胃食管反流病中安慰剂反应率的相关研究

Study of Placebo Response Rate in the Treatment of Gastroesophageal Reflux Disease

目的：对胃食管反流病（GERD）随机对照试验中的安慰剂反应率进行Meta分析并研究影响该反应率的因素。方法：检索EMBASE，CochraneControlledTrialRegister和Medline数据库中公开发表的关于双盲、随机、安慰荆对照治疗GERD的英文文献，所有文献均包括质子泵抑制剂／H2受体阻滞剂，治疗时间至少为2周。对文献试验数据进行Meta分析，绘制森林图，同时绘制漏斗图检查发表偏倚。结果：纳入24个研究，共包括8917名患者。有效治疗的反应率与安慰剂反应率相比的OR为3．70（95％CI：2．77～4．95）。所有的安慰剂反应率为18．84％（2．93％-47．05％）。运用质子泵抑制剂治疗的患者与H：受体阻滞剂治疗者相比，安慰剂反应率明显降低（14．50％vs．24．68％，P=0．05）。糜烂性食管炎患者的安慰剂反应率与非糜烂性食管炎者相比略低，两者差异无显著性（P〉0．05）。结论：在GERD随机对照试验中，安慰剂反应率确实存在。该反应率降低与质子泵抑制剂的运用相关，而与腐蚀性食管炎的存在与否无关。

Objective： To perform a meta analysis of placebo response rate in randomized clinical trials of gastroesophageal reflux disease （GERD）and to investigate the influential factors of placebo response rate. Methods： The published English documents about randomized, double blind and placebo controlled trials of the treatment of GERD in Medline, Cochrane, Controlled Trial Register and EMBASE databases were searched. All these documents included proton-pump inhibitors or H2-receptor antagonists. The treatment duration was at least two weeks. Meta analysis was performed for the trial data in documents. The forest plot was drawn. Meanwhile, the funnel plot was drawn to determine the publication bias. Results： Twenty four studies with 8917 patients were enrolled. The odds ratio （OR） of the response rate of effective treatment to placebo response rate was 3.70 [95% CI：2.77 -4.95]. The overall placebo response rate was 18.84% （2.93%-47.05%）. Compared with the patients treated by H2-receptor antagonists, the placebo response rate of patients treated by proton-pump inhibitors significantly decreased （ 14.50%vs.24.68% ,P=0.05 ）. There was no significant difference in placebo response rate between patients with erosive esophagitis and patients with non-erosive esophagitis. Conclusion： The placebo response rate certainly exists in randomized controlled trials of GERD. The decreasing of the placebo response is related to the application of proton-pump inhibitors, hut has no association with erosive esophagitis.