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Randomized Controlled Trial
. 2008 Dec 21;14(47):7208-13.
doi: 10.3748/wjg.14.7208.

Vitamin E treatment for children with chronic hepatitis B: a randomized placebo controlled trial

Patrick Gerner  1 , 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
Affiliations
Randomized Controlled Trial

Vitamin E treatment for children with chronic hepatitis B: a randomized placebo controlled trial

Patrick Gerner et al. World J Gastroenterol. .

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-alpha 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.

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Figures

Figure 1
Figure 1
The significant vitamin E levels before, during and after treatment (mean ± SD) in patients treated with placebo or vitamin E.
See this image and copyright information in PMC

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