Silymarin in treatment of non-alcoholic steatohepatitis: A randomized clinical trial

Abstract Background: No pharmacologic agents have been approved for the treatment of non-alcoholic steatohepatitis (NASH) that is common in our region. The present study was designed to evaluate the efficacy of silymarin, a known herbal drug, in the treatment of NASH. Methods: This clinical-trial study was conducted on 64 patients with NASH who were randomly divided as case group (33) and control group (31). Abdominal sonography and persistent elevation in levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.2 times of the upper normal limit within the last six months were selected as inclusion criteria. They were advised to take low-fat, low carbohydrate diet, do regular sport activity to lose weight up to 4 Kg. Patients in the case group received 210 mg/day silymarin orally for 8 weeks and those in the control group received placebo. After 8 weeks, the patients were reevaluated and their AST and ALT levels were measured. This study was registered in the Iranian Registry of Clinical Trial (www.irct.ir) with registration number ID: IRCT201202159018N1. Results: The mean age of patients in case and control groups was 43.6±8.3 and 39.4±10.5 years, respectively. Their BMI were 27.4±1.7 and 27.5±1.9, respectively. Their weights were also 79±9.2 and 76.9±9.5 kg, respectively. Serum concentrations of ALT were 91.3±21.3 and 38.4±11.8 in case group before and after the study respectively, whiles the figures were 84.6±23.3 and 52.3±29 in the control group (P=0.026). The same trend was seen for AST (P=0.038). Conclusion: The patients who had taken silymarin experienced more notable fall in hepatic enzymes.