title: A pilot study on the liver protective effect of silybin-phosphatidylcholine complex (IdB1016) in chronic active hepatitis.
abstract: In order to assess the liver protective activity and the antioxidant properties of a new silybin complex (IdB1016), we carried out a short-term pilot study on 20 patients with chronic active hepatitis (CAH), randomly assigned to 240 mg of silybin b.i.d. (10 patients, 4 m/6 f, mean age: 50 years) or placebo (10 patients, 2 m/8 f, mean age: 55 years). Blood samples were collected before and after 7 days of treatment for liver function tests (LFTs), malonaldehyde (MDA) as an index of lipid peroxidation, and copper (Cu) and zinc (Zn), two trace elements involved in protecting cells against free radical-mediated lipid peroxidation. In the treated group, there was a statistically significant reduction of mean (+/- SEM) serum concentrations of aspartate aminotransferase (AST) from 88.0 (+/- 13.3) to 65.9 (+/- 7.5) u/l, (p < 0.01), of alanine 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 phosphatase (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. These results show that IdB1016 may improve LFTs related to hepatocellular necrosis and/or increases membrane permeability in patients affected by CAH.
authors.affiliation: Istituto di Clinica Medica II, Universitá degli Studi di Firenze, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Buzzelli
authors.forename: S
authors.initials: S
authors.lastname: Moscarella
authors.forename: A
authors.initials: A
authors.lastname: Giusti
authors.forename: A
authors.initials: A
authors.lastname: Duchini
authors.forename: C
authors.initials: C
authors.lastname: Marena
authors.forename: M
authors.initials: M
authors.lastname: Lampertico
mesh_terms: D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000494:pharmacology*; D003300:Copper / Q000097:blood; D005260:Female; D016166:Free Radical Scavengers; D006521:Hepatitis, Chronic / Q000188:drug therapy* / Q000378:metabolism; D006801:Humans; D008099:Liver / Q000187:drug effects* / Q000378:metabolism; D008111:Liver Function Tests; D008297:Male; D008315:Malondialdehyde / Q000097:blood; D008875:Middle Aged; D010713:Phosphatidylcholines / Q000494:pharmacology*; D010865:Pilot Projects; D012838:Silymarin / Q000494:pharmacology*; D015032:Zinc / Q000097:blood
chemical_list: D000975:Antioxidants; D016166:Free Radical Scavengers; D010713:Phosphatidylcholines; D012838:Silymarin; C067772:IdB 1016; D008315:Malondialdehyde; D003300:Copper; D015032:Zinc