Research Quality Assessment in MASLD Clinical Trials: A Metascientific Evaluation of Study Design and Reporting Standards

Introduction: The rapid expansion of therapeutic strategies for metabolic dysfunction–associated steatotic liver disease (MASLD) has intensified the production of clinical evidence, yet persistent concerns remain regarding its methodological integrity, epistemic stability, and clinical relevance. Understanding how trial design, outcome selection, and reporting practices shape the MASLD evidence landscape is critical for interpreting therapeutic claims. Objective: To conduct a metascientific appraisal of randomized trial quality and reporting standards within MASLD therapeutic research, quantifying structural vulnerabilities across evidence synthesis layers. Methods: We systematically identified meta-analyses (2010–2026) from PubMed, Embase, Web of Science, Scopus, and Cochrane Central Register. Included meta-analyses underwent dual-reviewer assessment using Cochrane RoB 2 for bias evaluation and 2025 CONSORT criteria for reporting completeness. Results: Eleven meta-analyses incorporating 186 randomized trials (≈17,827 participants) met inclusion criteria. Over half of constituent trials exhibited uncertain or high risk of bias, with inadequate blinding (41–59%) and allocation concealment (38–64%) as predominant weaknesses. Median heterogeneity reached I²=56%, driven by divergent diagnostic criteria and outcome definitions. Biochemical endpoints predominated (78% of trials) versus histological measures (46%), reflecting structural bias toward surrogate markers. Reporting deficiencies were pervasive: sample size justification absent in 48–67% of trials and trial registration unclear in 35–58%. Only 18% of meta-analyses achieved high metascientific quality ratings (≥6/8 points). Conclusion: Promising therapeutic signals in MASLD coexist with intrinsically fragile methodological architecture. Strengthening epistemic foundations, through standardized endpoints, transparent protocol registration, and rigorous adherence to reporting standards, is essential to translate experimental advances into clinically reliable interventions.