Conlin Anne Elizabeth, Parnes Lorne S
Department of Otolaryngology, University of Ottawa, Ottawa, Ontario, Canada.
Arch Otolaryngol Head Neck Surg. 2007 Jun;133(6):573-81. doi: 10.1001/archotol.133.6.573.
To identify, evaluate, and review randomized controlled trials (RCTs) on the treatment of sudden sensorineural hearing loss (SSHL).
A MEDLINE search and hand search were conducted to identify RCTs published between January 1966 and February 2006 in the English language on the treatment of SSHL. Search terms included hearing loss, sensorineural (MeSH term), sensorineural hearing loss (text words), and sudden deafness (text words).
Prospective RCTs on the treatment of patients diagnosed as having SSHL.
One independent observer extracted study data. Validity was evaluated using standard criteria. Characteristics and results were reviewed systematically.
A total of 21 RCTs were identified regarding various treatments, including systemic and intratympanic steroids; antiviral and hemodilution agents; mineral, vitamin, and herbal preparations; batroxobin; carbogen; and hyperbaric oxygen. All studies used audiometric outcome measures. Only 2 studies used identical criteria to define SSHL. The method of randomization was described in 2 studies. Validity scores ranged from 2 to 8 (of 9). Positive results were reported favoring systemic steroids, intratympanic steroids, batroxobin, magnesium, vitamin E, and hyperbaric oxygen, although there were serious limitations in each study with a positive finding. There was no difference in audiometric outcomes reported across all studies of antiviral and hemodilution agents and no difference in one study of systemic steroids vs placebo.
To our knowledge, no valid RCT exists to determine effective treatment of SSHL. Systemic steroids cannot be considered the gold standard of treatment of SSHL, given the severe limitations of the landmark study supporting their use.
识别、评估和综述关于突发性感音神经性听力损失(SSHL)治疗的随机对照试验(RCT)。
进行了MEDLINE检索和手工检索,以识别1966年1月至2006年2月间发表的英文关于SSHL治疗的RCT。检索词包括听力损失、感音神经性(医学主题词)、感音神经性听力损失(文本词)和突发性耳聋(文本词)。
关于诊断为SSHL患者治疗的前瞻性RCT。
一名独立观察者提取研究数据。使用标准标准评估有效性。系统回顾特征和结果。
共识别出21项关于各种治疗的RCT,包括全身和鼓室内使用类固醇;抗病毒和血液稀释剂;矿物质、维生素和草药制剂;巴曲酶;卡波金;以及高压氧。所有研究均使用听力测定结果指标。只有2项研究使用相同标准定义SSHL。2项研究描述了随机化方法。有效性评分范围为2至8(满分9分)。报告了支持全身类固醇、鼓室内类固醇、巴曲酶、镁、维生素E和高压氧的阳性结果,尽管每项有阳性发现的研究都存在严重局限性。所有抗病毒和血液稀释剂研究报告的听力测定结果无差异,一项全身类固醇与安慰剂的研究也无差异。
据我们所知,不存在确定SSHL有效治疗方法的有效RCT。鉴于支持其使用的标志性研究存在严重局限性,全身类固醇不能被视为SSHL治疗的金标准。