A consortium including 4 clinical sites, a data coordinating center, and project scientists and medical officers from the National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is being formed as a cooperative agreement to design and implement three phase l/ll trials of silymarin for patients with liver disease. Although silymarin has been used to treat liver disease for hundreds of years, there has not been rigorous research to indicate that such therapy is safe or efficacious. There is a potential role for silymarin, particularly for treating patients with chronic hepatitis C virus who have contraindications to therapy with interferon and ribavirin. The current lack of therapy for non-alcoholic steatohepatitis provides silymarin with a potential role in treating patients with this condition. ? Our proposed DCC will bring together expertise in biostatistics; pharmacodynamics and pharmacokinetics, particularly of silymarin; hepatology; epidemiology; data management; and computer systems to assist the consortium with designing and implementing multiple studies. Working in collaboration with the clinical sites and NIH scientists and personnel, the DCC will provide the consortium with assistance in: ? ? 1. Study design, implementation, and management of approximately three multi-center phase l/ll clinical trials. ? 2. Developing research databases containing information about approximately 480 participants recruited at 4 clinical sites to address safety and efficacy of silymarin for treating patients with liver disease. ? 3. Provide clinical, methodological, data management, and statistical expertise to design the studies, accurately computerize the data, monitor study operations and patient safety, analyze the data, and report the results. ? 4. Provide administrative support to the Steering Committee, subcommittees of the Steering Committee, NIH project scientists and medical officers, and Data and Safety Monitoring Board. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01AT003566-01
Application #
7123231
Study Section
Special Emphasis Panel (ZAT1-SM (01))
Program Officer
Duffy, Linda C
Project Start
2006-08-15
Project End
2010-07-31
Budget Start
2006-08-15
Budget End
2007-07-31
Support Year
1
Fiscal Year
2006
Total Cost
$356,994
Indirect Cost
Name
University of Pittsburgh
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
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Adeyemo, O; Doi, H; Rajender Reddy, K et al. (2013) Impact of oral silymarin on virus- and non-virus-specific T-cell responses in chronic hepatitis C infection. J Viral Hepat 20:453-62
Fried, Michael W; Navarro, Victor J; Afdhal, Nezam et al. (2012) Effect of silymarin (milk thistle) on liver disease in patients with chronic hepatitis C unsuccessfully treated with interferon therapy: a randomized controlled trial. JAMA 308:274-82
Reddy, K Rajender; Belle, Steven H; Fried, Michael W et al. (2012) Rationale, challenges, and participants in a Phase II trial of a botanical product for chronic hepatitis C. Clin Trials 9:102-12
Schrieber, Sarah J; Hawke, Roy L; Wen, Zhiming et al. (2011) Differences in the disposition of silymarin between patients with nonalcoholic fatty liver disease and chronic hepatitis C. Drug Metab Dispos 39:2182-90
Hawke, Roy L; Schrieber, Sarah J; Soule, Tedi A et al. (2010) Silymarin ascending multiple oral dosing phase I study in noncirrhotic patients with chronic hepatitis C. J Clin Pharmacol 50:434-49