Baldo Paolo, Doree Carolyn, Molin Paola, McFerran Don, Cecco Sara
Pharmacy Unit, Drug Information Centre, CRO Aviano - Centro di RiferimentoOncologico IRCCS, Aviano (PN), Italy.
Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD003853. doi: 10.1002/14651858.CD003853.pub3.
This is an update of a Cochrane review first published in The Cochrane Library in Issue 4, 2006 and previously updated in 2009.Tinnitus is described as the perception of sound or noise in the absence of real acoustic stimulation. It has been compared with chronic pain, and may be associated with depression or depressive symptoms which can affect quality of life and the ability to work. Antidepressant drugs have been used to treat tinnitus in patients with and without depressive symptoms.
To assess the effectiveness of antidepressants in the treatment of tinnitus and to ascertain whether any benefit is due to a direct tinnitus effect or a secondary effect due to treatment of concomitant depressive states.
We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; PsycINFO; CINAHL; Web of Science; BIOSIS; ICTRP and additional sources for published and unpublished trials. The date of the most recent search was 5 January 2012.
Randomised controlled clinical studies of antidepressant drugs versus placebo in patients with tinnitus.
Two authors critically appraised the retrieved studies and extracted data independently. Where necessary we contacted study authors for further information.
Six trials involving 610 patients were included. Trial quality was generally low. Four of the trials looked at the effect of tricyclic antidepressants on tinnitus, investigating 405 patients. One trial investigated the effect of a selective serotonin reuptake inhibitor (SSRI) in a group of 120 patients. One study investigated trazodone, an atypical antidepressant, versus placebo. Only the trial using the SSRI drug reached the highest quality standard. None of the other included trials met the highest quality standard, due to use of inadequate outcome measures, large drop-out rates or failure to separate the effects on tinnitus from the effects on symptoms of anxiety and depression. All the trials assessing tricyclic antidepressants suggested that there was a slight improvement in tinnitus but these effects may have been attributable to methodological bias. The trial that investigated the SSRI drug found no overall improvement in any of the validated outcome measures that were used in the study although there was possible benefit for a subgroup that received higher doses of the drug. This observation merits further investigation. In the trial investigating trazodone, the results showed an improvement in tinnitus intensity and in quality of life after treatment, but in neither case reached statistical significance. Reports of side effects including sedation, sexual dysfunction and dry mouth were common.
AUTHORS' CONCLUSIONS: There is as yet insufficient evidence to say that antidepressant drug therapy improves tinnitus.
这是对一篇Cochrane系统评价的更新，该评价首次发表于《Cochrane图书馆》2006年第4期，此前于2009年进行过更新。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。它被比作慢性疼痛，可能与抑郁或抑郁症状相关，而这会影响生活质量和工作能力。抗抑郁药物已被用于治疗有或没有抑郁症状的耳鸣患者。
评估抗抑郁药物治疗耳鸣的有效性，并确定任何益处是由于对耳鸣的直接作用还是由于治疗伴随的抑郁状态产生的继发作用。
我们检索了Cochrane耳、鼻、喉疾病组试验注册库；Cochrane对照试验中央注册库（CENTRAL）；PubMed；EMBASE；PsycINFO；CINAHL；科学引文索引；BIOSIS；国际临床试验注册平台（ICTRP）以及其他已发表和未发表试验的来源。最近一次检索日期为2012年1月5日。
抗抑郁药物与安慰剂对比治疗耳鸣患者的随机对照临床研究。
两名作者对检索到的研究进行严格评价并独立提取数据。必要时我们与研究作者联系以获取更多信息。
纳入了6项涉及610例患者的试验。试验质量总体较低。其中4项试验观察了三环类抗抑郁药对耳鸣的影响，共研究了405例患者。1项试验在一组120例患者中研究了选择性5-羟色胺再摄取抑制剂（SSRI）的作用。1项研究比较了曲唑酮（一种非典型抗抑郁药）与安慰剂。只有使用SSRI药物的试验达到了最高质量标准。其他纳入试验均未达到最高质量标准，原因包括结局指标不充分、脱落率高或未能将对耳鸣的影响与对焦虑和抑郁症状的影响区分开。所有评估三环类抗抑郁药的试验均表明耳鸣有轻微改善，但这些效果可能归因于方法学偏倚。研究SSRI药物的试验发现，在所使用的任何经过验证的结局指标上均未发现总体改善，尽管接受较高剂量药物的亚组可能有益。这一观察结果值得进一步研究。在研究曲唑酮的试验中，结果显示治疗后耳鸣强度和生活质量有所改善，但均未达到统计学显著性。包括镇静、性功能障碍和口干在内的副作用报告很常见。
尚无足够证据表明抗抑郁药物治疗能改善耳鸣。
