Indian Journal of Community-Medicine Vol. XXIX, No.1, Jan.-Mar.

, 2004

A COMPARATIVE STUDY OF DOTS AND NON-DOTS INTERVENTIONS IN TUBERCULOSIS CURE

Murali Madhav S., Udaya Kiran N
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: more duration were tested by three sputum smears

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 1000 die from TB 1. 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 1100 registered out-
patients 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
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.

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Results:
Table I: Age and sex distribution of DOTS and non-DOTS groups in the study.
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.
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
DOTS and non-DOTS therapy in tuberculosis cure
Indian Journal of Community Medicine Vol. XXIX, No.1, Jan.-Mar., 2004
certified DOTS as "one of the most cost-effective of all health
interventions3" (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.
19 Murali Madhav S. et al