Lechien Jerome R, Saussez Sven, Schindler Antonio, Karkos Petros D, Hamdan Abdul Latif, Harmegnies Bernard, De Marrez Lisa G, Finck Camille, Journe Fabrice, Paesmans Marianne, Vaezi Michael F
From the Laryngopharyngeal Reflux Study Group of Young-Otolaryngologists of the International Federations of Oto-rhino-laryngological Societies (YO-IFOS).
the Laboratory of Anatomy and Cell Biology, Faculty of Medicine, UMONS Research Institute for Health Sciences and Technology.
Laryngoscope. 2019 May;129(5):1174-1187. doi: 10.1002/lary.27591. Epub 2018 Dec 30.
To investigate the therapeutic benefit of proton pump inhibitors (PPIs) over placebo in patients with laryngopharyngeal reflux (LPR) and to analyze the epidemiological factors of heterogeneity in the literature.
An electronic literature search was conducted to identify articles published between 1990 and 2018 about clinical trials describing the efficiency of medical treatment(s) on LPR. First, a meta-analysis of placebo randomized controlled trials (RCTs) comparing PPIs versus placebo was conducted according to diet. The heterogeneity, response to PPIs, and evolution of clinical scores were analyzed for aggregate results. Second, a systematic review of diagnosis methods, clinical outcome of treatment, and therapeutic regimens was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.
The search identified 1,140 relevant publications, of which 72 studies met the inclusion criteria for a total of 5,781 patients. Ten RCTs were included in the meta-analysis. The combined relative risk was 1.31 in favor of PPIs and increased to 1.42 when patients did not receive diet recommendations. Randomized controlled trials were characterized by a significant heterogeneity due to discrepancies in clinical therapeutic outcomes, diagnosis methods (lack of gold standard diagnostic tools), and therapeutic scheme. The epidemiological analysis of all articles supports the existence of these discrepancies in the entire literature. In particular, many symptoms and signs commonly encountered in LPR are not assessed in the treatment effectiveness. The lack of diagnosis precision and variability of inclusion criteria particularly create bias in all reported and included articles.
This meta-analysis supports a mild superiority of PPIs over placebo and the importance of diet as additional treatment but demonstrates the heterogeneity between studies, limiting the elaboration of clear conclusions. International recommendations are proposed for the development of future trials. Laryngoscope, 129:1174-1187, 2019.
探讨质子泵抑制剂(PPIs)对比安慰剂治疗喉咽反流(LPR)患者的疗效,并分析文献中异质性的流行病学因素。
进行电子文献检索,以确定1990年至2018年间发表的关于描述LPR药物治疗疗效的临床试验的文章。首先,根据饮食情况对比较PPIs与安慰剂的安慰剂随机对照试验(RCTs)进行荟萃分析。对汇总结果分析异质性、对PPIs的反应以及临床评分的变化。其次,使用系统评价和荟萃分析的首选报告项目声明对诊断方法、治疗的临床结局和治疗方案进行系统评价。
检索到1140篇相关出版物,其中72项研究符合纳入标准,共纳入5781例患者。10项RCTs纳入荟萃分析。合并相对风险为1.31,支持PPIs治疗,当患者未接受饮食建议时,该风险增加至1.42。随机对照试验的特点是由于临床治疗结局、诊断方法(缺乏金标准诊断工具)和治疗方案的差异而存在显著异质性。对所有文章的流行病学分析支持了整个文献中存在这些差异。特别是,LPR中常见的许多症状和体征在治疗效果评估中未被评估。诊断准确性的缺乏和纳入标准的变异性尤其在所有报告和纳入的文章中造成了偏差。
这项荟萃分析支持PPIs略优于安慰剂以及饮食作为辅助治疗的重要性,但证明了研究之间的异质性,限制了明确结论的得出。为未来试验的开展提出了国际建议。《喉镜》,2019年,129卷:1174 - 1187页 。