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Randomized Controlled Trial
. 2016 Nov 15;16(1):398.
doi: 10.1186/s12888-016-1115-z.

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

Giulia Malaguarnera  1   2 , Gaetano Bertino  3 , Giuseppe Chisari  4 , Massimo Motta  5   3 , Michele Vecchio  6 , Marco Vacante  5 , Filippo Caraci  7   8 , Carmela Greco  5 , Filippo Drago  4 , Giuseppe Nunnari  3 , Michele Malaguarnera  5   4
Affiliations
Randomized Controlled Trial

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

Giulia Malaguarnera et al. BMC Psychiatry. .

Abstract

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).

Keywords: Anxiety; Depression; Hepatitis C; Interferon; Silybin; Work ability index.

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Fig. 1
Fig. 1
Trial profile of Peg-IFNα2b plus RBV plus Silybin- Vitamin E- phospholipids treatment
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