Background/aims: Silybum marianum is a herbal preparation commonly used by subjects with chronic hepatitis C (CHC). The aims of this pilot study were to assess the efficacy and safety of S. marianum on serum hepatitis C virus (HCV) RNA, alanine aminotransferase levels and well-being in patients with CHC.
Methods: Twenty-four subjects with CHC were enrolled into a randomized, double-blind, placebo-controlled, crossover study. Subjects received 12 weeks of S. marianum (either 600 mg or 1200 mg/day) and placebo separated by a 4-week washout interval. Baseline biochemical, virological, psychological and quality-of-life tests were performed, with biochemical tests repeated monthly, and HCV RNA titer and quality-of-life and psychological assessments repeated at the end of both treatment periods.
Results: Seventeen patients completed the trial. Mean changes in HCV RNA titers, serum ALT levels and Short Form-36 scores were not significantly different for subjects on S. marianum compared to those on placebo. There was no significant change in mean State-Trait Anxiety Inventory State-Anxiety scores on S. marianum from baseline. Adverse events were similar with S. marianum and placebo.
Conclusions: S. marianum is well tolerated in subjects with CHC, but does significantly affect serum HCV RNA, alanine aminotransferase levels, quality of life or psychological well-being in subjects with this condition.