Ref8P22
A pilot study on the liver protective
effect of silybin-phosphatidylcholine complex (IdB1016) in
chronic active hepatitis.
Buzzelli G, Moscarella S, Giusti A, Duchini A, Marena C,
Lampertico M.
Istituto di Clinica Medica II, Universita degli Studi di
Firenze, Italy.
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.
Publication Types:
- Clinical Trial
- Randomized Controlled Trial
Ref8P22
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