Rationale, challenges, and participants in a Phase II trial of a botanical product for chronic hepatitis C.
Abstract | BACKGROUND: PURPOSE: We describe our strategy for a phased approach for studying the impact of silymarin in hepatitis C, in the context of the unique challenges of botanical product clinical trials and the development of specific and curative antiviral therapy. METHODS: This multicenter, randomized, double-masked, placebo-controlled trial was conducted with four clinical centers and a data-coordinating center in the United States, to assess the impact of silymarin therapy in patients with chronic hepatitis C who failed conventional antiviral therapy. RESULTS: Key aspects relevant to performing clinical trials of botanical products include early identification of an appropriate product with standard product chemistry, acquisition of pharmacokinetic and dosing information, selection of the appropriate study group, and choosing rigorous outcome variables. POTENTIAL LIMITATIONS: Trial participants were chronic hepatitis C patients who were nonsustained virologic responders to IFN-based therapy; therefore, the findings are not generalizable to all hepatitis C populations. Further, alanine aminotransferase, a biochemical liver test, rather than hepatitis viral RNA or liver histology was the primary end point. CONCLUSIONS: The challenges identified and addressed during development of this United States multicenter Phase II trial to evaluate silymarin for treatment of patients with chronic hepatitis C infection who had failed to respond successfully to previous IFN-based therapy are common and must be addressed to conduct rigorous trials of botanical products.
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Authors | K Rajender Reddy, Steven H Belle, Michael W Fried, Nezam Afdhal, Victor J Navarro, Roy L Hawke, Abdus S Wahed, Edward Doo, Catherine M Meyers, SyNCH Study Group |
Journal | Clinical trials (London, England)
(Clin Trials)
Vol. 9
Issue 1
Pg. 102-12
(Feb 2012)
ISSN: 1740-7753 [Electronic] England |
PMID | 22058086
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
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Topics |
- Adult
- Aged
- Double-Blind Method
- Female
- Hepatitis C, Chronic
(drug therapy)
- Humans
- Male
- Middle Aged
- Phytotherapy
- Research Design
- Silymarin
(therapeutic use)
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