Acute unilateral vestibulopathy and corticosteroid treatment - A randomized placebo-controlled double-blind trial

医学 安慰剂 麻醉 随机对照试验 倍他米松 皮质类固醇 眩晕 临床终点 萧条(经济学) 内科学 外科 替代医学 病理 经济 宏观经济学
作者
Julia Sjögren,Per-Anders Fransson,Måns Magnusson,Mikael Karlberg,Fredrik Tjernström
出处
期刊:Journal of vestibular research [IOS Press]
标识
DOI:10.1177/09574271241307649
摘要

Background The efficacy of corticosteroids for treating acute vestibular neuritis, or acute unilateral vestibulopathy (AUVP), remains controversial. Objective This study aimed to evaluate whether corticosteroids improve vestibular function and reduce symptoms in both acute and chronic phases of AUVP. Methods This randomized, placebo-controlled, double-blind trial included patients with AUVP (ages 18–80) from emergency departments at three sites in southern Sweden. Patients were randomly assigned to one of three groups: placebo, 3-day or 10-day corticosteroid treatment. The steroid groups received intravenous betamethasone followed by oral steroids, while the placebo group received intravenous saline followed by oral placebo. The primary outcome was canal paresis (%) after 12 months, measured via caloric testing. Secondary outcomes included vHIT gain, Diary Vertigo score, Dizziness Handicap Inventory, and Hospital Anxiety and Depression Scale. Analyses were conducted on an intention-to-treat basis. The trial was registered with the EU Clinical Trials Register (EudraCT Number: 2014-005484-32) and ClinicalTrials.gov (NCT00802529). Results From December 2015 to March 2021, 350 patients were screened, and 69 were included: 23 in the 10-day corticosteroid group, 22 in the 3-day corticosteroid group, and 24 in the placebo group. All groups showed significant improvement in caloric function over time ( p = .002), with no significant differences between groups at any time point ( p = .629). Change in caloric asymmetry from baseline to 12 months did not differ between the treatment groups and the placebo group: mean difference −8.34 (95% CI –25.93 to 9.26; p = .347) in the 10-day steroid group and −6.61 (−24.67 to 11.45; p = .467) in the 3-day steroid group, compared with placebo. Secondary outcomes showed no significant differences between groups. Corticosteroid treatments were well tolerated with no safety concerns. Conclusions Corticosteroid treatment does not significantly improve caloric recovery, vHIT gain recovery, or subjective well-being in patients with AUVP.

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