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科学工具、虚假治疗还是心理疗愈的触发因素:临床试验参与者如何看待安慰剂。

Scientific tools, fake treatments, or triggers for psychological healing: how clinical trial participants conceptualise placebos.

机构信息

University of Southampton School of Medicine, Southampton, Hampshire SO16 5ST, United Kingdom.

出版信息

Soc Sci Med. 2012 Mar;74(5):767-74. doi: 10.1016/j.socscimed.2011.11.020. Epub 2012 Jan 18.

DOI:10.1016/j.socscimed.2011.11.020
PMID:22285289
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3288621/
Abstract

Placebos are an essential tool in randomised clinical trials, where they are used to control for bias and contextual healing effects. Placebos and their effects are also studied from multiple diverse perspectives, but the perspectives of placebo recipients are seldom considered. Research shows that people form cognitive and affective representations of active treatments such as medicines, and that they use these representations to guide their behaviour; it seems reasonable to suggest that people might also think about and develop representations of placebos. We adopted a qualitative approach to examine in detail how participants in one RCT, conducted in the USA, conceptualised placebos. 12 people were interviewed 3 times each, at the start, middle, and end of a trial of placebo effects and acupuncture for Irritable Bowel Syndrome (IBS). The interview data were analysed inductively and we identified four ways in which the participants conceptualised placebos: placebos are necessary for research; placebo effects are fake; placebo acupuncture is not real acupuncture; placebos have real effects mediated by psychological mechanisms. Participants' conceptualisations of placebos were dynamic and situated in a broader psychological and socio-cultural context. Seeing placebo effects as legitimate seemed to be facilitated by having more holistic models of healing, viewing IBS as psychological, and seeing treatment as multifactorial. However, some participants maintained a negative view of placebo effects (e.g. as illusions) that was apparently inconsistent with their other beliefs (e.g. in mind-body healing mechanisms). This may indicate a dominance of negative discourses around placebos at a socio-cultural level. Negative views of placebos are inconsistent with evidence that placebo treatments can have positive effects on symptoms. RCT participants should be informed about potential benefits of placebo treatments to avoid misunderstandings and unease. Future work should improve methods of providing participants with full accurate information about placebos and their effects.

摘要

安慰剂是随机临床试验中的重要工具,用于控制偏倚和情境治疗效果。安慰剂及其效应也从多个不同的角度进行研究,但很少考虑安慰剂接受者的观点。研究表明,人们会对药物等主动治疗形成认知和情感的表象,并且会利用这些表象来指导自己的行为;因此,人们可能也会思考并形成对安慰剂的表象,这似乎是合理的。我们采用定性方法详细研究了美国一项随机对照试验(RCT)中,参与者如何概念化安慰剂。12 名参与者在一项安慰剂效应和针灸治疗肠易激综合征(IBS)的 RCT 开始、中间和结束时分别接受了 3 次访谈。对访谈数据进行了归纳分析,我们确定了参与者概念化安慰剂的四种方式:安慰剂对于研究是必要的;安慰剂效应是虚假的;安慰剂针灸不是真正的针灸;安慰剂通过心理机制产生真实的效果。参与者对安慰剂的概念化是动态的,并且处于更广泛的心理和社会文化背景中。对安慰剂效应的合法性持更全面的治疗观念,将 IBS 视为心理问题,以及将治疗视为多因素的观点,似乎有利于将安慰剂效应视为合法。然而,一些参与者仍然对安慰剂效应持有负面看法(例如,将其视为幻觉),这显然与他们的其他信念(例如,身心治疗机制)不一致。这可能表明在社会文化层面上,围绕安慰剂存在负面话语的主导地位。对安慰剂的负面看法与安慰剂治疗对症状有积极影响的证据不一致。RCT 参与者应该被告知安慰剂治疗的潜在益处,以避免误解和不适。未来的工作应该改进向参与者提供有关安慰剂及其效应的完整准确信息的方法。

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本文引用的文献

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How the psychosocial context of clinical trials differs from usual care: a qualitative study of acupuncture patients.临床试验的心理社会环境如何不同于常规护理:一项针对针灸患者的定性研究。
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Does inclusion of a placebo arm influence response to active antidepressant treatment in randomized controlled trials? Results from pooled and meta-analyses.在随机对照试验中,包含安慰剂组是否会影响对活性抗抑郁药治疗的反应?汇总和荟萃分析的结果。
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"Maybe I made up the whole thing": placebos and patients' experiences in a randomized controlled trial.“或许这一切都是我编造的”:随机对照试验中的安慰剂与患者体验
Cult Med Psychiatry. 2009 Sep;33(3):382-411. doi: 10.1007/s11013-009-9141-7.