Influence of control group on effect size in trials of acupuncture for chronic pain: a secondary analysis of an individual patient data meta-analysis.
Influence of control group on effect size in trials of acupuncture for chronic pain: a secondary analysis of an individual patient data meta-analysis.
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DOI：
10.1371/journal.pone.0093739
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Acupuncture Trialists' Collaboration
中科院分区：
文献类型：
--
作者：
MacPherson H;Vertosick E;Lewith G;Linde K;Sherman KJ;Witt CM;Vickers AJ;Acupuncture Trialists' Collaboration
在最近的一项个体患者数据荟萃分析中，发现对于慢性疼痛患者，针灸优于假手术和非假手术对照。在本文中，我们确定了所使用的假手术和非假手术对照类型的差异，并分析了它们对针灸效果大小的影响。根据对涉及头痛和偏头痛、骨关节炎以及背部、颈部和肩部疼痛患者的针灸试验的文献检索，29 项试验符合纳入标准，其中 20 项涉及假手术对照 (n = 5,230)，18 项涉及非假手术对照 (n = 14,597)。对于假手术对照，我们分析了非针假手术、穿透性假手术针和非穿透性假手术针。对于非假对照，我们分析了非指定的常规护理和方案指导护理。使用元回归，我们探讨了控制选择对针灸效果的影响。针刺组各类别均明显优于对照组。对于使用穿透针进行假控制的试验，针灸的效应大小比使用非穿透性假或无针假控制的试验要小。排除显示针灸效果非常大的外围研究后，效应大小的差异为-0.45（95% C.I. -0.78，-0.12；p = 0.007）或-0.19（95% C.I. -0.39，0.01；p = 0.058）。在非假手术对照试验中，与非特定常规护理相比，针灸的效应量大于方案指导护理。尽管效应大小差异很大（0.26），但在较宽的置信区间（95% C.I. -0.05, 0.57, p = 0.1）下并不显着。无论对照的亚型如何，针灸均明显优于对照。虽然对照的选择应由研究问题驱动，但我们的研究结果可以帮助为针灸研究设计提供信息，特别是在样本量方面。穿刺针似乎具有重要的生理活性。我们建议避免这种类型的假冒行为。
In a recent individual patient data meta-analysis, acupuncture was found to be superior to both sham and non-sham controls in patients with chronic pain. In this paper we identify variations in types of sham and non-sham controls used and analyze their impact on the effect size of acupuncture. Based on literature searches of acupuncture trials involving patients with headache and migraine, osteoarthritis, and back, neck and shoulder pain, 29 trials met inclusion criteria, 20 involving sham controls (n = 5,230) and 18 non-sham controls (n = 14,597). For sham controls, we analysed non-needle sham, penetrating sham needles and non-penetrating sham needles. For non-sham controls, we analysed non-specified routine care and protocol-guided care. Using meta-regression we explored impact of choice of control on effect of acupuncture. Acupuncture was significantly superior to all categories of control group. For trials that used penetrating needles for sham control, acupuncture had smaller effect sizes than for trials with non-penetrating sham or sham control without needles. The difference in effect size was −0.45 (95% C.I. −0.78, −0.12; p = 0.007), or −0.19 (95% C.I. −0.39, 0.01; p = 0.058) after exclusion of outlying studies showing very large effects of acupuncture. In trials with non-sham controls, larger effect sizes associated with acupuncture vs. non-specified routine care than vs. protocol-guided care. Although the difference in effect size was large (0.26), it was not significant with a wide confidence interval (95% C.I. −0.05, 0.57, p = 0.1). Acupuncture is significantly superior to control irrespective of the subtype of control. While the choice of control should be driven by the study question, our findings can help inform study design in acupuncture, particularly with respect to sample size. Penetrating needles appear to have important physiologic activity. We recommend that this type of sham be avoided.
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