Set up: One Tuberculosis Unit (TU) in Tiruvallur district, Tamil Nadu, India where Tuberculosis (TB) patients treated

under Directly Observed Treatment Short Course (DOTS) programme.

Objective: To identify the effects of weight gain among TB patients at the end of treatment on different factors such

as socio-economic and demographic characteristics, smoking and drinking habits, treatment under supervision, the type

of DOTS centres and problems in taking drugs.

Methods: TB patients registered between May 1999 and December 2004 formed the study population. Multiple

regression method was used for the analysis.

Results: Among 1557 smear-positive TB patients registered under DOTS programme, the changes in weight ranged

from a loss of 4 kgs to a gain of 20 kgs at the end of TB treatment; the average change in weight was 3.22 kgs. The gain

in weight at the end of treatment was associated with age (<45 years), DOT at government centres, no problems in taking

drugs as reported by patients and cure rate.

Conclusion: The findings showed that there is an association between gain in weight with DOT at government centres

and cure of patients

Gopi, P G

Subramani, R

Vasantha, M

NIRT Institutional Repository

Indian Journal of TuberculosisSummarySet up:  One Tuberculosis Unit (TU) in Tiruvallur district, Tamil Nadu, India where Tuberculosis (TB) patients treatedunder Directly Observed Treatment Short Course (DOTS) programme.Objective:  To identify the effects of weight gain among TB patients at the end of treatment on different factors suchas socio-economic and demographic characteristics, smoking and drinking habits, treatment under supervision, the typeof DOTS centres and problems in taking drugs.Methods:  TB patients registered between May 1999 and December 2004 formed the study population. Multipleregression method was used for the analysis.Results:   Among 1557 smear-positive TB patients registered under DOTS programme, the changes in weight rangedfrom a loss of 4 kgs to a gain of 20 kgs at the end of TB treatment; the average change in weight was 3.22 kgs.  The gainin weight at the end of treatment was associated with age (<45 years), DOT at government centres, no problems in takingdrugs as reported by patients and cure rate.Conclusion:    The findings showed that there is an association between gain in weight with DOT at government centresand cure of patients.Key words: Tuberculosis, Weight gain after treatment, Multiple regression.Original ArticleWEIGHT GAIN IN PATIENTS WITH TUBERCULOSIS TREATED UNDERDIRECTLY OBSERVED TREATMENT SHORT-COURSE (DOTS)M. Vasantha, P.G. Gopi  and R. Subramani(Received on 3.1.2008; Accepted after revision on 14.8.2008)[Indian J Tubrc 2009; 56: 5-9 ]INTRODUCTIONPatients with Tuberculosis (TB) often sufferfrom severe weight loss, a symptom that isconsidered immuno-suppressive and a majordeterminant of severity and disease outcome1.Malnutrition is an important risk factor for TB,because cell-mediated immunity (CMI) is the keyhost defense against TB.  The association betweenbody weight, TB mortality and morbidity has beenstudied extensively since 19862-4.  Directly ObservedTreatment Short-course (DOTS) is theinternationally recommended strategy for TBcontrol, adopted as the Revised National TB ControlProgramme (RNTCP) in India since 1997.  Thecountry was covered under the programme byMarch 2006 and has almost achieved the global targetof 85% cure and 70% case detection.  There areabout 8.9 million patients with TB in India, of whomhalf are infectious (sputum smear-positivepulmonary TB)5. Currently, nation wide coverageresults in a success rate of 86% and a death rate of4%6.The weight of the patient taken at differenttime points during treatment is an importantcomponent to assess the progress of   patients. Therelationship between change in weight amongpatients during anti-TB treatment and other factorssuch as socio-economic demographiccharacteristics, smoking and drinking habits,whether the patient took treatment undersupervision, the type of DOT centres and problemsin taking drugs has not been well documented.  Theobjective of the study was to identify  the  associationof weight gain during treatment to these factors andrelative importance of these in RNTCP.METHODSThe study was conducted at a rural TB unit(TU) in Tiruvallur district, South India.  The studyTuberculosis Research Centre, Chennai.Correspondence: The Director, Tuberculosis Research Centre (ICMR). Mayor V.R. Ramanathan Road, Chetput, Chennai-600 031.Ph: 91 044 28369600, 28369671; Fax: 91 044 28362528; E-mail: icmrtrc@vsnl.comIndian Journal of Tuberculosisarea included 209 villages and nine urban clustersconsisting of a population of 5,80, 000 scatteredacross approximately 200 km2.  The DOTSstrategy has been implemented in this area sinceMay 19997. Seventeen governmental healthfacilities (HFs) participate in the programme and,of these, seven offer diagnostic facilities forsputum examination.  All the patients diagnosedwith TB at one of these HFs are given DOT inaccordance with RNTCP policies7.   This studywas approved by the Scientific AdvisoryCommittee and the Institutional Ethics Committeeas per the Indian Council of Medical Research(ICMR) guidelines.Between May 1999 and December 2004,5366 TB patients were registered for treatmentunder DOTS in this area. Data on socio- economicand demographic characteristics was collectedwithin a week of starting the treatment. Trainedfield staff interviewed the patients at theirresidence and collected information on smokingand drinking habits (only from men), whether thepatient took treatment under supervision, the typeof DOTS centres and any problems in takingdrugs using a pre-tested semi-structuredquestionnaire.  Data regarding treatment outcomewas collected at the end of the treatment fromthe TB register maintained at the TU. Standardinternational definitions were followed to classifyTB patients according to outcome8. Weightrecorded at the initial stage of treatment and atthe end of anti-TB treatment was collected fromthe treatment cards of the patients.Data were scrutinized and entered twicein order to ensure accuracy, corrected fordiscrepancy and missing information.  Theanalysis was confined to smear-positive cases andhence extra-pulmonary cases and Category IIIpatients were removed from final analysis.Multiple regression (SPSS version 13.0) wasperformed to identify the association of weightgain on different factors.  The adjusted hazardratio and 95% confidence intervals (CI) wereestimated for the factors.  The level of statisticalsignificance was defined as p<0.05.RESULTSAmong the 5366 TB patients, 1557 smear-positive patients whose weight was available at theinitiation of treatment, and at the end of treatmentwere considered for the analysis.  Of the 1557 TBpatients registered under DOTS programme, 1175(75%) were males, 690 (44%) were aged 45 yearsor more, 623 (40%) were illiterate and 478 (31%)were unemployed.  Major life style indicators forthe patients included the following:  638 (41%)smokers and 474 (30%) alcoholics.  Of the 1557patients, 1285 (83%) were treated under CategoryI, and 272 (17%) were treated under Category II(Table 1).  For these patients, the treatment outcomeswere as follows: 1394 (89.5%) were cured, four(0.3%) completed treatment, 52 (3.3%) defaulted,nine (0.6%) expired, 97 (6.2%) failed treatment andone (0.1%) was transferred out.The mean weight of patients at the initialstage of treatment was 42 kgs.  At the end oftreatment, the change in weight for 1557 patientsby category- wise is set out in Table 2.  Overall, thechange in weight ranged from a loss of 4 kgs to again of 20 kgs with an average change in weight of3.22 kgs.  Weight remained constant from initialstage to the end of treatment for 98 (6.3%) patients.Sixty-eight (4.4%) patients lost weight (mean = -1.79, Standard Deviation (SD) = 1.43, range (-9,-1) where as 1391(89.3%) attained weight (mean =3.67, SD = 2.45, range (1, 20).  Among the 1391patients, 228 (16.4%) patients gained weight lessthan 2 kgs, 762 (54.8%) gained 2-4 kgs, 401 (28.8%)gained more than 4 kgs.Among the Category I patients, the changein weight ranged from -4 to 20 kgs with an averageof 3.34 kgs whereas among Category II, it rangedfrom -3 to 13 kgs with an average of 2.56 kgs.Weight remained constant from initial stage to endof treatment for 72 (5.6%) Category I patientscompared to 26 (9.6%) Category II patients. Thecorresponding figures for patients who lost weightwere 42 (3.3%) and 26 (9.6%); and for those gainedweight were 1171(91.1%) and 220 (80.8%)respectively. The difference in weight gain betweenM.  VASANTHA  ET  AL6Indian Journal of TuberculosisCategory 1 and Category II patients was statisticallysignificant (p<0.001).The gain in weight at the end of treatmentwas associated with age (<45 years) (p<0.05),Government DOTS centres (p<0.05), noproblems in taking drugs (p<0.01) and cure rate(p<0.05). (Table 3).DISCUSSIONThis study showed that weight gain duringthe treatment was associated with age (<45 years),DOT at government centres, no problems in takingdrug as reported by patients and cure of patients.TB control programme prevents infection and stopsprogression from infection to active disease, treatsall active cases and completely cures all of them.The DOTS strategy has been found to be veryeffective all over the world and our country hasalmost achieved the global target.  In the study area,the success rate of patients treated under DOTSduring the study period was about 80%.  Patientsput on treatment gaining body weight showimprovement towards the end of treatment.  Ourstudy has supported that the cure is significantlyassociated with patient’s gain in body weight.Another factor associated with gain in weight wasage of the patients; younger patients are more likelyto gain body weight during treatment compared toolder patients.  Patients who took treatment atGovernment centres and those who reported thatthey had no problems in taking drugs were morelikely to have gained body weight.There are many studies that have shownthe effect of body weight on the treatment outcome.An earlier report from our centre7 showed that 39(6%) of 676 TB patients died during the treatmentperiod, and that higher death rates wereindependently associated with base line body weight<35 kgs and a history of previous treatment for TB.The study recommended that nutritional interventionsshould be considered among underweight patientsto reduce mortality.  Another study from our centrefound that the higher death rates were independentlyassociated with patient’s age (≥45 years), previoushistory of treatment, alcoholism and initial bodyTable 1: Characteristics of TB patients registeredunder DOTS in a rural district, south India Factors n = 1557 Total (%)   Sex  Female 382 (25) Male 1175 (75) Age (Years)  <45 867 (56) ≥45 690 (44) Education  Illiterate 623 (40) Literate 828 (53) Non-availability 106 (7) Occupation  Unemployed 478 (31) Employed 974 (62) Non-availability 105 (7) Smoking  No 813 (52) Yes 638 (41) Non-availability 106 (7) Alcoholism  No 978 (63) Yes 474 (30) Non-availability 105 (7) DOT centre  Government  931 (60) Non-Government 529 (34) Non-availability  97 (6) Supervision under IP  No                      319 (20) Yes                    1130 (73) Non-availability                        108 (7) Problem in taking drugs  No 476 (30) Yes 588 (38) Non-availability 493 (32) Category  I 1285 (83) II 272 (17)  WEIGHT  GAIN  IN  TUBBDRCULOSIS  PATIENTS 7Indian Journal of Tuberculosisweight (<35 kgs)9.  In another study, the treatmentsuccess rate was increased as the body weightincreased, and the increase in trend was statisticallysignificant (Trend Chi square 22.0; p<0.001)(unpublished).   All these findings showed thatpatient’s body weight is associated with treatmentoutcome. Our study has substantiated this findingof the association between weight gains of patientswith cure of the patients. The proportion of CategoryI patients who gained weight was significantly highercompared to Category II patients. This findingemphasizes that patients under treatment have toTable 2: Category-wise distribution of change in weight at end of treatment periodDifference in weight (kgs) Category No. of patients No change No. (%) Loss No. (%) Gain No. (%) Average (Range) (kgs) I 1285 72 (5.6) 42 (3.3) 1171 (91.1) 3.34 (-4, 20) II 272 26 (9.6) 26 (9.6) 220 (80.8) 2.56 (-3, 13) Total 1557 98 (6.3) 68 (4.4) 1391 (89.3) 3.22 (-4, 20)     Table 3: Results of the multiple regression analysis of factors for gain in weight among 904 TBpatients at the end of treatmentM.  VASANTHA  ET  ALNon-standardised Co-efficient Factors  B S.E  Standardized Regression Co-efficient 95% C.I for B P Male  -0.035 0.232 -0.006 (-0.490, 0.420) 0.879 Age (<45 years) 0.349 0.173 0.071 (0.010, 0.689) <0.05 Cure of the patient  0.350 0.135 0.086 (0.084, 0.615) <0.05 Employed 0.059 0.181 0.012 (-0.296, 0.413) 0.745 Non-smokers -0.075 0.219 -0.015 (-0.505,0.355) 0.731 Non-alcoholics -0.134 0.210 -0.026 (-0.547,0.279) 0.525 DOT at Government. Centres 0.346 0.164 0.071 (0.025, 0.668) <0.05 Treatment under supervision 0.294 0.214 0.046 (-0.125,0.714) 0.169 No problems in taking drugs 0.434 0.163 0.089 (0.115, 0.753) <0.01 B – Regression co-efficient, S.E- Standard error, C.I – Confidence Interval The number of patients is less than 1557 due to non-availability of patients at the time of interview, within a week after treatment started.    8.Indian Journal of Tuberculosiscomplete the full course of DOT withoutinterruption.  Khan et al reported that among personswho were underweight at diagnosis, weight gain of5% or less among underweight tuberculosis patientsafter two months of treatment was associated withan increased risk of relapse10.A study from Japan reported that the ageingof the Japanese population partially accounts for theincrease in the number of patients with TB.  Thedisease is often transmitted from these aged patientsto those who were uninfected.  After admission, inpatients showing negative conversion of bacilli, therewas a positive correlation between the increase inPNI (Prognostic Nutritional Index) and the gain ofbody weight (p<0.01, r=0.30) 11.  Weight loss isassociated with impaired physical function as wellas increased mortality in patients with TB. Our studyhighlights the need to improve the body weight duringtreatment for a successful treatment outcome. Ahigher likelihood of weight gain was associated withpatients taking treatment in DOT at governmentcentres. Another important finding of this study wasthe need to have DOTS patient friendly.In conclusion, weight gain at the end oftreatment was associated with age (<45 years),DOT at government centres, no problems intaking drug as reported by patients and cure ofpatients. TB patients should be educated onoptimizing nutritional intake as part of theroutine management of TB control programme.ACKNOWLEDGEMENTSThe authors thank the staff of ElectronicData Processing Department of Epidemiology Unitfor computerization of data pertaining to this study.The authors appreciate the field staff and socialworkers for meticulous data collection under theguidance of Dr. C. Kolappan and Dr. K. Sadacharam.The authors are grateful to Mr. S. Radhakrishnanfor maintaining the TB register and other documents.The study was supported in part by the World HealthOrganization (WHO) with financial assistanceprovided by United States Agency for InternationalDevelopment (USAID) under the Model DOTSproject.REFERENCES1. Van Crevel R, Karyadi E, Netea M G, Verhoef H,Nelwan RH, West CE, Va der  Meer J W.  Decreasedplasma leptin concentrations in Tuberculosispatients are associated with wasting andinflammation.  J Clin Endocrinol Metab  2002;87(2):758-63.2. A Tverdal. Body mass index and incidence ofTuberculosis. Eur J respire Dis 1986; 69: 355-62.3. England A, Bjorge T, Sogaard AJ, Tverdal A. Bodymass index in adolescence in relation to totalmortality: 32-year follow-up of 227,000 Norwegianboys and girls. Am J Epidemiol 2003; 157(6): 517-23.4. Sacks LV, S Pendle. Factors related to in-hospitaldeaths in patients with Tuberculosis.  Arch InternMed 1998; 158(17): 1916-22.5. TB India 2005. RNTCP status report. New Delhi:Central TB Division, Directorate General of HealthServices, Ministry of Health and Family Welfare,Government of India; 2005.6. Central TB Division. Directorate of General HealthServices Ministry of Health and Family Welfare,Nirman Bhavan, New Delhi 110 011. http://www.tbcindia.org (Accessed on May April 2006).7. Santha T, Garg R, Frieden T.R, Chandrasekaran V,Subramani R, Gopi P.G, Selvakumar N, GanapathyS, Charles N, Rajamma J, Narayanan PR. Risk factorsassociated with default, failure and death amongtuberculosis patients treated in a DOTS programmein Tiruvallur District, South India, 2000. Int JTuberc Lung Dis 2002; 6(9): 780-88.8. Khatri G.R, Frieden T.R.  The status and prospectusof Tuberculosis control in India, Int J Tuberc LungDis 2000; 4: 193-200.9. Vasantha M, Gopi P G, Subramani R.  Survival ofTuberculosis patients treated under DOTS in a ruralTU, South India.  Indian J Tuberc 2008; 55: 64-69.10. Awal khan, Timothy R. Sterling, Randall Reves,Andrew vernon, Robert  Horsburgh C, and theTuberculosis Trails Consortium.  Lack of weightgain and  relapse risk in a large Tuberculosistreatment trial.  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Weight gain in patients with tuberculosis treated under directly observed treatment short-course (DOTS)

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