Effect of Vitamin E and Alpha Lipoic Acid in Nonalcoholic Fatty Liver Disease: A Randomized, Placebo-Controlled, Open-Label, Prospective Clinical Trial (VAIN Trial)

Abstract

Objective: Antioxidants, including alpha lipoic acid (ALA) and vitamin E, are efficacious for the treatment of nonalcoholic fatty liver disease (NAFLD). The objective was to evaluate the effects of ALA and vitamin E alone or combined as therapy for patients with NAFLD and nonalcoholic steatohepatitis (NASH). Design: Placebo-controlled, open-label, prospective study in which patients with NAFLD and NASH were randomized to treatment with ALA 300 mg (n = 40), vitamin E 700 IU (n = 40), ALA 300 mg plus vitamin E 700 IU (n = 40), or placebo (n = 35) daily for 6 months. Body mass index, homeostasis model assessment scores, fibrosis and steatosis markers, and diagnostic laboratory tests were assessed at baseline and at the end of the study. Results: Treatment with ALA and vitamin E alone or in combination, improved inflammatory cytokine levels, steatosis scores, homeostasis model assessment scores, and triglyceride levels after 6 months relative to baseline. Conclusion: Alpha lipoic acid and vitamin E, either alone or in combination, were effective treatments for patients with NAFLD and NASH.