Oral thymic extract for chronic hepatitis C in patients previously treated with interferon. A randomized, double-blind, placebo-controlled trial.
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.


METHODS
Randomized, double-blind, placebo-controlled trial.


METHODS
Tertiary referral center.


METHODS
38 patients with hepatitis C who did not respond to or were intolerant of interferon therapy.


METHODS
Complete Thymic Formula for 3 to 6 months or placebo for 3 months.


METHODS
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 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 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 x 10(6) copies/mL compared with 3.12 +/- 1.94 x 10(6) 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.
Raymond
R S
RS
University of Alabama at Birmingham, 35294-0007, USA.
Fallon
M B
MB
Abrams
G A
GA
D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006526:Hepatitis C / Q000276:immunology; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000201:enzymology; D006801:Humans; D007372:Interferons / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D004366:Nonprescription Drugs; D010919:Placebos; D012367:RNA, Viral / Q000097:blood; D013949:Thymus Extracts / Q000627:therapeutic use*
D000998:Antiviral Agents; D004366:Nonprescription Drugs; D010919:Placebos; D012367:RNA, Viral; D013949:Thymus Extracts; D007372:Interferons; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase