BBC地平线安慰剂背部疼痛研究:安慰剂有效性的公开试验

J. Howick, S. J. Kennedy, J. Myerscough, M. Mosley, C. Madigan
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引用次数: 0

摘要

背景:对随机试验的系统评价表明,共情护理(以人为本护理的核心组成部分)和安慰剂可以减轻慢性背痛。然而,这一证据很少得到实施,公众对同理心和安慰剂的了解也很有限。目的:我们在现实环境中进行了一项试验(“OPTICARE”)。这场审判及其后果被英国广播公司(BBC)的纪录片《地平线》(Horizon)拍摄下来。方法:年龄在18-75岁、自我报告持续背痛(>3个月)的符合条件的参与者被随机分配到:(1)对照组(SC):有一个标准的咨询和一个描述NHS背痛建议的传单。(2)标准安慰剂组(SP):接受为期三周的安慰剂丸疗程(2粒,每天两次)和标准(5-10分钟)全科医生(GP)咨询。(3)共情和安慰剂组(EP):接受与标准安慰剂组相同的SP治疗,并与医生进行更长时间(15-30分钟)的咨询,提示高度共情。使用视觉模拟量表和Roland Morris残疾问卷测量3周后疼痛的自我报告变化。这个过程由横财电影公司拍摄。结果:这部名为《安慰剂实验:我的大脑能治愈我的身体吗?》,于2018年10月4日在英国bbc2台首播。有190万人观看了直播。117名试验参与者中,几乎所有人都报告说,在现实世界中,安慰剂效应的减轻程度与临床试验中的情况相似。结论:这是我们所知道的最大的安慰剂研究,其主要目的是教育公众安慰剂的效果,也是第一份已知的为纪录片设计的研究报告。尽管该试验受到一些限制,包括污染和缺乏动力,但有人认为,安慰剂治疗的随机试验可以进行,从而使公众受益并受到教育。
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BBC Horizon placebo back pain study: a public trial of the effectiveness of placebos
Background: Systematic reviews of randomized trials show that empathic care (a core component of person-centered care) and placebos can reduce chronic back pain. However, this evidence has rarely been implemented and public knowledge of empathy and placebos is limited. Objectives: We conducted a trial (‘OPTICARE’) in a real-life setting. The trial and its aftermath were filmed for a British Broadcasting Corporation (BBC) Horizon documentary. Methods: Eligible participants aged 18-75 years with self-reported persistent back pain (>3 months) were randomised to: (1) Control group (SC): had a standard consultation and a leaflet describing NHS recommendations for back pain. (2) Standard placebo group (SP): received a three-week course of placebo pills (2 capsules, twice a day) and a standard (5-10 minute) general practice (GP) consultation. (3) Empathy and placebo group (EP): received the same as SP treatment as the standard placebo group and a longer (15-30 minute) consultation with a doctor prompted to be highly empathetic. Self-reported changes in pain after 3 weeks were measured using the Visual Analogue Scale and the Roland Morris Disability Questionnaire. The process was filmed by Windfall Films. Results: The documentary, entitled ‘The Placebo Experiment: Can My Brain Cure My Body?’ was first broadcast on BBC Two in the UK on 4 October 2018. It was watched by 1.9 million people. Almost all of the 117 participants in the trial reported a reduction in pain and magnitude of placebo effects is similar in real world settings as it is in clinical trials. Conclusions: This was the largest placebo study we are aware of that was conducted with a main purpose of educating the public about placebo effects and the first known published report of a study designed for a documentary. Although the trial suffered from a number of limitations, including contamination and lack of power, it is contended that randomised trials of placebo treatments can be conducted so that they benefit and educate the public.
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