Probiotics Efficacy and Safety as add-on Therapy to Metformin in Type 2 Diabetes Mellitus

Background: Insulin secretion is decreased, and peripheral insulin sensitivity is diminished, resulting in type 2 diabetesmellitus. Diet, oral antihyperglycemic medications, and insulin are all modalities for treatment.Objective: The goal of this study was to compare the efficacy of probiotics as an add-on treatment to metformin inpatients with Type 2 Diabetes Mellitus.Methods: The study participants were randomly allocated to one of two groups, Group A or Group B, using a computergeneratedrandomization chart, with each group consisting of 75 patients. Group A - For 12 weeks, patients in this groupwere administered Tab. Metformin 500 mg twice daily with meals. Group B - For 12 weeks, patients in this group wereadministered Tab. Metformin 500 mg twice daily with meals and Cap. Probiotics 1 capsule twice daily with meals. At theculmination of the second, fourth, eighth, and twelfth weeks, all patients were evaluated. Fasting and postprandial bloodglucose levels were measured at each visit. The HbA1c test was performed at the end of the 12th week.Results: The male predominance was seen with males 57% and females 43% in the group A and the male : female ratiowas 1.34:1. In Group B males were 55% and females were 45%. The male: female ratio was 1.20 : 1. The mean HbA1Cslightly reduced since the start till the end of the study. A total of 37% of the patients experienced minor self-limiting sideeffects in group A as compared to 6.66% of Group – B.Conclusion: In treatment for type 2 diabetes mellitus, probiotics as an add-on therapy with metformin was observedto lower fasting blood glucose, postprandial blood glucose, and HbA1c levels when compared to metformin alone. Interms of effectiveness, probiotics have shown no substantial significant outcomes in combination therapy. However, theprobiotics study group had fewer reported gastrointestinal adverse effects associated with metformin treatment.