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EFFECT OF SILYBUM MARIANUM ON SERUM ALT AND WELL BEING IN CHRONIC HEPATITIS C
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Adam Gordon, Daryl A Hobbs, Andrew J Francis, Stuart K Roberts, Melbourne, Australia.
Chronic hepatitis C (CHC) often causes significant morbidity in subjects via fatigue and impaired quality of life (QOL). Silybum marianum is a herbal preparation commonly used by subjects with CHC. However, limited information is available on its efficacy in improving liver chemistries and symptoms. Thus, the AIMS of this study are to assess the efficacy and safety of 600mg and 1200mg of silybum marianum on ALT levels and well being in patients with CHC.
We enrolled 24 subjects with CHC into a randomised, double-blinded, placebo-controlled, cross-over study. Subjects received 12 weeks of both silybum (either 600mg or 1200mg/d) and placebo given in random order across the cohort, with treatment periods separated by a 4 week washout interval. Subjects were followed for 12 weeks after the second treatment phase. Baseline biochemical, virological, psychological and QOL Short Form 36 (SF36) tests were performed. Biochemical tests were repeated monthly, and QOL assessments were repeated at the end of both treatment periods. ALT results were blinded to subjects and clinicians during the study. Comparisons were made using the Student t test and _2 analysis.
16 patients completed the trial, including 10 male subjects and 10 (63%) subjects with genotype 1 infection, this reflects the distribution of CHC in the Australia. The mean total SF36 score increased with silybum therapy compared to baseline (73.7±19.4 v 60.6±17.6;p=0.003) but not compared to placebo (p=0.74). Mean scores for individual SF36 domains and anxiety did not differ significantly between silybum and placebo. The mean ALT after treatment with silybum was not significantly different compared to placebo (87U/L±36 v 103U/L±60;p=0.10) and baseline levels (97U/L±46). Also, the mean change in ALT on silybum was not significantly different compared to placebo (+5U/L±32 v +5U/L±57;p=0.98). Three patients on silybum and 4 on placebo achieved a 25% reduction in ALT. The frequency of adverse events was similar with silybum and placebo (p=0.24). No significant adverse events occurred and no significant differences were seen with daily doses of 600mg and 1200mg silybum.
Silybum is safe and well tolerated in subjects with CHC. However silybum does not significantly affect QOL, anxiety or ALT values compared to placebo, and hence appears to have little efficacy in CHC.
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