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).
Authors
- Xiaotang Fan (ORCID: https://orcid.org/0000-0001-5694-1828)
- Yee Hui Yeo (ORCID: https://orcid.org/0000-0002-2703-5954)
- Shilong Xie
- Ming‐Hua Zheng (ORCID: https://orcid.org/0000-0003-4984-2631)
- Junping Shi (ORCID: https://orcid.org/0000-0001-9434-897X)
- Yuqiang Mi (ORCID: https://orcid.org/0000-0001-7809-2679)
- Fajuan Rui (ORCID: https://orcid.org/0009-0006-4895-2248)
- Wen Xie (ORCID: https://orcid.org/0000-0002-7314-8175)
- Fangping He (ORCID: https://orcid.org/0000-0002-6180-6054)
- Xiaoling Chi (ORCID: https://orcid.org/0000-0003-3193-1943)
- Shufei Zang (ORCID: https://orcid.org/0000-0003-0810-7649)
- Bihui Zhong (ORCID: https://orcid.org/0000-0002-4638-7699)
- Lang Bai (ORCID: https://orcid.org/0000-0001-6953-4498)
- Yongfeng Yang (ORCID: https://orcid.org/0000-0003-0402-4440)
- Jie Li (ORCID: https://orcid.org/0000-0003-0973-8645)
- Jing Wang (ORCID: https://orcid.org/0000-0003-3195-175X)
- Huiping Sheng (ORCID: https://orcid.org/0000-0003-0638-7747)
- Jinjun Chen (ORCID: https://orcid.org/0000-0003-4275-9149)
- Bingyuan Wang (ORCID: https://orcid.org/0000-0003-0970-8024)
- Jing Zhang (ORCID: https://orcid.org/0000-0002-7290-8304)
- Yu Song (ORCID: https://orcid.org/0000-0002-1023-4842)
- Wenjing Ni (ORCID: https://orcid.org/0000-0002-6967-7031)
Institutions
- Guangzhou University of Chinese Medicine (CN)
- Cedars-Sinai Medical Center (US)
- Nanjing University of Chinese Medicine (CN)
- Xinjiang Medical University (CN)
- Sun Yat-sen University (CN)
- Capital Medical University (CN)
- Sichuan University (CN)
- Fudan University (CN)
- Wenzhou Medical University (CN)
- First Affiliated Hospital of Wenzhou Medical University (CN)
- First Affiliated Hospital of Xinjiang Medical University (CN)
- Southwest Medical University (CN)
- Affiliated Hospital of Southwest Medical University (CN)
- West China Hospital of Sichuan University (CN)
- Affiliated Hospital of Hangzhou Normal University (CN)
- Nanjing Drum Tower Hospital (CN)
- Tianjin People's Hospital (CN)
- Ningxia Medical University (CN)
- The First Affiliated Hospital, Sun Yat-sen University (CN)
- Ningxia Medical University General Hospital (CN)
- First Hospital of China Medical University (CN)
- Obstetrics and Gynecology Hospital of Fudan University (CN)
- Beijing YouAn Hospital (CN)
- Beijing Ditan Hospital (CN)
- Zhejiang Medicine (China) (CN)
- Southern Medical University (CN)
- China Medical University (CN)
Publication Details
- Journal
- Cell Reports Medicine
- Published
- 2025-02-01
- DOI
- https://doi.org/10.1016/j.xcrm.2025.101939
- Citations
- 21
- Primary Topic
- Liver Disease Diagnosis and Treatment
- Type
- article
- Field-Weighted Citation Impact
- 28.44
Funders
- National Natural Science Foundation of China
- Natural Science Foundation of Jiangsu Province
- National Major Science and Technology Projects of China