Safety and Efficacy of Pharmacological Interventions for MASLD Hepatic Outcomes: Protocol for Sy

08 Apr 20264 min read0 viewsJournal Feed

GIST

Introduction Metabolic dysfunction-associated steatotic liver disease (MASLD) is a leading cause of morbidity and mortality due to chronic liver disease. There is an extensive body of evidence focusing on pharmacotherapy for MASLD.

Reviews on the topic have been largely limited to the efficacy of select agents, subgroups or outcomes. The current is a protocol for a comprehensive systematic review and network meta-analysis (NMA) evaluating the efficacy of examined pharmaceutical interventions in improving hepatic outcomes of MASLD.

Methods and analysis MEDLINE, Scopus, Web of Science, the Cochrane Library database and multiple trial registries will be searched for clinical trials on MASLD pharmacotherapy. Histological, radiological and paraclinical outcomes will be considered along with safety and tolerability.

Screening and data extraction will be conducted by pairs of independent reviewers. Risk of bias (RoB) will be assessed using the Cochrane RoB 2 tool.

Pairwise random-effects meta-analyses will be conducted followed by random-effects frequentist NMAs - according to the length of intervention - for each outcome in clinically distinct MASLD subgroups. Other effect moderators will be examined in subgroup analyses and meta-regression.

Clinical Editorial

Scope and objective framing

This source outlines a protocol to assess pharmacological interventions targeting hepatic outcomes in metabolic dysfunction-associated steatotic liver disease (MASLD) via a systematic review and network meta-analysis (NMA).
The aim is to evaluate the efficacy of various pharmaceutical therapies on hepatic endpoints within MASLD, including safety and tolerability.

Study design and analytical plan

Analyses will be tailored to the length of intervention and conducted within clinically distinct MASLD subgroups.

The project will conduct a comprehensive search across multiple databases and trial registries, encompassing MEDLINE, Scopus, Web of Science, Cochrane Library, and additional sources for clinical trials in MASLD pharmacotherapy.
Outcomes of interest span histological, radiological, and paraclinical measures, in addition to safety and tolerability data.
Methodologically, study screening and data extraction will occur in pairs to ensure independent verification.
Risk of bias will be assessed with the Cochrane RoB 2 tool.
Analytic approach comprises pairwise random-effects meta-analyses, followed by random-effects frequentist NMAs.

Subgroup considerations and evidence appraisal

The protocol anticipates exploring effect moderators through subgroup analyses and meta-regression.
Certainty of evidence will be appraised using GRADE and Confidence in Network Meta-Analysis approaches, indicating a dual emphasis on directness and network credibility.

Ethics, dissemination, and registration

Ethics approval was deemed unnecessary because no new data are generated; thus, the study relies on published records, with adherence to copyright terms.
The protocol has been registered with PROSPERO (CRD420251125615), and findings are slated for peer-reviewed publication.

Contextual notes and limitations

The document is a protocol and does not provide results, numerical effect estimates, or conclusions about specific agents or hepatic outcomes.
It explicitly states that no new data will be collected, and it references the intended analytic framework without reporting any empirical findings.