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Placebo Rates in Randomized Controlled Trials of Pouchitis Therapy

机译：囊炎治疗随机对照试验中的安慰剂率

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BackgroundApproximately half of the patients with ulcerative colitis (UC) who undergo restorative proctocolectomy develop pouchitis within 10years of surgery. Currently, there are no approved pouchitis treatments. It is important to quantify, and ultimately minimize, placebo rates to design and conduct efficient pouchitis trials.AimsTo quantify the placebo rate observed in pouchitis randomized controlled trials (RCTs) in meta-analysis.MethodsEmbase, MEDLINE, and the Cochrane Library were searched from inception to November 3, 2017, for placebo-controlled RCTs enrolling adult UC patients with, or at risk for developing, pouchitis. A fixed-effect binomial-normal model was used to pool placebo rates on the log-odds (logit) scale. Proportions and 95% confidence intervals were reported. Outcomes of interest included development of pouchitis, induction of remission/response, and maintenance of remission/response. The Cochrane risk of bias tool was used to evaluate study quality.ResultsTwelve trials (five prevention, five induction, and two maintenance) enrolling a total of 229 placebo patients were eligible for inclusion. The pooled placebo rates for development of pouchitis and induction of response were 47% (95% CI 39-56%) and 24% (95% CI 14-37%), respectively. An insufficient number of trials prevented additional data pooling and meta-regression analysis and no consistent definitions of outcome were identified.ConclusionsNo consistent methods for measuring pouchitis disease activity or defining response and remission were identified, highlighting the need for standardized definitions of outcomes for use in pouchitis trials. Additional high-quality trials are required to evaluate existing and novel therapies in this area.
机译：背景，溃疡性结肠炎（UC）的一半患者接受恢复性的嗜酸性切除术，在手术的10年内发育囊炎。目前，没有经批准的唇膜炎治疗方法。重要的是要量化，最终最大限度地减少安慰剂率，以进行设计和进行有效的牙龈炎。MEDSTO量化在META分析中的牙龈炎随机对照试验（RCT）中观察到的安慰剂率..从中搜索了患有症，MEDLINE和Cochrane图书馆成立于2017年11月3日，用于安慰剂控制的RCT，注册成人UC患者或有风险患有囊性囊炎。固定效果二项式正常模型用于池对Log-odds（Logit）比例的安慰剂速率。报告了比例和95％的置信区间。感兴趣的结果包括牙龈炎的开发，诱导缓解/响应以及缓解/响应的维护。偏置工具的Cochrane风险用于评估学习质量。招收229名安慰剂患者共征收229名的预计预计患者（五项预防，五项归纳和两项维护）。池炎的汇集安慰剂率和抗应答诱导的速率分别为47％（95％CI 39-56％）和24％（95％CI 14-37％）。试验数量不足，防止了额外的数据汇集和元回归分析，并且没有确定结果的一致定义。结论不一致的测量囊疾病活动或定义响应和缓解的方法，突出了用于使用的结果的标准定义牙龈炎试验。需要额外的高质量试验来评估该领域的现有和新疗法。

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