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

BACKGROUND: 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.