Placebo Rates in Metabolic Dysfunction-associated Steatohepatitis Clinical Trials: A Systematic Review and Meta-analysis

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dc.catalogadorgrr
dc.contributor.authorIdalsoaga Ferrer, Francisco Javier
dc.contributor.authorDiaz Piga, Luis Antonio
dc.contributor.authorAlghsoon, Saleh
dc.contributor.authorLawendy, Bishoy
dc.contributor.authorSharma,Neha
dc.contributor.authorDesalegn, Hailemichael
dc.contributor.authorYuan, Yuhong
dc.contributor.authorHa, My
dc.contributor.authorLe, Jessica
dc.contributor.authorMacDonald, John K.
dc.contributor.authorArrese, Marco
dc.contributor.authorLoomba, Rohit
dc.contributor.authorJairath, Vipul
dc.contributor.authorKhan, Mohammad Qasim
dc.contributor.authorArab, Juan Pablo
dc.date.accessioned2025-10-17T20:34:29Z
dc.date.available2025-10-17T20:34:29Z
dc.date.issued2025
dc.description.abstractBackground: High placebo response rates complicate drug development in metabolic dysfunction-associated steatohepatitis (MASH) clinical trials. We performed a meta-analysis to quantify placebo response and assess influencing factors.Methods: MEDLINE, Embase, and CENTRAL were searched from inception to May 7, 2025 for placebo-controlled trials of pharmacological interventions for MASH. Placebo response rates were pooled by random-effects model and meta-regression was used to evaluate the effects of patient and trial design factors on the primary outcomes.Results: One-hundred and twenty-seven studies (6,880 participants) were included. For the primary outcome, the pooled proportion of non-cirrhotic placebo patients achieving MASH resolution without worsening of fibrosis was 11% (95% CI: 8% to 14%). Meta-regression did not identify any significant patient or trial characteristics associated with placebo response. For the second primary outcome, the proportion of cirrhotic placebo patients whose Model for End-stage Liver Disease score increased from below 12 to ≥15 was 4% (95% CI 1% to 13%). Regarding secondary outcomes, 12% (95% CI: 8% to 18%) of placebo patients achieved normal alanine aminotransferase levels, and 22% (95% CI: 18% to 27%) showed an absolute reduction of 5% in hepatic fat content. Additionally, 19% of placebo patients (95% CI: 16% to 22%) achieved a relative reduction of 30% in fat content, while 2% (95% CI: 0.7% to 3%) progressed to cirrhosis.Conclusion: Placebo response rates among patients with MASH are generally elevated yet vary considerably depending on the outcome measured. This study provides valuable insights to enhance the design of future MASH trials.
dc.fuente.origenORCID
dc.identifier.pubmedid41076041
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/106253
dc.information.autorucEscuela de Medicina; Idalsoaga Ferrer, Francisco Javier; S/I; 1017394
dc.information.autorucEscuela de Medicina; Diaz Piga, Luis Antonio; 0000-0002-8540-4930; 179253
dc.information.autorucEscuela de Medicina; Arrese, Marco; 0000-0002-0499-4191; 76095
dc.language.isoen
dc.nota.accesocontenido parcial
dc.revistaClinical Gastroenterology and Hepatology
dc.rightsacceso restringido
dc.subjectMASH
dc.subjectMetabolic dysfunction-associated steatohepatitis
dc.subjectMASLD
dc.subjectMetabolic dysfunction-associated Steatotic liver disease
dc.subjectNAFLD
dc.subjectNon-alcoholic fatty liver disease
dc.subjectCirrhosis
dc.subject.ddc610
dc.subject.deweyMedicina y saludes_ES
dc.subject.ods03 Good health and well-being
dc.subject.odspa03 Salud y bienestar
dc.titlePlacebo Rates in Metabolic Dysfunction-associated Steatohepatitis Clinical Trials: A Systematic Review and Meta-analysis
dc.typeartículo de revisión
sipa.codpersvinculados1017394
sipa.codpersvinculados179253
sipa.codpersvinculados76095
sipa.indexPubmed
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