Clinical Studies on Silybin Phytosome

Clinical Study – Ref18C14

Randomized open study of the dose-effect relationship of a short course of IdB 1016 (Silybin Phytosome) 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 (Silybin Phytosome), in patients with chronic hepatitis of either alcoholic or viral cause. The results suggest that treatment with (Silybin Phytosome) 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 Silybin Phytosome, with phosphatidylcholine making up the balance. Therefore you must multiply by three to get the actual corresponding dosage of (Silybin Phytosome).

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 dose, 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 (Silybin Phytosome).