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

May 2014
Patrick P. Basu, Niraj J. Shah, Mark M. Aloysius, Robert S. Brown Jr.
Columbia University College of Physicians and Surgeons, New York, USA.
James J. Peters VA Medical Center, Mount Sinai School of Medicine, New York, USA.
King’s County Hospital, New York, USA.

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.

Keywords: Antioxidant, Liver Disease, Vitamin E, Alpha lipoic Acid