Author Contributions: Dr Belle had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Fried, Navarro, Afdhal, Belle, Wahed, Hawke, Doo, Reddy.
Acquisition of data: Fried, Navarro, Afdhal, Reddy.
Analysis and interpretation of data: Fried, Belle, Wahed, Hawke, Doo, Meyers, Reddy.
Drafting of the manuscript: Fried, Belle, Wahed, Hawke, Meyers, Reddy.
Critical revision of the manuscript: Fried, Navarro, Afdhal, Belle, Wahed, Hawke, Doo, Meyers, Reddy.
Statistical analysis: Belle, Wahed.
Obtained funding: Fried, Navarro, Afdhal, Belle, Reddy.
Study supervision: Fried, Navarro, Afdhal, Belle, Wahed, Hawke, Doo, Meyers, Reddy.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Fried reported receiving research grants from Genentech, Merck, Vertex, Gilead, Tibotec, Janssen, Bristol Myers Squibb, Abbott, and Rottapharm Madaus and serving as an ad hoc consultant to Genentech, Vertex, Merck, Tibotec, Gilead, Bristol Myers Squibb, and Novartis. Dr Navarro reported receiving research grants from Vertex and Rottapharm Madaus and serving as a consultant to Merck. Dr Afdhal reported receiving research grants from and serving as consultant to Merck, GlaxoSmithKline, Vertex, Abbott, Springbank, Medgenics, Boehringer Ingelheim, and Novartis and receiving research grants from Rottapharm Madaus. Dr Belle reported receiving research grants from Rottapharm Madaus. Dr Reddy reported receiving research grants from Genentech-Roche, Merck, Gilead, BMS, Ikaria, Anadys, Gore, Janssen, Vertex, and Rottapharm Madaus and serving on advisory boards for Genentech-Roche, Merck, Gilead, Janssen, and Vertex. No other authors reported disclosures.
Funding/Support: This study was supported with cooperative agreements from the National Institutes of Health (NIH) National Center for Complementary and Alternative Medicine (NCCAM) (UO1 AT003571, UO1 AT003560, UO1 AT003573, UO1 AT003566, and UO1 AT003574); with cofunding from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); and with support from the NIH Clinical & Translational Sciences Awards Division of Research Resources (UL1 RR024134, UL1 TR000083). Dr Fried is also supported by an NIH Mid-Career Award (DK066144). The trial was conducted under an Investigational New Drug Application from the US Food and Drug Administration. Rottapharm Madaus (Monza, Italy, and Cologne, Germany) donated the silymarin study medication and matching placebo. Abbott Molecular Inc (Des Plaines, Illinois) donated the Abbott RealTime HCV assays.
Role of the Sponsors: Neither Rottapharm Madaus nor Abbott Molecular Inc had any role in the design and conduct of the study or the collection or analysis of the data. Rottapharm Madaus provided nonbinding comments to the authors on a draft manuscript.
SyNCH Study Group Members and Centers: Clinical Centers:Beth Israel Deaconess Medical Center, Boston, Massachusetts: Nezam Afdhal, MD; Joseph Colagreco, DNP, APRN-BC, NP. Thomas Jefferson University, Philadelphia, Pennsylvania: Divya Gupta, MD, MS; Cynthia Miller, RN; Victor Navarro, MD; Manisha Verma, MD. University of North Carolina, Chapel Hill: Betty Batey, PA-C; Eric Borg, PharmD; Paris Davis, BA; Karen A. Dougherty, A-NP; Scott Elliott, PA-C; Donna Evon, PhD, Michael W. Fried, MD; Roy Hawke, PharmD, PhD; Meredith Howell, PharmD; Sarah Schrieber, PharmD; Tedi Soule, PharmD. University of Pennsylvania, Philadelphia: David E. Kaplan, MD; Christine Kennedy, BA; Amy Walton, MPH; K. Rajender Reddy, MD; Amina Wirjosemito, MPH. Data Coordinating Center:University of Pittsburgh, Pittsburgh, Pennsylvania: Steven Belle, PhD, MScHyg; Joy Bowen, BA; Marcia Kurs-Lasky, MS; Sharon Lawlor, MBA; Abdus Wahed, PhD; Ella Zadorozny, MS. National Institutes of Health:National Center for Complementary and Alternative Medicine: Linda Duffy, PhD; Catherine Meyers, MD; National Institute of Diabetes and Digestive and Kidney Diseases: Edward Doo, MD, Jay Hoofnagle, MD, Leonard Seeff, MD. Data and Safety Monitoring Board: Henry C. Bodenheimer, MD (chair) (Beth Israel Medical Center); Jacqueline Laurin, MD (Georgetown University); Kimberly Kristine McFann, PhD (University of Colorado); Richard I. Shader, MD (Tufts University); Mark Blumenthal (American Botanical Council).
Additional Contributions: We thank Melissa Miller, PhD, Department of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill, for performing the HCV RNA assays. Dr Miller was compensated for the technical costs of the assays.
This article was corrected for [Table 1: Footnote "d" out of order] on July 17, 2012.