Clinical Study - Ref19C6
Randomized open study of the dose-effect relationship of a short course of IdB 1016 (Siliphos®) in patients with viral or alcoholic hepatitis
A. Vailati, L.Aristia, E. Sozze, F. Milani, V. Inglese, PO. Calenda, P.A. Gossolo, E. Ascari
Department of Internal Medicine and Medical Therapy, 2nd Meidcal Clinic, University of Pavia, Italy
M. Lampertico, S. Comis, C. Marena
Medical Department, Inverni della Beffa, Via Ripamonti 99, 20041 Milan, Italy
Not on Medline
SUMMARY: A phase-II randomised open trial was performed to clinically evaluate the dose-response relationship to IdB 1016 (Siliphos®), in patients with chronic hepatitis of either alcoholic or viral cause. The results suggest that treatment with (Siliphos®) is of benefit in patients with viral or alcohol-induced hepatitis at the dose of 160 mg per day. But significant benefits were found at the dose of 240 mg per day. Still greater benefits were found with the dosage at 360 mg per day. All of these dosages are measured in silybin, which is 33% of the total in Siliphos®, with phosphatidylcholine making up the balance. Therefore you must multiply by three to get the actual corresponding dosage of (Siliphos®).
The lowest dose had some beneficial effect, but this study collected sufficient clinical and statistical evidence to indicate as minimum recommended dose the 240 mg per day (measured as silybin). Since there are no evidences of greater risks of adverse events with the 360 mg per day does, whereas there are indications this may provide greater effects on more parameters than the 240 mg dose, the use of the highest dose may be considered in patients in need of either a faster onset or of a greater extent in the pharmacodynamic action of IdB 1060 (Siliphos®).