title: Silybin-vitamin E-phospholipids complex reduces liver fibrosis in patients with chronic hepatitis C treated with pegylated interferon α and ribavirin.
abstract: Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting mainly from the complications of cirrhosis and HCC. The aim was to evaluate the impact on of supplementation with a new pharmaceutical complex of silybinvitamin E-phospholipids in patients with chronic hepatitis C treated with Pegylated-Interferon-α2b plus Ribavirin. In this prospective, randomized, placebo controlled, double blind clinical trial, 32 subjects with chronic hepatitis, received Pegylated-Interferon-α2b (1.5 mg/kg per week) plus Ribavirin and placebo, while 32 subjects received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus association of Silybin 47 mg + vitamin E 15 mg + phospholipids 97 mg in two pill for 12 months. Serum levels of the following markers of liver fibrosis were evaluated: transforming growth factor beta, hyaluronic acid, metalloproteinase 2, amino-terminal pro-peptide of type III procollagen, tissue inhibitor of matrix metalloproteinase type I. The comparison between group A and group B showed a significant difference in ALT (P<0.001), and viremia (P<0.05) after 12 months; in TGF beta levels after 12 months and at follow up (P<0.05); in MMP-2 after 6 months (P<0.05); in PIIINP after 6, 12 months and at follow up (P<0.05); in TIMP-1 after 6, 12 months and at follow up (P<0.001). In conclusion, the supplementation with silybin-vitamin E-phosholipids complex ameliorated the response to Peg-IFN plus RBV treatment and reduced serum levels of markers of liver fibrosis. The ameliorative effect of the complex maybe related to a direct effect on the activation of hepatic stellate cells, or mediated via antioxidants.
authors.affiliation: Research Center, The Great Senescence, University of CataniaItaly; Department of Biomedical and Biotechnological Sciences, University of CataniaItaly.
authors.forename: Michele
authors.initials: M
authors.lastname: Malaguarnera
authors.affiliation: Research Center, The Great Senescence, University of Catania Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Motta
authors.affiliation: Research Center, The Great Senescence, University of Catania Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Vacante
authors.affiliation: Research Center, The Great Senescence, University of CataniaItaly; Department of Biomedical and Biotechnological Sciences, University of CataniaItaly.
authors.forename: Giulia
authors.initials: G
authors.lastname: Malaguarnera
authors.affiliation: IRCCS Oasi Maria S.S. Institute for Research on Mental Retardation and Brain AgingTroina, Enna, Italy; Department of Drug Sciences, University of CataniaItaly.
authors.forename: Filippo
authors.initials: F
authors.lastname: Caraci
authors.affiliation: Department of Experimental and Clinical Medicine, University of Catania Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Nunnari
authors.affiliation: Research Center, The Great Senescence, University of CataniaItaly; Neurovisual Science Technology (NEST) CataniaItaly.
authors.forename: Caterina
authors.initials: C
authors.lastname: Gagliano
authors.affiliation: Research Center, The Great Senescence, University of Catania Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Greco
authors.affiliation: Department of Biomedical and Biotechnological Sciences, University of Catania Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Chisari
authors.affiliation: Department of Biomedical and Biotechnological Sciences, University of Catania Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Drago
authors.affiliation: Department of Experimental and Clinical Medicine, University of Catania Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Bertino
keywords: Silybin; hepatitis C; interferons; liver fibrosis; ribavirin