Effects ofSilybum marianumon serum hepatitis C virus RNA, alanine aminotransferase levels and well‐being in patients with chronic hepatitis C

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Abstract
Background/Aims: Silybum marianumis 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 ofS. marianumon 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 ofS. 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 onS. marianumcompared to those on placebo. There was no significant change in mean State‐Trait Anxiety Inventory State‐Anxiety scores onS. marianumfrom baseline. Adverse events were similar withS. marianumand placebo.Conclusions: S. marianumis 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.