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Silymarin (milk thistle) does not improve disease markers for chronic HCV infection

Clinical Question:
Is silymarin, an extract of milk thistle, beneficial in the treatment of chronic hepatitis C virus infection?

Bottom Line:
Oral silymarin does not significantly improve biochemical or virological markers of disease activity or improve quality of life scores in adults with chronic hepatitis C virus (HCV) infection that did not respond to prior treatment with interferon-based regimens. (LOE = 1b)

Reference:
Fried MW, Navarro VJ, Afdhal N, et al; for the Silymarin in NASH and C Hepatitis (SyNCH) Study Group. Effect of silymarin (milk thistle) on liver disease in patients with chronic hepatitis C unsuccessfully treated with interferon therapy. A randomized controlled trial. JAMA 2012;308(3):274-282.  [PMID:22797645]

Study Design:
Randomized controlled trial (double-blinded)

Funding:
Industry + govt

Allocation:
Concealed

Setting:
Outpatient (specialty)

Synopsis:
Many patients with chronic HCV infection that does not respond to traditional medical therapy self-medicate with silymarin, an extract of milk thistle. These investigators identified 154 adults who met standard diagnostic criteria for chronic HCV infection with quantifiable serum HCV RNA levels, had an alanine aminotransferase (ALT) level of 65 U/L or higher, and who were previously unsuccessfully treated with interferon-based therapy. Patients randomly received (concealed allocation assignment) silymarin 420 mg, silymarin 700 mg, or matched placebo 3 times daily for 24 weeks. Individuals masked to treatment group assignment assessed all outcomes. Complete follow-up occurred for 97% of participants for 24 weeks. Using intention-to-treat analysis, no significant differences occurred between the 2 treatment groups in reduced mean serum ALT levels, in achieving serum ALT levels of less than 45 U/L, in mean serum HCV RNA levels, or in physical or mental health components of standard quality-of-life scores. The frequency of adverse events also did not differ significantly between the treatment groups.

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