High oral doses of milk thistle, a botanical supplement used extensively by patients with chronic liver disease, is no more effective than placebo against chronic hepatitis C, according to preliminary findings of a clinical trial presented at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco last month.
Investigators at four U.S. clinical centers conducted the study involving 154 patients with hepatitis C who were previously unsuccessfully treated with interferon-based therapies and who had elevated serum liver enzymes that were above what’s considered the healthy range, according to an abstract of the study released at the AASLD meeting. The patients—mostly men, median age, 54—were randomly assigned to receive either a placebo or a standardized extract of milk thistle (also known as silymarin) at one of two higher-than-customary doses, three times a day for 24 weeks.
At the end of the study, investigators found no significant difference in liver enzyme levels across the three treatment groups, according to Michael Fried, M.D., a professor of Medicine and Director of Hepatology at the University of North Carolina. Of the138 patients who completed the treatments, only six (two in each treatment group) were found to have normalized or dramatically reduced liver enzyme levels, he reported. Silymarin at both higher doses was well tolerated, he said, with adverse effects that were comparable to placebo.
Bottom line: The findings, though notable, are preliminary since they have not yet been published in a peer-reviewed scientific journal.
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