Clinical Studies on Silybin Phytosome

Clinical Study – Ref19C6

Planta Med, 57 Supplement Issue 2, 1991

Preliminary Clinical Development of Silipide (Silybin Phytosome), A New Complex of Silybin, in Toxic Liver Disorders.

C. Marena and M. Lampertico

Medical Department, Inverni Della Beffa S.p.A., Milan, Italy

This study was conducted as a follow up to a study that confirmed excellent tolerablility at dosages up to 360 mg (as silybin equivalents) three times a day for three weeks. It was part of a comprehensive program of clinical investigations to evaluate the effect of the compound in patients with a variety of liver disorders.

This report is based on the preliminary data for 232 patients with liver disorders (including alcoholic and viral hepatitis) treated with IdB 1016 (Silybin Phytosome) capsules, 120 mg, two or three times a day for periods up to 120 days. Control subjects were also studied. 49 were treated with the commercially available extract (standardized to 70% silymarin). This standardized extract is known as Legalon in Europe and Thisilyn in the United States. 117 untreated or placebo treated were also studied. Evaluation was based mostly on biochemical markers.

The findings of the study confirm the effectiveness of silybin in restoring hepatic function in conditions associated with toxic or infectious liver damage. IdB 1016 (Silybin Phytosome) provides a chemically modified, well defined, more bioavailable formulation which exhibits greater clinical efficacy compared with the conventional standardized milk thistle extract (Legalon/Thisilyn).