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Silybin Treatment is Associated With Reduction in Serum Ferritin in Patients With Chronic Hepatitis C

Bares, Julie M. BS*; Berger, Jose MF; Nelson, James E. PhD* ‡; Messner, Donald J. PhD* †; Schildt, Sandra BA; Standish, Leanna J. ND, PhD; Kowdley, Kris V. MD* ‡

Journal of Clinical Gastroenterology: September 2008 - Volume 42 - Issue 8 - p 937-944
doi: 10.1097/MCG.0b013e31815cff36

Goals The goal of this study was to examine the effect of a standardized silybin and soy phosphatidylcholine complex (IdB 1016) on serum markers of iron status.

Background Milk thistle and its components are widely used as an alternative therapy for liver disease because of purported antioxidant, anti-inflammatory, and iron chelating properties.

Study Thirty-seven patients with chronic hepatitis C and Batts-Ludwig fibrosis stage II, III, or IV were randomized to 1 of 3 doses of IdB 1016 for 12 weeks. Serum ferritin, serum iron, total iron binding capacity, and transferrin-iron saturation were measured at baseline, during treatment, and 4 weeks thereafter. Wilcoxon signed rank tests were used to compare baseline and posttreatment values.

Results There was a significant decrease in serum ferritin from baseline to end of treatment (mean, 244 vs. 215 μg/L; median, 178 vs. 148 μg/L; P=0.0005); 78% of subjects had a decrease in serum ferritin level. There was no significant change in serum iron or transferrin-iron saturation. Multivariate logistic regression analysis in a model that included dose, age, sex, HFE genotype, history of alcohol use, and elevated baseline ferritin levels demonstrated that stage III or IV fibrosis was independently associated with decreased posttreatment serum ferritin level.

Conclusions Treatment with IdB 1016 is associated with reduced body iron stores, especially among patients with advanced fibrosis stage.

*Department of Medicine, University of Washington Medical Center

Benaroya Research Institute and Virginia Mason Medical Center, Seattle

Bastyr University, Kenmore, WA

The authors declare no conflict of interest.

Sources of support: National Center for Complementary and Alternative Medicine (NCCAM) R21AT000992. National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK) DK02957. Indena SpA (Milan, Italy) kindly donated the IdB 1016 for this study.

Reprints: Kris V. Kowdley, MD, Benaroya Research Institute, Virginia Mason Medical Center, 1201 9th Ave NE, Seattle, WA 98101 (e-mail:

Received for publication June 18, 2007; accepted October 3, 2007

© 2008 Lippincott Williams & Wilkins, Inc.