Placebo effects in trials evaluating 12 selected minimally invasive interventions: a systematic review and meta-analysis

Objectives: To analyse the impact of placebo effects on outcome in trials of selected minimally invasive procedures and to assess reported adverse events in both trial arms. Design: A systematic review and meta-analysis. Data sources and study selection: We searched MEDLINE and Cochrane library to identify systematic reviews of musculoskeletal, neurological and cardiac conditions published between January 2009 and January 2014 comparing selected minimally invasive with placebo (sham) procedures. We searched MEDLINE for additional randomised controlled trials published between January 2000 and January 2014. Data synthesis: Effect sizes (ES) in the active and placebo arms in the trials’ primary and pooled secondary end points were calculated. Linear regression was used to analyse the association between end points in the active and sham groups. Reported adverse events in both trial arms were registered. Results: We included 21 trials involving 2519 adult participants. For primary end poin...研究目的：分析安慰剂效应对选定微创手术试验结局的影响，并评估两组试验受试者报告的不良事件。研究设计：系统评价与荟萃分析（Meta-analysis）。数据来源与研究筛选：我们检索了MEDLINE数据库与Cochrane图书馆，以识别2009年1月至2014年1月间发表的、针对肌肉骨骼、神经及心脏疾病的系统评价，这些研究均对比了选定微创手术与安慰剂（假）手术的干预效果；同时检索MEDLINE数据库，以获取2000年1月至2014年1月间发表的额外随机对照试验。数据合成：计算试验主要结局指标与合并次要结局指标中，活性治疗组与安慰剂（假手术）组的效应量（Effect sizes, ES）；采用线性回归分析活性治疗组与假手术组的结局指标间的关联，并记录两组试验中报告的不良事件。研究结果：本研究共纳入21项试验，涉及2519名成年受试者。针对主要结局……