van Sonsbeek Sanne, Pullens Bas, van Benthem Peter Paul
ENT Surgery, Gelre Hospitals, Apeldoorn, Netherlands.
Cochrane Database Syst Rev. 2015 Mar 10;2015(3):CD008419. doi: 10.1002/14651858.CD008419.pub2.
Ménière's disease is an incapacitating disease in which recurrent attacks of vertigo are accompanied by hearing loss, tinnitus and/or aural fullness, all of which are discontinuous and variable in intensity. A number of different therapies have been identified for patients with this disease, ranging from dietary measures (e.g. a low-salt diet) and medication (e.g. betahistine (Serc®), diuretics) to extensive surgery (e.g. endolymphatic sac surgery). The Meniett® low-pressure pulse generator (Medtronic ENT, 1999) is a device that is designed to generate a computer-controlled sequence of low-pressure (micro-pressure) pulses, which are thought to be transmitted to the vestibular system of the inner ear. The pressure pulse passes via a tympanostomy tube (grommet) to the middle ear, and hence to the inner ear via the round and/or oval window. The hypothesis is that these low-pressure pulses reduce endolymphatic hydrops.
To assess the effects of positive pressure therapy (e.g. the Meniett device) on the symptoms of Ménière's disease or syndrome.
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PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials.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 search was 6 June 2014.
Randomised controlled trials (RCTs) comparing positive pressure therapy (using the Meniett or a similar device) with placebo in patients with Ménière's disease. The primary outcome was control of vertigo; secondary outcomes were loss or gain of hearing, severity of tinnitus, perception of aural fullness, functional level, complications or adverse effects, and sick days.
Two authors independently selected studies, assessed risk of bias and extracted data. We contacted authors for additional data. Where possible, we pooled study results using a fixed-effect, mean difference (MD) meta-analysis and tested for statistical heterogeneity using both the Chi² test and I² statistic. This was only possible for the secondary outcomes loss or gain of hearing and sick days. We presented results using forest plots with 95% confidence intervals (Cl).
We included five randomised clinical trials with 265 participants. All trials were prospective, double-blind, placebo-controlled randomised controlled trials on the effects of positive pressure therapy on vertigo complaints in Ménière's disease. Overall, the risk of bias varied: three out of five studies were at low risk, one was at unclear risk and one was at high risk of bias. Control of vertigo For the primary outcome, control of vertigo, it was not possible to pool data due to heterogeneity in the measurement of the outcome measures. In most studies, no significant difference was found between the positive pressure therapy group and the placebo group in vertigo scores or vertigo days. Only one study, at low risk of bias, showed a significant difference in one measure of vertigo control in favour of positive pressure therapy. In this study, the mean visual analogue scale (VAS) score for vertigo after eight weeks of treatment was 25.5 in the positive pressure therapy group and 46.6 in the placebo group (mean difference (MD) -21.10, 95% CI -35.47 to -6.73; scale not stated - presumed to be 0 to 100). Secondary outcomes For the secondary outcomes, we carried out two pooled analyses. We found statistically significant results for loss or gain of hearing . Hearing was 7.38 decibels better in the placebo group compared to the positive pressure therapy group (MD) (95% CI 2.51 to 12.25; two studies, 123 participants). The severity of tinnitus and perception of aural fullness were either not measured or inadequate data were provided in the included studies. For the secondary outcome functional level , it was not possible to perform a pooled analysis. One included study showed less functional impairment in the positive pressure group than the placebo group (AAO-HNS criteria, one- to six-point scale: MD -1.10, 95% CI -1.81 to -0.39, 40 participants); another study did not show any significant results. In addition to the predefined secondary outcome measures, we included sick days as an additional outcome measure, as two studies used this outcome measure and it is a complementary measurement of impairment due to Ménière's disease. We did not find a statistically significant difference in sick days. No complications or adverse effects were noted by any study.
AUTHORS' CONCLUSIONS: There is no evidence, from five included studies, to show that positive pressure therapy is effective for the symptoms of Ménière's disease. There is some moderate quality evidence, from two studies, that hearing levels are worse in patients who use this therapy. The positive pressure therapy device itself is minimally invasive. However, in order to use it, a tympanostomy tube (grommet) needs to be inserted, with the associated risks. These include the risks of anaesthesia, the general risks of any surgery and the specific risks of otorrhoea and tympanosclerosis associated with the insertion of a tympanostomy tube. Notwithstanding these comments, no complications or adverse effects were noted in any of the included studies.
梅尼埃病是一种使人衰弱的疾病，反复出现的眩晕发作伴有听力损失、耳鸣和/或耳胀满感，所有这些症状都是间断性的且强度可变。已为该疾病患者确定了多种不同的治疗方法，从饮食措施（如低盐饮食）和药物治疗（如倍他司汀（敏使朗®）、利尿剂）到广泛的手术治疗（如内淋巴囊手术）。梅尼埃低压脉冲发生器（美敦力耳鼻喉科，1999年）是一种设计用于产生计算机控制的低压（微压）脉冲序列的设备，这些脉冲被认为会传输到内耳的前庭系统。压力脉冲通过鼓膜造孔管（通气管）进入中耳，进而通过圆窗和/或卵圆窗进入内耳。其假设是这些低压脉冲可减轻内淋巴积水。
评估正压疗法（如梅尼埃装置）对梅尼埃病或综合征症状的影响。
我们检索了Cochrane耳鼻喉疾病小组试验注册库；Cochrane对照试验中央注册库（CENTRAL）；PubMed；EMBASE；CINAHL；科学引文索引；剑桥科学文摘；国际临床试验注册平台以及其他已发表和未发表试验的来源。检索日期为2014年6月6日。
比较正压疗法（使用梅尼埃或类似装置）与安慰剂治疗梅尼埃病患者的随机对照试验（RCT）。主要结局是眩晕的控制；次要结局是听力的丧失或改善、耳鸣的严重程度、耳胀满感、功能水平、并发症或不良反应以及病假天数。
两位作者独立选择研究、评估偏倚风险并提取数据。我们联系作者获取额外数据。在可能的情况下，我们使用固定效应、平均差（MD）荟萃分析汇总研究结果，并使用卡方检验和I²统计量检验统计异质性。这仅适用于次要结局听力的丧失或改善以及病假天数。我们使用带有95%置信区间（CI）的森林图展示结果。
我们纳入了五项随机临床试验，共265名参与者。所有试验均为前瞻性、双盲、安慰剂对照的随机对照试验，研究正压疗法对梅尼埃病眩晕症状的影响。总体而言，偏倚风险各不相同：五项研究中有三项偏倚风险较低，一项风险不明，一项偏倚风险较高。眩晕的控制 对于主要结局，眩晕的控制，由于结局测量的异质性，无法汇总数据。在大多数研究中，正压疗法组和安慰剂组在眩晕评分或眩晕天数方面未发现显著差异。只有一项偏倚风险较低的研究显示在一项眩晕控制测量指标上正压疗法有显著差异。在该研究中，正压疗法组治疗八周后眩晕的平均视觉模拟量表（VAS）评分为25.5，安慰剂组为46.6（平均差（MD）-21.10，95%CI -35.47至-6.73；量表未说明 - 推测为0至100）。次要结局 对于次要结局，我们进行了两项汇总分析。我们发现听力的丧失或改善有统计学显著结果。与正压疗法组相比，安慰剂组听力提高了7.38分贝（MD）（95%CI 2.51至12.25；两项研究，123名参与者）。纳入研究中未测量耳鸣的严重程度或未提供足够的数据。对于次要结局功能水平，无法进行汇总分析。一项纳入研究显示正压组的功能损害比安慰剂组少（美国耳鼻咽喉头颈外科学会标准，1至6分制：MD -1.10，95%CI -1.81至-0.39，40名参与者）；另一项研究未显示任何显著结果。除了预定义的次要结局指标外，我们将病假天数作为一项额外的结局指标纳入分析，因为有两项研究使用了该结局指标，且它是梅尼埃病所致损害的补充测量指标。我们未发现病假天数有统计学显著差异。任何研究均未提及并发症或不良反应。
五项纳入研究没有证据表明正压疗法对梅尼埃病症状有效。两项研究提供了一些中等质量的证据，表明使用这种疗法的患者听力水平更差。正压疗法设备本身微创。然而，为了使用它，需要插入鼓膜造孔管（通气管），存在相关风险。这些风险包括麻醉风险、任何手术的一般风险以及与插入鼓膜造孔管相关的耳漏和鼓室硬化的特定风险。尽管如此，纳入研究中均未提及并发症或不良反应。
