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Planta Med, 57 Supplement Issue 2, 1991
Preliminary
Clinical Development of Silipide (Siliphos®), 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 (Siliphos®) 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 (Siliphos®) provides a chemically
modified, well defined, more bioavailable formulation which
exhibits greater clinical efficacy compared with the conventional
standardized milk thistle extract (Legalon/Thisilyn).
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