Clinically and Statistically Significant Changes Seen in Sham Surgery Arms of Randomized, Controlled Benign Prostatic Hyperplasia Surgery Trials
Clinically and Statistically Significant Changes Seen in Sham Surgery Arms of Randomized, Controlled Benign Prostatic Hyperplasia Surgery Trials
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DOI：
10.1016/j.juro.2015.06.091
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发表时间：
2015-12-01
影响因子：
6.6
通讯作者：
McVary, Kevin
中科院分区：
文献类型：
--
作者：
Welliver, Charles;Kottwitz, Michael;McVary, Kevin
目的：药物试验经常涉及安慰剂组，以更公平地评估研究药物的疗效。然而，良性前列腺增生手术试验很少包括假手术组，因为这些患者的模拟治疗存在固有风险。因此，安慰剂对假手术治疗良性前列腺增生的反应在很大程度上是未知的。材料和方法：我们系统地回顾了现有的文献，寻找随机对照试验，涉及内窥镜或前列腺内注射良性前列腺增生的治疗，其中包括假手术臂从1990年1月至2015年2月。纳入了包括客观症状问卷和3个月时最大尿流的研究。结果进行了分析与加权的基础上，研究样本size.Results：初步搜索共产生了1,998个潜在的研究。在对摘要和全文进行综述后，部分纳入了14个随机对照试验。在假内窥镜手术后3个月的AUASS（美国泌尿外科协会症状评分）研究中观察到平均从22.3降至16.7（-27%）（p = 0.0003），3个月时最大尿流增加1.3 ml/s（14%，p = 0.001）。3个月时基于前列腺注射的研究相似，从21.3降至15.7（-26%，p
Purpose: Medication trials frequently involve a placebo arm to more fairly assess the efficacy of the study drug. However, benign prostatic hyperplasia surgery trials rarely include a sham surgery group due to the inherent risks associated with simulating treatment in these patients. As a result the placebo response to sham surgery for benign prostatic hyperplasia is largely unknown.Materials and Methods: We systematically reviewed the available literature to look for randomized, controlled trials involving endoscopic or intraprostatic injection benign prostatic hyperplasia treatments that included a sham surgical arm from January 1990 to February 2015. Studies that included an objective symptom questionnaire and maximum urinary flow at 3 months were included. Results were analyzed together with weighting based on study sample size.Results: The initial search yielded a total of 1,998 potential studies. After reviewing abstracts and full text articles 14 randomized, controlled trials were included in some part. An average decrease from 22.3 to 16.7 (-27%) was seen in studies of the AUASS (American Urological Association symptom score) 3 months after a sham endoscopic procedure (p = 0.0003) with an increase in maximum urinary flow of 1.3 ml per second (14%, p = 0.001) at 3 months. Prostate injection based studies at 3 months were similar with a decrease from 21.3 to 15.7 (-26%, p