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Copyright ©2008 The WJG Press and Baishideng. All rights reserved.
World J Gastroenterol. Dec 21, 2008; 14(47): 7208-7213
Published online Dec 21, 2008. doi: 10.3748/wjg.14.7208
Vitamin E treatment for children with chronic hepatitis B: A randomized placebo controlled trial
Patrick Gerner, Hans-Georg Posselt, Andreas Krahl, Antje Ballauff, Albina Innerhofer, Christa Binder, Tobias G Wenzl, Matthias Zense, Ariadne Hector, Gerhard Dockter, Rüdiger Adam, Jenny Neubert, Martin Claßen, Robert van Gemmern, Stefan Wirth
Patrick Gerner, Children’s Hospital Duisburg-Essen University, Klinik 2, Essen 45122, Germany; Witten/Herdecke University, HELIOS Klinikum, Wuppertal, Germany
Hans-Georg Posselt, Ariadne Hector, Children’s Hospital Frankfurt University, Frankfurt am Main 60590, Germany
Andreas Krahl, Children’s Hospital, Darmstadt 64287, Germany
Antje Ballauff, Children’s Hospital Essen University, Klinik 2, Essen 45122, Germany
Albina Innerhofer, Christa Binder, Children’s Hospital St. Anna Wien, Austria 1090, Germany
Tobias G Wenzl, Children’s Hospital Aachen University, Aachen 52074, Germany
Matthias Zense, Children’s Hospital St. Clemens, Münster 48153, Germany
Gerhard Dockter, Children’s Hospital Homburg University, Homburg/Saar 66421, Germany
Rüdiger Adam, Children’s Hospital Mannheim University, Mannheim 68167, Germany
Jenny Neubert, Children’s Hospital Düsseldorf University, Düsseldorf 40225, Germany
Martin Claßen, Children’s Hospital Bremen University, Bremen 28195, Germany
Robert van Gemmern, Pharmacy of HELIOS Klinikum, Wuppertal 42883, Germany
Stefan Wirth, Children’s Hospital HELIOS Klinikum, Wuppertal, 42283, Germany; Witten/Herdecke University, Witten/Herdecke, Germany
Author contributions: Gerner P and Wirth S conducted the study; van Gemmern R controlled and organized medication and placebo; All other coauthors included at least five patients to the study and treated them in their home hospitals.
Correspondence to: Patrick Gerner, MD, Children’s Hospital Duisburg-Essen University, Klinik 2, Essen 45122, Germany. patrick.gerner@uk-essen.de
Telephone: +49-201-7233350 Fax: +49-201-7233360
Received: June 25, 2008
Revised: October 13, 2008
Accepted: October 20, 2008
Published online: December 21, 2008
Abstract

AIM: To evaluate the safety and efficacy of vitamin E in children with chronic hepatitis B.

METHODS: We randomly assigned patients with chronic hepatitis B, positive for hepatitis B e antigen (HBeAg), to receive either vitamin E or placebo once daily for 6 mo in a 3:1 ratio and double-blind manner. The primary end point was HBeAg seroconversion, defined as the loss of HBeAg, undetectable levels of serum hepatitis B virus DNA, and the appearance of antibodies against HBeAg 12 mo after therapy.

RESULTS: At baseline visit, 49 patients had normal and 43 had increased serum aminotransferase levels. Twenty-nine patients did not respond to previous treatment with interferon-α or lamivudine. Seventy-six children completed the study; 16 were non-compliant (n = 7), lost to follow-up (n = 7), or started another antiviral treatment (n = 3). Intention-to-treat analysis showed HBeAg seroconversion in 16 children (23.2%) treated with vitamin E and two (8.7%) in the placebo group (P = 0.13). Vitamin E was well tolerated.

CONCLUSION: There is only a tendency that vitamin E may promote HBeAg seroconversion. Therefore larger studies are needed to clarify the role of antioxidants in the therapy of chronic hepatitis B.

Keywords: Vertical transmission, Immune tolerance, Re-treatment, Infant