and Gyne

Phenazopyridine: A Review of the Gold Standard Uroanalgesic

215

Saurabh Mishra

ORIGINAL STUDY

Evaluation of Effi cacy and Safety of Septilin Syrup in Respiratory Tract Infections: An Open Clinical Study

221

Subhasish Bhattacharya, Suprabha Hegde

CLINICAL STUDY

Practice of Prelacteal Feeds and Colostrum among Normally Delivered Mothers in SSG Hospital, Vadodara, Gujarat

227

Jivraj Damor, Navneet Padhiyar

CASE REPORT

Chronic Diarrhea in a HIV-positive Patient due to M. tuberculosis and Cryptosporidium Coinfection

231

Sourya Acharya, Samarth Shukla, SN Mahajan, Nilima Tankhiwale, Amit Gupta

CD117-negative Colonic GIST: A Rare Diagnosis

235

Hanish Bansal, Rahul Roy, Raj Kamal Jenaw, Rajendra Mandia

Advisory Bodies Heart Care Foundation of India Congenital Facial Palsy with Bilateral Anotia 1RQ 5HVLGHQW ,QGLDQV &KDPEHU RI &RPPHUFH ,QGXVWU\ Geeta Gathwala, Jagjit Singh, Poonam Dalal World Fellowship of Religions

238

Indian Journal of

Clinical Practice

Volume 22, Number 5, October 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

Photo quiz

A Bubble Under the Tongue of a Child

Printed at IG Printers Pvt. Ltd., New Delhi E-mail: igprinter@rediffmail.com printer_ig@yahoo.com

244

Practice Guidelines

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.

ACOG Guideline on Sexual Dysfunction in Women

246

expert opinion 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.

What is the Treatment of Tuberculosis with HIV? 248 JM Joshi

Conference calendar

Conference Calendar

251

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FROM THE DESK OF GROUP EDITOR-IN-CHIEF CLINICAL PRA

Do not Ignore Yellow Plaques on the Eyelids

Dr KK Aggarwal

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

X

anthelasmas are soft, cholesterol-filled plaques that develop under the skin, usually on or around the eyelids and most often near the nose. They occur mainly in middle-aged and older adults and in women more often than in men. They are always benign and rarely impair vision. But they can be a sign of hyperlipidemia - elevated blood fat levels in 50% of the people.

The presence of xanthelasma on the eyelids is an independent predictor of future heart blockages. In a large prospective study by Dr Anne Tybjaerg-Hansen of Rigshospitalet in Copenhagen published in BMJ during a mean follow-up of 22 years, adults participating in a long-term Danish Heart Study who had xanthelasmata at baseline had an adjusted hazard ratio for acute heart attack of 1.48. In the study those with the eyelid lesions had lower levels of apolipoprotein A1 and high-density lipoprotein (HDL) cholesterol as against those who had arcus corneae they had higher levels of lipoprotein (a).

The plaques are especially common in people with inherited disorders of low-density lipoprotein (LDL) metabolism. They occur in 75% of older people with familial hypercholesterolemia (very high cholesterol levels) and in 10% of people with high levels of apolipoprotein B. Treating any underlying lipid condition may reduce the size of xanthelasma. If no lipid abnormality is present then xanthelasma is largely a cosmetic problem.

There are several ways to remove xanthelasma. These include cryotherapy (freezing the lesions with liquid nitrogen), laser ablation, surgical excision, electrodesiccation (destruction of the lesion with an electric needle), and chemical cauterization (application of a topical agent such as trichloroacetic acid to dissolve the plaques).

Take Home Message    

All patients with xanthelasmas should get lipid profile done.

Look for low HDL and low Apo A1 levels.

Look for high Apo B levels.

Get LP(a) level done, it will usually be normal.

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

213

AD/76/OCT/2011

DRUG REVIEW

Phenazopyridine: A Review of the Gold Standard Uroanalgesic Saurabh Mishra

ABSTRACT Symptomatic urinary tract infections (UTIs) are among the most common of bacterial infections. Th ough relatively benign and self-limiting, these symptoms greatly distress the patient and have a detrimental influence on patient quality-of-life.

Phenazopyridine is a urinary tract analgesic that is effective for symptomatic relief of the pain, burning, frequency and urgency associated with UTI during the first 24-48 hours of therapy. It lacks the anticholinergic side effects of other urinary antispasmodics like flavoxate and oxybutynin and is well-tolerated.

Key words: Urinary tract infections, urinary tract analgesic

U

rinary tract infections (UTIs) are common conditions in clinical practice.1 Most cases present to primary care physicians in the outpatient clinical setting. Many conditions of the genitourinary tract cause dysuria, which is defined as symptoms of discomfort, pain and/or burning associated with micturition.

Infection is the most common cause of dysuria and presents as cystitis, pyelonephritis or urethritis, depending on the area of the urinary tract that is most affected.2 Pain occurring at the beginning of or during urination suggests a urethral site of disease, whereas pain after voiding implies pathology within the bladder or prostate area. Sometimes a patient will relate a history of pain in the suprapubic area.3 But, dysuria has many causes.

Symptomatic UTIs are among the most common of bacterial infections.4 Though relatively benign and selflimiting, these symptoms greatly distress the patient and have a detrimental influence on patient quality-oflife.5 Phenazopyridine is a urinary tract analgesic that is used for symptomatic relief of the pain, burning, frequency and urgency associated with UTI during the first 24-48 hours of therapy.

Phenazopyridine: The Gold Standard Uroanalgesic Phenazopyridine hydrochloride, an azo dye, has for long been used as a urinary tract antiseptic and analgesic.6 Chemically, phenazopyridine is 2,6-Pyridinediamine, 3-(phenylazo)-, monohydrochloride.7 Mechanism of Action

Phenazopyridine hydrochloride acts as a topical analgesic on the mucosal lining of the urinary tract and thus relieves pain, burning, urgency and frequency. Its exact mechanism of action is not known.7 It is not an antibiotic. In a recent study, phenazopyridine was found to directly inhibit the mechanosensitive A-fibers in the normal rat bladder. The study evaluated the effect of phenazopyridine on afferent nerve activity by direct measurement of both A- and C-fibers, and compared the outcome with the effects of a local anesthetic (lidocaine) and an analgesic (acetaminophen). Intravenous administration of phenazopyridine significantly decreased dose-dependently only the A-fibres but not the C-fiber activity. According to the researchers, phenazopyridine exerts its clinical effect in conditions of urinary bladder hypersensitivity by direct inhibition of the mechanosensitive A-fibers.8 Pharmacokinetics

Consultant Dept. of Urology Moolchand Medcity, New Delhi

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

Phenazopyridine is mainly metabolized by hydroxylation; the azo ring is usually not cleaved.9 5-hydroxyl PAP is the major metabolite (48.3% of the dose).10 215

drug review

Indications

Symptomatic relief of urinary burning, itching, urgency and frequency associated with the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures or the passage of sounds or catheters in adults.

Dose

100-200 mg orally thrice-daily after meals.7 Phenazopyridine Efficacy: Clinical Evidence Urinary Tract Infections

Kirwin et al evaluated the effects of phenazopyridine 500 mg (two tablets thrice-daily) administration in urogenital infections in 118 patients. Treatment with phenazopyridine led to significant reduction of the organized sediment in 65 patients (55.1%), together with relief of distressing symptoms characteristic of urogenital infections occurred viz. pain on urination, burning on urination, nocturia. Also, the intervals between bladder evacuations became normal or were greatly extended (Fig. 1). In the remaining 53 cases, relief of symptoms occurred in all but a few exceptions, although there was no concomitant reduction in the organized urinary sediment. Phenazopyridine was welltolerated with no toxic effects of the drug observed in the study.12 Phenazopyridine, administered for two days, has also been shown to be useful in the management of autonomic dysreflexia associated with cystitis.13 Co-administration with Antibiotics

Phenazopyridine can be co-administered with antibiotics and alleviate pain and discomfort during the interval before the antibiotic begins to control the infection. When used along with an antibiotic for the treatment of a UTI, phenazopyridine should not be given for more than two days as there is insufficient 216

98

95.3 93.6

94 Patients (%)

The elimination half-life is 7.35 hours.11 Phenazopyridine is rapidly excreted by the kidneys directly into the urine.

About 65% of the drug is excreted unchanged into the urine. About 40% is excreted hepatically.9 The major urinary metabolite of PAP is 4-acetylaminophenol (NAPA) followed in order by 5,4’-dihydroxy-PAP, 5-hydroxy-PAP, 4’-hydroxy-PAP and 2’-hydroxy-PAP.10

90 86

85

83.7

Intervals between bladder evacuations

Nocturia

82 78 74 Painful urination

Burning on urination

Symptoms

Figure 1. Symptom relief.

data to support benefits of administration beyond this time period.7 Phenazopyridine, when given along with antibiotics  (ciprofloxacin, doxycycline) led to a satisfactory response with 91% reduction in burning micturition and 89% reduction in pain during voiding of urine in patients with uncomplicated UTIs.9 Oral co-administration of phenazopyridine increases  bioavailability of ciprofloxacin with regard to the amount absorbed and mean residence time (MRT) in the body, which is advantageous during treatment. The study compared the pharmacokinetic behavior of ciprofloxacin administered alone versus ciprofloxacin combined with phenazopyridine.

Area under the concentration-time curve to last measurable concentration (AUCt) and area under the concentration-time curve extrapolated to infinity (AUCinfinity) were 35% and 29% higher, respectively, in the combined treatment arm. A significant delay in tmax (from 1 to 1.5 hours) and a statistical increase of 29% in MRT were also observed with phenazopyridine coadministration.14  Phenazopyridine is frequently used as an addon to sulfonamides in the treatment of bacterial UTIs because of its putative analgesic effect on the urinary tract mucosa. It does not alter the effectiveness of sulfonamides against uropathogenic bacterial species in mice.15 The combined bacteriostatic activity of sulfonamide compounds and phenazopyridine upon Balantidium coli has been demonstrated in vitro.15,16 Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

drug review Phenazopyridine Relieves Pain due to Bladder Spasms

Bladder spasms, or detrusor contractions due to irritation of the trigone area, may occur in patients with indwelling urinary catheters, particularly if the balloon is sitting low within the bladder.

These are a distressing complication for the patient.

Phenazopyridine hydrochloride helps relieve the pain caused by catheters.17 Chronic Radiation Cystitis

Radiation therapy is an integral part of adjunctive treatment in approximately 66% of cancer patients and its use has increased cancer survival. So, there is a greater need to address the adverse effects of the radiation experienced by cancer survivors. Phenazopyridine is used as symptomatic treatment for chronic cystitis associated with radiation therapy.18 Confirmation of Ureteric Patency during Cystoscopy using Phenazopyridine

associated with fever, rash, jaundice, eosinophilia and hepatitis.21 Sulfhemoglobinemia has been reported.22 Phenazopyridine can cause acute renal insufficiency in people with pre-existing renal damage.23 It should be avoided in patients with G6PD deficiency.24 As phenazopyridine discolors the urine, it interferes with the standard urine dipstick test, especially the leukocyte esterase parameters.25 Safety in Pregnancy

Phenazopyridine is currently classified in pregnancy category B. It is used to relieve UTI symptoms, such as burning, pain, urgency and frequency, associated with irritation of the lower urinary tract caused by infection.

The Collaborative Perinatal Project monitored 50,282 mother-child pairs in which 1,109 exposures anytime during pregnancy and 219 exposures during the firsttrimester were documented. Results indicated no increase in the rates of major malformations or any other adverse effects.26

Oral phenazopyridine can be used prior to pelvic surgery to confirm ureteric patency during intraoperative cystoscopy in patients undergoing pelvic reconstructive surgery. An observational retrospective case series of patients who were given phenazopyridine preoperatively prior to pelvic surgery in a tertiary care center between July 2004 and June 2005 concluded that preoperative oral phenazopyridine is safe, inexpensive and easy to administer immediately prior to surgery, making it an ideal dye agent for use in conjunction with intraoperative cystoscopy planned during pelvic surgery.

Women received a single oral dose of phenazopyridine (100-200 mg) one hour preoperatively with a sip of water. Bilateral ureteric patency, confirmed by the visualization of a bright orange (or reddish) jet of urine expelled from each ureteric orifice and bladder mucosal integrity was confirmed in all 32 cases. Bladder mucosal appearance was unaltered. Phenazopyridine continued to be excreted during prolonged procedures.

It was well-tolerated by all patients.19

Other Antispasmodics

Adverse Effects and Drug Interactions

Oxybutynin

Phenazopyridine is an azo dye and the urine is colored typically to a dark orange to reddish color.

The patient should be so informed. Gastrointestinal upset is seen in upto 10% of patients and can be reduced by administration with food.20 It has been

Oxybutynin acts by cholinergic blockade and direct spasmolytic activity on smooth muscle.29 By relaxing bladder muscle, it increases bladder (vesical) capacity, decreases frequency of uninhibited detrusor and delays the initial desire to void thus decreasing urgency

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

Flavoxate

Flavoxate hydrochloride has a direct inhibitory action on smooth muscle in addition to anticholinergic and local analgesic properties.27 Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle. It is indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis.

The adverse effects reported with flavoxate include: Nausea, vomiting, dry mouth, vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness, leukopenia (one case which was reversible upon discontinuation of the drug), tachycardia and palpitation, increased ocular tension, blurred vision, disturbance in eye accommodation and allergy.28

217

drug review and the frequency of both incontinent episodes and voluntary urination. The most common adverse events include: Insomnia, nervousness, dizziness, somnolence, headache, blurred vision, dry eyes, dry mouth, constipation, nausea, urinary hesitation and urinary retention.30 Macrolide antibiotics such as erythromycin and clarithromycin may alter mean pharmacokinetic parameters (i.e., Cmax and AUC) of oxybutynin. Hence, caution should be used when such drugs are co-administered.31 A prospective, randomized, placebo-controlled trial examined the effects of phenazopyridine extendedrelease versus oxybutynin for the management of postoperative ureteral stent discomfort. Both groups reported comparable results as regards bothersome score for flank pain, suprapubic pain, urinary frequency, urgency and dysuria. Patients in the phenazopyridine group reported less hematuria on postoperative Day 1 when compared with placebo, which was statistically significant. The oxybutynin group required fewer narcotics; this finding however was not statistically significant.32 Limitations

Flavoxate and oxybutynin have anticholinergic effects such as dry mouth, constipation and other anticholinergic effects. They may also potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.30 Hence, the major limitation in the use of nonselective drugs like flavoxate and oxybutynin is often failure to obtain desired therapeutic responses without concomitant side effects. The anticholinergic side effects, though usually not serious, are sufficiently disturbing to decrease patient compliance, particularly during long-term administration.33 Conclusion UTIs are a significant clinical problem. The associated symptoms of burning micturition, pain during voiding and increased frequency of urination9 are associated with great morbidity. Because UTIs are so common, there is often an ambiguity about how to best manage them. Diagnosis solely based on clinical symptoms is often erroneous. UTIs also account for a considerable percentage of antibiotic prescriptions.34 218

However, the potential effectiveness of antibiotics must also be balanced against the mounting concerns about increasing workload for self-limiting illness and the growing problem of antibiotic resistance.35 Symptomatic treatment only has been suggested as an approach until culture results are available in order to decrease unnecessary antibiotic prescriptions.36 Other urinary antispasmodics such as oxybutynin and flavoxate are muscarinic receptor antagonists and exert some nonspecific direct relaxant effect (antispasmodic) on smooth muscle including that of the urinary tract.

They are thus indicated for overactive bladder. They may be used to manage symptoms of dysuria. But, the anticholinergic side effects of these drugs limit their tolerability with continued use and patient acceptance declines.20 Also, drug interactions with antibiotics like macrolides are known to occur.

Phenazopyridine hydrochloride has been widely used as a urinary tract analgesic20 to relieve symptoms of burning, pain due to UTI. It can be co-administered with antibiotics without altering their efficacy and helps to alleviate dysuria in the interval before the antibiotic acts to control the infection. It lacks the anticholinergic side effects of other urinary antispasmodics like flavoxate and oxybutynin and is well-tolerated. Phenazopyridine is therefore a very useful and highly efficacious symptomatic analgesic therapy as an add-on to antibiotic treatment to relieve pain and burning micturition of uncomplicated UTI. References 1. Korman TM, Grayson ML. Treatment of urinary tract infections. Aust Fam Physician 1995;24(12):2205-11.

2. Bremnor JD, Sadovsky R. Evaluation of dysuria in adults. Am Fam Physician 2002;65(8):1589-97.

3. Keith Wrenn. Chapter 18. Dysuria, Frequency, and Urgency. In: Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition, Walker HK, Hall WD, Hurst JW (Eds.), Butterworths: Boston;1990.

4. Warren JW, Abrutyn E, Hebel JR, Johnson JR, Schaeffer AJ, Stamm WE. Guidelines for antimicrobial treatment of uncomplicated acute bacterial cystitis and acute pyelonephritis in women. Infectious Diseases Society of America (IDSA). Clin Infect Dis 1999;29(4):745-58.

5. Ellis AK, Verma S. Quality of life in women with urinary tract infections: is benign disease a misnomer? J Am Board Fam Pract 2000;13(6):392-7.

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

drug review 6. Gaines KK. Phenazopyridine hydrochloride: the use and abuse of an old standby for UTI. Urol Nurs 2004;24(3):207-9.

21. Ahmad S. Hemolytic anemia and hepatitis induced by phenazopyridine. Arch Intern Med 1980;140(10): 1398-9.

7. Pyridium drug description. Available at: www.rxlist. com.

22. Gopalachar AS, Bowie VL, Bharadwaj P. Phenazopyridineinduced sulfhemoglobinemia. Ann Pharmacother 2005;39(6):1028-30.

8. Aizawa N, Wyndaele JJ. Effects of phenazopyridine on rat bladder primary afferent activity, and comparison with lidocaine and acetaminophen. Neurourol Urodyn 2010;29(8):1445-50.

9. Deepalatha C, Deshpande N. A comparative study of phenazopyridine (pyridium) and cystone as short-term analgesic in uncomplicated urinary tract infection. Int J Pharm Pharm Sci 2011;3(Suppl 2):224-6.

10. Thomas BH, Whitehouse LW, Solomonraj G, Paul CJ. Excretion of phenazopyridine and its metabolites in the urine of humans, rats, mice and guinea pigs. J Pharm Sci 1990;79(4):321-5.

23. Qureshi N, Hedger RW. Phenylazopyridine (Pyridium) and acute renal failure. Ann Intern Med 1979;90(3):443.

24. Frank JE. Diagnosis and management of G6PD deficiency. Am Fam Physician 2005;72(7):1277-82.

25. Kerr JE, Magee-Nolan C, Schuster BL. Interference by phenazopyridine with the leukocyte esterase dipstick.

JAMA 1986;256(1):38-9.

26. Lee M, Bozzo P, Einarson A, Koren G. Urinary tract infections in pregnancy. Can Fam Physician 2008;54(6):853-4.

11. Thomas BH, Whitehouse LW, Solomonraj G, Paul CJ. Metabolism and disposition of phenazopyridine in rat.

Xenobiotica 1993;23(2):99-105.

27. Lavelle JP, Teahan S, Kim DY, Chancellor MB. Medical and minimally invasive treatment of urinary incontinence. Rev Urol 1999;1(2):111-9.

12. Kirwin TJ, Lowsley OS, Menning J. The effects of pyridium in certain urogenital infections. Am J Surg 1943;62(3):330-5.

28. Flavoxate. Available at: http://www.rxlist.com/urispasdrug.htm.

13. Paola FA, Sales D, Garcia-Zozaya I. Phenazopyridine in the management of autonomic dysreflexia associated with urinary tract infection. J Spinal Cord Med 2003;26(4):409-11.

14. Marcelín-Jiménez G, Angeles AP, Martínez-Rossier L, Fernández SA. Ciprofloxacin bioavailability is enhanced by oral co-administration with phenazopyridine: a pharmacokinetic study in a Mexican population. Clin Drug Investig 2006;26(6):323-8.

15. Heifetz CL, Fisher MW. Phenazopyridine-sulfonamide combination antibacterial therapy in mice. Antimicrob Agents Chemother 1973;3(1):134-5.

16. Neter E, Loomis TA. The combined bacteriostatic activity of sulfonamide compounds and pyridium upon B. coli in vitro. Urol Cutaneous Rev 1941;45:295-7.

17. Sulzbach LM. Ask the Experts. Crit Care Nurse 2002;22(3):84-7.

18. Berkey FJ. Managing the adverse effects of radiation therapy. Am Fam Physician 2010;82(4):381-8, 394.

19. Hui JY, Harvey MA, Johnston SL. Confirmation of ureteric patency during cystoscopy using phenazopyridine HCl: a low-cost approach. J Obstet Gynaecol Can 2009;31(9):845-9.

20. Antimicrobial agents: Sulfonamides, trimethoprimsulfamethoxazole, quinolones. Chapter 44. In: Goodman & Gilman’s the Pharmacological Basis of Therapeutics.

10th edition, Hardman, Limbird (Eds.), McGraw-Hill 2001: p1185.

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

29. Brooks ME, Braf ZF. Oxybutynin chloride: clinical uses and limitations. Paraplegia 1980;18(1): 64-8.

30. Oxybutynin. Available ditropan-drug.htm.

at:

http://www.rxlist.com/

31. Oxybutynin chloride extended release tablets. http:// www.fda.gov/ohrms/dockets/ac/07/briefing/20074295b_02_05_Ditropan%20XL%202004%20Label. pdf.

32. Norris RD, Sur RL, Springhart WP, Marguet CG, Mathias BJ, Pietrow PK, et al. A prospective, randomized, double-blinded placebo-controlled comparison of extended release oxybutynin versus phenazopyridine for the management of postoperative ureteral stent discomfort. Urology 2008;71(5):792-5.

33. Muscarinic receptor agonists and antagonists. Chapter 7.

In: Goodman & Gilman’s the Pharmacological Basis of Therapeutics. 10th edition, Hardman, Limbird (Eds.), McGraw-Hill 2001: p169.

34. Schmiemann G, Kniehl E, Gebhardt K, Matejczyk MM, Hummers-Pradier E. The diagnosis of urinary tract infection: a systematic review. Dtsch Arztebl Int 2010;107(21):361-7.

35. Leydon GM, Turner S, Smith H, Little P; UTIS team. Women’s views about management and cause of urinary tract infection: qualitative interview study. BMJ 2010;340:c279.

36. Litza JA, Brill JR. Urinary tract infections. Prim Care Clin Office Pract 2010;37(3):491-507, vii.

219

ORIGINAL STUDY

Evaluation of Efficacy and Safety of Septilin Syrup in Respiratory Tract Infections: An Open Clinical Study Subhasish Bhattacharya*, Suprabha Hegde**

ABSTRACT Forty patients of either sex in the age group of six months to six years presenting with respiratory tract infections (RTI) and whose parents were willing to give the informed consent and comply with the study procedures were included in the study. Detailed history of the duration, frequency and severity of the infection was elicited. A thorough examination of ear, nose, throat including chest examination, general physical examination including respiratory rate were also conducted and recorded in case report form. Septilin syrup was given at a following dose: Infants: Half to 1 teaspoonful three times daily, Children: 1-2 teaspoonfuls three times daily for a period of six months. Safety and efficacy of the investigational product was evaluated bimonthly intervals upto six months. Statistical analysis was performed by Fisher’s exact test to find out the level of significance. All the subjects completed the study and data was available for analysis. Th ere was significant reduction in the number of patients suffering from common cold, chronic bronchitis, repeated sinusitis, chronic otitis media and repeated bronchitis. Though there was reduction in the number of patients suffering from chronic tonsillitis and adenoiditis, and chronic laryngotracheobronchitis, the values were not statistically significant. Septilin syrup provided adequate relief from the symptoms and its acceptance by patients was good. There were no clinically significant adverse reactions, either reported or observed, during the entire study period and overall compliance to the treatment was adequate. Therefore, it may be concluded that Septilin syrup is effective and safe in patients suffering from RTI. Key words: Septilin syrup, respiratory tract infections, open clinical study

T

he burden of respiratory tract infections (RTI) in pediatrics is extremely high, in both industrialized and developing countries.

The burden of these diseases is reflected by: 1) High incidence; 2) Substantial morbidity and potential sequelae; 3) Tendency of overdiagnosis, especially in streptococcal pharyngitis and acute otitis media; 4) Associated overuse and misuse of antibiotics and 5) Relevant contributor to healthcare costs and indirect societal costs.1 Upper respiratory tract infections (URTI) including nasopharyngitis, pharyngitis, tonsillitis and otitis media constitute 87.5% of the total episodes of respiratory infections. Recurrent throat problems in children are

*Professor, Dept. of Pediatrics Medical College, Kolkata **Research Associate R&D Center, Th e Himalaya Drug Company Makali, Bangalore Address for correspondence Dr Suprabha Hegde Research Associate R&D Center, Th e Himalaya Drug Company Makali, Bangalore - 562 123 E-mail: dr.suprabha@himalayahealthcare.com

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

common and have an impact on the family. Time off school or parental time off work was significantly associated with parental worry and disruption, but not with eagerness for surgery.2 Rhinoviruses account for 25-30% of URTI; respiratory syncytial viruses (RSVs), parainfluenza, influenza viruses, human metapneumovirus and adenoviruses 25-35%; coronaviruses 10% and unidentified viruses account for the remainder.3 Transmission of organisms causing URTI occurs by aerosol, droplet or direct hand-to-hand contact with infected secretions, with subsequent passage to the nares or eyes. Thus, transmission occurs more commonly in crowded conditions, like in daycare settings that favor the colonization and spread of pathogens causing RTI.4 Environmental risk factors include passive smoking, exposure to pollutants and absence of breastfeeding.5 Familial predisposition is a risk factor for recurrent and severe disease. Defects in the immune systems are known to be associated with frequent RTI.6 Children with protein, calorie and vitamin malnutrition suffer from RTI. Deficiency of vitamin A can also cause recurrent infections of the respiratory tracts and lack of vitamin B12 can impair immunoglobulin production.7 221

original study A triad of rhinorrhea, cough and fever characterize recurrent URTI. Because most URTI are self-limiting, their complications are more important than the infections. Acute viral infections predispose children to bacterial infections of the sinuses and middle ear and aspiration of the infected secretions and cells may result in lower respiratory tract infections (LRTI).8 Repeated attacks of tonsillitis may lead to complications like rheumatic heart disease or poststreptococcal glomerulonephritis, untreated otitis media may lead to devastations such as perforation of the tympanic membrane, labyrinthitis, sensorineural hearing loss and facial nerve palsy, and rhinitis may lead to complications such as laryngotracheobronchitis, pharyngitis and mucocele.

as tonsillectomy, adenoidectomy and myringotomy with/without placement of tympanostomy tubes) in the prevention of recurrent RTI with poor results.

A number of herbs are claimed to be effective in the management of RTI. Septilin syrup is a polyherbal formulation with Commiphora wightii, Maharasnadi quath, Emblica officinalis, Tinospora cordifolia and extracts of Rubia cordifolia, Glycyrrhiza glabra, Inula racemosa and Trikatu. Various clinical studies have observed the beneficial immunomodulation offered

by Septilin syrup in various disorders. This study was planned to evaluate the efficacy and safety of Septilin syrup in RTI.

The common LRTI in children are pneumonia and bronchiolitis. Currently, the most common causes of viral LRTI are RSVs. They tend to be highly seasonal unlike the parainfluenza viruses, the next most common cause of viral LRTIs. Pneumonia can be caused by both bacteria and viruses. Bacterial pneumonia is often caused by Streptococcus pneumoniae (pneumococcus) or Haemophilus influenzae, mostly type B (Hib), and occasionally by Staphylococcus aureus or other streptococci. Only about 8-12 of the many types of pneumococci cause most cases of bacterial pneumonia, although the specific types may vary between adults and children and among different geographic locations. Other pathogens, such as Mycoplasma pneumoniae and Chlamydia pneumoniae, cause atypical pneumonia, but their etiological role in children under the age of five in developing countries is unclear.

To evaluate the clinical efficacy and safety of Septilin syrup in RTI.

The current management of RTI is based on curative measures. Antibacterial and antiviral chemoprophylaxis is only exceptionally appropriate in the treatment of RTI. The development and spread of antibacterial resistance in bacteria that commonly cause communityacquired RTI is a major global healthcare problem.9 Unnecessary antibiotic therapy (overuse) and poor therapeutic choice, dosage and/or duration (misuse) both contribute to bacterial resistance, avoidable toxicity and increased costs. The data on antiviral chemoprophylaxis during influenza in children are preliminary and conflicting. Also, the efficacy of surgery is unclear; many trials and reviews attempted to define the role of ear, nose and throat surgery (such 222

Aim of the Study

Material and Methods This was an open, prospective clinical trial undertaken on 40 patients in the age group of six months to six years presenting with RTI at Dept. of Pediatrics, Medical College and Hospital, Kolkata, India, after getting an approval from the Independent Ethical Committee. A written informed consent was obtained from the parents of all the children participating in the study and they were informed of the voluntary nature of the trial. The study was done in accordance with regulatory standards of good clinical practice.

Study Procedure

Forty patients in the age group of six months to six years with various RTI like common cold, chronic bronchitis, chronic tonsillitis and adenoiditis, repeated sinusitis, chronic otitis media, repeated bronchitis and chronic laryngotracheobronchitis were selected for the trial. Detailed history of the duration, frequency, severity of the infection was elicited. A thorough examination of ear, nose, throat including chest examination, general physical examination including respiratory rate were also conducted and recorded in case report form. Septilin syrup was given at a following dose: Infants: Half to 1 teaspoonful three times daily, Children: 1-2 teaspoonfuls three times daily for a period of six months. Safety and efficacy of the investigational product was evaluated at bi-monthly intervals upto six months.

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

original study Inclusion Criteria

Patients of either sex in the age group of six months to six years presenting with RTI and whose parents were willing to give the informed consent and comply with the study procedures were included for the study.

Exclusion Criteria

Children with congenital abnormality like cleft lip, cleft palate, any severe systemic illness of pneumonia, cardiac, renal, hepatic disorders and whose parents were not ready to provide informed consent or comply with the study procedures were excluded from the study.

Follow-up and Assessment

All the subjects were followed-up at bi-monthly intervals upto six months. At each visit patients were evaluated for reduction in signs and symptoms of common cold, chronic bronchitis, chronic tonsillitis and adenoiditis, sinusitis, chronic otitis media and chronic laryngotracheobronchitis. Overall response was also evaluated.

Primary and Secondary Endpoints

The predefined primary endpoints were reduction in the signs and symptoms of RTI after treatment with study drug. The predefined secondary endpoints for safety were assessed by incidence of adverse events, and compliance to the drug therapy.

Adverse Events

None of the subjects had reported adverse effect and all the subjects completed the study. Any adverse effects reported, or observed by the subjects 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 subject’s clinical state or other modes of therapy administered to the subject) and ‘Probable’ (follows a known response pattern to the suspected drug that could not be reasonably explained by the known characteristics of the subject’s clinical state).

Subjects were allowed to voluntarily withdraw from the study, if they had experienced serious discomfort during the study or sustained serious clinical events Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

requiring specific treatment. For subjects 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.

Statistical Analysis

Statistical analysis was carried out using Fisher’s exact test to find out the level of significance. The minimum level of significance was fixed at p < 0.05. Statistical analysis was performed using Graphpad Prism Version 4.03, for windows (Graphpad Software, San Diego, California USA).

Results All the 40 subjects completed the 6-month treatment period. Twenty-four males and 16 females children with mean age of 3.25 ± 1.80 and mean weight of 10.12 ± 3.80 were participated in the study (Table 1).

There was significant reduction in the number of patients suffering from chronic bronchitis from six patients at entry to 4, 2 and 1 at the end of 2, 4 and 6 months of treatment, respectively, with significance of p < 0.015 at six months as compared to baseline values. Significant reduction was also observed in chronic otitis media from seven patients at entry to 6, 4 and 2 at the end of 2, 4 and 6 months of treatment, respectively, with significance of p < 0.02 at six months as compared to baseline values. There was a significant reduction in the number of patients suffering from repeated bronchitis from eight patients at entry to 5, 3 and 1 at the end of 2, 4 and 6 months of treatment, respectively, with significance of p < 0.001 at six months as compared to baseline values. Similarly, number of patients suffering from common cold and repeated sinusitis significantly declined at the end of 2, 4 and 6 months when compared to their respective baseline values (Table 2). Though there was reduction in the number of patients suffering from chronic tonsillitis and adenoiditis, and chronic laryngotracheobronchitis, the values were not statistically significant.

Table 1. Demographic Data Total number of patients

40

Mean age in years (mean ± SD)

3.25 ± 1.80

Mean weight in kgs (mean ± SD)

10.12 ± 3.80

Sex ratio (M:F)

24:16

223

original study Table 2. Number of Children showing Symptoms at Baseline and Follow-up Visits

Table 3. The Percentage Response to Septilin Syrup in Children with RTI

RTI

RTI

Common cold

At entry

2M

4M

6M

7

5

3

2

Chronic bronchitis

6

Chronic tonsillitis and adenoiditis

4

Repeated sinusitis

5

Chronic otitis media Repeated bronchitis Chronic laryngotracheobronchitis

7 8 3

Common cold

71.43

Chronic bronchitis

83.33

Chronic tonsillitis and adenoiditis

75.00

NS

NS

p < 0.021

4

2

1

NS

NS

p < 0.015

Repeated sinusitis

80.00

3

2

1

Chronic otitis media

71.43

NS

NS

NS

Repeated bronchitis

87.50

Chronic laryngotracheobronchitis

66.67

3

2

1

NS

NS

p < 0.048

6

4

2

NS

NS

p < 0.021

5

3

1

NS

p < 0.026

p < 0.001

3

2

1

NS

NS

NS

p values as compared to respective initial values; Statistical analysis performed using Fisherâ&#x20AC;&#x2122;s exact test.

The overall response for Septilin syrup was 71% in common cold, 83% in chronic bronchitis, 75% in chronic tonsillitis and adenoiditis, 80% in repeated sinusitis, 71% in chronic otitis media, 87% in repeated bronchitis and 67% in chronic laryngotracheobronchitis (Table 3).

There were no clinically significant adverse reactions, either reported or observed, during the entire study period and overall compliance to the treatment was adequate.

Discussion Except during the neonatal period, RTI are the most common causes of both illness and mortality in children under five. The WHO clinical guidelines for case management (WHO 1991) use two key clinical signs: Respiratory rate, to distinguish children with pneumonia from those without, and lower chest wall indrawing, to identify severe pneumonia requiring referral and hospital admission. Children with audible stridor when calm and at rest or with danger signs of severe disease such as inability to feed also require referral.

Rational approach to diagnosis and management of RTI is needed, or else the child is subjected to unnecessary investigations and multiple drugs. Prompt 224

Response (%)

recognition of infection and aggressive treatment are essential to avoid life-threatening complications and improve prognosis. Antibiotics should be judiciously chosen depending on age, socioeconomic status, severity of infection and the type of organism expected and always given in adequate doses and proper duration. Children at highest risk for developing resistant bacteria are those who have failed previous treatments, have had numerous previous antibiotic prescriptions, or received low doses of antibiotics over a prolonged period.

Septilin syrup has immunomodulatory, antioxidant, anti-inflammatory, antiallergic and antimicrobial actions. It has an excellent short- and long-term safety.

T. cordifolia has potent immunomodulatory and immunostimulatory actions, which increase the levels of antibodies and activate macrophages.10,11 E. officinalis enhances cell survival and increases phagocytosis and g-IFN production.12 Glycyrrhizin from G. glabra potentiates the reticuloendothelial system,13 enhances immunostimulation14 and acts on macrophage function in vitro, leading to stimulation of macrophages de novo.15 b-glycyrrhetinic acid from G. glabra is a potent inhibitor of the classical complement pathway.16 R. cordifolia,17 E. officinalis18 and G. glabra,19 have potent antioxidant actions. G. glabra20 has been reported for its anti-inflammatory properties.

T. cordifolia improves the phagocytic and intracellular bactericidal capacities of neutrophils.21 Glycyrrhizin from G. glabra has potent antiviral activity.22 E. officinalis has antibacterial properties, especially against Escherichia coli, Klebsiella pneumoniae, Klebsiella ozaenae, Proteus mirabilis, Pseudomonas aeruginosa, Salmonella typhi, Salmonella paratyphi A and B and Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

original study Serratia marcescens.23 R. cordifolia has antibacterial properties.24 T. cordifolia25 and E. officinalis26 have antipyretic properties. G. glabra is an expectorant and hence is beneficial in asthma, acute or chronic bronchitis, and chronic cough.27-29

3. Denny FW Jr. Am J Respir Crit Care Med 1995;152 (4 Part 2):S4-12.

A study conducted on Commiphora mukul shows that essential oil, chloroform extract and seven sesquiterpenoids compounds newly isolated from the oleo-gum-resin of C. mukul showed a wide range of inhibiting activity against both gram-positive and gram-negative bacteria.30 M. quath has analgesic, antiphlogistic and antipyretic properties. It is used for the treatment of rheumatism and arthritis, several neurological disorders, as well as genitourinary disorders.31

6. DeBaets F, et al. Eur J Pediatr 1992;151(4):274-8.

Root of I. racemosa has shown its therapeutic activity against various infectious organisms.32 â&#x20AC;&#x2DC;Trikatuâ&#x20AC;&#x2122; - an Ayurvedic formulation comprising of a 1:1:1 ratio of dried fruits of Piper nigrum, Piper longum and dried rhizomes of Zingiber officinale is widely used to enhance the bioavailability of drugs.33 Piperine from P. nigrum is absorbed rapidly across the intestinal barrier. It acts as an apolar molecule, which forms apolar complex with drugs and solutes. This modulates membrane dynamics, due to its easy partitioning thus helping in efficient permeability across the barriers. These membrane modulations help in better bioavailability of nutrients and medications.34,35

14. Wagner H, Jurcic K. Phytomedicine 2002;9(5):390-7.

The beneficial effects of Septilin syrup can be attributed to the combined effect of the individual potent herbs present in it.

23. Saeed S, et al. Pak J Pharm Sci 2007;20(1):32-5.

Conclusion

26. Perianayagam JB, et al. J Ethnopharmacol 2004;95(1): 83-5.

Results of the present clinical trial showed that Septilin syrup significantly relieved symptoms in RTI like common cold, chronic bronchitis, repeated sinusitis, chronic otitis media and repeated bronchitis.

It provided adequate relief from the symptoms and its acceptance by patients was excellent. There were no adverse reactions, either reported or observed, during the entire study period and overall compliance to the treatment was adequate. Therefore, it may be concluded that Septilin syrup is effective and safe in patients suffering from RTI.

4. Klein JO. Pediatr Infect Dis J 2000;19(5 Suppl): S89-92.

5. Uhari M, et al. Clin Infect Dis 1996;22(6):1079-83.

7. Kilic SS. In: Recent Advances in Pediatrics 2004:1-18.

8. Berman S. N Engl J Med 1995;332(23):1560-5.

9. Felingham D, et al. Clin Microbiol Infect 2002;8: Suppl 2:12-42.

10. Kapil A, et al. J Ethnopharmacol 1997;58(2):89-95.

11. Bishayi B, et al. J Toxicol Sci 2002;27(3):139-46.

12. Sai Ram M, et al. Phytother Res 2003;17(4):430-3.

13. Shimizu N, et al. Chem Pharm Bull 1991;39(8):2082-6.

15. Nose M, et al. Biol Pharm Bull 1998;21(10):1110-2.

16. Kroes BH, et al. Immunology 1997;90(1):115-20.

17. Cai Y, et al. J Agric Food Chem 2004;52(26): 7884-90.

18. Ganju L, et al. Biomed Pharmacother 2003;57(7): 296-300.

19. Vaya J, et al. Free Radic Biol Med 1997;23(2):302-13.

20. Herold A, et al. Roum Arch Microbiol Immunol 2003;62(3-4):217-27.

21. Thatte UM, et al. J Postgrad Med 1992;38(1):13-5.

22. Badam L. J Commun Dis 1997;29(2):91-9.

24. Qiao YF, et al. Yao Xue Xue Bao 1990;25(11):834-9.

25. Ikram M, et al. J Ethnopharmacol 1987;19(2):185-92.

27. Haggag EG, et al. J Herb Pharmacotherapy 2003;3(4): 41-54.

28. Puodziuniene G, et al. Medicina 2005;41(6):500-5.

29. Bielory L. Ann Allergy Asthma Immunol 2004;93 (2 Suppl 1):S45-54.

30. Saeed MA, Sabir AW. Fitoterapia 2004;75(2):204-8.

31. Anonymous. The Ayurvedic Formulary of India, Dept. of ISM & H, Ministry of Health & FW. Govt. of India.

Part I, Edition 4th:2004: p. 51.

32. Lokhande PD, et al. Res J Med Plants 2007;1(1):7-12.

References

33. Johri RK, et al. J Ethnopharmacol 1992;37(2):85-91.

1. Schaad UB. Eur Respir Rev 2005;14(95):74-7.

2. Howel D, et al. Fam Pract 2002;19(3):242-6.

34. Khajuria A, et al. Indian J Exp Biol 1998;36(1):46-50.

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

35. Khajuria A, et al. Phytomedicine 2002;9(3):224-31.

225

CLINICAL STUDY

Practice of Prelacteal Feeds and Colostrum among Normally Delivered Mothers in SSG Hospital, Vadodara, Gujarat Jivraj Damor*, Navneet Padhiyar**

ABSTRACT Prelacteal feed is anything given to the newborn to drink or eat before starting breastfeeding. This practice is to be strongly condemned and avoided. The unhygienic way of giving prelacteal feeds makes the child more vulnerable to infection. This also deprives the child from colostrum. All mothers should be counseled in the antenatal period about the importance of colostrum and adverse effect of prelacteal feeds.

Key words: Nutrition, prelacteal, feeding, breastfeeding

T

he â&#x20AC;&#x2DC;Breast is bestâ&#x20AC;&#x2122; as said by Dr Hugh Jolly and when weighing up the pros of nutritional wellbeing of a population is both, an outcome and an indicator of national development. Nutrition is, therefore, an issue of survival, health and development for current and succeeding generations.1 Prelacteal feeding is anything given to the newborn to drink or eat before starting breastfeeding.

This practice is to be strongly condemned and avoided.

The unhygienic way of giving prelacteal feeds makes the child more vulnerable to infections. This also deprives the child from colostrum.

Feeding sweet carbohydrate preparations in the first three days of life is an old custom as mentioned in Charak Samhita.2 It was customary to evacuate the meconium by giving honey and ghee during the first four days of life.

Bhosale et al3 found that out of 217 urban mothers, 22% mothers had given prelacteal feeds. In a study

by Jethi and Shrivastava on knowledge, attitude and practices regarding infant feeding among mothers,4 it was observed that utility of colostrum in infant nutrition is underestimated and there is lack of knowledge regarding colostrum. *Associate Professor **Assistant Professor Dept. of PSM Govt. Medical College, Vadodara Address for correspondence Dr Navneet Padhiyar D/27, Akanksha Duplex Laxmipura Road, Gorwa, Vadodara - 390 016 E-mail: jivrajdamor@yahoo.co.in

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

In study carried out by Kumar D (2006), colostrum was discarded in 15.9% of cases due to family restriction (30.2%) and social custom (25.6%).5 Eighty-six percent of the infants received colostrum as per the Multiple Indicator Cluster Survey (MICS) in urban Vadodara in 2006.6 In a study carried out by Saurav Chatterjee (2008), 96.4% of infants received colostrum.7 Material and Methods As per register of labor room of Dept. of Obstetrics and Gynecology, SSG Hospital, Vadodara, average 6-7 deliveries are conducted per day, out of which 3-4 deliveries are normal deliveries. Majority of mothers come from rural and slum areas of Vadodara district.

Statistical Evaluation

On the same day of data collection, forms were checked and corrected. The data so collected was entered into computer using Epi Info (version 6.04d) software. Data cleaning was carried out, checked for discrepancies, and rectified. The data was then analyzed for various parameters and cross tabulation was done using Epi Info (version 6.04d) software. Analysis was done in September 2008.

Observations About 96.2% of mothers did not give prelacteal feeds to their children. This shows that awareness is increasing among mothers. 98.4% of the children 227

Clinical study Table 1. Distribution of Neonates by History of Colostrum Given

who had received colostrum were not given prelacteal feeds.

Colostrum

Discussion

Frequency

%

Yes

132

69.8

No

57

30.2

Total

189

100

Colostrum is nature’s way of protecting the infant against childhood infections especially during the first year of life. Due to the wrong belief that it is infectious, the most precious component of the breast milk is often discarded.

Table 2. Distribution of Neonates according to History of ANC and Colostrum Feeding ANC taken

History of colostrum feeding

Total

Given

Not given

Taken

120 (71.8%)

47 (28.14%)

167

Not taken

12 (54.5%)

10 (45.45%)

22

132

57

189

Total

Table 3. Reasons for Giving Colostrum Reasons

Frequency

Advised by doctor

65 (49.24%)

Advised by sister

7 (5.3%)

Advised by family members (sister, sister-in-law, mother)

9 (6.8%)

Advised by AWW

3 (2.27%)

Read in books

2 (1.5%)

Seen on TV, posters, charts, booklets

46 (34.84%)

Table 4. Reasons for not Giving Colostrum Reasons

Frequency

Unhygienic milk, infectious, sticky milk, not good 32 (24.24%) for health, watery, bad milk, dirty milk Advised by mother, other family members like sister-in-law, her sister, etc.

11 (8.33%)

Advised by sweeper

4 (3.03%)

Advised by pediatrician

1 (0.7%)

Baby having hiccough

6 (4.5%)

BF not yet started after 24 hours

1 (0.7%)

No specific reason

2 (1.5%)

BF: Breastfeeding

228

Actually, every child should receive colostrum but in our study, only 69.8% of the neonates studied had received colostrum. It was a good point that 54% of health staff were responsible for this success. In this study, 30.2% of the neonates were deprived of colostrum due to their parents’ wrong belief of colostrum being infectious, unhygienic, not good for health, very sticky milk, bad milk, etc.; the next common reason being their following relatives’ advice (8.3%). The most surprising reason which one mother told was that she had been advised by a Pediatrician to do so.

Out of 88.4% of mothers who came for antenatal care, 71.8% of mothers gave colostrum; this shows that reasons for not giving colostrum can be reduced by proper health education during antenatal period.

In the study carried out by Saurav Chatterjee, 96.4% of the infants received colostrum.7 In another study carried out by Kumar D, colostrum was discarded in 15.9% of cases due to family restriction (30.2%) and social custom (25.6%).5 About 86.6% of the infants received colostrum as per the MICS.6 Thus, it was seen that there is no difference between the present scenario in the urban slums and that of two years back.

Conclusions  Only few neonates were given prelacteal feedings.  Majority of neonates had received colostrum.

Recommendations 



All antenatal mothers should be properly counseled regarding infant and young child feeding practices during antenatal check-up i.e. strengthening of antenatal care.

Proper support by health staff in institution would promote early initiation of breastfeeding and discourage prelacteal feeding.

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

Clinical study ď Ź

All mothers should be counseled in the antenatal period about the importance of colostrum and adverse effect of prelacteal feeds.

References 1. Indian National Guidelines on Infant and Young Child Feeding. Ministry of Women and Child Development Food and Nutrition Board, Government of India, 2nd edition, 2006.

2. Charaka Samhita, Vol III, 46, P-1164.

3. Bhosale NA, Deshpande SG, Zodpey SP, Jog SN, Vasudeo ND. Infant feeding practices in urban population: a clinic based study. Indian J Med Sci 1997;51(10):396-9.

4. Jethi SC, Shrivastava DK. Knowledge, attitudes and practice regarding infant feeding among mother substitutes. Indian Pediatr 1987;24(10):921-5.

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

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

6. Multiple Indicator Cluster Survey. Vadodara, 2006.

7. Chatterjee S, Saha S. A study on knowledge and practice of mothers regarding infant feeding and nutritional status of under-five children attending immunisation clinic of a medical college. The Internet Journal of Nutrition and Wellness 2008;5(1).

n

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

n

n

229

CASE REPORT

Chronic Diarrhea in a HIV-positive Patient due to M. tuberculosis and Cryptosporidium Coinfection Sourya Acharya*, Samarth Shukla**, SN Mahajan†, Nilima Tankhiwale‡, Amit Gupta¶

ABSTRACT Human immunodeficiency virus (HIV) infection frequently involves the gastrointestinal tract. The symptoms can be myriad ranging from acute and chronic diarrhea, weight loss, dysphagia, abdominal pain to malabsorption. Typical infectious diseases affecting the intestinal tract in HIV-infected patients are caused by protozoa (microsporidium, cryptosporidium), bacteria (Clostridium diffi cile, Salmonella, Shigella, Campylobacter, Mycobacterium avium complex (MAC), Mycobacterium tuberculosis (MTB), viruses (cytomegalovirus, herpes simplex) and fungi (Candida species). Coinfection with two species are rare. We present a case of MTB and cryptosporidium coinfection presenting as chronic diarrhea in an HIV-positive patient.

Key words: Diarrhea, malabsorption, protozoa, bacteria, fungus, MTB, MAC, HIV

T

he gastrointestinal tract (GIT) is the major target for pathogens in human immunodeficiency virus (HIV)-infected patients and as many as a third of patients with acquired immunodeficiency syndrome (AIDS) are initially seen by a gastroenterologist.1 In these instances, apart from weight loss and malabsorption, diarrhea is the most frequent manifestation in AIDS and HIVpositive patients.2,3 The prevalence of chronic diarrhea approaches to 100% in developing countries, causing a significant morbidity and mortality.4 Furthermore, HIV patients suffering from chronic diarrhea have a very low quality-of-life and an extra burden of cost for management of the same.

Case Report A 46-year-old male presented to us with complaints of increased frequency of watery stools (5-6 times a day), abdominal pains, weight loss of more than 8 kgs and moderate grade fever off and on over a period of three months. There was no history of blood in stools, melena, vomiting. On examination, *Associate Professor, Dept. of Medicine **Associate Professor, Dept. of Pathology †Professor and Head, Dept. of Medicine ‡Professor and Head, Dept. of Microbiology ¶Resident, Dept. of Medicine JN Medical College, DMIMS, Sawangi (Meghe), Wardha Address for correspondence Dr Sourya Acharya Dept. of Medicine JN Medical College, DMIMS Sawangi (Meghe), Wardha - 442 004, Maharashtra E-mail: souryaacharya@yahoo.co.in

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

he was thin-built. General physical examination revealed mild pallor. His vitals were stable with signs of mild dehydration. Abdominal and other systemic examination did not reveal anything significant.

Rectal examination revealed no palpable masses or blood clots.

Investigations: Hb 8 g/dl, TLC 4,300/mm3, total platelet count 2,50,000/mm3, urine examination normal. ESR was 78 mm in 1st hour. Blood culture was negative.

ELISA was positive for HIV-1. Stool examination with acid-fast stain revealed oocysts of Cryptosporidium parvum and rod-shaped Mycobacterium tuberculosis (MTB) bacilli coinfection (Figs. 1 and 2). CD4 count was 178/mm3. USG abdomen was normal. The patient did not consent for endoscopic examination.

He was started with highly-active antiretroviral therapy (HAART) (zidovudine, lamivudine and indinavir), antituberculosis treatment (ATT) (WHO Category 1) and nitazoxanide 500 mg b.i.d. for 14 days apart from IV fluids, oral rehydration solution (ORS) and loperamide 2 mg o.d. His condition improved after one week. Diarrhea subsided and he took voluntary discharge. He came for first follow-up after 15 days and denied having diarrhea and fever and reported feeling well. His repeat stool examination was normal. He is due for second follow-up after two months.

Discussion HIV-infected patients with diarrhea or other symptoms of enterocolitis should be carefully evaluated to identify 231

Case Report

Figure 1. Stool sample stained with modified Ziehl-Neelsen stain showing multiple rod-shaped tubercular bacilli.

Figure 2. Stool sample stained with modified Ziehl-Neelsen stain showing oocysts of C. parvum along with TB bacilli.

treatable conditions. Historical assessments should focus on the nature and duration of the symptoms, concomitant medications, travel and other exposures, such as through food, water or sexual contact. The standard diagnostic evaluation should include stool leukocyte examination to identify inflammatory causes of diarrhea, such as bacterial pathogens and cytomegalovirus (CMV), and guide empirical therapy; other infectious agents, such as protozoa and Mycobacterium avium complex (MAC) are typically not associated with the finding of fecal leukocytes. Stool should be cultured for enteric bacterial pathogens, assayed for Clostridium difficile toxin and examined for ova and parasites. Stool specimens should be examined on at least three occasions with modified acid-fast stain to identify cryptosporidium, cyclospora and isospora. Special trichrome staining may be useful for 232

the identification of microsporidians.5 If noninvasive stool studies are not diagnostic and symptoms persist, endoscopic evolution with biopsy may prove helpful, particularly in patients with chronic diarrhea and severe immunodeficiency (CD4+ cells <100/mm3).6 Patients with signs and symptoms suggestive of large bowel involvement should undergo colonoscopy and biopsy.

Upper endoscopy with duodenal biopsy is useful for patients with symptoms of small bowel disease or those with persistent symptoms and negative evaluation of the lower GIT.7 In addition to hematoxylin and eosin (H&E) staining, duodenal histologic specimens should be stained with fungal stains and modified acid-fast stain for cryptosporidium as well as electron microscopy for microsporidia. Polymerase chain reaction (PCR) assay of biopsy specimens may also prove valuable in the diagnosis of some pathogens, such as microsporidia.8 Small bowel aspirates are generally not useful in the evaluation of unexplained diarrhea. Approximately 20-50% of patients with chronic diarrhea have a negative GIT evaluation.9 In large study of chronic diarrhea in HIV patients, 52% patients yielded putative pathogens; the most common were Cryptosporidium spp. (17%), Salmonella typhimurium (13%) and M. tuberculosis (13%).10 Detection of cryptosporidium cysts was the single most significant predictor of death. However, no evidence of coinfection was documented. The study concluded that HIV-infected patients with chronic diarrhea have a poor outcome overall, and even with extensive investigations, a putative pathogen was identified in only just over half the patients. The most important step is to exclude tuberculosis and the most useful investigation appears to be Ziehl-Neelsen staining.

Other potentially treatable gram-negative bacterial pathogens, were, however, common but require culture facilities.

Another study examined the relationships between diarrhea, CD4 cell counts and stool pathogens in a community-based cohort of HIV-infected adults. The rate of diarrhea was 661 episodes per 1,000 per year of observation. CD4 counts were significantly lower in individuals with diarrhea than those without.

Forty-nine percent of diarrheal stools and 39% of stools from asymptomatic patients contained enteric pathogens. The most frequent isolates were helminths (29.5% of all stools), followed by bacteria (19.2%) and then protozoa (8.9%). Rates of isolation of Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

Case Report diarrhea-associated pathogens were 29% from diarrheal stools and 17% from asymptomatic stools. The association between diarrhea and infection with bacteria or protozoa was weak and there was no association with helminths. C. parvum infection alone was associated with low CD4 counts. The study concluded that diarrhea was common and most strongly associated with low CD4 counts. Bacteria were frequently found, even in stools from asymptomatic individuals. Over two-thirds of diarrheal episodes were undiagnosed, suggesting that unidentified agents or primary HIV enteropathy are important causes of diarrhea in this population. None of the patientsâ&#x20AC;&#x2122; stool samples detected coinfection with two species.11 Our case is one of the rarest in its own kind because this patient was simultaneously infected with two different species, which were diagnosed in his stool sample with acid-fast stain emphasizing the importance of stool examination in evaluation of diarrhea in AIDS. The cryptosporidium intestinal protozoan survives and replicates within the intestinal microvilli, eventually generating oocysts that are excreted in the stool and are responsible for the spread of infection.

Autoinfection can also occur, explaining how ingestion of small numbers of oocysts can cause severe, persistent infection in the immunocompromised host. Loss of cell-mediated immunity increases the risk of infection and explains the higher incidence of cryptosporidium intestinal disease in AIDS patients. The mechanisms by which cryptosporidium causes diarrhea are not completely understood. The pathogen affects intestinal ion transport and causes inflammatory damage to the intestinal microvilli, resulting in malabsorption.

The oocyst is resistant to chlorination. Cryptosporidium presents with chronic watery diarrhea, often associated with abdominal cramps. Most cases occur in immunocompromised hosts, most frequently patients with AIDS. Diagnosis can be made by stool smear. Stool samples should be stained not only with iodine, but also with modified Kinyounâ&#x20AC;&#x2122;s acidfast stain, and concentrated. Cryptosporidium cysts are acid-fast; however, fecal smears have proved less specific and sensitive than fecal antigen tests that are now commercially available. In our case, the oocysts were evident in the stool examination. For treatment of patients with HIV, HAART should be combined with 14 days of nitazoxanide treatment.

This agent is not effective when the CD4 count falls Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

below 50 cells/mm3. HAART was shown to reduce the relative risk to contract cryptosporidiosis by 96% and to produce a therapeutic improvement in cryptosporidiosis infection.12 Carr and colleagues13 demonstrated that patients with chronic diarrhea responded clinically to combination therapy including at least one protease inhibitor and gained on average 15 kg weight. Pathogens remained at undetectable levels during follow-up but some developed recurrent diarrhea by 7-13 months. Similar results are seen in another RCT in which watery stools resolved, weight gain was documented and parasites eradicated.14 Susceptibility of microsporidium and cryptosporidium to antibiotic therapy may also be heightened

by ART.15 The effectiveness of HAART in reducing chronic diarrhea may be due to increased production of interferon-gamma, which destroys cryptosporidium.16 The commonly observed phenomenon of remission of diarrhea after beginning ART suggests that HIV has an enteropathogenic role, either directly or indirectly.

Mycobacterial involvement of the bowel either by tuberculosis or MAC may lead to diarrhea.

A prospective study investigated the causes of chronic diarrhea in AIDS patients in Thailand.17 Extensive investigations included multiple stool examinations for ova and parasites, using the stool formalin-ether concentration method, stool culture, stool acid-fast bacilli (AFB) stain, stool modified AFB stain, esophagogastroduodenoscopy with duodenal aspirate and biopsy, and colonoscopy with biopsy. Biopsied specimens were examined with H&E, Giemsa, Gram, Periodic acidSchiff (PAS) and AFB stains. Definitive causes were found in 29 patients (64.4%). Of these 29, seven patients were found to harbor more than one pathogen (15.5%).

The most commonly found enteric pathogen was C. parvum (20.0%). Less frequently found pathogens were M. tuberculosis (17.8%).

There are several theories regarding the development of tuberculosis of the intestine.18 These are through ingestion of TB infected materials and direct invasion of intestinal mucosa. Another is through hematogenous route by blood to the liver and excreted to the bile with subsequent invasion of the mucosa or by the intestines from primary or secondary tuberculoma. Tuberculosis of the GIT is noted for its protean manifestations. Several studies conducted in both developed and developing countries, despite frequency of occurrence, have not identified pathognomonic symptoms or syndromes.

233

Case Report In foreign literature, the most common features are fever and abdominal pain and only one-third of patients had diarrhea.19 As far as chronic diarrhea in AIDS patients are concerned, the most common mycobacterium is the nontubercular mycobacteria (NTM), that too MAC in particular. M. ulcerans, M. fortuitum, M. kansasii, and smaller percentages of M. gordonae and M. chelonae have also been detected but again MTB is not so common. Treatment of intestinal tuberculosis in AIDS is with HAART and ART.

7.

8.

9.

Conclusion Gastrointestinal manifestations in AIDS throws real challenges for the treating physician and to the community as well. Apart from treating the complications a meticulous search should be undertaken to identify the culprit organism. A CD4 count is mandatory for correlation. Simple stool specimen examination with appropriate staining still holds promise in diagnosis. Further investigations like cultures, endoscopic intestinal biopsies, serologic studies, PCR and stool antigen testing should be done as necessary depending on the circumstances.

C. parvum still rules the GIT of AIDS patients.

Amongst the Mycobacterium spp., MAC is the common cause of chronic diarrhea. Coinfection is rarely encountered. Treatment is species-specific; in addition, HAART therapy depends on the CD4 counts.

10.

11.

12.

13.

14.

References 1. Dancygier H. AIDS and gastrointestinal endoscopy.

Endoscopy 1992;24(1-2):169-75.

2. Smith PD, Quinn TC, Strober W, Janoff EN, Masur H. NIH conference. Gastrointestinal infections in AIDS. Ann Intern Med 1992;116(1):63-77.

3. Dworkin B, Wormser GP, Rosenthal WS, Heier SK, Braunstein M, Weiss L, et al. Gastrointestinal manifestations of the acquired immunodeficiency syndrome: a review of 22 cases. Am J Gastroenterol 1985;80(10):774-8.

4. Mayer HB, Wanke CA. Diagnostic strategies in HIVinfected patients with diarrhea. AIDS 1994;8(12): 1639-48.

5. Goodgame RW. Understanding intestinal spore-forming protozoa: cryptosporidia, microsporidia, isospora, and cyclospora. Ann Intern Med 1996;124(4):429-41.

6. Wilcox CM, Schwartz DA, Cotsonis G, Thompson SE 3rd. Chronic unexplained diarrhea in human immunodeficiency virus infection: determination

234

15.

16.

17.

18.

19.

of the best diagnostic approach. Gastroenterology 1996;110(1):30-7.

Bown JW, Savides TJ, Mathews C, Isenberg J, Behling C, Lyche KD. Diagnostic yield of duodenal biopsy and aspirate in AIDS-associated diarrhea.

Am J Gastroenterol 1996;91(11):2289-92.

David F, Schuitema AR, Sarfati C, Liguory O, Hartskeerl RA, Derouin F, et al. Detection and species identification of intestinal microsporidia by polymerase chain reaction in duodenal biopsies from human immunodeficiency virus-infected patients.

J Infect Dis 1996;174(4):874-7.

Blanshard C, Francis N, Gazzard BG. Investigation of chronic diarrhoea in acquired immunodeficiency syndrome. A prospective study of 155 patients. Gut 1996;39(6):824-32.

Mwachari C, Batchelor BI, Paul J, Waiyaki PG, Gilks CF. Chronic diarrhoea among HIV-infected adult patients in Nairobi, Kenya. J Infect 1998;37(1):48-53.

Brink AK, Mahè C, Watera C, Lugada E, Gilks C, Whitworth J, et al. Diarrhea, CD4 counts and enteric infections in a community-based cohort of HIV-infected adults in Uganda. J Infect 2002;45(2):99-106.

Pozio E. Highly Active Antiretroviral Therapy and opportunistic protozoan infections. Parassitologia 2004;46(1-2):89-93.

Carr A, Marriott D, Field A, Vasak E, Cooper DA. Treatment of HIV-1-associated microsporidiosis and cryptosporidiosis with combination antiretroviral therapy. Lancet 1998;351(9098):256-61.

Foudraine NA, Weverling GJ, van Gool T, Roos MT, de Wolf F, Koopmans PP, et al. Improvement of chronic diarrhoea in patients with advanced HIV-1 infection during potent antiretroviral therapy. AIDS 1998;12(1):35-41.

Maggi P, Larocca AM, Quarto M, Serio G, Brandonisio O, Angarano G, et al. Effect of antiretroviral therapy on cryptosporidiosis and microsporidiosis in patients infected with human immunodeficiency virus type 1. Eur J Clin Microbiol Infect Dis 2000;19(3): 213-7.

Harp JA, Whitmire WM, Sacco R. In vitro proliferation and production of gamma interferon by murine CD4+ cells in response to Cryptosporidium parvum antigen.

J Parasitol 1994;80(1):67-72.

Manatsathit S, Tansupasawasdikul S, Wanachiwanawin D, Setawarin S, Suwanagool P, Prakasvejakit S. et al.

Causes of chronic diarrhea in patients with AIDS in Thailand: a prospective clinical and microbiological study. J Gastroenterol 1996;31(4):533-7.

Elder NC. Extrapulmonary tuberculosis. A review. Arch Fam Med 1992;1(1):91-8.

Hibbs RG, Kamal M, Farid Z. Abdominal tuberculosis in Cairo, Egypt. Trans R Soc Trop Med Hyg 1994;88(3): 317-8.

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

CASE REPORT

CD117-negative Colonic GIST: A Rare Diagnosis Hanish Bansal*, Rahul Roy**, Raj Kamal Jenaw†, Rajendra Mandia‡

ABSTRACT Gastrointestinal stromal tumors (GIST) represent 0.1-3% of all GI cancers and have an incidence of 10-20 cases per million. These tumors are most common in the stomach followed by small intestine and rare in colon and rectum (<5%).

Currently defined as CD117-positive spindle cell or epithelioid neoplasms, CD117-negative GISTs do exist and account for approximately 6% of the GI mesenchymal tumors. We report such a case of colonic GIST with negative CD117 in young women in whom a segmental resection of involved colonic segment was performed. Relevant literature is briefly reviewed.

Key words: Mesenchymal, CD117, imatinib

Case Report A 32-year-old woman presented with a lump in left upper abdomen for last one month, early satiety and weight loss. There was no history of alteration in bowel habits or any other complaints. She gave a history of laparoscopic tubal ligation nine years back.

On abdominal examination, a lump 15  10 cm size was found to occupy the left hypochondrium and left lumbar region extending into the epigastric and umbilical region. The lump had indistinct margins and smooth surface (Fig. 1) and it moved with respiration.

On palpation, the lump was firm in consistency, mobile, dull on percussion and nonballotable. Digital rectal examination was unremarkable.

Blood investigations revealed anemia (Hb - 9.6 g/dl).

Liver function tests were normal. Carcinoembryonic antigen (CEA) and alpha-fetoprotein (AFP) were within normal limits.

*Postgraduate Student (3rd Year) **Postgraduate Resident †Professor and Unit Head ‡Associate Professor Surgical Unit 4, Dept. of General Surgery SMS Medical College, Jaipur Address for correspondence Dr Hanish Bansal Dept. of General Surgery 10-B, Udham Singh Nagar, Ludhiana, Punjab - 141 001 E-mail: y2khanish@gmail.com

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

Figure 1. Picture showing the abdominal lump.

Computed tomography (CT) of the abdomen revealed a soft tissue density mass lesion 15  10  13 cm in size which showed heterogeneous enhancement along the left lumbar region extending into the left iliac fossa (Fig. 2). Fine needle aspiration cytology (FNAC) revealed a mesenchymal neoplasm of uncertain malignant potential.

Provisional diagnosis of a mesenchymal tumor with uncertain malignant potential was kept and exploratory laparotomy was planned. A growth arising from the splenic flexure of colon and descending colon (about 15  15  10 cm) was found intraoperatively (Fig. 3). There were no peritoneal, omental and liver deposits and no free fluid was present. A wide excision of growth and a colo-colic resection anastomosis was performed. Postoperative course was uneventful 235

Case Report Discussion GISTs are the most common mesenchymal tumors of the digestive tract but they remain rare. They represent 0.1-3% of all GI cancers and have an incidence of 10-20 cases/million.1 They have been called by many names such as STUMP (smooth muscle tumors of uncertain malignant potential), GANT (gastrointestinal autonomic nerve tumors) and GIPACT (gastrointestinal pacemaker cell tumors) in the past.

GISTs are currently defined as CD117-positive (>10% tumor cell positivity) spindle cell or epithelioid neoplasms with minimal or incomplete myogenic or neural phenotype. Tumors of true smooth muscle, neural, fibroblastic or vascular origin are not considered in the category of GISTs.2

Figure 2. CT scan showing huge mass occupying left half of abdomen.

CD117-negative GISTs do exist, accounting for approximately 6% of the GI mesenchymal tumors.

Although generalizations about the malignant potential of CD117-negative GISTs cannot be made, a correlation to KIT mutations at codons 557/558 and mitotic counts, but not to tumor size, does exist.3 In 1998, Kindblom et al reported that GIST expresses KIT tyrosine-kinase receptor, supporting its origin from a stem cell that differentiates into interstitial cells of Cajal.4 Since then, GISTs have been defined as KIT-expression mesenchymal tumors of the GI tract regardless of whether there are co-expressed differentiation markers of myogenic phenotype (e.g., a-smooth muscle actin [SMA] or desmin) or neurogenic phenotype (e.g., S-100 and neuron-specific enolase).5

Figure 3. Peroperative picture showing the colonic mass.

and patient was discharged on postoperative Day 7.

Gross examination on histopathology revealed a mass measuring 12 Ă&#x2014; 10 Ă&#x2014; 4 cm. On cutting along the antimesenteric border, mucosal folds were edematous, externally nodular capsulated with attached fat. Cut surface was variegated showing grey white necrotic areas. Microscopic examination revealed morphology of gastrointestinal stromal tumor (GIST) of high malignant potential with 30 mitosis/10 HPF (highpower fields). Both resected ends were free from tumor.

The tumor stained negative for CD117.

236

The most common anatomical sites of origin are the stomach (40-60%), small intestine (30-40%) and less commonly colon, rectum and esophagus.6 When in a colonic location, about two-thirds of these GISTs occur in the left or transverse colon.7 The most common symptom at presentation is bleeding. The patients may also have various symptoms such as abdominal pain, early satiety, bloating, obstruction or they present with an abdominal tumor with no symptoms. About 10-25% of patients have metastasis at time of initial presentation. There are no pathognomonic radiological imaging findings for characterizing a GIST; however, it should be included in the differential diagnosis if one or more large, round or oval, well-delineated GI tumors occur in combination with central necrosis.8 Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

Case Report Carney’s syndrome is characterized by the syndromal association of a GIST with an extra adrenal paraganglioma and a pulmonary chondroma.

Microscopically, GISTs are well-circumscribed smooth lobulated, uncapsulated tumors having a homogenous ‘whorled silk’ appearance. They are composed of spindle cells or epithelioid cells, or a mixture of both, and may show areas of cystic degeneration, necrosis or focal hemorrhage.9

References 1. Miettinen M, Lasota J. Gastrointestinal stromal tumors: definition, clinical, histological, immunohistochemical, and molecular genetic features and differential diagnosis.

Virchows Arch 2001;438(1):1-12.

2. Miettinen M. New challenges in the identification of gastrointestinal stromal tumors and other possible KITdriven tumors. Am J Clin Pathol 2002;117(2):183-5.

3. Tzen CY, Mau BL. Analysis of CD117-negative gastrointestinal stromal tumors. World J Gastroenterol 2005;11(7):1052-5.

Evaluation of malignancy of GISTs is based on mitotic count, tumor size and extra-GI spread. Tumors with mitotic counts higher than 5/10 HPF or >10 cm have a significant risk for recurrence and metastasis and are considered histologically malignant; however, some tumors with mitotic activity <1/10 HPF may metastasize indicating some uncertainty in malignant potential of GISTs, especially those >5 cm.10 Transabdominal needle biopsy is not recommended for making a diagnosis in potentially resectable cases because of the risk of tumor seeding.11

4. Kindblom LG, Remotti HE, Aldenborg F, MeisKindblom JM. Gastrointestinal pacemaker cell tumor (GIPACT): gastrointestinal stromal tumors show phenotypic characteristics of the interstitial cells of Cajal.

Am J Pathol 1998;152(5):1259-69.

Surgical resection is the mainstay of treatment and the goal of surgery is to completely resect the tumor and to achieve negative margins. GISTs metastasize only rarely to local regional lymph nodes, and thus lymphadenectomy is warranted only for evident nodal involvement. Although radiotherapy and chemotherapy have not been found to be of much help as adjuvant treatment of these tumors, trials are underway to define the role of imatinib (STI 571), a selective and competitive inhibitor of tyrosine kinase, as adjuvant therapy following complete gross excision, as it has been found to be beneficial in the treatment of metastatic and locally advanced GISTs.12

7. Miettinen M, Sarlomo-Rikala M, Sobin LH, Lasota J. Gastrointestinal stromal tumors and leiomyosarcomas in the colon: a clinicopathologic, immunohistochemical, and molecular genetic study of 44 cases. Am J Surg Pathol 2000;24(10):1339-52.

Conclusion

11. Burkill GJ, Badran M, Al-Muderis O, Meirion Thomas J, Judson IR, Fisher C, et al. Malignant gastrointestinal stromal tumor: distribution, imaging features, and pattern of metastatic spread. Radiology 2003;226(2):527-32.

The diagnosis of GISTs is difficult, especially in the rarer sites, since there are no pathognomonic features to suggest GIST on preoperative clinical examination and investigations, and only a detailed histopathological analysis of the specimen reveals their true nature. We could find very little literature about CD117-negative colonic GISTs, which motivated us to report this case so as to throw more light regarding this unusual presentation.

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

5. Fletcher CD, Berman JJ, Corless C, Gorstein F, Lasota J, Longley BJ, et al. Diagnosis of gastrointestinal stromal tumors: A consensus approach. Hum Pathol 2002;33(5):459-65.

6. Tran T, Davila JA, El-Serag HB. The epidemiology of malignant gastrointestinal stromal tumors: an analysis of 1,458 cases from 1992 to 2000. Am J Gastroenterol 2005;100(1):162-8.

8. Sigmund G, Buitrago-Téllez CH, Torhorst J, Steinbrich W. Radiology of gastrointestinal stromal tumors (GIST) and a case of Carney syndrome. Rofo 2000;172(3):287-94.

9. Mukhopadyay S, Gupta SD. Gastrointestinal stromal tumours: bench-to-bedside review. GI Surgery Annual 2002;9:101-48.

10. Miettinen M, Sarlomo-Rikala M, Lasota J. Gastrointestinal stromal tumours. Ann Chir Gynaecol 1998;87(4):278-81.

12. van Oosterom AT, Judson I, Verweij J, Stroobants S, Donato di Paola E, Dimitrijevic S, et al; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Safety and efficacy of imatinib (STI571) in metastatic gastrointestinal stromal tumours: a phase I study. Lancet 2001;358(9291): 1421-3.

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CASE REPORT

Congenital Facial Palsy with Bilateral Anotia Geeta Gathwala*, Jagjit Singh**, Poonam Dalal**

ABSTRACT Congenital facial palsy (CFP) is generally considered developmental or acquired in origin. Most of the cases are related to birth trauma. We herein report a case of CFP with bilateral anotia and external auditory canal atresia.

Key words: Congenital facial palsy, anotia

C

ongenital facial palsy (CFP) is generally considered to be either developmental or acquired in origin. Developmental facial paralysis is associated with other anomalies including those of pinna and external auditory canal, ranging from mild defects to severe microtia and atresia.1 We herein report a rare case of congenital right facial paralysis associated with bilateral anotia and atresia of right external auditory canal.

Case Report A 6-month-old male infant was admitted to the pediatric ward with lower respiratory tract infection.

There was history of facial asymmetry and absent ears since birth. There was no history suggestive of intrauterine infection or drug intake during pregnancy.

The baby was full-term normal vaginal delivery.

Physical examination showed bilateral anotia, bilateral preauricular tag and right lower motor neuron type of facial palsy (Figs. 1, 2 and 3). There was no other cranial nerve palsy and the rest of the examination including neurological examination was normal.

Magnetic resonance imaging (MRI) brain was normal.

High-resolution CT temporal bone done to define the etiology of facial nerve palsy revealed absence of pinna; right auditory canal was not visualized and the middle

*Senior Professor and Head **Assistant Professor Dept. of Pediatrics Pt. BD Sharma PGIMS, Rohtak, Haryana Address for correspondence Dr Jagjit Singh Flat No. 15, Couple Hostel, Medical Enclave Pt. BD Sharma PGIMS, Rohtak -124 001, Haryana E-mail: drjagjitsingh@hotmail.com

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ear ossicles were reported normal. Brainstem evoked response audiometry (BERA) was normal.

Discussion Congenital facial nerve palsy is an infrequent condition with a reported incidence of 2.1 per 1,000 live births.2 In 78% of cases, CFP is related to birth trauma. No such history was available in the index case.

Other causes include, intrauterine posture, intrapartum compression and familial and congenital aplasia of the nucleus; the last being most frequently reported for bilateral cases. There are a number of syndromes that include CFP as part of their symptoms, including the cardiofacial, Moebius, Poland and Goldenhar syndrome.1,3 Some cases of CFP have been attributed to agenesis of the petrous portion of the temporal bone, with resulting agenesis of the facial and auditory nerves, the external ear and the mastoid region.4 Most commonly, developmental facial paralysis is associated with other anomalies. The most common site reported is the maxilla including defects such as cleft palate, hypoplastic maxilla and duplication of the palate. Others have demonstrated a propensity for anomalies of the pinna and external auditory canal, ranging from mild defects to severe microtia and atresia.1 A striking association of grossly abnormal pinna, multiple defects and facial palsy has been reported in 9-15% of patients. The index case had bilateral anotia and right auditory canal atresia with right facial palsy.

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

Case Report

Figure 1. Showing anotia of right side with skin tags.

No external auditory meatus seen.

Figure 3. Showing lower motor neuron type of facial palsy on the right side with bilateral anotia.

(thalidomide, isotretinon). Embryonic insult, severe enough to cause aural atresia would also affect other organ systems. Aberration in the canalization process of external auditory canal can lead to stenosis, canal tortuosity or fibrosis/osseous obliteration. Since middle ear structure develops independently, the tympanic cavity and ossicles may be normal.

Defects in the canalization process may also be associated with faulty formation of pinna.5 In the index case, right-sided CFP was associated with anotia and right-sided atresia. No other abnormalities were observed.

Figure 2. Showing anotia of left side and the external auditory meatus.

Aural atresia occurs in approximately 1 in 20,000 live births. Atresia and microtia are parts of several syndromes with inherited defects or acquired embryopathies owing to intrauterine infections (rubella, syphilis), ischemic injury (hemifacial microsomia) or toxin exposure Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

Several surgical techniques are employed for treatment of CFP. The ideal time for the intervention is controversial. Some clinicians advocate early (pre-school) surgery for the animation of childrenâ&#x20AC;&#x2122;s faces6,7 while others propose surgery not before adolescence.8 Muscle transplantation for facial paralysis has been shown to be effective.7 However, the possibilities of reconstructive surgery are limited. Traumatic facial palsy in neonates is associated with good prognosis. In contrast, facial palsies as in the index case carry a poor functional outcome.9,10 241

Case Report References 1. Bergstrom L, Baker BB. Syndromes associated with congenital facial paralysis. Otolaryngol Head Neck Surg 1981;89(2):336-42.

2. Falco NA, Eriksson E. Facial nerve palsy in the newborn: incidence and outcome. Plast Reconstr Surg 1990;85(1):1-4.

3. Jemec B, Grobbelaar AO, Harrison DH. The abnormal nucleus as a cause of congenital facial palsy. Arch Dis Child 2000;83(3):256-8.

Surgery. 16th edition, Snow JB Jr, Ballenger JJ (Eds.), BC Decker: Hamilton, Ontario 2003:pp. 997-1008.

6. Harrison DH. Treatment of infants with facial palsy.

Arch Dis Child 1994;71(3):277-80.

7. Zuker RM, Goldberg CS, Manktelow RT. Facial animation in children with MĂśbius syndrome after segmental gracilis muscle transplant. Plast Reconstr Surg 2000;106(1):1-8; discussion 9.

8. May M. Facial paralysis at birth: medicolegal and clinical implications. Am J Otol 1995;16(6):711-2.

4. Smith JD, Crumley RL, Harker LA. Facial paralysis in the newborn. Otolaryngol Head Neck Surg 1981;89(6):1021-4.

9. Laing JH, Harrison DH, Jones BM, Laing GJ. Is permanent congenital facial palsy caused by birth trauma? Arch Dis Child 1996;74(1):56-8.

5. Parisier SC, Fayad JN, Kimmelman CP. Microtia, canal atresia, and middle ear anomalies. Chapter 42.

In: Ballengerâ&#x20AC;&#x2122;s Otorhinolaryngology Head and Neck

10. Toelle SP, Boltshauser E. Long-term outcome in children with congenital unilateral facial nerve palsy.

Neuropediatrics 2001;32(3):130-5.

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Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

PHOTO QUIZ

A Bubble Under the Tongue of a Child

A

n eight-year-old girl presented with swelling in the floor of her mouth that began 10 days prior. She denied any recent fever or illness.

Physical examination revealed a nontender, bluish, fluctuant sublingual mass with no obvious extension into the neck (see accompanying figure). No cervical adenopathy was present.

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

A. Dermoid cyst.

B. Lipoma.

C. Ranula.

D. Soft tissue space abscess.

Discussion The answer is C: ranula.

Ranulas are mucus retention pseudocysts in the floor of the mouth. They can originate from trauma to or obstruction of the sublingual salivary gland. Less commonly, the submandibular gland or the minor salivary glands of the mouth may be involved. There are two main types of ranulas. Oral ranulas originate superior to the mylohyoid muscle. Cervical or plunging ranulas, which penetrate through the belly of the mylohyoid muscle, often produce an externally visible neck mass.

Complete excision of the pseudocyst with the affected salivary gland is associated with the least likelihood of recurrence.1 Marsupialization of the cyst with packing can also be performed, and some success has been reported with placement of a single suture into the dome of the cyst.2 Watchful waiting may be an appropriate medical treatment for oral ranulas.3

Source: Adapted from Am Fam Physician. 2011;84(4):441-442.

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Injections of onabotulinumtoxinA or sclerosing agents are considered experimental, and surgical management is usually preferred.4-6 Dermoid cysts are firm, slow-growing benign tumors that contain mature skin cells and are covered with a thick wall. They can contain multiple structures in the skin, including sebaceous glands, hair follicles, and other structures derived from the ectoderm. Dermoid cysts may occur in the skin, intracranially, intraspinally, paraspinally, or intra-abdominally.7 Most cysts found on the floor of the mouth occur in persons 10-30 years of age.7 Treatment is complete surgical excision.

Summary Table Condition

Characteristics

Dermoid cyst

)LUP VORZ JURZLQJ EHQLJQ WX mature skin cells; often possesses multiple epidermal appendages, such as hair follicles or sebaceous glands

Lipoma

Benign fatty tumor composed of mature fat cells, usually with a soft, rubbery consistency; VORZ JURZLQJ \HOORZ VXUIDFH

Ranula

Localized collection of mucus underneath the tongue, usually arising from trauma to the sublingual salivary gland

Soft tissue Localized collection of pus usually space abscess surrounded by inflamed tissue resulting from an infection; typically painful and may be associated with fever

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

Photo Quiz Lipomas are common benign fatty tumors composed of mature fat cells that can develop almost anywhere in the body. Lipomas represent about 1 to 5 percent of all neoplasms of the oral cavity.8 Superficial lipomas are slow-growing, soft, rubbery masses that may have a yellow surface discoloration. Treatment is surgical excision for symptomatic or rapidly enlarging lesions.

An abscess is a localized collection of pus that usually forms in response to infection. The surrounding tissue is typically erythematous, inflamed, and painful. Fever may be present. Standard treatment is incision and drainage of the abscess.

References 1. Zhao YF, Jia J, Jia Y. Complications associated with surgical management of ranulas. J Oral Maxillofac Surg.

2005;63(1):51-54.

2. Morton RP, Bartley JR. Simple sublingual ranulas: pathogenesis and management. J Otolaryngol.

1995;24(4):253-254.

3. Pandit RT, Park AH. Management of pediatric ranula.

Otolaryngol Head Neck Surg. 2002;127(1):115-118.

4. Fukase S, Ohta N, Inamura K, Aoyagi M. Treatment of ranula with intracystic injection of the streptococcal preparation OK-432. Ann Otol Rhinol Laryngol.

2003;112(3):214-220.

5. Roh JL, Kim HS. Primary treatment of pediatric plunging ranula with nonsurgical sclerotherapy using OK-432 (Picibanil). Int J Pediatr Otorhinolaryngol.

2008;72(9):1405-1410.

6. Chow TL, Chan SW, Lam SH. Ranula successfully treated by botulinum toxin type A: report of 3 cases.

Oral Surg Oral Med Oral Pathol Oral Radiol Endod.

2008;105(1):41-42.

7. Schwartz RA, Ruszczak Z. Dermoid cyst: overview.

Medscape Reference Web site. http://emedicine. medscape.com/article/1112963-overview.

Accessed September 21, 2010.

8. Fregnani ER, Pires FR, Falzoni R, Lopes MA, Vargas PA. Lipomas of the oral cavity: clinical findings, histological classification and proliferative activity of 46 cases. Int J Oral Maxillofac Surg. 2003;32(1):49-53.

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Erratum: In the Indian Journal of Clinical Practice March 2011, Vol 21, No 10, the article titled “Identification and ranking of problems perceived among urban school-going adolescents in Vadodara in India” by PV Kotecha, Sangita V Patel, VS Mazumdar, RK Baxi, S Misra, KG Mehta, M Diwanji, H Bakshi was erroneously printed as Clinical Study.

In the Indian Journal of Clinical Practice June 2011, Vol 22, No 1, the article titled “A Case-control study of pelvic inflammatory disease and its association with multiparity” was erroneously printed by SV Patel, RK Baxi, PV Kotecha, VS Mazumdar, HN Bakshi, KG Mehta was erroneously printed as Clinical Study.

In the Indian Journal of Clinical Practice June 2011, Vol 22, No 1, the article titled “BMIs and self-perception of weight and height among adolescent student in rural areas of Vadodara” by PV Kotecha, Sangita V Patel, VS Mazumdar, RK Baxi, Shobha Misra, Harsha Bakshi, Mansi Diwanji, Ekta Modi, Kedar Mehta was erroneously printed as Case Study.

These articles are Original Articles. The error is sincerely regretted.

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

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PRACTICE GUIDELINES

ACOG Guideline on Sexual Dysfunction in Women

S

exual dysfunction is common in U.S. women but is underdiagnosed and undertreated, partly because patients are not likely to discuss it with t h e i r physician unless they are asked. In addition to patientsâ&#x20AC;&#x2122; reluctance to initiate a conversation about sex, obstacles for physicians include a lack of adequate training and confidence, a perception that there are few treatment options, inadequate time to obtain a sexual history, and underestimation of the prevalence of sexual dysfunction.

Initial Approach to the Patient A caring and compassionate physician who is comfortable discussing sex, who knows the patient and has seen her before, and who seems concerned about her sexual health is one with whom patients will feel most comfortable discussing sex. A thorough sexual history should be obtained using a brief set of questions or a screening questionnaire. The patientâ&#x20AC;&#x2122;s medical, surgical, social, and psychiatric history also should be obtained, and information about the use of prescription and over-the-counter medications should be elicited. After the initial evaluation, treatment can be initiated or a referral can be made to a marriage counselor or sex therapist, depending on the training and comfort level of the physician.

Types of Sexual Dysfunction Sexual dysfunction in women includes several conditions that are characterized by loss of sexual desire, impaired arousal, inability to achieve orgasm, or pain during sex. A diagnosis should be made when symptoms cause distress or interpersonal problems.

Hypoactive Sexual Desire Disorder

Hypoactive sexual desire disorder (i.e., persistent or recurrent deficiency or absence of sexual desire or receptivity to sexual activity) is the most common sexual dysfunction in women, with an estimated prevalence between 5.4 and 13.6 percent. The disorder peaks in women 40 to 60 years of age and in those

Source: Adapted from Am Fam Physician. 2011;84(6):705-709.

246

who have undergone surgical menopause. In this age group, it may be situational, such as in depression or chronic disease (e.g., endocrine disorders with adrenal insufficiency), or it may be associated with medication use. However, it is more often an isolated event. In younger women, this disorder is often associated with situational circumstances, such as dysfunctional relationships, chronic disease, depression, gynecologic disorders, and use of certain medications (e.g., selective serotonin reuptake inhibitors [SSRIs], oral contraceptives, corticosteroids).

Treatment of hypoactive sexual desire disorder consists of psychotherapy and antidepressants for patients who have associated anxiety. Transdermal testosterone is also effective for short-term therapy; however, there is little evidence to support long-term use (longer than six months). Monitoring androgen levels before or during treatment has not been proven useful.

Female Sexual Arousal Disorder

Female sexual arousal disorder (i.e., inability to complete sexual activity with adequate lubrication) occurs in approximately 5 percent of U.S. women.

It often affects women with gynecologic or chronic medical conditions and those who are taking certain medications (especially SSRIs). The disorder typically resolves when the underlying condition is treated or the medication is adjusted.

Female Orgasmic Disorder

Female orgasmic disorder (i.e., persistent or recurrent delay in or absence of orgasm after a normal excitement phase) occurs in 3.4 to 5.8 percent of U.S. women. It can be either primary (i.e., patient has never achieved orgasm) or secondary (i.e., resulting from another sexual dysfunction, typically hypoactive sexual desire disorder). Primary orgasmic disorder may be genetic and is often associated with a history of trauma or abuse. It typically does not resolve without treatment.

Psychotherapy and couples counseling may be helpful for women with primary orgasmic disorder associated with abuse. There is no effective therapy Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

Practice Guidelines for unexplained primary orgasmic disorder in which the patient has never achieved orgasm, even through masturbation. Secondary orgasmic disorder typically resolves with treatment of the primary dysfunction.

Adjunctive education on masturbation techniques may be helpful.

Sexual Pain Disorders

Vaginismus (i.e., recurrent or persistent involuntary spasm of the muscles of the outer one-third of the vagina that interferes with sex) occurs in 1 to 6 percent of women. It is common in women with hypoactive sexual desire disorder and in those with sexual aversion; these disorders often have the same situational and psychosocial causes, and resolve with treatment of those causes. In other women, vaginismus is associated with gynecologic disorders, chronic medical conditions, and the use of certain medications, and resolves with treatment or adjustment of medications. The most effective treatment is a combination of cognitive and behavioral psychotherapy known as systematic desensitization. Patients are taught deep muscle relaxation techniques, which they use while dilators of increasing diameter are gradually inserted into the vagina. The goal is to desensitize the patient to her fear that vaginal penetration will be painful, and give her a sense of control so that vaginal muscle contractions are no longer an automatic response to penetration. If treatment is ineffective, the patient may benefit from referral for pelvic floor physical therapy.

Dyspareunia (i.e., recurrent or persistent genital pain associated with sex and not caused exclusively by lack of lubrication or by vaginismus) is a common problem in postmenopausal women, among whom the prevalence is approximately 8 to 22 percent. Pain on vaginal entry may reflect provoked vestibulodynia, inadequate lubrication, or vaginismus. Physical examination will reproduce the pain when the vulva or vagina is touched with a cotton swab or when a finger is inserted into the vagina. Pain may worsen over time because of arousal disorders and loss of desire.

Hysterectomy and Menopause The main indications for hysterectomy are uterine leiomyomas, menstrual disorders, uterine prolapse, and endometriosisâ&#x20AC;&#x201D;all of which can lead to decreased sexual function. In addition to concerns about the risks of surgery, many women worry about their sexual function after the procedure. Prospective studies evaluating the effect of hysterectomy on postoperative sexual function have not shown a difference between total and subtotal hysterectomy.

Estrogen affects sexual performance through maintenance of genital tissues and secretions, pelvic muscle tone, and elasticity. In postmenopausal women, decreased estrogen levels induce vulvovaginal atrophy, leading to pain and trauma during sex. Vaginal application of estrogen results in improved dyspareunia, less vaginal dryness, improved vaginal mucosal maturation indices, and reduced vaginal pH. Because oral forms of estrogen may not alleviate vulvovaginal atrophy, topical formulations may be preferable.

Tablets, gels, creams, and vaginal rings are equally effective. Systemic absorption of vaginal estrogen is limited, but still a concern. The lowest effective dose should be used for the least amount of time to alleviate symptoms. The optimal duration of treatment has not been determined, but daily treatment for a few weeks has been advocated, with gradual tapering based on symptoms.

Androgen levels decrease in women of reproductive age until menopause, after which no further decrease is observed. Many studies have shown that sexual desire and sexual activity increase with androgen supplementation; however, the results of other studies have been equivocal. Although transdermal testosterone is an effective short-term treatment for hypoactive sexual desire disorder in women, it has not been approved by the U.S. Food and Drug Administration for this use. The main risks associated with androgen therapy in women are hirsutism, acne, virilization, and cardiovascular complications. A possible association with breast cancer also has been reported. n

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

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EXPERT OPINION

What is the Treatment of Tuberculosis with HIV? JM Joshi

T

he overlapping epidemics of human immunodeficiency virus (HIV) and tuberculosis (TB) have resulted in large number cases of HIV-TB coinfection. However, TB is also an opportunistic infection (OI) that occurs when CD4 counts begin to fall and occurs earlier than other OIs at a mean CD4+ cell count of 350/mm3. In the early stage, the clinical picture of TB is similar to that of immunocompetent individuals. In the late stage, disseminated TB, extrapulmonary TB, smear-negative TB are said to occur frequently. Multidrug-resistant tuberculosis (MDR-TB) outbreaks have been reported in institutional settings, but there is little evidence that MDR-TB is associated with HIV in general population.

The diagnosis of TB, therefore, is same as in HIVnegative individuals i.e. by sputum microscopy in cases of pulmonary TB and by histology in cases of extrapulmonary TB. Tests like radiography, serology, tuberculin skin test (TST) may be used as diagnostic aids. Induration more than 5 mm is considered as positive test. Specific empiric anti-TB therapy (SEATT) with isoniazid (H), ethambutol (E) pyrazinamide (Z) without rifampicin (R) or streptomycin (S) can be used as a method for rapid presumptive diagnosis and treatment of febrile patients with clinical and radiological suspicion of tuberculosis where no bacteriological or histological proof is available. R and S are added once response (fever used as guide for response) to therapy has been documented. R and S not used initially to be sure that response is due to action of specific anti-TB drugs (HEZ) on Mycobacterium tuberculosis. Culture and drug susceptibility test (DST) must be performed in patients in whom MDR-TB is suspected.

Prevention of TB in HIV-positive individuals is by  BCG vaccination  Chemoprophylaxis using isoniazid 5 mg/kg Primary chemoprophylaxis: Mother to newborn.

Professor and Head Dept. of Respiratory Medicine TN Medical College and BYL Nair Ch. Hospital, Mumbai

248

Table 1. World Health Organization Treatment Categories CAT 1

2EHRZ, 4HR

CAT 2

2SHERZ, 1EHRZ, 5RHE

CAT 3

2HRZ, 4HR

CAT 4

Refer to specialist center

Drugs preferably used as fixed dose combination (FDC) and given as directly observed therapy (DOT).

Secondary chemoprophylaxis: If TST >5 mm induration. Secondary chemoprophylaxis is also called treatment of latent TB infection (LTBI) or isoniazid preventive therapy (IPT).

Treatment of HIV and TB coinfection is a therapeutic challenge. The chemotherapy of TB is as per World Health Organization (WHO) treatment regimens (Table 1) in appropriate doses (Table 2). Response to treatment of TB in HIV is good but relapse rates are three times higher. However, prolonging duration of therapy does not improve the treatment outcome and relapses which are due to drug susceptible organisms can be retreated with first-line drugs again (WHO, Category II). Possibility of acquiring drug resistance is higher due to poor compliance to therapy due to behavioral pattern, increased incidence of side effects and malabsorption of drugs due to associated diarrhea, all of which can contribute to the selection of drug resistant mutants.

Toxicity to anti-TB drugs is higher, particularly thiacetazone, which is not used due to increased risk of serious toxicity. Paradoxical response or ‘immune reconstitution’ results in paradoxical increase in lesions despite successful chemotherapy and may mislead the treating physician for e.g.:  Pulmonary TB: Pulmonary lesions may increase in size and new lesions or pleural effusions may occur.  TB lymphadenopathy: New nodes may appear, existing nodes may enlarge, cold abscess and sinus may form.  TB meningitis: May be complicated by hydrocephalus; tuberculomas and abscesses may form or increase in size.

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

expert opinion Table 2. TB Treatment (Drug Doses) Daily (mg/kg)

Thrice weekly (mg/kg)

INH (H)

5 (4-6)

10 (8-12)

RMP (R)

10 (8-12)

10 (8-12)

EMB (E)

15 (15-20)

30 (25-35)

PZA (Z)

25 (20-30)

35 (30-40)

SM (S)

15 (12-18)

15 (12-18)

Table 3. When to Start Antiretroviral Therapy along with Anti-TB Therapy Status CD4

<200/mm3

Therefore, whenever possible, in those patients with less serious immunodeficiency levels, consideration should be given to the possibility of postponing ART for patients with HIV/tuberculosis coinfection.

Patients with a CD4+ cell count >350/mm3 must not begin ART in the event of tubercular disease.

Nucleoside reverse transcriptase inhibitors (NRTIs) regimens are compatible with simultaneous use of rifampicin such as: 2 NRTI + Abacavir (ABC) 2 NRTI + Efavirenz (EFV)

When to start antiretroviral therapy

The NRTIs used are:

Start TB therapy Start ART as soon as TB therapy can be tolerated

Zidovudine (ZDV) + Lamivudine (3TC)

CD4 between 200 and 350/mm3

Start TB therapy

CD4 >350/mm3

Treat TB, start ART as indicated

Start ART after two month of TB therapy

All these are immunologically mediated complications of the disease. Reassurance and corticosteroids may be required along with anti-TB therapy.

Additional care is required when antiretroviral therapy (ART) is given along with anti-TB therapy (ATT).

Rifampin is the main drug used for treatment of TB with a therapeutic success rate of 95%. Use of rifampicin with most protease inhibitors (PIs) and/or nonnucleoside reverse transcriptase inhibitors (NNRTIs) cause interaction in the hepatic microsomal system and the intestinal wall and reduce serum levels of ART with risk of developing drug resistance. In addition, owing to the large quantity of tablets/capsules to be taken, correct adherence to both regimens is a significant challenge for any patient (Table 3).

or Stavudine (d4T) + Lamivudine (3TC) The various options of ART with ATT are:  To postpone ART until after completion of antiTB therapy  To use non-PI and/or NNRTIs containing antiretroviral combinations (NRTI-based regimens)  To use non-RMP regimens e.g. 2SHEZ + 10HE (last option).

Suggested Reading 1. Treatment of tuberculosis. Guidelines for National Programmes. 3rd edition, WHO 2003. Geneva, WHO/ CD5/TB 2003.313.

2. TB/HIV research priorities in resource-limited settings. Report of an expert consultation. WHO, Geneva, February 2005. WHO/HIV/2005.03,WHO/ HTM/2005.355.

3. Anglaret X, Saba J, Perronne C, Lacassin F, Lonquet P, Leport C, et al. Empiric antituberculosis treatment: benefits for early diagnosis and treatment of tuberculosis.

Tuber Lung Dis 1994;75(5):334-40.

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Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

CONFERENCE CALENDAR

Conference Calendar Allergy and Asthma in High Performance Sport November 1, 2011 Venue: Governors Hall, St Thomas’ Hospital, London, UK Website: http://www.allergyacademy.org/Courses/ aahps2011/Pages/Home.aspx Modern Technologies in Diagnosis and Treatment of Gastroenterological Patients November 3-4, 2011 Venue: Congress Hall, Dnepropetrovsk, Ukraine Website: http://www.nbscience.com/29.html Family Medicine Forum 2011 November 3-5, 2011 Venue: Palais Des Congres De Montereal, Montréal, Quebec, Canada Website: http://www.cfpc.ca/fmf/ Higher Education in Nursing: Problems and Prospects November 10-11, 2011 Venue: Congress Hall, Zhitomir, Ukraine Website: http://www.nbscience.com/30.html Eighth International Conference of the Society of Integrative Oncology November 10-12, 2011 Venue: InterContinental Hotel, Cleveland, Ohio, United States Website: http://www.integrativeonc.org 2nd Annual Essentials in Primary Care CME Conference November 10-13, 2011 Venue: Hilton Marco Island Resort, Marco Island, Florida, United States Website: https://www.cmemeeting.org/pages/page. asp?page_id=135262 Clinic Seminars in Dermatology November 11, 2011 Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

Venue: Renaissance Hotel, Cleveland Ohio, United States Website: http://www.ccfcme.org/Dermaseminars11 Allergy and the Skin Study Day November 15, 2011 Venue: St Thomas’ Hospital, London, United Kingdom Website: http://www.allergyacademy.org/Courses/ assd2011/Pages/Home.aspx Current issues of Endocrinology and Endocrine Surgery November 17-18, 2011 Venue: Congress Hall, Kiev Shevchenka blrd, Ukraine Website: http://www.nbscience.com/31.html Epidemiology, Immunopathogenesis, Diagnosis, Treatment Chlamydia and 725&+ LQIHFWLRQV November 23, 2011 Venue: Institute of Urology, Kotcubinskogo str, Kiev, Ukraine Website: http://www.nbscience.com/32.html Natural Products in Healthcare November 24-26, 2011 Venue: Gurunanak College of Pharmacy, Nagpur, Maharashtra, India Website: http://gurunanakcollegeofpharmacy.com/ brouchure_final.pdf

3HGLDWULFV )RFXV RQ $GROHVFHQ Medicine and Young Adults November 24-26, 2011 Hollywood, FL, United States Website: http://www.mceconferences.com/conferencedetail.php?conf_id=CR776-6-23 Orthopedics and Sports Medicine for Primary Care November 24-26, 2011 Orlando, FL, United States Website: http://www.mceconferences.com/conferencedetail.php?conf_id=DN707-30 251

EMEDINEWS SECTION

From eMedinewS

Giardia Linked to Irritable Bowel 0%&6 3(7 &7 ,PDJLQJ 3RLQWV WR %RQH Syndrome, Chronic Fatigue Met Prognosis Metabolic activity of bone metastases measured with PET-CT imaging predicted breast cancer patients’ prognosis, researchers found. Higher maximum standardized uptake value on the PET portion of the PET-CT study predicted greater mortality risk in patients with bone metastases (p < 0.001 for trend) in the single center study by Komal Jhaveri, MD, of Memorial Sloan-Kettering Cancer Center in New York City, and colleagues. (Source: Medpage Today) Kids’ Cognition may be Harmed by Fired up Cartoons A few minutes of watching ‘SpongeBob SquarePants’ appeared to have negative effects on executive function in 4-year-old, researchers reported. In a randomized controlled study, kids who watched the fast-paced cartoon about sea creatures for nine minutes did less well on tests of attention and cognition than those who spent the same amount of time drawing, according to Angeline Lillard, PhD, and Jennifer Peterson of the University of Virginia in Charlottesville. They also did less well than children who watched a more realistic, slower-paced educational cartoon about a pre-school boy, Lillard and Peterson reported online in Pediatrics.

(Source: Medpage Today)

Giardia lamblia infection is linked to increased risks for irritable bowel syndrome (IBS) and chronic fatigue, according to the results of a historic cohort study reported online September 12 in Gut. “G. lamblia is a common cause of gastroenteritis worldwide, but there is limited knowledge about the long-term complications,” write Dr Knut-Arne Wensaas, from the Dept. of Public Health and Primary Health Care at the University of Bergen in Bergen, Norway. “…IBS is a common short- and long-term complication after bacterial gastroenteritis.” (Source: Medscape Medical News) ‘Million Hearts’ Plan to Shape Physician Quality Reporting The Dept. of Health and Human Services (HHS) has unveiled an ambitious plan to reduce cardiovascular disease that will have a wide effect on physicians, ranging from quality bonuses to electronic health record (EHR) systems. The so-called Million Hearts Initiative aims to prevent 1 million heart attacks and strokes over the next five years through clinical interventions and changes in diet, exercise and tobacco use. (Source: Medscape Medical News) EASD: Novel Drug BRIGHTENs Diabetes Research

The investigational drug ipragliflozin improved :+2 5RDGPDS WR &RQWDLQ 5LVH RI 'UXJ glycemic control and decreased body weight and resistant TB in Europe blood pressure, according to the phase III BRIGHTEN An action plan to combat the alarming rise in the study. In the BRIGHTEN study, patients treated incidence of multidrug-resistant (MDR) and extensively with ipragliflozin achieved a mean decrease of 1.23% drug-resistant (XDR) tuberculosis (TB) in Europe was in glycosylated hemoglobin A1C (HbA1C) compared announced by the WHO Regional Office for Europe with placebo (p < 0.001), said Atsunori Kashiwagi, today. It is the first WHO region to develop an MD, director of medical affairs at Shiga University of MDR-TB and XDR-TB action plan. The Consolidated Medical Science, in his oral presentation at the annual Action Plan to Prevent and Combat Multidrug- and meeting of the European Association for the Study of Extensively Drug-resistant Tuberculosis 2011-2015 Diabetes. In addition, “fasting plasma glucose was was announced by Ogtay Gozalov, MD, key author of reduced by 45.8 mg/dl compared with placebo and body weight was decreased by 1.47 kg compared with the Action Plan and Medical Officer WHO/EURO, placebo - both significant findings at p < 0.001,” and Lucica Ditiu, MD, executive secretary, Stop TB Kashiwagi said. (Source: Medpage Today) Partnership. (Source: Medscape Medical News) 252

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

emedinews Section Millennium Development Goals on Health ‘Will not be Met’ Researchers say just nine of 137 developing countries will achieve ambitious targets to improve the health of women and children. The analysis in The Lancet updates previous estimates of progress on the fourth and fifth Millennium Development Goals (MDGs). The experts predict that no country in sub-Saharan Africa will meet the goals to dramatically reduce deaths by 2015.

But they say progress is speeding up in most countries.

The targets were set by world leaders in 2000. MDG4 aims to reduce the death rate for children-aged under five by two-thirds between 1990 and 2015. MDG5 states an ambition to cut deaths among pregnant women and new mothers by three-quarters during the same timescale. (Source: http://www.bbc.co.uk/news/ health-14974145) Expanding Flu Shots to Older Kids Cuts Flu ER Visits Vaccinating older children against seasonal influenza results in a 34% drop in the number of children aged 2-4 years who show up at emergency departments with flu-like symptoms, according to findings of a large study appearing in the current issue of the Canadian Medical Association Journal. (Medscape Medical News) Lab Update Hematology Tips When to Suspect Acute Leukemia

Acute leukemia, especially in children, can be missed if you are not careful. The most common symptom is fever which lasts beyond two weeks and which does not respond to normal treatment modalities.

Many children present with unexplained limping, joint swellings or just crying spells due to severe bone and soft tissue infiltrates. Suspect leukemia if ESR is beyond 100, even if WBC counts appear normal. Make sure a bone marrow study is done on all suspected cases since it is the only way to pick up acute leukemia with certainty. A trephine biopsy may also be needed if the aspirate reveals a ‘dry tap’. Childhood leukemia is curable most of the time (about 60% in India and about 85% in western countries).

—Dr Arpan Gandhi and Dr Navin Dang

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

Gastro Update What are the prevention strategies for cystic fibrosis liver disease?

The potential approaches to preventing cystic fibrosis (CF) liver disease include: 

Optimizing nutritional status



Avoiding hepatotoxic medicines



Immunization against hepatitis A and B to protect the individual from additional hepatic insults.

Although no therapy has been shown to alter the course of progression to cirrhosis in CF, there is evidence that treatment with ursodeoxycholic acid (UDCA) improves serum liver biochemistries, hepatobiliary symptoms, and histology in these patients; it is generally well-tolerated. Potential mechanisms for these observed benefits include improvement in bile flow, displacement of toxic bile acids, cytoprotection, or stimulation of biliary bicarbonate secretion.

Despite the lack of conclusive evidence that UDCA alters the course and outcome of CF liver disease, the CF Foundation Hepatobiliary Disease Consensus Group concluded that it is prudent for all CF patients with cholestasis-fibrosis-cirrhosis to receive UDCA therapy.

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

Legal Question of the Day Is it wrong on the part of an MBBS doctor to present his name as follows? ‘Dr ABC, MBBS Physician and Surgeon’?

There is no question of its being wrong. It is a statement of facts. The degree of MBBS is not a single but a double degree, the two degrees being as follows: Bachelor of Medicine; Bachelor of Surgery A person having the two degrees and registered with the Medical Council on the basis of these degrees commits no wrong in holding out as a physician and surgeon.

—Dr MC Gupta, Advocate

253

emedinews Section

Medicolegal Update Testamentary Capacity



The medical competency to make a valid will is called testamentary capacity.  Lawyers generally call the doctor for evaluation at the time of making the will to avoid later disputes about testamentary capacity on medical ground. The Court may invalidate a will if it is found that the person at the time of making his will was not of a sound mind and did not have the mental capacity to understand the act and its consequences.  The doctor certifying the medical competence must keep in mind two necessary parts of medical evaluation means the testator must understand what he or she is doing in making a will, and its consequences, the nature and extent of his or her property; and his or her relation to living descendants, spouse and parents, and others whose interests are affected by the will.  The second part that is much more important for the doctor is that the person must not suffer from any mental disorder/illness that involves delusions, illusion or hallucinations.  To make unfit on the medical ground of insane delusions, the delusions must be extreme. The delusions must also affect the bequest. If the individual has another independent and sane reason for the bequest, then the delusions do not vitiate his or her testamentary capacity.







Any history or presence of loss of memory/head injury or Alzheimer’s disease must be ruled out by the doctor in writing in the certificate.

The doctrine of undue influence must be kept in mind by the doctor since the courts distinguish ‘reasonable persuasion’ from ‘undue influence.’ It is often the case that lessened capacity as in the case of someone who is mentally frail is taken to render undue influence more likely. To the extent that elders are more susceptible to overreaching, this doctrine may come into effect. A reference from geriatric physician is required in such cases.

If the examining doctor has reason to believe that the person is under influence of some person, who is prevention him from exercising his own discretion in making his will, it is better for the doctor to defer the certification for another examination and make another medical examination in his/her own safe clinic with assured privacy for the person and encourage him to speak out freely since a will is invalid, if it is executed under undue influence.

The given medical certificate must mention the following:… that the certificate is issued for the purpose of making a will and to the best of my examination, medical knowledge and believe the examined person is fit/unfit to make a valid will. I am a registered medical doctor and my detail is as under with address of contact.

—Dr Sudhir Gupta, Additional Professor Forensic Medicine and Toxicology, AIIMS

Fitness Update Naturally-rich in Omega-3, Chia Seeds offer Important Health Benefits

Consumption of chia seeds as a source of alpha-linolenic acid (ALA) may provide protection for the heart and liver, according to new research. The study, published in The Journal of Nutritional Biochemistry, reports that laboratory subjects fed chia seed supplements were protected from heart and liver problems associated with a high-fat diet, including improved insulin sensitivity and glucose tolerance, reduced visceral adiposity, decreased liver fat and lower cardiac and hepatic inflammation

254

and fibrosis. The research, from the University of Queensland, Australia, demonstrated that the chia seeds brought about lipid redistribution in the subjects, with lipids lured away from the visceral fat and the liver.

“To the best of our knowledge, this is the first report of lipid redistribution with a rich dietary source of any omega-3 fatty acid associated with cardioprotection and hepatoprotection,” said the University of Queensland researchers.

—Rajat Bhatnagar, International Sports and Fitness Distribution, LLC, http://www.isfdistribution.com

Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

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Indian Journal of Clinical Practice strongly disapproves of the submission of the same articles simultaneously to different journals for consideration as well as duplicate publication and will decline to accept fresh manuscripts submitted by authors who have done so.

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Introduction – The introduction should state why the study was carried out and what were its specific aims/objectives.

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Note: Please keep a copy of your manuscript as we are not responsible for its loss in the mail. Manuscripts will not be returned to authors.

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Indian Journal of Clinical Practice, Vol. 22, No. 5, October 2011

Confidence intervals for the measurements should be provided wherever appropriate.

Results These should be concise and include only the tables and figures necessary to enhance the understanding of the text.

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Discussion –

This should consist of a review of the literature and relate the major findings of the article to other publications on the subject. The particular relevance of the results to healthcare in India should be stressed, e.g., practicality and cost.

References These should conform to the Vancouver style. References should be numbered in the order in which they appear in the texts and these numbers should be inserted above the lines on each occasion the author is cited (Sinha12 confirmed other reports13,14...). References cited only in tables or in legends to figures should be numbered in the text of the particular table or illustration. Include among the references papers accepted but not yet published; designate the journal and add ‘in press’ (in parentheses). Information from manuscripts submitted but not yet accepted should be cited in the text as ‘unpublished observations’ (in parentheses).

At the end of the article the full list of references should include the names of all authors if there are fewer than seven or if there are more, the first six followed by et al., the full title of the journal article or book chapters; the title of journals abbreviated according to the style of the Index Medicus and the first and final page numbers of the article or chapter. The authors should check that the references are accurate. If they are not this may result in the rejection of an otherwise adequate contribution.

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Please complete the following checklist and attach to the manuscript: 1. Classification (e.g. original article, review, selected

Paintal AS. Impulses in vagal afferent fibres from specific pulmonary deflation receptors. The response of those receptors to phenylguanide, potato S-hydroxytryptamine and their role in respiratory and cardiovascular reflexes.

Q. J. Expt. Physiol. 1955;40:89-111.

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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.

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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.

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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.

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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.

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.

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