Attempt to treat acute type B hepatitis with an orally administered thymic extract (thymomodulin): preliminary results

A double-blind trial with thymomodulin (TM) was performed in a consecutive series of 50 inpatients affected with acute type B hepatitis. Twenty-six randomly selected patients received TM (Leucotrofina, Ellem), 1 ampoule b.i.d. per os for 30 days, and 24 patients received the same amount of placebo for the same period. TM-treated patients showed accelerated AST and ALT decrease and an earlier HBsAg clearance. However, only the difference in ALT decrease was statistically significant in comparison with the controls (p less than 0.02). Before the treatment was started, lymphocyte subsets, as determined by monoclonal antibodies, showed a different pattern in the two groups despite strict randomization. Nevertheless, by the end of the trial, mean T4+/T8+ ratios were increased in the treated group, but remained unchanged in the control group. The trends in the two groups were significantly different (p less than 0.005). Further information is expected from a long-term follow-up.