Ref11,P1
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.
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