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Indian Journal of Community Medicine

A Comparative Study of DOTS and Non-Dots Interventions in Tuburculosis Cure

Author(s): Murali Madhav S., Udaya Kiran N

Vol. 29, No. 1 (2004-01 - 2004-03)

Deptt. of Community Medicine, Kasturba Medical College, Mangalore

Abstract:

Research question: What is the difference between the impact of DOTS (directly observed treatment short-course) and non-DOTS (self-administered, short course chemotherapy) interventions on the cure rates of patients with pulmonary tuberculosis?
Objectives: To compare the therapeutic efficacy of DOTS and non-DOTS interventions in tuberculosis cure.
Study design: Randomised trial.
Setting: District T.B. Centre, Mangalore.
Participants: 306 newly diagnosed sputum-positive out patients of pulmonary TB (180 male and 126 female).
Statistical analysis: Chi-square test.
Results: 91% of the DOTS group and 53% of the non-DOTS group were observed to be cured of tuberculosis, using the sputum smear as the test to monitor cure (statistically significant difference was observed). These results clearly demonstrate that DOTS is a significantly superior health intervention in tuberculosis patients compared to self-administered regimen.

Key Words: Tuberculosis cure rate, DOTS group, non-DOTS group, Sputum smear, RNTCP

Introduction:

Tuberculosis (TB) is one of India's most serious health problems. India accounts for 28% of the global T.B. burden. Every day in India more than 20,000 people become infected with the tubercle bacillus; more than 5000 develop the disease and more than 1,000 die from TB1. The emergence of multi-drug resistant TB (MDR TB) and the spread of HIV/AIDS are contributing to the worsening impact of the disease - the principal reasons for the WHO declaring TB a global emergency in 19932.

Directly-observed treatment short-course (DOTS) is based on scientifically sound technology and direct observation of drug intake of the patient by treatment observers, thus obviating the drug default problem, which is a major cause for MDR TB. Since DOTS was introduced on a global scale, cure rates among new cases in China and Peru were 96% and 91% respectively3. It was introduced on a pilot-basis in India in 1993, and large scale expansion began in 1998. By early 2001, more than one third of the country was covered by the programme1.

Material and Methods:

The study was conducted on 306 out patients of pulmonary tuberculosis, from among 1,100 registered outpatients in the age-group of 31 -60 years (180 male and 126 female), in the District T.B. Centre, Mangalore between January to July 2003. All patients with cough of 3 weeks or more duration were tested by three sputum smears examinations. Sputum smears were taken on three occasions - (i) On spot (when patient presented to centre) (ii) Morning and (iii) on spot (when patients were observed in centre on next day) over a period of two days. Atleast two of the three sputum smears were required to be positive for M. tuberculosis for patient to be identified as sputum positive case4. Only newly diagnosed sputum positive cases of pulmonary tuberculosis were included in the study. Sputum smear examinations for monitoring the disease control were done at the end of intensive phase of treatment, during continuation phase and at the end of treatment duration (at 2, 4 and 6 months on three occasions). Seriously ill patients and patients with extra-pulmonary tuberculosis were excluded for purpose of the study.

Informed documentary consent was obtained from all patients prior to study. Patients were randomly allocated to the two study groups, 153 in the DOTS-group and 153 in the non-DOTS group. The treatment regimen administered to the patients was 2(HRZE)3/4(HR)35 The treatment administered to the patients in the DOTS group was directly-observed by the health workers and nurses (treatment observers). The patients in the non-DOTS group were supplied with the same drug in the same doses on a fortnightly basis. There was no difference in the methodology of sputum smear examinations preformed for monitoring the disease control between DOTS and non-DOTS groups, in the study.

Results:

Table I: Age and sex distribution of DOTS and non-DOTS groups in the study.

Age in Years DOTS Group Non-DOTS Group
  M F Total M F Total
31-40 15 10 25 11 14 25
41-50 31 19 50 29 13 42
51-60 44 34 78 50 36 86
Total 90 63 153 63 63 153

Table I shows the age and sex distribution of DOTS and non-DOTS groups included in the study.

Table II: Treatment outcome for DOTS group and non- DOTS group.

  DOTS Group Non-DOTS Group
Treatment Initiated (n) 153 153
Number Cured 139 81
Cure Rate 90.8% 52.9%
p<.001; highly significant.

As shown in Table II, 91% of the DOTS group and 53% of the non-DOTS group were observed to be smear-negative after 6 months of chemotherapy. The difference in the outcome was observed to be statistically highly significant. The present findings confirm that DOTS is a significantly superior health intervention compared to self-administered regimen in the prognosis of tuberculosis patients.

MDR-TB was recorded in 14 patients in the DOTS group and 35 patients in the non-DOTS group in the study.

Discussion:

In the RNTCP (Revised National TB control Programme) status report, 2001 of Govt. of India, it was observed that 84% of tuberculosis patients were cured by DOTS compared to less than 40% cured in the non-DOTS group1. Compared to this study in which observation of 44% difference in outcome between the two groups was reported, a comparable but smaller percentage of difference in outcome of 38% was observed in present study. It may be accounted for by the fact that the tuberculosis centre at Mangalore draws patients largely from high-literacy geographical zone of Dakshina Kannada and Kerala. Therefore, the non-DOTS group observed higher treatment compliance in present study compared to former study, thus resulting in higher cure rates in present study in both groups.

It maybe mentioned here that the advantages of DOTS are as follows:

  1. it provides high cure rates upto 95%3
  2. it prevents the emergence of MDRTB2
  3. the World Bank has certified DOTS as "one of the most cost-effective of all health interventions"3
  4. it improves the longevity of AIDS patients by controlling TB among them.

These findings of the present study are consistent with the observations made at the National Consensus Conference regarding involvement of Medical Colleges in RNTCP held at New Delhi in 1997. Phased and effective implementation of the RNTCP is the best strategy and perhaps the only chance of controlling TB in India during this generation. Ensuring diagnosis and cure of TB cases by RNTCP policies is the only effective way to stop the spread of multi-drug resistant TB in India5. Results of treatment of TB by the DOTS strategy have been most encouraging6. The present study is a small step in the validation of these observations regarding DOTS intervention.

Acknowledgement:

The first author greatefully acknowledges the help and support provided by Dr. B.S. Sajjan, Professor and Head of Community Medicine, Kasturba Medical College, Mangalore in executing this study.

References:

  1. Govt. of India. Ministry of Health and Family Welfare, Central TB Division: TB India 2001: RNTCP Status Report, New Delhi; Govt. of India, 2001; 6-21.
  2. Govt. of India. Ministry of Health and Family Welfare, Central TB Division: TB India 2001: RNTCP; New Delhi; Govt. of India, 1997; 1-5.
  3. WHO. Tuberculosis Fact Sheet. No. 104. Geneva: WHO 2000; 1-3.
  4. Enarson DA, Rieder HL, Arnadotter T, Trebucq A. Management of TB - A Guide for Low-income countries, Paris: International union against tuberculosis and lung diseases, 2000; 63.
  5. Govt. of India, Ministry of Health and Family Welfare. Proceedings of the National Consensus Conference on TB control, New Delhi: Govt. of India, 1997; 19-22.
  6. Crofton J. Good news from India. International Journal of Tuberculosis and Lung Diseases. 2000; 4: 189-90.
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