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Article Type

Original Study

Abstract

Objectives: The aim of the study was to evaluate the impact of oral silymarin in hepatitis C virus (HCV) infection when added to conventional treatment [pegylated interferon (IFN)+ribavirin]. Background: Oral silymarin is widely used for the treatment of HCV as an additive to the conventional therapy but its efficacy is unclear. Participants and methods: Sixty consecutive HCV patients referred to our clinic for treatment were recruited. All patients were on combined 180 μg of IFN subcutaneous weekly injection and 800–1200 mg/day ribavirin orally. Patients were randomized into two groups each of 30 patients: the first group received silymarin 140 mg/day orally, whereas the other group did not. Patients had their liver enzymes [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)] and complete blood count checked at baseline and at 12 weeks from the start of treatment. PCR was performed at 12 and 24 weeks from the start of treatment and at 24 weeks after treatment completion. Results: The mean age was 37.6 ± 7.9 years, and 23 (38%) patients were female. There was no significant difference between groups regarding their age, sex, AST, ALT, or complete blood count. Compared with patients who did not have silymarin, patients who had silymarin showed significantly lower ALT (29.5 ± 15.7 vs. 44.4 ± 30.4 U/l, P = 0.021), lower AST (26.6 ± 11.5 vs. 40 ± 31 U/l, P = 0.03), similar hemoglobin (11 ± 1.1 vs. 10.6 ± 0.9 g/dl, P = 0.1), higher platelets (170.1 ± 61.9 vs. 133.6 ± 43 × 103/mm3, P = 0.011), and a higher white cell count (3.6 ± 1.1 vs. 2.9 ± 0.8 × 103/mm3, P = 0.011). According to PCR, 24 (80%) patients who received silymarin showed an early virologic response at 12 weeks, whereas only 18 (60%) patients who did not receive silymarin showed early virologic response (P = 0.09). Twenty-four weeks after the completion of therapy, sustained virologic response occurred in all silymarin patients and in only 13 (43%) patients who did not have silymarin (P = 0.003). Conclusion: Silymarin may increase the antiviral response and adds a protective benefit against side effects of the conventional IFN/ribavirin therapy in HCV patients.

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