Mostafaei Hadi, Janisch Florian, Mori Keiichiro, Quhal Fahad, Pradere Benjamin, Hajebrahimi Sakineh, Roehrborn Claus G, Shariat Shahrokh F
Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Research Center for Evidence Based Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, Medical University of Hamburg, Hamburg, Germany.
Eur Urol Focus. 2022 Jan;8(1):239-252. doi: 10.1016/j.euf.2021.02.005. Epub 2021 Mar 3.
The role of a placebo response in the management of overactive bladder (OAB) remains unclear.
The aim of this review is to methodically study the placebo response extracted from the control arms of randomized clinical trials assessing therapy in patients with OAB.
Medline (PubMed), The Cochrane Library, EMBASE, and Scopus were searched to identify randomized controlled trials (RCTs) published until September 2019. Randomized placebo-controlled trials investigating oral drug therapy for OAB were included. The articles were critically appraised by two reviewers. The primary outcomes were the placebo response in the main patient-reported urinary outcomes together with assessing the impact of patient demographic factors on the placebo response.
The initial search resulted in 1982 records after reviewing the titles and abstracts, and reference lists of other systematic reviews; 57 studies with an overall estimated 12 901 patients were included in the meta-analysis. The included studies were of overall high/acceptable quality. The standardized mean difference was -0.45 (95% confidence interval [CI] -0.51 to -0.40; p<0.001) for daily micturition episodes, -0.33 (95% CI -0.42 to -0.24; p<0.001) for daily nocturia episodes, -0.46 (95% CI -0.55 to -0.37; p<0.001) for urgency urinary incontinence episodes, -0.50 (95% CI -0.61 to -0.39; p<0.001) for daily urgency episodes, -0.51 (95% CI -0.60 to -0.43; p<0.001) for daily incontinence episodes, and 0.25 (95% CI 0.211-0.290; p<0.001) for volume voided per micturition. The meta-regression of age-related impact of the placebo response on nocturia showed a slope of -0.02 (p<0.001).
Placebo has a statistically significant effect on improving symptoms and signs associated with OAB; this effect is age dependent. However, there is no consensus on what change of OAB symptoms and signs is clinically meaningful for the affected patient. Taken together, the placebo response seems to be non-negligible in OAB, supporting the need for placebo control in RCTs.
Placebo is an inert treatment method often used in clinical research for comparison with active treatment. However, studies show that placebo has an effect of its own. A placebo response means the total improvement resulting from receiving a placebo. In our study, placebo had a significant role in improving the symptoms of overactive bladder.
安慰剂反应在膀胱过度活动症（OAB）管理中的作用仍不明确。
本综述的目的是系统研究从评估OAB患者治疗的随机临床试验的对照组中提取的安慰剂反应。
检索了Medline（PubMed）、Cochrane图书馆、EMBASE和Scopus，以识别截至2019年9月发表的随机对照试验（RCT）。纳入了调查OAB口服药物治疗的随机安慰剂对照试验。由两名评审员对文章进行严格评估。主要结局是主要患者报告的排尿结局中的安慰剂反应，同时评估患者人口统计学因素对安慰剂反应的影响。
初步检索在查看标题、摘要以及其他系统评价的参考文献列表后得到1982条记录；57项研究共纳入约12901例患者，纳入荟萃分析。纳入的研究总体质量高/可接受。每日排尿次数的标准化平均差为-0.45（95%置信区间[CI]-0.51至-0.40；p<0.001），每日夜尿次数为-0.33（95%CI-0.42至-0.24；p<0.001），急迫性尿失禁发作次数为-0.46（95%CI-0.55至-0.37；p<0.001），每日急迫发作次数为-0.50（95%CI-0.61至-0.39；p<0.001），每日失禁发作次数为-0.51（95%CI-0.60至-0.43；p<0.001），每次排尿量为0.25（95%CI0.211-0.290；p<0.001）。安慰剂反应对夜尿症的年龄相关影响的元回归显示斜率为-0.02（p<0.001）。
安慰剂对改善与OAB相关的症状和体征具有统计学显著效果；这种效果与年龄有关。然而，对于OAB症状和体征的何种变化对受影响患者具有临床意义尚无共识。综上所述，安慰剂反应在OAB中似乎不可忽视，支持在RCT中进行安慰剂对照的必要性。
安慰剂是一种惰性治疗方法，常用于临床研究中与活性治疗进行比较。然而，研究表明安慰剂有其自身的作用。安慰剂反应是指接受安慰剂后产生的总体改善。在我们的研究中，安慰剂在改善膀胱过度活动症症状方面具有重要作用。
