title: Silybin supplementation during HCV therapy with pegylated interferon-α plus ribavirin reduces depression and anxiety and increases work ability.
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.
  
  
  BACKGROUND
  NCT01957319 , First received: September 25, 2013. Last updated: September 30, 2013 (retrospectively registered).
authors.affiliation: Research Center "The Great Senescence", University of Catania, Catania, Italy. giulia.malaguarnera@live.it.|Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy. giulia.malaguarnera@live.it.
authors.forename: Giulia
authors.identifier: http://orcid.org/0000-0003-3655-4307
authors.initials: G
authors.lastname: Malaguarnera
authors.affiliation: Department of Experimental and Clinical Medicine, University of Catania, Catania, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Bertino
authors.affiliation: Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Chisari
authors.affiliation: Research Center "The Great Senescence", University of Catania, Catania, Italy.|Department of Experimental and Clinical Medicine, University of Catania, Catania, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Motta
authors.affiliation: U.O.C Physical Medicine and Rehabilitation, A.O.U. Policlinico Vittorio Emanuele, Catania, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Vecchio
authors.affiliation: Research Center "The Great Senescence", University of Catania, Catania, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Vacante
authors.affiliation: Department of Drug Sciences, University of Catania, Catania, Italy.|IRCCS Associazione Oasi Maria S.S., Institute for Research on Mental Retardation and Brain Aging, Troina, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Caraci
authors.affiliation: Research Center "The Great Senescence", University of Catania, Catania, Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Greco
authors.affiliation: Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Drago
authors.affiliation: Department of Experimental and Clinical Medicine, University of Catania, Catania, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Nunnari
authors.affiliation: Research Center "The Great Senescence", University of Catania, Catania, Italy.|Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Malaguarnera
mesh_terms: D000328:Adult; D000975:Antioxidants / Q000008:administration & dosage; D000998:Antiviral Agents / Q000008:administration & dosage; D001007:Anxiety / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology; D003863:Depression / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy / Q000523:psychology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D012254:Ribavirin / Q000008:administration & dosage*; D000077385:Silybin; D012838:Silymarin / Q000008:administration & dosage*; D016896:Treatment Outcome; D000066477:Work Performance
chemical_list: D000975:Antioxidants; D000998:Antiviral Agents; D016898:Interferon-alpha; D012838:Silymarin; D012254:Ribavirin; D000077385:Silybin
keywords: Anxiety; Depression; Hepatitis C; Interferon; Silybin; Work ability index