Taking milk thistle (silymarin) does not seem to improve disease status or symptoms with chronic hepatitis C (JAMA 2012; 308: 274-82).
This multicenter, randomized, double-blind, placebo-controlled study examined 154 patients with chronic hepatitis C (HCV). Mean age was 54 years (71% male). The study required participants to have an ALT ≥ 65 U/L and all patients had been previously unsuccessfully treated with interferon-based therapy.
Silymarin (Silybum marianum) is an extract of milk thistle. In the HALT-C trial, 33% of patients with chronic HCV and cirrhosis reported current or past use of silymarin. It has been shown to have anti-inflammatory and immunomodulator properties via inhibition of NG-κB; in addition, it may have direct effects on HCV replication.
Of the 154 patients, 52 received placebo, 50 received 420-mg silymarin dose, and 52 received 700-mg dose. The trial name was ‘Silymarin in NASH and C Hepatitis’ or SyNCH. All patients were instructed to take medication three times a day. Only 2 patients in each group (~4%) met the primary outcome of an ALT ≤ 45 U/L. In addition, HCV RNA levels remained unchanged and were similar between placebo-treated patients and silymarin-treated patients.
In addition, there were no significant changes in physical or mental health components of quality-of-life scores: CES-D (Center for Epidemiologic Studies-Depression), CLDQ (Chronic Liver Disease Questionnaire), and SF-36 (Short-Form 36).
Adverse effects were similar, though silymarin-treated patients had increased GI adverse effects,12% vs 5% among placebo-treated patients. Though, the study was not powered to detect significant differences with respect to adverse effects.
The major limitation of the study was the patient selection; that is, patients not responsive to interferon may not be representative of all patients with chronic HCV. While newer HCV therapies have become much more effective, due to their expense, effective less-costly therapies would be helpful.
Unfortunately, milk thistle/silymarin is not likely therapeutic for HCV and thus not cost-effective either.
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