Silybin-Phosphatidylcholine Complex Monograph

form, suggests phytosomal silybin might be useful against hepatitis C in chronically infected patients who do not benefit from interferon treatment.23 Ten patients who failed to measurably respond to recombinant interferon alpha 2b were studied according to a crossover, randomized, double-blind trial design. After 6-12 months of interferon withdrawal, patients were randomly assigned to receive either phytosomal silybin (360 mg silybin daily) or placebo for two months. After a one-month washout period subjects were crossed over to the other treatment. After statistical analysis phytosomal silybin significantly lowered both ALT and AST, while the placebo failed to do so. Cirrhosis Phytosomal silybin is likely safe for cirrhotic patients. Researchers at the University of Padua collaborated with Indena to study uptake of silybin phytosome in 10 patients with compensated liver cirrhosis (Child’s Grade A).24 The patients first received a single 120-mg dose of silybin as phytosome daily, and blood silybin levels were monitored. This was followed by a multipledose study in which patients received a 120-mg dose twice daily for eight days. The patients absorbed the silybin phytosome as well as healthy subjects, although there was great variability from patient to patient. In this study, the profile of data from the eight-day dosing period did not show significant differences from the first day’s data.24 From this finding the researchers concluded that (on average) patients were not accumulating silybin in poorly functioning livers, nor were any clinically adverse effects reported. Another study on cirrhotic patients (n=9) used a higher dose of silybin as phytosome (360 mg) for one day.25 Great inter-patient variability was found, with no clinically adverse effects. Since hepatitis patients can develop adverse effects at this high intake,22 such short-term experience does not prove this dosage is safe for long-term use by patients with cirrhosis. Side Effects and Toxicity This phytosomal form of silybin has been studied for safety.4,18,26 Overall, it is well tolerated in humans. According to researchers Marena and Lampertico,18 healthy volunteers (total number not disclosed) received 360 mg silybin-phytosome complex three times