Dimitriadis Panagiotis A, Zis Panagiotis
*Department of Ear, Nose and Throat Surgery, Sheffield Teaching Hospitals NHS Trust †Academic Department of Neurosciences, University of Sheffield, Sheffield, UK.
Otol Neurotol. 2017 Oct;38(9):1370-1375. doi: 10.1097/MAO.0000000000001555.
To estimate the frequency and strength of nocebo effects in trials for Menière disease (MD).
A literature search was conducted in PUBMED. The search terms we used were " Menière or Menière's," "treatment," and "placebo." Limitations included article type to be Clinical Trial or Randomized Controlled Trial, text availability to be Full text, Species to be Humans and Language to be English.
We included placebo-controlled pharmaceutical RCTs that referred specifically to MD and recruited at least 10 adults in each arm. We excluded those studies with JADAD score ≤3.
Thirty-six articles were screened identifying 12 eligible studies. Studies were included after consensus of both authors.
The meta-analysis was conducted using the RevMan programme as suggested by the Cochrane Collaboration Group. Data were analyzed using a random effects model.
Nocebo is an important confounding factor of the reported AEs in RCTs for treatment of MD and subsequently in the clinical practice. The pooled estimate of the percentage of placebo-treated patients with at least one AE was 42.3% (95% CI 8.1% to 16.3%), in comparison to 53.8% (95% CI 48.0% to 59.5%) for active drug-treated patients. Reporting of RCTs in MD is suboptimal and we recommend authors to endorse the CONSORT checklist.
评估梅尼埃病（MD）试验中反安慰剂效应的频率和强度。
在PUBMED中进行文献检索。我们使用的检索词为“梅尼埃或梅尼埃病”、“治疗”和“安慰剂”。限制条件包括文章类型为临床试验或随机对照试验、文本可获取性为全文、物种为人类且语言为英语。
我们纳入了专门提及MD且每组至少招募10名成年人的安慰剂对照药物随机对照试验。我们排除了JADAD评分≤3的研究。
筛选了36篇文章，确定了12项符合条件的研究。经两位作者达成共识后纳入研究。
按照Cochrane协作组的建议，使用RevMan程序进行荟萃分析。使用随机效应模型分析数据。
反安慰剂是MD治疗随机对照试验中报告的不良事件的重要混杂因素，随后在临床实践中也是如此。接受安慰剂治疗的患者中至少出现一种不良事件的百分比汇总估计为42.3%（95%CI 8.1%至16.3%），而接受活性药物治疗的患者为53.8%（95%CI 48.0%至59.5%）。MD随机对照试验的报告并不理想，我们建议作者采用CONSORT清单。
