Steroids for idiopathic sudden sensorineural hearing loss

  • Review
  • Intervention

Authors

  • Benjamin PC Wei,

    1. Royal Victorian Eye and Ear Hospital/University of Melbourne, Department of Otolaryngology, Melbourne, Victoria 3002, Australia
    2. Royal Victorian Eye and Ear Hospital/University of Melbourne, Department of Surgery, Melbourne, Australia
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  • Dimitra Stathopoulos,

    1. Royal Victorian Eye and Ear Hospital/University of Melbourne, Department of Otolaryngology, Melbourne, Victoria 3002, Australia
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  • Stephen O'Leary

    Corresponding author
    1. Royal Victorian Eye and Ear Hospital/University of Melbourne, Department of Otolaryngology, Melbourne, Victoria 3002, Australia
    • Stephen O'Leary, Department of Otolaryngology, Royal Victorian Eye and Ear Hospital/University of Melbourne, 32 Gisborne Street, Melbourne, Victoria 3002, Australia. sjoleary@unimelb.edu.au.

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Abstract

Background

This is an update of a Cochrane review first published in The Cochrane Library in Issue 1, 2006 and previously updated in 2009.

Idiopathic sudden sensorineural hearing loss (ISSHL) is a clinical diagnosis characterised by a sudden deafness of cochlear or retrocochlear origin in the absence of a clear precipitating cause. Steroids are commonly prescribed to treat this condition. There is no consensus on their effectiveness.

Objectives

To determine whether steroids in the treatment of ISSHL a) improve hearing (primary) and b) reduce tinnitus (secondary).

To determine the incidence of significant side effects from the medication.

Search methods

We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the most recent search was 22 April 2013.

Selection criteria

We identified all randomised controlled trials (with or without blinding) in which steroids were evaluated in comparison with either no treatment or a placebo. We considered trials including the use of steroids in combination with another treatment if the comparison control group also received the same other treatment. The two authors reviewed the full-text articles of all the retrieved trials of possible relevance and applied the inclusion criteria independently.

Data collection and analysis

We graded trials for risk of bias using the Cochrane approach. The data extraction was performed in a standardised manner by one author and rechecked by the other author. Where necessary we contacted investigators to obtain the missing information. Meta-analysis was neither possible nor considered appropriate because of the heterogeneity of the populations studied and the differences in steroid formulations, dosages and duration of treatment. We analysed and reported the quality of the results of each study individually. A narrative overview of the results is presented.

Main results

Only three trials, involving 267 participants, satisfied the inclusion criteria and all three studies were at high risk of bias. One trial showed a lack of effect of oral steroids in improving hearing compared with the placebo control group. The second trial showed a significant improvement of hearing in 61% of the patients receiving oral steroid and in only 32% of the patients from the control group (combination of placebo-treated group and untreated control group). The third trial also showed a lack of effect of oral steroids in improving hearing compared with the placebo control. However, this trial did not follow strict inclusion criteria for participant selection and analysis of data was limited by significant exclusion of participants from the final analysis and lack of participant compliance to the treatment protocol. No clear evidence was presented in two trials about any harmful side effects of the steroids. Only one study declared that no patients suffered from adverse effects of the steroid treatment.

Authors' conclusions

The value of steroids in the treatment of idiopathic sudden sensorineural hearing loss remains unclear since the evidence obtained from randomised controlled trials is contradictory in outcome, in part because the studies are based upon too small a number of patients.

摘要

类固醇治疗特发性耳聋

研究背景

这是一篇Corchrane系统综述的更新,它首次发表在Corchrane图书馆2006年第1期,预计在2009年进行更新。

特发性耳聋的临床诊断要点是无明显诱因的起于耳蜗或蜗后的突发性耳聋。类固醇一般被指定用于治疗这种情况。对于它的疗效尚没有共识。

研究目的

为了确定类固醇治疗特发性耳聋是否会提升听力(主要结局)和减少耳鸣(次要结局)。

确定使用它治疗出现的不良反应发生率。

检索策略

我们检索了Cochrane耳鼻喉疾病试验注册组、PubMed、EMBASE、CINAHL、Web of Science数据库、剑桥科学文摘数据库、ICTRP,发表及未发表的试验。最近一次检索的日期是2013年4月22日。

标准/纳入排除标准

我们检索了所有评估类固醇对比无治疗或者安慰剂的随机对照试验(有或没有盲法)。如果对照组也使用同样的其他治疗,我们也考虑纳入类固醇联合其他治疗的试验。两个作者根据纳入标准独立评价检索到试验的全文。

数据收集与分析

我们使用Cochrane 偏倚风险评估的的方法将研究质量分级。一个作者采用标准化的方式进行资料提取,由另一个作者进行核查。必要的时候我们联系研究者获取缺失的信息。由于受试者的异质性、类固醇剂型、剂量、治疗持续时间不同,meta分析是不适用的。我们单独的分析和报告了每个研究结果的质量。并对研究结果进行描述性的概述。

主要结果

只有3个试验(包括267名受试者)符合纳入标准,它们的偏倚风险都很高。一个试验结果显示口服类固醇对比安慰剂在提升听力方面没有很好的疗效。第二个试验显示接受口服类固醇治疗的患者有61%听力显著的提高,而对照组(安慰剂和无治疗结合)仅有32%。第三个试验也显示口服类固醇对照安慰剂在提升听力方面缺乏疗效。然而,在受试者招募时这个试验没有遵循严格的纳入标准,且数据分析时将受试者排除在最终分析的局限性,且患者依从性差。两个试验没有报告类固醇有任何有害的的副作用。只有一项研究报告了没有患者在类固醇治疗后出现不良反应。

作者结论

因为从随机对照试验中获取的证据在结果上是矛盾的,部分由于样本量太小,类固醇治疗特发性耳聋的价值仍然是不清楚的。

翻译注解

译者:冯雪(北京中医药大学循证医学中心);审校:梁宁。翻译由北京中医药大学循证医学中心组织与提供。

Plain language summary

Steroids for the treatment of sudden hearing loss with unknown cause

A sudden onset of hearing loss due to disease of the hearing organs is a medical emergency and requires prompt recognition and treatment. In addition to the hearing impairment, patients may also suffer from symptoms of tinnitus (background ringing noise), a sensation of ear fullness and dizziness. In many instances medical specialists are able to find the cause and treat the hearing impairment. However, in a large proportion of patients, no known cause of the sudden hearing loss can be found. Steroids are commonly used to treat patients with sudden hearing loss of an unknown origin. The specific action of the steroids in the hearing apparatus is uncertain. It is possible that the steroid treatment improves hearing because of its ability to reduce inflammation and oedema (swelling) in the hearing organs. The review of the trials showed a lack of good-quality evidence for the effectiveness of steroids in the treatment of sudden hearing loss of an unknown origin. The quality of the trials was generally low and more research is needed.

概要

类固醇治疗不明原因引起的突发性耳聋

由听觉器官疾病引起的突发性耳聋是一个紧急的医疗事故需要及时的辨别和治疗。除了听力损害外,病人也可能会感到耳鸣(背景噪音),耳部闷胀感和眩晕。在大多数情况下,医学专家可以找到原因并且对听力障碍给予治疗。然而,很大比例的患者突发耳聋的原因是不知道的。类固醇通常用于治疗不明原因引起的突发性耳聋患者。类固醇对于听觉器官的明确疗效是不确定的。类固醇治疗可能会提升听力因为它可以减少听觉器官的炎症和水肿(肿胀)。综述显示缺乏高质量的证据证明类固醇治疗不明原因引起的突发性耳聋的有效性。试验的质量普遍较低,需要进一步的研究。

翻译注解

译者:冯雪(北京中医药大学循证医学中心);审校:梁宁。翻译由北京中医药大学循证医学中心组织与提供。

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