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


CONCLUSIONS
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.
Gerner
Patrick
P
Children's Hospital, Duisburg-Essen University, Klinik 2, Essen 45122, Germany. patrick.gerner@uk-essen.de
Posselt
Hans-Georg
HG
Krahl
Andreas
A
Ballauff
Antje
A
Innerhofer
Albina
A
Binder
Christa
C
Wenzl
Tobias G
TG
Zense
Matthias
M
Hector
Ariadne
A
Dockter
Gerhard
G
Adam
Rüdiger
R
Neubert
Jenny
J
Classen
Martin
M
van Gemmern
Robert
R
Wirth
Stefan
S
D000975:Antioxidants / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004279:DNA, Viral / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D000637:Transaminases / Q000097:blood; D016896:Treatment Outcome; D014810:Vitamin E / Q000009:adverse effects / Q000627:therapeutic use*
D000975:Antioxidants; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D014810:Vitamin E; D000637:Transaminases