Overview

Silybin Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin Reduces Depression and Increases Work Ability

Status:
Completed

Trial end date:
2013-07-01

Target enrollment:
0

Participant gender:
All

Summary

Background: Hepatitis C virus infection and interferon treatment have shown to be risk factors for depression, distressing, psychosocial burden and poor health-related quality of life. Aim: To determine the effect of a Sylibin-vitamin E-phoshpolipids complex on work ability and whether health related factors (anxiety and depression) were associated with work ability in subjects with chronic hepatitis C treated with Peg-IFN-α and RBV. Patients and Methods: In this prospective, randomized, placebo controlled, double blind clinical trial, 31 subjects (Group A) with chronic hepatitis, received Pegylated-Interferon-α2b (1.5 mg/kg per week) plus Ribavirin and placebo, while 31 subjects (Group B) received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus association of Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12 months. All subjects underwent laboratory exams and questionnaires to evaluate depression (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work ability (Work ability Index - WAI).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Catania

Treatments:

alpha-Tocopherol
Interferons
Ribavirin
Silybin
Silymarin
Tocopherols
Tocotrienols
Vitamin E
Vitamins

Criteria

Inclusion Criteria:

- HCV infection

Exclusion Criteria:

- cancer severe jaundice pulmonary and renal chronic diseases prostatic diseases
autoimmune diseases diabetes mellitus decompensated cirrhosis pregnancy
hemoglobinopathies hemocromatosis