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The objective was to evaluate the efficacy of Metformin add-on therapy to standard ATT in newly diagnosed Pulmonary Tuberculosis patients with the following parameters, sputum smear conversion and drug resistance pattern and to assess the safety of Metformin add-on therapy. The study was started after obtaining approval from Institutional Human Ethics Committee. It was a prospective, randomised controlled study involving 100 participants. Pulmonary tuberculosis patients who were non-diabetic and positive for sputum AFB were randomly allocated to two groupsControl and Metformin group (50 patients in each group). In control group, patients received standard Anti Tuberculosis Treatment (ATT). In Metformin group, patients were given Metformin 250 mg BD daily along with standard ATT. Sputum smear examination for AFB (Acid fast bacilli) was done every week and resistance pattern (CBNAATGeneXpert and / or Line Probe Assay) was assessed at the end of intensive phase. Complete Blood Count (CBC), Random Blood Sugar (RBS), Renal Function Tests (RFT) and Liver Function Tests (LFT) were done at baseline and at end of the study. Adverse events were recorded. The results showed that the average time taken for sputum smear conversion was 3.4 weeks in Metformin group and 4.7 weeks in control group. It was significantly less in Metformin group (p = 0.012, unpaired t test). Drug resistance pattern at the end of 2 months showed that 1 patient in Metformin group showed resistance to Rifampicin and 4 patients in control group showed resistance (3 patients for Rifampicin and 1 for Isoniazid). 12% of the patients in Metformin group experienced adverse events, and 8% in control group. There were no serious adverse events and most of the adverse events were gastrointestinal related and minor in nature. There were no significant changes noted in RBS, CBC, LFT and RFT parameters.This study provides hands on and preliminary data that supports Metformin added to standard ATT may potentially benefit TB patients by i) significantly reducing the time needed for sputum smear conversion and ii) reducing the occurrence of drug resistance. However larger studies with varied outcome measures are needed to confirm the positive observations noted in this study.

Clinical Evaluation of Efficacy and Safety of Metformin addon Therapy to Standard ATT in Newly Diagnosed Pulmonary Tuberculosis Patients