Imai Takao, Uno Atsuhiko, Yamato Akiyuki, Takimoto Yasumitsu, Sato Go, Matsuda Kazunori, Takeda Noriaki, Nishiike Suetaka, Kawashima Kayoko, Iga Tomoko, Ueno Yuya, Ohta Yumi, Sato Takashi, Kamakura Takefumi, Shingai-Higashi Kayoko, Mikami Shinji, Kimura Naomiki, Nakajima Takashi, Tanaka Akihisa, Inohara Hidenori
Department of Otorhinolaryngology - Head and Neck Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Department of Otorhinolaryngology - Head and Neck Surgery, Bell Land General Hospital, Osaka, Japan.
Front Neurol. 2023 Feb 27;14:1095041. doi: 10.3389/fneur.2023.1095041. eCollection 2023.
Patients with benign paroxysmal positional vertigo of the posterior canal (pc-BPPV) exhibit BPPV fatigue, where the positional nystagmus diminishes with the repeated performance of the Dix-Hallpike test (DHt). BPPV fatigue is thought to be caused by the disintegration of lumps of otoconial debris into smaller parts and can eliminate positional nystagmus within a few minutes [similar to the immediate effect of the Epley maneuver (EM)]. In this study, we aimed to show the non-inferiority of the repeated DHt to the EM for eliminating positional nystagmus after 1 week.
This multicenter, randomized controlled clinical trial was designed based on the CONSORT 2010 guidelines. Patients who had pc-BPPV were recruited and randomly allocated to Group A or Group B. Patients in Group A were treated using the EM, and patients in Group B were treated using repeated DHt. For both groups, head movements were repeated until the positional nystagmus had been eliminated (a maximum of three repetitions). After 1 week, the patients were examined to determine whether the positional nystagmus was still present. The groups were compared in terms of the percentage of patients whose positional nystagmus had been eliminated, with the non-inferiority margin set at 15%.
Data for a total of 180 patients were analyzed (90 patients per group). Positional nystagmus had been eliminated in 50.0% of the patients in Group A compared with 47.8% in Group B. The upper limit of the 95% confidence interval for the difference was 14.5%, which was lower than the non-inferiority margin.
This study showed the non-inferiority of repeated DHt to the EM for eliminating positional nystagmus after 1 week in patients with pc-BPPV and that even the disintegration of otoconial debris alone has a therapeutic effect for pc-BPPV. Disintegrated otoconial debris disappears from the posterior canal because it can be dissolved in the endolymph or returned to the vestibule activities of daily living.
This study provides Class II evidence of the non-inferiority of repeated DHt to the EM for eliminating positional nystagmus after 1 week.
UMIN000016421.
后半规管良性阵发性位置性眩晕（pc-BPPV）患者会出现BPPV疲劳，即重复进行Dix-Hallpike试验（DHt）时，位置性眼震会减弱。BPPV疲劳被认为是耳石碎片团块分解成较小部分所致，且能在几分钟内消除位置性眼震[类似于Epley手法（EM）的即时效果]。在本研究中，我们旨在证明重复DHt在消除1周后位置性眼震方面不劣于EM。
本多中心随机对照临床试验依据CONSORT 2010指南设计。招募pc-BPPV患者并随机分为A组或B组。A组患者采用EM治疗，B组患者采用重复DHt治疗。两组均重复头部运动，直至位置性眼震消失（最多重复三次）。1周后，检查患者以确定位置性眼震是否仍存在。比较两组位置性眼震已消除患者的百分比，非劣效界值设定为15%。
共分析了180例患者的数据（每组90例）。A组50.0%的患者位置性眼震已消除，B组为47.8%。差异的95%置信区间上限为1,4.5%，低于非劣效界值。
本研究表明，对于pc-BPPV患者，重复DHt在消除1周后位置性眼震方面不劣于EM，且仅耳石碎片分解对pc-BPPV就有治疗效果。分解后的耳石碎片可从后半规管消失，因为它可溶解于内淋巴或返回前庭 日常生活活动。
本研究为重复DHt在消除1周后位置性眼震方面不劣于EM提供了II级证据。
UMIN000016421。
