Effect of a probiotic and metformin on liver aminotransferases in non-alcoholic steatohepatitis: a double blind randomized clinical trial

ABSTRACT

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. 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. 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. Probiotic combination with Metformin improves liver aminotransferases better than metformin alone in patients with NASH