Effects of Silybum marianum on serum hepatitis C virus RNA, alanine aminotransferase levels and well-being in patients with chronic hepatitis C.
OBJECTIVE
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.
Gordon
Adam
A
Department of Gastroenterology, The Alfred Hospital, Victoria, Australia.
Hobbs
Daryl A
DA
Bowden
D Scott
DS
Bailey
Michael J
MJ
Mitchell
Joanne
J
Francis
Andrew J P
AJ
Roberts
Stuart K
SK
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D016174:Hepacivirus / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000523:psychology / Q000821:virology; D006801:Humans; D008297:Male; D020944:Silybum marianum; D008517:Phytotherapy / Q000009:adverse effects; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use; D011788:Quality of Life; D012367:RNA, Viral / Q000097:blood; D012838:Silymarin / Q000009:adverse effects / Q000627:therapeutic use
D010936:Plant Extracts; D012367:RNA, Viral; D012838:Silymarin; D000410:Alanine Transaminase