Malinvaud D, Londero A, Niarra R, Peignard Ph, Warusfel O, Viaud-Delmon I, Chatellier G, Bonfils P
Department of ENT and CNRS UMR 8119, Hôpital Européen Georges Pompidou, Faculté de médecine Paris Descartes, Université Paris 5, Paris, France; Center of Neurophysics, Physiology and Pathology (CN2P), CNRS UMR 8119, Université Paris Descartes, Paris, France.
Department of ENT and CNRS UMR 8119, Hôpital Européen Georges Pompidou, Faculté de médecine Paris Descartes, Université Paris 5, Paris, France.
Hear Res. 2016 Mar;333:127-135. doi: 10.1016/j.heares.2015.12.023. Epub 2016 Jan 8.
Subjective tinnitus (ST) is a frequent audiologic condition that still requires effective treatment. This study aimed at evaluating two therapeutic approaches: Virtual Reality (VR) immersion in auditory and visual 3D environments and Cognitive Behaviour Therapy (CBT).
This open, randomized and therapeutic equivalence trial used bilateral testing of VR versus CBT. Adult patients displaying unilateral or predominantly unilateral ST, and fulfilling inclusion criteria were included after giving their written informed consent. We measured the different therapeutic effect by comparing the mean scores of validated questionnaires and visual analog scales, pre and post protocol. Equivalence was established if both strategies did not differ for more than a predetermined limit. We used univariate and multivariate analysis adjusted on baseline values to assess treatment efficacy. In addition of this trial, purely exploratory comparison to a waiting list group (WL) was provided.
Between August, 2009 and November, 2011, 148 of 162 screened patients were enrolled (VR n = 61, CBT n = 58, WL n = 29). These groups did not differ at baseline for demographic data. Three month after the end of the treatment, we didn't find any difference between VR and CBT groups either for tinnitus severity (p = 0.99) or tinnitus handicap (p = 0.36).
VR appears to be at least as effective as CBT in unilateral ST patients.
主观性耳鸣（ST）是一种常见的听力学病症，仍需要有效的治疗方法。本研究旨在评估两种治疗方法：沉浸式虚拟现实（VR）听觉和视觉3D环境以及认知行为疗法（CBT）。
本开放性、随机化和治疗等效性试验采用VR与CBT的双侧测试。纳入表现为单侧或主要为单侧ST且符合纳入标准的成年患者，并获得其书面知情同意。我们通过比较验证问卷和视觉模拟量表的平均得分，在方案前后测量不同的治疗效果。如果两种策略的差异不超过预定限度，则确定为等效。我们使用基于基线值调整的单变量和多变量分析来评估治疗效果。除了该试验外，还提供了与等待列表组（WL）的纯探索性比较。
在2009年8月至2011年11月期间，162名筛查患者中的148名被纳入研究（VR组n = 61，CBT组n = 58，WL组n = 29）。这些组在基线时的人口统计学数据无差异。治疗结束三个月后，我们发现VR组和CBT组在耳鸣严重程度（p = 0.99）或耳鸣障碍（p = 0.36）方面均无差异。
在单侧ST患者中，VR似乎至少与CBT一样有效。
