European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025
Intratympanic corticosteroid injection for Ménière's disease: systematic review of randomized controlled trials.
СтатьяСистематический обзорНазвание и аннотация: Перевод в очереди
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Martínez Helena Guilera, Larrosa Francesc, Sandoval Marta, Remacha Joan, Bernal-Sprekelsen Manuel
Аннотация
INTRODUCTION: Menière's disease is a chronic inner ear disorder marked by episodic vertigo, tinnitus, fluctuating sensorineural hearing loss, and aural fullness, all of which significantly impair quality of life. Intratympanic corticosteroids (ITCs) have emerged as a potential therapy, but their clinical efficacy and safety remain uncertain.
METHODS: A systematic review was conducted of randomized controlled trials (RCTs) comparing ITC to placebo in adult MD patients. Comprehensive searches were performed across multiple electronic databases. Six RCTs met the inclusion criteria, evaluating formulations such as dexamethasone and the sustained-release OTO-104. Outcomes were synthesized narratively, and the certainty of evidence was assessed using the GRADE framework.
RESULTS: Evidence for the primary outcome-vertigo control-was rated as low certainty, due to methodological heterogeneity, inconsistent findings, and imprecision. Two trials demonstrated significant improvements with ITC compared to placebo, but results were not consistent across studies. Evidence for secondary outcomes, including tinnitus and aural pressure, was of very low to low certainty. Safety outcomes were supported by moderate-certainty evidence, with no serious adverse events reported across studies.
CONCLUSIONS: This review highlights the persistent uncertainty surrounding the clinical effectiveness of ITCs in MD. While some evidence supports modest benefit for vertigo control, inconsistencies and low certainty limit generalizability. Future RCTs should prioritize standardized outcome measures and robust methodological design to better define the therapeutic role of ITCs in Menière´s disease.MD.
METHODS: A systematic review was conducted of randomized controlled trials (RCTs) comparing ITC to placebo in adult MD patients. Comprehensive searches were performed across multiple electronic databases. Six RCTs met the inclusion criteria, evaluating formulations such as dexamethasone and the sustained-release OTO-104. Outcomes were synthesized narratively, and the certainty of evidence was assessed using the GRADE framework.
RESULTS: Evidence for the primary outcome-vertigo control-was rated as low certainty, due to methodological heterogeneity, inconsistent findings, and imprecision. Two trials demonstrated significant improvements with ITC compared to placebo, but results were not consistent across studies. Evidence for secondary outcomes, including tinnitus and aural pressure, was of very low to low certainty. Safety outcomes were supported by moderate-certainty evidence, with no serious adverse events reported across studies.
CONCLUSIONS: This review highlights the persistent uncertainty surrounding the clinical effectiveness of ITCs in MD. While some evidence supports modest benefit for vertigo control, inconsistencies and low certainty limit generalizability. Future RCTs should prioritize standardized outcome measures and robust methodological design to better define the therapeutic role of ITCs in Menière´s disease.MD.