Vitamin E (300 mg) in the treatment of MASH: A multi-center, randomized, double-blind, placebo-controlled study
Yu Song, Wenjing Ni, Ming‐Hua Zheng, Huiping Sheng, Jing Wang, Shilong Xie, Yongfeng Yang, Xiaoling Chi, Jinjun Chen, Fangping He, Xiaotang Fan, Yuqiang Mi, Jing Zhang, Bingyuan Wang, Lang Bai, Wen Xie, Bihui Zhong, Yee Hui Yeo, Fajuan Rui, Shufei Zang, Jie Li, Junping Shi
Abstract
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.