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

Summary

In a multicenter double-blind RCT of 124 biopsy-proven MASH patients without diabetes, daily vitamin E 300 mg significantly improved the primary histologic endpoint versus placebo and improved steatosis, lobular inflammation, and fibrosis stages. No treatment-related serious adverse events were identified.

Key Findings

• Vitamin E 300 mg/day achieved the primary histologic improvement in 29.3% vs 14.1% with placebo (modified ITT).
• Steatosis, lobular inflammation, and fibrosis stages improved significantly in the vitamin E group.
• Twelve serious adverse events occurred but were not deemed treatment-related.

Clinical Implications

Vitamin E 300 mg/day could be considered as an adjunct option for biopsy-proven MASH in appropriate non-diabetic adults, while monitoring liver disease and aligning with lifestyle interventions. Broader confirmation and long-term outcomes are needed before widespread uptake.

Limitations

• Single-country cohort (Chinese population) may limit generalizability.
• Non-diabetic participants only; applicability to diabetics is unclear.
• Modest sample size (n=124) and histology-based endpoints; long-term clinical outcomes not reported in abstract.

Future Directions

Replicate findings in larger, multiethnic cohorts including patients with diabetes; assess durability of histologic response, non-invasive biomarkers, and hard outcomes (decompensation, HCC, mortality). Dose–response and combination therapy studies are warranted.