A Placebo-Controlled Trial of Silymarin in Patients with Nonalcoholic Fatty Liver Disease

Nonalcoholic fatty liver disease (NAFLD) is a chronic liver condition that is characterized by significanthepatic lipid deposition with or without necroinflammation and fibrosis. Researchers have proposed that oxidativestress may play a role in pathogenesis of NAFLD, and there is challenging evidence for the efficacy of antioxidant agentsin its treatment. Therefore, we tried silymarin as an antioxidant in a randomized controlled trial for a group of patientswith NAFLD.Methods: During an 18-month period, a placebo-controlled study was conducted among patients with nonalcoholic steatohepatitis(NASH) referred to the Ahvaz Jundishapur University Hospital (AJSUH) and Hepatitis Clinic from 2007 to2008. Based on sonography findings and elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST)levels or liver biopsy, we selected 100 NASH patients who were referred to our center for management of liver disease.Patients who had positive viral markers and other hepatic diseases and patients who had ingested ethanol or drugsknown to produce fatty liver disease within the previous 6 months were excluded from the study. Patients were randomizedto two groups: Group A received a placebo, and Group B received treatment with 280 mg of silymarin. Treatmentwas continued for 24 weeks, and cases were evaluated every 4 weeks in the outpatient clinic.Results: A total of 100 subjects who met the inclusion and exclusion criteria were included in the analysis. Group A (50cases, 29 males and 21 females) and Group B (50 cases, 28 males and 22 females). The mean age was 39.0 ± 10.70 yearsfor Group A and 39.28 ± 11.117 years for Group B. The age range for both groups was 20 to 50 years. The mean serumALT levels in the silymarin group were 113.03 and 73.14 IU/mL before and after treatment, respectively (P = 0.001). ALTnormalization (ALT 40) was observed in 18% and 52% of patients in Groups A and B, respectively (P = 0.001). ASTnormalization (AST 40) was observed in 20% of cases in the placebo group and 62% of cases in the silymarin-treatedgroup (P = 0.0001). No significant side effects were reported in our cases.Conclusions: Silymarin treatment appears to be significantly effective in biochemical improvement and decreasingtransaminases levels in patients with NAFLD.