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原理比欺骗更重要吗?一项开放标签安慰剂镇痛的随机对照试验。

Is the rationale more important than deception? A randomized controlled trial of open-label placebo analgesia.

机构信息

Department of Psychology, Division of Clinical Psychology and Psychotherapy, University of Basel, Basel, Switzerland.

Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School (HMS), Boston, MA, USA.

出版信息

Pain. 2017 Dec;158(12):2320-2328. doi: 10.1097/j.pain.0000000000001012.


DOI:10.1097/j.pain.0000000000001012
PMID:28708766
Abstract

Research on open-label placebos questions whether deception is a necessary characteristic of placebo effects. Yet, comparisons between open-label and deceptive placebos (DPs) are lacking. We therefore assessed effects of open-label placebos and DPs in comparison with no treatment (NT) with a standardized experimental heat pain paradigm in a randomized controlled trial in healthy participants. Participants (N = 160) were randomly assigned to NT, open-label placebo without rationale (OPR-), open-label placebo with rationale (OPR), and DP. We conducted baseline and posttreatment measurements of heat pain threshold and tolerance. Apart from the NT, all groups received an application of a placebo cream. Primary outcomes were planned comparisons of heat pain tolerance and the corresponding intensity and unpleasantness ratings. Objective posttreatment pain tolerance did not differ among groups. However, for subjective heat pain ratings at the posttreatment tolerance level, groups with a rationale (OPR and DP) reported diminished heat pain intensity (t(146) = -2.15, P = 0.033, d = 0.43) and unpleasantness ratings (t(146) = -2.43, P = 0.016, d = 0.49) compared with the OPR-group. Interestingly, the OPR and the DP groups did not significantly differ in heat pain intensity (t(146) = -1.10, P = 0.272) or unpleasantness ratings (t(146) = -0.05, P = 0.961) at the posttreatment tolerance level. Our findings reveal that placebos with a plausible rationale are more effective than without a rationale. Even more, open-label placebos did not significantly differ in their effects from DPs. Therefore, we question the ubiquitously assumed necessity of concealment in placebo administration.

摘要

开放性安慰剂对安慰剂效应是否需要欺骗提出了质疑。然而,目前缺乏开放性安慰剂与欺骗性安慰剂(DP)之间的比较。因此,我们在一项健康参与者的随机对照试验中,使用标准化的实验性热痛范式,评估了开放性安慰剂和 DP 与无治疗(NT)之间的效果。参与者(N = 160)被随机分配到 NT、无理由的开放性安慰剂(OPR-)、有理由的开放性安慰剂(OPR)和 DP。我们进行了基线和治疗后热痛阈值和耐痛度的测量。除 NT 组外,所有组均接受安慰剂乳膏的应用。主要结局是计划比较热痛耐痛度以及相应的强度和不适评分。客观治疗后耐痛度在各组之间无差异。然而,对于治疗后耐痛度水平的主观热痛评分,有理由的组(OPR 和 DP)报告的热痛强度(t(146) = -2.15,P = 0.033,d = 0.43)和不适评分(t(146) = -2.43,P = 0.016,d = 0.49)降低。有趣的是,OPR 组和 DP 组在热痛强度(t(146) = -1.10,P = 0.272)或不适评分(t(146) = -0.05,P = 0.961)方面没有显著差异。我们的发现表明,有合理理由的安慰剂比没有理由的安慰剂更有效。更重要的是,开放性安慰剂在其效果上与 DP 没有显著差异。因此,我们对安慰剂给药中普遍假设的隐蔽必要性提出了质疑。

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