Herbal product use by persons enrolled in the hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) Trial

Authors


  • Potential conflict of interest: Financial relationships of the authors with Hoffmann-La Roche Inc., are as follows: G. Szabo receives research support; G.T. Everson is a consultant, on the speaker's bureau, and receives research support; M.L. Shiffman is a consultant, on the speaker's bureau, and receives research support; K.L. Lindsay is a consultant and receives research support; A.S.F. Lok is a consultant and receives research support; A.M. Di Bisceglie is a consultant, on the speaker's bureau, and receives research support; and W.M. Lee receives research support. Authors with no financial relationships with Hoffmann-La Roche Inc. to disclose are: L.B. Seeff, T.M. Curto, H.L. Bonkovsky, J.L. Dienstag, and M.G. Ghany. Dr. Lee is a consultant for Lilly AstraZeneca. Dr. Lok is a consultant for and received grants from Schering-Plough. Dr. Lindsay is a consultant for and received grants from Valeant Pharmaceuticals. She received grants from Vertex Pharmaceuticals, Human Genome Sciences. She is also a consultant for Zymogenetics, Kendle International, and King Pharmaceuticals, Inc. Dr. Shiffman received grants from Schering-Plough and Vertex. He advises and received grants from Valeant, Wyeth, and Novartis. Dr. Dienstag advises GlaxoSmithKline, Bristol-Myers Squibb, Idenix Pharmaceuticals, Achillion Pharmaceuticals, Metabasis Therapeutics, SciClone, Nucleonics, and Valeant. She is a consultant for Oxxon Therapeutics, ComninatoRx, and Pharmasset. She also advises and received grants from Vertex.

  • This is publication number 27 from the HALT-C Trial Group.

Abstract

Herbal products, used for centuries in Far Eastern countries, are gaining popularity in western countries. Surveys indicate that persons with chronic hepatitis C (CHC) often use herbals, especially silymarin (milk thistle extract), hoping to improve the modest response to antiviral therapy and reduce side effects. The Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) Trial, involving persons with advanced CHC, nonresponders to prior antiviral therapy but still willing to participate in long-term pegylated interferon treatment, offered the opportunity to examine the use and potential effects of silymarin. Among 1145 study participants, 56% had never taken herbals, 21% admitted past use, and 23% were using them at enrollment. Silymarin constituted 72% of 60 herbals used at enrollment. Among all participants, 67% had never used silymarin, 16% used it in the past, and 17% used it at baseline. Silymarin use varied widely among the 10 participating study centers; men were more frequent users than women, as were non-Hispanic whites than African Americans and Hispanics. Silymarin use correlated strongly with higher education. No beneficial effect of silymarin was found on serum alanine aminotransferase or hepatitis C virus (HCV) RNA levels. Univariate analysis showed significantly fewer liver-related symptoms and better quality-of-life parameters in users than nonusers, but after reanalysis adjusted for covariates of age, race, education, alcohol consumption, exercise, body mass index, and smoking, only fatigue, nausea, liver pain, anorexia, muscle and joint pain, and general health remained significantly better in silymarin users. In conclusion, silymarin users had similar alanine aminotransferase and HCV levels to those of nonusers but fewer symptoms and somewhat better quality-of-life indices. Because its use among these HALT-C participants was self-motivated and uncontrolled, however, only a well-designed prospective study can determine whether silymarin provides benefit to persons with chronic hepatitis C. (HEPATOLOGY 2008.)

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