COMPARISON OF THERAPEUTIC EFFECTS OF SILYMARIN AND VITAMIN E IN NONALCOHOLIC FATTY LIVER DISEASE: RESULTS OF AN OPEN-LABELE, PROSPECTIVE, RANDOMIZED STUDY

Nonalcoholic fatty liver disease (NAFLD) is a clinicopathologic condition characterized by significant lipid deposition, despite a proposed role of oxidative stress in its pathogenesis antioxidant treatments have not been investigated sufficiently. During a five-year period a cross-sectional study was conducted among patients with NAFLD referred to the Ahvaz JundiShapour University Hospitals (AJSUH) and Hepatitis Clinic from 2003 to 2006. The study included 142 NAFLD patients attending our center for management of liver disease. Viral hepatitis and other hepatic diseases and patients who had  intake of ethanol or drugs known to produce fatty liver disease within the previous 6 months were excluded. Patients were randomized to two groups to receive vitamin E 400 IU per day (71 patients) or Silymarin treatment, Silybum marianum extract containing silymarin 70 mg three times daily (71 patients). Treatment was continued for 12 weeks and cases were evaluated every 4 weeks in the out-patient clinic. 142 subjects (60.95% male, 39.05% mean age 45.2.5±10.3), who met the inclusion and exclusion criteria, were included in the analysis. At the end of the 12-week treatment period there was a significant decrease in the serum AST and ALT levels in both treatment groups. The mean serum baseline ALT level was 85 + 10 IU/mL and AST level was 51.9 + 10 IU/mL in study groups.

The mean aspartate transaminase (AST) levels changed to normal 56.30% (40 of 71 cases) in the vitamin E group and 74.6% (53 of 71 patients) in the S. marianum group (P=0.01).

The decrease in AST level in the S. marianum group as compared to the vitamin E group was significant (P<0.007). No side effects were reported in our cases.

S. marianum and vitamin E treatment appears to be significantly effective in biochemical improvement and decreasing the ALT and AST levels in patients with NAFLD.