A Comparative Study in Patients of Sputum Positive Pulmonary Koch’s on ATT With and without Metformine- Randomized Control Trial

Abstract

Aim: To compare the adjuvant effect of Metformin with ATT to that of ATT alone
Methods: A comparative study was conducted in the Department of Medicine, Darbhanga
Medical College and Hospital, India. 200 patients were included in this study. Patients with
new smear positive pulmonary tuberculosis, Aged above 13 years, patients who never received
treatment with multidrug anti-Tb therapy for more than a weekend Is willing to attend a
treatment centre for supervised treatment and remain within in the study.
Results: The mean age of the patients in control group was 42 (±11.8) years and in Metformin
group, it was 40.3 (±10.1) years. In control group, there were 70 males and 30 females and in
Metformin group, 75 males and 25 females. The average time taken for sputum smear
conversion was significantly lower in the Metformin group in comparison with the control
group (p = 0.015, unpaired t-test). It was about 3.6 (±1.84) weeks in Metformin group while it
was 4.8 (±2.41) weeks in the control group. All the subjects enrolled in the study were nondiabetics. At the time of enrollment, their fasting and post prandial blood sugar and HbA1c
values were measured and only those who were having normal values were selected for the
study. The mean fasting blood sugar was 97.5±8.8mg/dl and 93.2±11.4mg/dl and the mean
sugar values at post prandial state was 128.22±24.15 mg/dl and 126.98±30.11 mg/dl in control
and Metformin groups respectively at the time of enrollment. In control group, the baseline
HbA1c was 4.82±0.61 % and it was 4.95±0.83 % in Metformin group. Adverse events were
seen in 10 patients (10%) in control group and 13 patients (13%) in Metformin group. The
difference was not statistically significant (p value = 0.744, chi square test). All of the adverse
events were only minor in nature and gastrointestinal related problems like nausea, vomiting
and gastritis.Conclusion: The supports Metformin added to standard ATT potentially benefiting TB
patients as evidenced by significant reduction in the time needed for sputum smear conversion
and reduction in the occurrence of drug resistance.