JMIR Publications

ABSTRACT

Background:

Background:

Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease with limited approved pharmacotherapies. Vitamin E, an antioxidant, has shown potential but evidence on its efficacy and safety remains inconsistent across patient subgroups.

Objective:

This protocol outlines a systematic review and meta-analysis of randomized controlled trials (RCTs) that will evaluate the effects of Vitamin E on liver function and safety outcomes in MASH, aiming to provide evidence for clinical patient care, nutritional guidance, and health education in liver disease management.

Methods:

Methods:

This protocol will follow the PRISMA-P guidelines and has been registered with PROSPERO. PubMed, Embase, Cochrane Library, and Web of Science will be searched from inception without language restrictions. Eligible RCTs will enroll adults with MASH, comparing Vitamin E (any dose) with placebo or active comparators administered equally across groups. Primary outcomes will be changes in alanine aminotransferase (ALT) and the incidence of adverse events and serious adverse events. Two reviewers will independently perform study selection, data extraction, and risk of bias assessment using RoB 2. Random-effects meta-analyses will be conducted, with subgroup analyses by dosage, diabetes status, fibrosis stage, and treatment duration. GRADE will be used to assess evidence certainty.

Results:

Meta‑analyses will be conducted using RevMan 5.4 and R with the meta package. For continuous outcomes such as changes in ALT, mean differences (MD) or standardized mean differences (SMD) with 95% confidence intervals (CI) will be calculated. For dichotomous safety outcomes, risk ratios (RR) with 95% CIs will be used.

Conclusions:

his protocol outlines a planned systematic review and meta-analysis that will provide theoretical basis and practical reference for the optimization of clinical nursing work. To our knowledge, this will be one of the first meta-analyses to focus concurrently on liver function biomarkers as efficacy outcomes and on a broad spectrum of adverse events as primary safety endpoints, specifically within the framework of the updated MASLD nomenclature. By restricting inclusion to RCTs and employing rigorous methodological tools such as RoB 2 and the GRADE framework, this study will aim to provide a high-quality evidence synthesis that addresses key uncertainties remaining in the field. Clinical Trial: PROSPERO registration number: CRD420261348120.