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).
|
