Department of Otorhinolaryngology-Head and Neck Surgery, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands
Apeldoorn Dizziness Centre, Gelre Ziekenhuizen, Apeldoorn, Gelderland, The Netherlands.
BMJ Open. 2024 Aug 29;14(8):e076872. doi: 10.1136/bmjopen-2023-076872.
Intratympanic corticosteroids are commonly used in the treatment of Menière's disease (MD). However, few and small randomised controlled trials (RCT) on the effectiveness of intratympanic corticosteroids have been performed. A recent Cochrane review suggested that a well-conducted placebo-controlled RCT with a large study population is required to evaluate the effectiveness of the use of intratympanic corticosteroids in MD. The following protocol describes a phase-3 multicentre, double-blinded, randomised, placebo-controlled trial to compare the effectiveness of methylprednisolone (62.5 mg/mL) to a placebo (sodium chloride 0.9%).
We aim to recruit 148 patients with unilateral MD from six hospitals in the Netherlands. Patients will be randomly assigned to either the methylprednisolone or the placebo group. Two injections will be given, one at baseline and one after 2 weeks. Follow-up assessments will be done at 3, 6, 9 and 12 months. The primary outcome will be the frequency of vertigo attacks. Attacks will be evaluated daily with the DizzyQuest app. Secondary outcomes include hearing loss, tinnitus, health-related quality of life, use of co-interventions and escape medication, (serious) adverse events and cost-effectiveness. These will be evaluated with audiometry and multiple commonly used, validated questionnaires. For the primary and secondary outcomes mixed model analysis, generalised estimating equation analysis and logistic regression analysis will be used.
This study was submitted via the Clinical Trials Information System, reviewed and approved by the Medical Research Ethics Committee Leiden The Hague Delft and the local institutional review board of each participating centre. All data will be presented ensuring the integrity and anonymity of patients. Results will be published in scientific journals and presented on (inter)national conferences.
This study is registered at ClinicalTrials.gov Protocol Registration and Results System, with the registration ID: NCT05851508.
鼓室内皮质类固醇常用于治疗梅尼埃病（MD）。然而，关于鼓室内皮质类固醇疗效的小型随机对照试验（RCT）很少。最近的 Cochrane 综述表明，需要进行一项精心设计的安慰剂对照 RCT，且研究人群庞大，以评估鼓室内皮质类固醇治疗 MD 的有效性。本方案描述了一项 3 期、多中心、双盲、随机、安慰剂对照试验，旨在比较甲泼尼龙（62.5mg/ml）与安慰剂（氯化钠 0.9%）的疗效。
我们旨在从荷兰的六家医院招募 148 例单侧 MD 患者。患者将随机分配到甲泼尼龙组或安慰剂组。基线时和 2 周后各给予一次注射。随访评估将在 3、6、9 和 12 个月进行。主要结局是眩晕发作频率。每日使用 DizzyQuest 应用程序评估发作情况。次要结局包括听力损失、耳鸣、健康相关生活质量、辅助干预和逃逸药物的使用、（严重）不良事件和成本效益。这些将通过听力测试和多种常用的、经过验证的问卷进行评估。主要和次要结局将采用混合模型分析、广义估计方程分析和逻辑回归分析。
本研究通过临床试验信息系统提交，已由莱顿-海牙-代尔夫特医学研究伦理委员会和每个参与中心的当地机构审查委员会审查和批准。所有数据将以确保患者的完整性和匿名性的方式呈现。结果将发表在科学期刊上，并在（国际）会议上展示。
本研究在 ClinicalTrials.gov 注册，注册号为 NCT05851508。
