Hobson Jonathan, Chisholm Edward, El Refaie Amr
ENT Department, Royal Preston Hospital, Sharoe Green Lane, Fulwood, Preston, UK, PR2 9HT.
Cochrane Database Syst Rev. 2010 Dec 8(12):CD006371. doi: 10.1002/14651858.CD006371.pub2.
Tinnitus is described as the perception of sound or noise in the absence of real acoustic stimulation. Numerous management strategies have been tried for this potentially debilitating, heterogeneous symptom. External noise has been used as a management tool for tinnitus, in different capacities and with different philosophical intent, for over a century.
To assess the effectiveness of sound-creating devices (including hearing aids) in the management of tinnitus in adults. Primary outcome measures were changes in the loudness or severity of tinnitus and/or impact on quality of life. Secondary outcome measures were change in pure-tone auditory thresholds and adverse effects of treatment.
We searched the Cochrane ENT Group Trials Register; CENTRAL (2009, Issue 3); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; mRCT and additional sources for published and unpublished trials. The date of the most recent search was 11 September 2009.
Prospective randomised controlled trials recruiting adults with persistent, distressing, subjective tinnitus of any aetiology in which the management strategy included maskers, noise-generating device and/or hearing aids, used either as the sole management tool or in combination with other strategies, including counselling.
Two authors independently examined the 362 search results to identify studies for inclusion in the review, of which 33 were potentially relevant. Both authors extracted data independently.
Six trials (553 participants) are included in this review. Studies were varied in design, with significant heterogeneity in the evaluation of subjective tinnitus perception, with different scores, scales, tests and questionnaires as well as variance in the outcome measures used to assess the improvement in tinnitus sensation/quality of life. This precluded meta-analysis of the data. There was no long-term follow up. We assessed the risk of bias as medium in three and high in three studies. No side effects or significant morbidity were reported from the use of sound-creating devices.
AUTHORS' CONCLUSIONS: The limited data from the included studies failed to show strong evidence of the efficacy of sound therapy in tinnitus management. The absence of conclusive evidence should not be interpreted as evidence of lack of effectiveness. The lack of quality research in this area, in addition to the common use of combined approaches (hearing therapy plus counselling) in the management of tinnitus are, in part, responsible for the lack of conclusive evidence. Other combined forms of management, such as Tinnitus Retraining Therapy, have been subject to a Cochrane Review. Optimal management may involve multiple strategies.
耳鸣被描述为在没有真实声音刺激时对声音或噪音的感知。针对这种可能使人衰弱且具有异质性的症状,人们尝试了多种管理策略。在一个多世纪以来,外部噪音一直被用作耳鸣的管理工具,其作用方式和理念各不相同。
评估发声设备(包括助听器)对成人耳鸣管理的有效性。主要结局指标是耳鸣响度或严重程度的变化和/或对生活质量的影响。次要结局指标是纯音听阈的变化和治疗的不良反应。
我们检索了Cochrane耳鼻喉科组试验注册库;Cochrane系统评价数据库(2009年第3期);PubMed;EMBASE;护理学与健康领域数据库;科学引文索引;生物学文摘数据库;剑桥科学文摘数据库;mRCT以及已发表和未发表试验的其他来源。最近一次检索日期为2009年9月11日。
前瞻性随机对照试验,招募患有任何病因的持续性、令人痛苦的主观性耳鸣的成年人,其管理策略包括掩蔽器、发声装置和/或助听器,可单独作为管理工具使用,或与其他策略(包括咨询)联合使用。
两位作者独立检查了362条检索结果,以确定纳入综述的研究,其中33项可能相关。两位作者独立提取数据。
本综述纳入了6项试验(553名参与者)。研究设计各不相同,在主观耳鸣感知评估方面存在显著异质性,使用了不同的评分、量表、测试和问卷,以及用于评估耳鸣感觉/生活质量改善情况的结局指标也存在差异。这使得无法对数据进行荟萃分析。没有长期随访。我们评估三项研究的偏倚风险为中等,三项研究为高。未报告使用发声设备有副作用或明显的发病率。
纳入研究的有限数据未能有力证明声音疗法在耳鸣管理中的疗效。缺乏确凿证据不应被解释为缺乏有效性的证据。该领域缺乏高质量研究,以及耳鸣管理中常用联合方法(听力治疗加咨询),在一定程度上导致了缺乏确凿证据。其他联合管理形式,如耳鸣再训练疗法,已接受Cochrane系统评价。最佳管理可能涉及多种策略。