Milk thistle showed no benefit in HCV

Issue: August 2012

Among patients with chronic hepatitis C, silymarin, also known as milk thistle, did not improve serum alanine aminotransferase levels more than placebo, recent data suggest.

Researchers from the Silymarin in NASH and C Hepatitis (SyNCH) study group conducted the multicenter, double blind, placebo-controlled trial in four medical centers in the United States. The 154 patients were enrolled from May 2008 to May 2010 and had chronic hepatitis C, serum alanine aminotransferase (ALT) levels of at least 65 U/L and were unsuccessfully treated with interferon-based therapy.

Participants were randomly assigned to receive 420 mg silymarin, 700 mg silymarin or placebo three times daily for 24 weeks. Primary outcome measure was serum ALT level in the normal range or serum ALT level decline of at least 50%.

Only two participants in each group met the primary outcome. Mean decline in serum ALT at the end of treatment did not differ between the groups: for placebo, the mean decline was –4.3 U/L, for the 420 mg silymarin group, the mean decline was –14.4 U/L, and for the 700 mg silymarin group the mean decline was –11.3 U/L.

There were also no significant differences in HCV RNA levels or in quality-of-life measures. Adverse events were similar across the three groups.

“Oral silymarin, used at higher than customary doses, did not significantly alter biochemical or virological markers of disease activity in patients with chronic HCV infection who had prior treatment with interferon-based regimens,” the researchers wrote. “Silymarin did not provide greater benefit than placebo for patients with treatment-resistant chronic HCV infection.”

References:

Fried MW. JAMA. 2012;308:274-282.

Disclosures:

The researchers report financial relationships with Abbott, Anadys, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Gilead, GlaxoSmithKline, Gore, Ikaria, Janssen, Medgenics, Merck, Novartis, Roche, Rottapharm Madaus, Springbank, Tibotec and Vertex.