Comparison of the Therapeutic Effects of Melatonin, Metformin and Vitamin E on Non-Alcoholic Fatty Liver Disease: A Randomized Clinical Trial

Background and Objective: Currently, no therapeutic or surgical treatment for non-alcoholic fatty liver disease (NAFLD) has been officially approved. This is a serious void in the medical field given the increasing prevalence of NAFLD cases in developing countries. Our study compared the therapeutic effect of metformin, melatonin and vitamin E on serum parameters that are associated with NAFLD pathogenesis. Materials and Methods: This randomized clinical trial was performed on 140 patients with NAFLD who were referred to the central hospital of Qazvin. Patients were assigned randomly into four groups. The first group received metformin (500mg daily) with two placebos, the second group received melatonin (10mg daily) with two placebos, the third group received daily 800 IU vitamin E with two placebos and the fourth group received three placebos daily. All four groups were placed on the same diet regimen and had the same lifestyle changes to increase their daily activity time. Ultrasonography was used for the evaluation of the appearance of liver. Weight, BMI, AST, ALT, lipid profile and FBS were measured at baseline, 3 months and 6 months later. Results: All of the therapeutic agents caused a decrease in aminotransferases but metformin was also more potent in improving lipid profiles. A significant difference in LDL was obtained by melatonin (mean change in the control vs. melatonin 15.9; P=0.032) and AST (mean change in control vs. melatonin -18.3; P<0.001). Metformin improved liver appearance in ultrasonography imaging better than the other treatments (P=0.043). Conclusion: Metformin can be considered an effective medication but melatonin may accelerate the healing process in NAFLD patients.