Julia Sjögren, Per-Anders Fransson, Måns Magnusson, Mikael Karlberg, Fredrik Tjernström
{"title":"急性单侧前庭大腺炎与皮质类固醇治疗--随机安慰剂对照双盲试验。","authors":"Julia Sjögren, Per-Anders Fransson, Måns Magnusson, Mikael Karlberg, Fredrik Tjernström","doi":"10.1177/09574271241307649","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The efficacy of corticosteroids for treating acute vestibular neuritis, or acute unilateral vestibulopathy (AUVP), remains controversial.</p><p><strong>Objective: </strong>This study aimed to evaluate whether corticosteroids improve vestibular function and reduce symptoms in both acute and chronic phases of AUVP.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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 (<i>p</i> = .002), with no significant differences between groups at any time point (<i>p</i> = .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; <i>p</i> = .347) in the 10-day steroid group and -6.61 (-24.67 to 11.45; <i>p</i> = .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.</p><p><strong>Conclusions: </strong>Corticosteroid treatment does not significantly improve caloric recovery, vHIT gain recovery, or subjective well-being in patients with AUVP.</p>","PeriodicalId":49960,"journal":{"name":"Journal of Vestibular Research-Equilibrium & Orientation","volume":" ","pages":"9574271241307649"},"PeriodicalIF":2.9000,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Acute unilateral vestibulopathy and corticosteroid treatment - A randomized placebo-controlled double-blind trial.\",\"authors\":\"Julia Sjögren, Per-Anders Fransson, Måns Magnusson, Mikael Karlberg, Fredrik Tjernström\",\"doi\":\"10.1177/09574271241307649\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The efficacy of corticosteroids for treating acute vestibular neuritis, or acute unilateral vestibulopathy (AUVP), remains controversial.</p><p><strong>Objective: </strong>This study aimed to evaluate whether corticosteroids improve vestibular function and reduce symptoms in both acute and chronic phases of AUVP.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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 (<i>p</i> = .002), with no significant differences between groups at any time point (<i>p</i> = .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; <i>p</i> = .347) in the 10-day steroid group and -6.61 (-24.67 to 11.45; <i>p</i> = .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.</p><p><strong>Conclusions: </strong>Corticosteroid treatment does not significantly improve caloric recovery, vHIT gain recovery, or subjective well-being in patients with AUVP.</p>\",\"PeriodicalId\":49960,\"journal\":{\"name\":\"Journal of Vestibular Research-Equilibrium & Orientation\",\"volume\":\" \",\"pages\":\"9574271241307649\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2024-12-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Vestibular Research-Equilibrium & Orientation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/09574271241307649\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"NEUROSCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Vestibular Research-Equilibrium & Orientation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/09574271241307649","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"NEUROSCIENCES","Score":null,"Total":0}
Acute unilateral vestibulopathy and corticosteroid treatment - A randomized placebo-controlled double-blind trial.
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.
期刊介绍:
Journal of Vestibular Research is a peer-reviewed journal that publishes experimental and observational studies, review papers, and theoretical papers based on current knowledge of the vestibular system. Subjects of the studies can include experimental animals, normal humans, and humans with vestibular or other related disorders. Study topics can include the following:
Anatomy of the vestibular system, including vestibulo-ocular, vestibulo-spinal, and vestibulo-autonomic pathways
Balance disorders
Neurochemistry and neuropharmacology of balance, both at the systems and single neuron level
Neurophysiology of balance, including the vestibular, ocular motor, autonomic, and postural control systems
Psychophysics of spatial orientation
Space and motion sickness
Vestibular rehabilitation
Vestibular-related human performance in various environments