The effect of melatonin, metformin and ursodeoxycholic acid on non-alcoholic fatty liver disease: A randomized, double-blinded controlled trial

Objective: This study was to investigate and compare the effect of melatonin, metformin, and ursodeoxycholic acid (UDCA) on non-alcoholic fatty liver disease(NAFLD). Methods : In this randomized double-blinded clinical trial, 120 patients with NAFLD who had been referred to Gastrointestinal and Liver Diseases Research Center, Rasht, Iran, between September 2015 and January 2016. Patients were randomly assigned to 4 groups. Each group received melatonin, metformin, UDCA, or placebo in addition to a weight loss diet for 3 months. Results : A significant reduction was observed in levels of steatosis, alanine aminotransferase, alkaline phosphatase, body weight, BMI, waist circumstance and triacylglycerol among participants in groups with metformin or melatonin administration. In addition a significant decrease in fasting plasma glucose, and total cholesterol concentration was detected following metformin and UDCA administration, respectively. Conclusions : The present study suggests that the addition of metformin or melatonin to a low-caloric diet may be effective in the treatment of patients with NAFLD.