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

BACKGROUND: Diabetes mellitus is characterized by chronic hyperglycemia with associated disturbances in carbohydrate, fat and protein metabolism due to absolute or relative deficiency in insulin secretion and insulin action. Chronic low grade inflammation and elevated levels of circulating pro inflammatory cytokines are also features of insulin resistance and type 2 diabetes. Many studies have shown that probiotics improve insulin resistance by reducing the inflammatory response in diabetetes & improve the blood glucose level by inhibiting the mediators like reactive oxygen metabolites & cytokines production. AIM OF THE STUDY: To determine the efficacy and safety of probiotics as an add on therapy to metformin in type 2 Diabetes Mellitus. OBJECTIVES 1. To study the efficacy of probiotics as an add on therapy with metformin in patients with type 2 diabetes mellitus in comparison to metformin monotherapy. 2. To study the tolerability of probiotics in patients with type2 diabetes. METHODS: In this randomized open labelled comparative study 100 patients were selected according to inclusion criteria and randomized into 2 groups, with 50 patients of newly diagnosed type 2 diabetes mellitus patients in each group. Control group received T.metformin 500mg bd and study group received T.metformin 500mg bd with meals and cap.probiotics bd with meals for 12 weeks. Fasting blood glucose &post prandial blood glucose were monitored at 2nd, 4th, 8th and 12th week, HbA1c was done at the end of 12th week. Adverse effects were monitored throughout the study. RESULTS: Significant reduction of fasting blood glucose, post prandial blood glucose and HbA1c in both control and study group. But there was no statistically significant difference between control and study group. The gastro intestinal side effects associated with metformin of study group was less than control group. CONCLUSION: With respect to efficacy Probiotics has not produced any significant additional beneficial effects in combination therapy. But the reported gastrointestinal side effects associated with metformin were found to be less with the probiotics study group which was statistically significant