Aim: Clinical Evaluation of Efficacy and Safety of Metformin add- on Therapy to Standard ATT in Newly Diagnosed Pulmonary Tuberculosis Patients. Methods: This was a prospective, open labelled, randomised, parallel group study conducted in KMCH,Katihar, Bihar in Department of Pulmonary Medicine for 1 year. involving 100 tuberculosis patients. Patients were screened and those who fulfilled the selection criteria were included in the study. Patients were randomly allocated to either of the two groups – Control group and Metformin group with 50 patients in each group. In control group, patients received only standard ATT and in Metformin group, patients received Metformin 250 mg twice daily along with standard ATT. Results: The mean age of the patients in control group was 44 (±11.8) years and in Metformin group, it was 40.3 (±11.1) years. In control group, there were 35 males and 15 females and in Metformin group, 33 males and 17 females. There was no significant difference seen in age and gender distribution of the patients between two groups, as evidenced by the p value more than in unpaired t test for age and chi square test for gender. The average time taken for sputum smear conversion was significantly lower in the Metformin group in comparison with the control group (p = 0.011, unpaired t-test). It was about 3.5 (±1.64) weeks in Metformin group while it was 4.8 (±2.21) weeks in the control group. All the subjects enrolled in the study were non-diabetics. 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 96.5±8.8mg/dl and 92.2±11.4mg/dl and the mean sugar values at post prandial state was 127.22±24.15 mg/dl and 125.98±30.11 mg/dl in control and Metformin groups respectively at the time of enrollment. In control group, the baseline HbA1c was 4.82±0.41 % and it was 4.95±0.63 % in Metformin group. Adverse events were seen in 5 patients (10%) in control group and 7 patients (14%) in Metformin group. The difference was not statistically significant (p value = 0.81, chi square test). All of the adverse events were only minor in nature and gastrointestinal related problems like nausea, vomiting and gastritis. Conclusion: It was observed that the average time taken for sputum smear conversion was 3.5 weeks in Metformin group and 4.8 weeks in control group. There were no serious adverse events and most of the adverse events were gastrointestinal related and minor in nature.

Aim: Clinical Evaluation of Efficacy and Safety of Metformin add- on Therapy to Standard ATT in Newly Diagnosed Pulmonary Tuberculosis Patients. Methods: This was a prospective, open labelled, randomised, parallel group study conducted in KMCH,Katihar, Bihar in Department of Pulmonary Medicine for 1 year. involving 100 tuberculosis patients. Patients were screened and those who fulfilled the selection criteria were included in the study. Patients were randomly allocated to either of the two groups – Control group and Metformin group with 50 patients in each group. In control group, patients received only standard ATT and in Metformin group, patients received Metformin 250 mg twice daily along with standard ATT. Results: The mean age of the patients in control group was 44 (±11.8) years and in Metformin group, it was 40.3 (±11.1) years. In control group, there were 35 males and 15 females and in Metformin group, 33 males and 17 females. There was no significant difference seen in age and gender distribution of the patients between two groups, as evidenced by the p value more than in unpaired t test for age and chi square test for gender. The average time taken for sputum smear conversion was significantly lower in the Metformin group in comparison with the control group (p = 0.011, unpaired t-test). It was about 3.5 (±1.64) weeks in Metformin group while it was 4.8 (±2.21) weeks in the control group. All the subjects enrolled in the study were non-diabetics. 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 96.5±8.8mg/dl and 92.2±11.4mg/dl and the mean sugar values at post prandial state was 127.22±24.15 mg/dl and 125.98±30.11 mg/dl in control and Metformin groups respectively at the time of enrollment. In control group, the baseline HbA1c was 4.82±0.41 % and it was 4.95±0.63 % in Metformin group. Adverse events were seen in 5 patients (10%) in control group and 7 patients (14%) in Metformin group. The difference was not statistically significant (p value = 0.81, chi square test). All of the adverse events were only minor in nature and gastrointestinal related problems like nausea, vomiting and gastritis. Conclusion: It was observed that the average time taken for sputum smear conversion was 3.5 weeks in Metformin group and 4.8 weeks in control group. There were no serious adverse events and most of the adverse events were gastrointestinal related and minor in nature.