Effect of a Probiotic and Metformin on Liver Aminotransferases in Non‑alcoholic Steatohepatitis: A Double Blind Randomized Clinical Trial

International Journal of Preventive Medicine (Int J Prev Med)2008-78024520130226Effect of a Probiotic and Metformin on Liver Aminotransferases in Non‑alcoholic Steatohepatitis: A Double Blind Randomized Clinical Trial531537ENDepartment of Gastroenterology and Liver Disease, Isfahan University of Medical Science, Isfahan, IranDepartment of Gastroenterology and Liver Disease, Isfahan University of Medical Science, Isfahan, IranDepartment of Gastroenterology and Liver Disease, Isfahan University of Medical Science, Isfahan, IranNorth Khorasan University of Medical Sciences, Bojnurd, Iran,Department of Clinical Nutrition and Dietetics, Shahid Beheshti University of Medical Science, Tehran, IranInstitute for Science and Technology in Medicine, Faculty of Health, University of Keele, Staffordshire, United Kingdom20130226Background: Non‑alcoholic steatohepatitis (NASH) is a clinicopathological entity that is being recognized more frequently in recent years. This study aimed to evaluate the effects of Metformin, with and without a probiotic supplement on liver aminotransferases in patients with NASH. Methods: Sixty four patients 18-75 years with NASH confirmed by biopsy and histological assessment were enrolled to study. Patients were randomized to one of the following treatments for 6 months: Group I, probiotic (Protexin two tablets per day) plus Metformin 500 mg two tablets per day (Met/Pro), or group II, Metformin 500 mg two tablets per day plus two placebo tablet (Met/P). After 6 month alanine aminotransferase (ALT), aspartate aminotransferase, and ultrasound grading of NASH were assessed. Results: In group I, serum alanine aminotransferase (ALT: 133.7 ± 70 vs. 45.2 ± 32.5; P < 0.00), and aspartate aminotransferase activity (AST: 123.1 ± 72 vs. 44.2 ± 33.9; P < 0.001), and ultrasound grading of NASH (P < 0.001) all decreased significantly by the end of the treatment period. In group II, while serum alanine aminotransferase (ALT) was not significantly reduced (118.4 ± 67.9 vs. 112.5 ± 68.7; P < 0.064), aspartate aminotransferase activity (AST: 125.3 ± 71 vs. 113.4 ± 71; P < 0.001), and ultrasound grading of NASH did fall significantly (P < 0.01). Body mass index (BMI), fasting blood sugar (FBS), cholesterol, and triglyceride fell significantly in both groups. Conclusions: Probiotic combination with Metformin improves liver aminotransferases better than metformin alone in patients with NASH. Keywords: Aminotransferase, insulin resistance, nonalcoholic steatohepatitis, non‑alcoholic fatty liver disease, probiotic, randomized clinical trialhttp://ijpm.mui.ac.ir/index.php/ijpm/article/view/1086http://ijpm.mui.ac.ir/index.php/ijpm/article/download/1086/1053