Randomized, Vitamin E-Controlled Trial of Bicyclol Plus Metformin in Non-Alcoholic Fatty Liver Disease Patients with Impaired Fasting Glucose

Background Non-alcoholic fatty liver disease (NAFLD) is associated with a high morbidity in patients with impaired fasting glucose (IFG). Bicyclol is a synthetic compound known to protect the liver against oxidation and lipid injuries. Objective The objective of this study was to evaluate the efficacy and safety of metformin and bicyclol in the treatment of NAFLD patients with IFG. Methods After lifestyle changes and metformin treatment (500 mg orally three times daily), the 248 patients enrolled with NAFLD and IFG were equally randomized to two 24-week treatment groups: bicyclol 25 mg three times daily or vitamin E (α-tocopherol) 100 mg three times daily (control). Anthropometric measurements, serum biochemistry, liver/spleen computed tomography ratio, and changes in liver histological parameters were compared before and after treatments. Results A total of 223 patients completed the treatment, and there were significant improvements in body mass index, waist-to-hip ratio, and biochemical parameters in both groups ( P