Vitamin E (300 mg) in the treatment of MASH: A multi-center, randomized, double-blind, placebo-controlled study

The efficacy and safety of a lower dose of vitamin E for metabolic dysfunction-associated steatohepatitis (MASH) treatment are unclear. This multi-center, randomized, double-blind, placebo-controlled study includes 124 non-diabetic participants with biopsy-proven MASH. Participants are randomly assigned to receive oral vitamin E 300 mg or the placebo in a 1:1 ratio. The primary outcome is improvement in hepatic histology. In the modified intention-to-treat population, 29.3% of participants in the vitamin E group achieve the primary outcome compared with 14.1% in the placebo group. Significant improvement in steatosis, lobular inflammation, and fibrosis stages is observed in the vitamin E group. 12 serious adverse events are reported in this trial but are not considered to be related to the treatment. Vitamin E 300 mg daily achieves sound improvements in liver histology in the Chinese population with MASH. This study is registered at ClinicalTrials.gov (NCT02962297). • MASH is a leading cause of chronic liver diseases worldwide • Vitamin E 300 mg improves liver histology and liver functions in MASH patients • No adverse events are considered to be related to the treatment • This clinical trial proves the promising future usage of vitamin E Song et al. prove that vitamin E 300 mg per day for 96 weeks significantly improves liver histology, including steatosis, lobular inflammation, and fibrosis stages; reduces liver stiffness measurement; and decreases liver enzymes and proinflammatory cytokines levels, while it does not show a great effect on lipid and glucose profiles.