Devantier Louise, Guldfred Frank Liviu-Adelin, Djurhuus Bjarki Ditlev, Händel Mina Nicole, Schmidt Jesper Hvass, Hougaard Dan Dupont, Edemann-Callesen Henriette
Department of Clinical Medicine, Aarhus University, Noerrebrogade 44, building 10G, 2nd floor, 8000, Aarhus C, Denmark.
Department of Oto-Rhino-Laryngology, Regional Hospital West Jutland, Laegaardvej 12, Holstebro, 7500, Denmark.
Eur Arch Otorhinolaryngol. 2019 May;276(5):1263-1273. doi: 10.1007/s00405-019-05359-y. Epub 2019 Feb 27.
The objective was to critically assess the current evidence investigating the efficacy of using a positive pressure device in patients with definite or probable Menière's disease.
We performed a systematic literature search in MEDLINE, EMBASE and PsycINFO up to February 2018. We included both systematic reviews and primary literature [randomized controlled trials (RCTs)] investigating positive pressure treatment, in patients (≥ 18 years of age), with Menière's disease. We assessed the internal validity of systematic reviews using the AMSTAR tool and risk of bias of primary studies using the Cochrane Risk of bias tool. We performed a meta-analysis for each outcome based on the identified studies. The overall certainty of evidence for the outcomes was assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE).
The search for systematic reviews identified four relevant reviews. These all included the same four RCTs. An updated search identified one additional RCT. In total, five RCTs were included in the data synthesis. Our data synthesis showed no effect of positive pressure treatment on primary nor secondary outcomes. No serious adverse events were reported. The overall certainty of evidence ranged from very low to low, due to the serious risk of bias and imprecision.
The current available evidence does not support positive pressure device treatment in patients with Menière's disease. However, the limitations of the current literature hinder the possibility of any solid conclusion. There remains a need for randomized controlled trials of high quality to fully access the utility of this treatment.
本研究旨在严格评估目前关于使用正压装置治疗确诊或疑似梅尼埃病患者疗效的证据。
截至2018年2月，我们在MEDLINE、EMBASE和PsycINFO数据库中进行了系统的文献检索。纳入了针对年龄≥18岁的梅尼埃病患者进行正压治疗的系统评价和原始文献[随机对照试验（RCT）]。我们使用AMSTAR工具评估系统评价的内部效度，使用Cochrane偏倚风险工具评估原始研究的偏倚风险。根据纳入的研究，对每个结局进行荟萃分析。使用推荐分级、评估、制定与评价（GRADE）系统评估结局证据的总体确定性。
检索到的系统评价中有4篇相关综述。这些综述均纳入了相同的4项RCT。更新检索后又发现了1项RCT。数据综合分析共纳入了5项RCT。我们的数据综合分析表明，正压治疗对主要结局和次要结局均无效果。未报告严重不良事件。由于存在严重的偏倚风险和不精确性，证据的总体确定性为极低到低。
目前可得的证据不支持对梅尼埃病患者使用正压装置治疗。然而，当前文献的局限性阻碍了得出任何确凿结论的可能性。仍需要高质量的随机对照试验来全面评估这种治疗方法的效用。
