ORAL THYMIC EXTRACT FOR CHRONIC HEPATITIS-C IN PATIENTS PREVIOUSLY TREATED WITH INTERFERON - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLEDTRIAL

Background: Hepatitis C is an important cause of chronic liver disease . It is claimed that Complete Thymic Formula, an over-the-counter herb al dietary supplement, is beneficial for patients with hepatitis C. Ob jective: To evaluate the efficacy and safety of Complete Thymic Formul a. 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. Interven tion: Complete Thymic Formula for 3 to 6 months or placebo for 3 month s. Measurements: Serial measurements of hepatitis C virus (HCV) RNA ti ters. Results: No differences were noted at 3 months between the place bo group (n = 13) and the treatment group (n = 19) in mean HCV RNA tit ers (4.06 +/- 1.52 x 10(6) copies/mL compared with 3.48 +/- 1.92 x 10( 6) copies/mL; P > 0.2). The 19 patients who completed 6 months of trea tment with Complete Thymic Formula remained positive for HCV, and thei r mean HCV RNA titers were similar at 6 months and at baseline (2.78 /- 1.96 x 10(6) copies/ml compared with 3.12 +/- 1.94 x 10(6) copies/m L; P > 0.2). Conclusions: Complete Thymic Formula did not benefit pati ents who had previously received interferon therapy. Patients should b e advised about use of this over-the-counter compound.