Pain Research, Department Surgery & Cancer, Faculty of Medicine, Imperial College, London, United Kingdom.
Research Centre, University College of Osteopathy, London, United Kingdom.
Pain. 2023 Mar 1;164(3):509-533. doi: 10.1097/j.pain.0000000000002730. Epub 2022 Jul 11.
Sham interventions in randomized clinical trials (RCTs) of physical, psychological, and self-management (PPS) therapies for pain are highly variable in design and believed to contribute to poor internal validity. However, it has not been formally tested whether the extent to which sham controls resemble the treatment under investigation consistently affects trial outcomes, such as effect sizes, differential attrition, participant expectancy, and blinding effectiveness. Placebo- or sham-controlled RCTs of PPS interventions of clinical pain populations were searched in 12 databases. The similarity of control interventions to the experimental treatment was rated across 25 features. Meta-regression analyses assessed putative links between employed control interventions, observed effect sizes in pain-related outcomes, attrition, and blinding success. The sample included 198 unique control interventions, dominated by manual therapy and chronic musculoskeletal pain research. Meta-analyses indicated small-to-moderate benefits of active treatments over control interventions, across subgroups of manual therapies, exercise, and rehabilitation, and psychological intervention trials. Multiple meta-regression modelling demonstrated that similarity between sham control and tested interventions predicted variability in pain-related outcomes, attrition, and blinding effectiveness. Influential variables were differences relating to the extent of intervention exposure, participant experience, and treatment environments. The results support the supposed link between blinding methods and effect sizes, based on a large and systematically sourced overview of methods. However, challenges to effective blinding are complex and often difficult to discern from trial reports. Nonetheless, these insights have the potential to change trial design, conduct, and reporting and will inform guideline development.
在针对疼痛的物理、心理和自我管理（PPS）疗法的随机临床试验（RCT）中，假干预措施在设计上差异很大，被认为会降低内部有效性。然而，尚未正式检验假对照与所研究的治疗方法之间的相似程度是否会一致影响试验结果，例如效应大小、差异损耗、参与者预期和盲法效果。在 12 个数据库中搜索了针对临床疼痛人群的 PPS 干预措施的安慰剂或假对照 RCT。通过 25 个特征来评估对照干预与实验治疗的相似性。荟萃回归分析评估了所采用的对照干预措施、观察到的疼痛相关结局、损耗和盲法效果之间的潜在联系。样本包括 198 个独特的对照干预措施，主要是手动疗法和慢性肌肉骨骼疼痛研究。荟萃分析表明，在手动疗法、运动和康复以及心理干预试验的亚组中，活性治疗相对于对照干预措施具有较小到中等的益处。多项荟萃回归模型表明，假对照与测试干预之间的相似性预测了疼痛相关结局、损耗和盲法效果的可变性。有影响力的变量是与干预暴露程度、参与者经验和治疗环境有关的差异。这些结果支持了基于对方法的系统综述和大量来源的方法与效应大小之间的假定联系。然而，有效的盲法面临的挑战很复杂，并且常常难以从试验报告中辨别出来。尽管如此，这些见解有可能改变试验设计、实施和报告，并为指南制定提供信息。
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