Silybin-vitamin E-phospholipids complex reduces liver fibrosis in patients with chronic epatiti C treated with pegylated interferon α and ribavirin

Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting mainly from thecomplications of cirrhosis and HCC. The aim was to evaluate the impact on of supplementation with a new pharmaceuticalcomplex of silybinvitaminE-phospholipids in patients with chronic hepatitis C treated with Pegylated-Interferon-α2b plus Ribavirin. In this prospective, randomized, placebo controlled, double blind clinical trial, 32subjects 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 ofSilybin 47 mg + vitamin E 15 mg + phospholipids 97 mg in two pill for 12 months. Serum levels of the followingmarkers 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 comparisonbetween group A and group B showed a significant difference in ALT (P<0.001), and viremia (P<0.05) after 12months; in TGF beta levels after 12 months and at follow up (P<0.05); in MMP-2 after 6 months (P<0.05); in PIIINPafter 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 plusRBV treatment and reduced serum levels of markers of liver fibrosis. The ameliorative effect of the complex mayberelated to a direct effect on the activation of hepatic stellate cells, or mediated via antioxidants.