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Botanical treatment did not improve liver disease among patients with chronic HCV
Patients with chronic HCV did not benefit from taking silymarin, a milk thistle extract, compared with those receiving placebo in a recent study.
In a multicenter, double blind trial, researchers randomly assigned 154 patients with chronic HCV to receive placebo (n=52) or 420 mg (n=50) or 700 mg (n=52) silymarin three times a day for 24 weeks. All participants had serum ALT levels of 65 U/L or greater and had previously undergone unsuccessful interferon-based (IFN) treatment. The primary outcome measure was an ALT level of 45 U/L or less, or a 50% or larger reduction in baseline ALT to less than 65 U/L.
After 24 weeks, two patients in each group achieved the primary endpoint (P≥.99), including two participants in each treated group and one in the placebo group who reached an ALT level of 45 U/L or lower (P=.80). The average ALT reduction was –14.4 U/L in the 420-mg group and –11.3 U/L for the 700-mg group, compared with –4.3 U/L among those receiving placebo (P=.75 for difference).
HCV RNA levels also did not differ significantly between the groups, with a mean decrease of –0.03 log10 IU/mL in the 420-mg group and a mean increase of 0.04 IU/mL in the 700-mg group, compared with a mean increase of 0.07 IU/mL in the placebo group (P=.54 for difference).
Adverse events were infrequent and incidence rates did not differ significantly between the groups (34 patients receiving placebo, 31 in the 420-mg group and 29 in the 700-mg group, P=.84). Gastrointestinal disorders were most commonly reported and were experienced by 12% of all treated patients and 5% of those receiving placebo (P=.56). Twelve serious events occurred, including 11 among treated patients and one in the placebo group (P=.08). Three treated patients discontinued treatment because of adverse events.
“Milk thistle fruit extracts have been widely used in the setting of liver disease, but rigorous trials have not been conducted,” the researchers wrote. “We found that silymarin did not significantly improve serum ALT levels compared with placebo when administered to patients with chronic HCV infection previously unsuccessfully treated with IFN-based therapy.”
Disclosure: See the study for a full list of relevant disclosures.