A PILOT-STUDY ON THE LIVER PROTECTIVE EFFECT OF SILYBINPHOSPHATIDYLCHOLINE COMPLEX (LDB1016) IN CHRONIC ACTIVE HEPATITIS

In order to assess the liver protective activity and the antioxidant p roperties of a new silybin complex (IdB1016), we carried out a short-t erm pilot study on 20 patients with chronic active hepatitis (CAH), ra ndomly assigned to 240 mg of silybin b. i. d. (10 patients, 4 m/6 f, m ean age: 50 years) or placebo (10 patients, 2 m/8 f, mean age: 55 year s). Blood samples were collected before and after 7 days of treatment for liver function tests (LFTs), malonaldehyde (MDA) as an index of li pid peroxidation, and copper (Cu) and zinc (Zn), two trace elements in volved in protecting cells against free radical-mediated lipid peroxid ation. In the treated group, there was a statistically significant red uction of mean (+/-SEM) serum concentrations of aspartate aminotransfe rase (AST) from 88.0 (+/-13.3) to 65.9 (+/-7.5) u/l, (p < 0.01), of al anine aminotransferase (ALT) from 115.9 (+/-12.9) to 82.5 (+/-10.6) u/ l (p < 0.01), of gamma-glutamyltranspeptidase (gamma-GT) from 51.4 (+/ -9.3) to 41.3 (+/-4.2) u/l (p < 0.02) and of total bilirubin (TB) from 0.76 (+/-0.08) to 0.53 (+/-0.04) mg/dl (p <0.05). Alkaline phosphatas e (AP) fell slightly from 143.4 (+/-6.4) to 137.5 (+/-7.8) u/l. There were no significant changes in MDA, Cu or Zn serum concentrations. The se results show that IdB1016 may improve LFTs related to hepatocellula r necrosis and/or increases membrane permeability in patients affected by CAH.