(+)-Cyanidanol-3 for alcoholic liver disease: results of a six-month clinical trial.

A prospective randomized double-blind trial of (+)-cyanidanol-3 at a dose of 2 g daily (500 mg qds) for six months versus placebo has failed to demonstrate statistically significant clinical, biochemical or histological benefit in patients with biopsy-proven alcoholic liver disease although certain trends were identified. The group receiving the active drug tended to drink more both before and during the trial and had mean serum aspartate aminotransferase (AsT) and gamma-glutamyltranspeptidase (gamma-GT) levels which were higher on admission to the trial. After the fourth week of treatment, the mean serum levels of these enzymes remained consistently lower in the group receiving the active drug. In order to reproduce the beneficial effects of the drug observed in the rat, it is suggested that further trials be conducted with the dosage so far used in man (ca. 20-40 mg/kg daily) increased toward that successfully employed in animal experiments (200 mg/kg daily).