Clinical and Experimental Medical Journal
Volume/Issue:
Volume 3: Issue 1
Effects of silymarin supplementation in patients with chronic hepatitis C receiving PEG-IFN + ribavirin antiviral therapy. A placebo-controlled double blind study
Authors:
Alajos Pár 1st Department of Medicine, University of Pécs, Department of Pathology, Pécs, Hungary
Ifjúság u. 13, H-7643, Pécs, Hungary

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Erzsébet Rőth Institute of Surgery, University of Pécs, Department of Pathology, Pécs, Hungary

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Attila Miseta Institute of Laboratory Medicine, University of Pécs, Department of Pathology, Pécs, Hungary

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Géza Hegedűs Municipal Hospital of Baranya County, Pécs, Hungary

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Gabriella Pár 1st Department of Medicine, University of Pécs, Department of Pathology, Pécs, Hungary

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Béla Hunyady 1st Department of Medicine, University of Pécs, Department of Pathology, Pécs, Hungary

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Áron Vincze 1st Department of Medicine, University of Pécs, Department of Pathology, Pécs, Hungary

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Pages:
119–129
Online Publication Date:
01 Mar 2009
Publication Date:
01 Mar 2009
Article Category:
Research Article
DOI:
https://doi.org/10.1556/CEMED.3.2009.28517
Keywords:
oxidative stress; hepatitis C; interferon + ribavirin; silymarin; GPX, glutathione peroxidase; GSH, glutathione; HAI, histological activity index; HCV, hepatitis C virus; MDA, malondialdehyde; MPO, myeloperoxidase; NK, natural killer; PEG-IFN, peginterferon; RBV, ribavirin; ROM, reactive oxygen metabolite; ROS, reactive oxygen species; SOD, superoxide dismutase; SVR, sustained virological response
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Abstract

Objectives

Since oxidative stress may play a pathogenetic role in chronic hepatitis C and the sustained virological response to antiviral therapy is limited in HCV1 genotype infection, a double blind study was performed in HCV1 patients receiving peginterferon + ribavirin treatment, in order to assess the efficacy of supplementation with an antioxidant flavonoid, silymarin.

Patients and Methods

32 naïve HCV1-positive patients with biopsy-proven chronic hepatitis C, to be treated with peginterferon + ribavirin, have been randomised as follows: Group A: 16 patients received antiviral therapy for 6 to 12 months plus placebo for the first 3 months; Group B: 16 patients were treated with peginterferon + ribavirin for 6 to 12 months plus they received 166 mg oral silymarin twice a day for 3 months. Serum alanine aminotransferase and HCV RNA levels, as well as parameters of oxidative stress such as plasma or RBC haemolysate malondialdehyde, superoxide dismutase, glutathione peroxidase, catalase and myeloperoxidase were determined at Months 0, 1, 3, 6, and 12. Sustained virological response as undetectable HCV RNA was evaluated at 24 weeks after the end of therapy.

Results

In the silymarin group a more rapid decrease in malondialdehyde levels as well as a marked decrease in superoxide dismutase and an increase in myeloperoxidase activity were found at Month 12. Alanine aminotransferase normalised in 6/16 (vs. control 9/16) cases, and sustained virological response occurred in 3/16 (vs. 7/16) patients.

Discussion

Although silymarin supportation to antiviral therapy improved oxidative stress, it could exert any beneficial effect neither on alanine aminotransferase levels nor on sustained virological response. These contradictory findings may be related to randomisation bias as patients in Group B had more negative predictors of response: they were older with higher fibrosis score and even with more severe pre-treatment baseline oxidative stress. Regarding the recently published in vitro experiments with silibinin on HCV replication as well as the newest convincing clinical observations, we suggest further studies with more than threefold doses of silymarin in controlled trials to assess the value of this supplementation in HCV patients receiving antiviral treatment.

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Cover Clinical and Experimental Medical Journal
Clinical and Experimental Medical Journal
Print ISSN:
2060-6249
Online ISSN:
2060-968X

Clinical and Experimental Medical Journal
Language English
Size  
Year of
Foundation		 2007
Publication
Programme		 ceased
Volumes
per Year		  
Issues
per Year		  
Publisher Akadémiai Kiadó
Publisher's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245
Responsible
Publisher		 Chief Executive Officer, Akadémiai Kiadó
ISSN 2060-6249 (Print)
ISSN 2060-968X (Online)

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