Clinical Study - Bizzoni

European Bulletin of Drug Research, Volume 1, No. 3, July 1992

Randomized controlled study of the efficacy and tolerablility of a short course of IdB 1016 in the treatment of chronic persistent hepatitis

R. Marcelli*, P. Bizzoni*, D. Conte**, M.O Lisena**, M. Lampertico***

C. Marena***, M.F. De Marco**, E. Del Ninno*

*Institute of Internal Medicine A. Migliavecce Center for Liver Diseases, University of Milan, Italy, **Department of Gastroenterology, University of Bari, Italy, *** Medical Depeartment, Inverni della Beffa, Milan, Italy

A phase-II randomised controlled trial was performed to evaluate the response to IdB 1016 (Siliphos), a complex of silybin and phosphatidylcholine, in patients with histologically proven chronic persistent hepatitis. Thirty one patients received IdB 1016 capsules dosed at 120 mg expressed as silybin equivalents and thirty four patients received placebo. The administration schedule for all treatments was 1 capsule b.i.d., for three months.

The therapy was generally well tolerated. IdB 1016 treatment resulted in a remarkable and statistically significant decrease of mean serum activity of both, asparate (P<0.05 and alanine (P=0.01) aminotransferases, significantly more favourable than those of the reference group. The data suggest that treatment with IdB 1016 is a benefit in patients with chronic persistent hepatitis.