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.
RCT Entities:
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.
Authors: P Andreone; S Fiorino; C Cursaro; A Gramenzi; M Margotti; L Di Giammarino; M Biselli; R Miniero; G Gasbarrini; M Bernardi Journal: Antiviral Res Date: 2001-02 Impact factor: 5.970
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Authors: M G Mutchnick; K L Lindsay; E R Schiff; G D Cummings; H D Appelman; R R Peleman; M Silva; K C Roach; F Simmons; S Milstein; S C Gordon; M N Ehrinpreis Journal: J Viral Hepat Date: 1999-09 Impact factor: 3.728
Authors: Monika van Zonneveld; Pieter Honkoop; Bettina E Hansen; Hubertus G M Niesters; Sarwa Darwish Murad; Robert A de Man; Solko W Schalm; Harry L A Janssen Journal: Hepatology Date: 2004-03 Impact factor: 17.425
Authors: Chee-Kin Hui; Nancy Leung; Tony W H Shek; Hung Yao; Wai-Ki Lee; Jak-Yiu Lai; Sik-To Lai; Wai-Man Wong; Lawrence S W Lai; Ronnie T P Poon; Chung-Mau Lo; Sheung-Tat Fan; George K K Lau Journal: Hepatology Date: 2007-09 Impact factor: 17.425