Vitamin E (300 mg) in the Treatment of MASH: A Multi-center, Randomized, Double-blind, Placebo-controlled Study

Overview

Journal Cell Rep Med

Publisher Cell Press

Specialties Biology
General Medicine

Date 2025 Feb 19

PMID 39970876

Authors

Yu Song

Wenjing Ni

Minghua 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

Affiliations

Soon will be listed here.

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).

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