Silybin supplementation during HCV therapy with pegylated interferon-α plus ribavirin reduces depression and anxiety and increases work ability

Background Hepatitis C virus infection and interferon treatment are often associated with anxiety, depressive symptoms and poor health-related quality of life. To evaluate the Silybin-vitamin E-phospholipids complex effect on work ability and whether health related factors (anxiety and depression) were associated with work ability in subjects with chronic hepatitis C treated with Pegylated-Interferon-α2b (Peg–IFN) and Ribavirin (RBV). Methods Thirty-one patients (Group A) with chronic hepatitis and other 31 subjects in Group B were recruited in a randomized, prospective, placebo controlled, double blind clinical trial. Group A received 1.5 mg/kg per week of Peg–IFN plus RBV and placebo, while Group B received the same dosage of Peg–IFN plus RBV plus association of Silybin 94 mg + vitamin E 30 mg + phospholipids 194 mg in pills for 12 months. All subjects underwent to laboratory exams and questionnaires to evaluate depression (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work ability (Work ability Index - WAI). Results The comparison between group A and group B showed significant differences after 6 months in ALT ( P < 0.001), and viremia ( P < 0.05), after 12 months in ALT ( P < 0.001), and AST ( P < 0.001), at follow up in AST ( P < 0.05), and ALT ( P < 0.001). Significant difference were observed after 1 month in WAI ( p < 0.001) and BDI ( P < 0.05), after 6 months in WAI ( P < 0.05) and STAI ( P < 0.05), after 12 months and at follow up in WAI, STAI and BDI ( p < 0.01). Conclusions The supplementation with Silybin-vitamin E -phospholipids complex increased work ability and reduced depression and anxiety in patients treated with Peg–IFN and RBV. Trial registration NCT01957319 , First received: September 25, 2013. Last updated: September 30, 2013 (retrospectively registered).