Vitamin E as treatment for chronic hepatitis B: results of a randomized controlled pilot trial

Background and aims: Interferon-alpha: treatment has been the treatment of choice for chronic hepatitis with unpredictable results. Recently, Lamivudi ne has been licensed for use against HBV infection with good results. Unfor tunately, recurrence of viremia after lamivudine withdrawal is common and p rolonged treatment can induce the emergence of resistant mutant strains. It has been shown that Vitamin E can increase the host immune response, and t his may provide protection against infectious diseases. Methods: We evaluat ed vitamin E supplementation as therapy for chronic hepatitis B in a pilot study including 32 patients. Patients were randomly allocated to receive vi tamin E at the dose of 300 mg twice daily for 3 months (15 patients) or no treatment (17 patients). They were seen monthly during the first 3 months a nd thereafter quarterly for additional 12 months. Results: The two groups w ere comparable at enrollment. At the end of the study period, alanine amino transferase (ALT) normalization was observed in 7 (47%) patients in vitamin E group and only in 1 (6%) of the controls (P = 0.011); HBV-DNA negativiza tion was observed in 8 (53%) patients in the vitamin E group as compared to 3 (18%) in the control group, respectively (P = 0.039). A complete respons e (normal ALT and negative HBV-DNA) was obtained in 7 (47%) patients taking vitamin E and in none of the controls (P = 0.0019). Conclusion: Vitamin E supplementation might be effective in the treatment of chronic hepatitis B. (C) 2001 Elsevier Science B.V. All rights reserved.