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

authors:

avatar Seyed Jalal Hashemi 1 , avatar Eskandar Hajiani 2 , * , avatar Ebrahim Haidari Sardabi 1

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Emam Hospital, Ahvaz Jundishapur University of Medical Sciences, Khoozestan, IR.Iran
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Emam Hospital, Ahvaz Jundishapur University of Medical Sciences, ehajiani@ajums.ac.ir, Khoozestan, IR.Iran
Hepatitis Monthly: Vol.9, issue 4; 265-270
article type: Research Article
received: April 26, 2009
accepted: November 9, 2009

How To Cite Hashemi S, Hajiani E, Sardabi E. A Placebo-Controlled Trial of Silymarin in Patients with Nonalcoholic Fatty Liver Disease. Hepat Mon. 2009;9(4): 265-270. 

Abstract

Background and Aims: Nonalcoholic fatty liver disease (NAFLD) is a chronic liver condition that is characterized by significant hepatic lipid deposition with or without necroinflammation and fibrosis. Researchers have proposed that oxidative stress may play a role in pathogenesis of NAFLD, and there is challenging evidence for the efficacy of antioxidant agents in its treatment. Therefore, we tried silymarin as an antioxidant in a randomized controlled trial for a group of patients with NAFLD.

Methods: During an 18-month period, a placebo-controlled study was conducted among patients with nonalcoholic steatohepatitis (NASH) referred to the Ahvaz Jundishapour University Hospital (AJSUH) and Hepatitis Clinic from 2007 to 2008. 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 drugs known to produce fatty liver disease within the previous 6 months were excluded from the study. Patients were randomized to two groups: Group A received a placebo, and Group B received treatment with 280 mg of silymarin. Treatment was 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 (50 cases, 29 males and 21 females) and Group B (50 cases, 28 males and 22 females). The mean age was 39.0 ± 10.70 years for Group A and 39.28 ± 11.117 years for Group B. The age range for both groups was 20 to 50 years. The mean serum ALT levels in the silymarin group were 113.03 and 73.14 IU/mL before and after treatment, respectively (P = 0.001). ALT normalization (ALT < 40) was observed in 18% and 52% of patients in Groups A and B, respectively (P = 0.001). AST normalization (AST < 40) was observed in 20% of cases in the placebo group and 62% of cases in the silymarintreated group (P = 0.0001). No significant side effects were reported in our cases.

Conclusions: Silymarin treatment appears to be significantly effective in biochemical improvement and decreasing transaminases levels in patients with NAFLD.

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