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Oral Thymic Extract for Chronic Hepatitis C in Patients Previously Treated with Interferon
A Randomized, Double-Blind, Placebo-Controlled Trial
- Robert S. Raymond, MD;
- Michael B. Fallon, MD; and
- Gary A. Abrams, MD
- From the University of Alabama at Birmingham, Birmingham, Alabama. Acknowledgment: The authors thank Preventive Therapeutics, Inc., for providing Complete Thymic Formula and placebo. Grant Support: By the University of Alabama at Birmingham Liver Center, Birmingham, Alabama. Requests for Reprints: Gary A. Abrams, MD, University of Alabama at Birmingham Liver Center, Division of Gastroenterology and Hepatology, 401 Zeigler Research Building, 703 South 19th Street, Birmingham, AL 35294-0007. Current Author Addresses: Drs. Abrams and Fallon: University of Alabama at Birmingham Liver Center, Division of Gastroenterology and Hepatology, 401 Zeigler Research Building, 703 South 19th Street, Birmingham, AL 35294.
Abstract
Background: Hepatitis C is an important cause of chronic liver disease. It is claimed that Complete Thymic Formula, an over-the-counter herbal dietary supplement, is beneficial for patients with hepatitis C.
Objective: To evaluate the efficacy and safety of Complete Thymic Formula.
Design: Randomized, double-blind, placebo-controlled trial.
Setting: Tertiary referral center.
Patients: 38 patients with hepatitis C who did not respond to or were intolerant of interferon therapy.
Intervention: Complete Thymic Formula for 3 to 6 months or placebo for 3 months.
Measurements: Serial measurements of hepatitis C virus (HCV) RNA titers.
Results: No differences were noted at 3 months between the placebo group (n = 13) and the treatment group (n = 19) in mean HCV RNA titers (4.06 ± 1.52 × 106 copies/mL compared with 3.48 ± 1.92 × 106 copies/mL; P > 0.2). The 19 patients who completed 6 months of treatment with Complete Thymic Formula remained positive for HCV, and their mean HCV RNA titers were similar at 6 months and at baseline (2.78 ± 1.96 × 106 copies/mL compared with 3.12 ± 1.94 × 106 copies/mL; P > 0.2).
Conclusions: Complete Thymic Formula did not benefit patients who had previously received interferon therapy. Patients should be advised about use of this over-the-counter compound.
- Copyright ©2004 by the American College of Physicians
