Webster Rebecca K, Rubin G James
Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.
The National Institute for Health Research Health Protection Research Unit in Emergency Preparedness and Response, King's College London, London, United Kingdom.
Front Psychiatry. 2019 Feb 5;9:775. doi: 10.3389/fpsyt.2018.00775. eCollection 2018.
Nocebo effects contribute to a large proportion of the non-specific side-effects attributed to medications and are mainly generated through negative expectations. Previous reviews show that interventions designed to change participants' expectations have a small effect on pain experience. They are also effective in reducing side-effects caused by exposure to sham medications. To date, there has been no review of the influence of such interventions on symptoms attributed to real medicinal treatments. To review studies using a randomized controlled design testing the effect of brief psychological interventions compared to usual practice on the side-effect experience to medicinal treatments in healthy volunteers and patients. We searched Web of Science, Scopus, Medline, PsycINFO, PsycARTICLES, and Cochrane CENTRAL using search terms for randomized controlled trials along with "nocebo," "placebo effect," "medication," "side-effects," and associated terms. Studies were eligible if they studied a human population, used an active medicine, delivered a brief psychological intervention intended to influence side-effect reporting compared to usual care or no intervention, and used a randomized controlled design. Because of the heterogeneity of the literature we used a narrative synthesis and assessed evidence quality using the GRADE approach. Our database search and supplementary search of the reference sections of included studies retrieved 50,140 citations. After screening, full text review and manual reference searches, 27 studies were included. The quality of the studies and evidence was judged to be low. The strongest and most consistent effect came from omitting side-effect information, although surprisingly de-emphasizing side-effects did not affect side-effect reporting. Other techniques, including priming, distraction, and altering the perception of branding, produced mixed results. Brief psychological interventions can influence side-effect reporting to active medications. Research is currently investigating new ways to de-emphasize side-effects whilst still upholding informed consent, but larger confirmatory trials with suitable control groups are needed. The literature in this area would be improved by more detailed reporting of studies.
反安慰剂效应在很大一部分归因于药物的非特异性副作用中起作用，并且主要是通过负面预期产生的。以往的综述表明，旨在改变参与者预期的干预措施对疼痛体验的影响很小。它们在减少接触安慰剂药物所引起的副作用方面也很有效。迄今为止，尚未有关于此类干预措施对真实药物治疗所致症状影响的综述。为了综述使用随机对照设计的研究，这些研究测试了与常规治疗相比，简短心理干预对健康志愿者和患者药物治疗副作用体验的影响。我们在科学网、Scopus、Medline、PsycINFO、PsycARTICLES和Cochrane CENTRAL中进行搜索，使用了随机对照试验的检索词以及“反安慰剂”“安慰剂效应”“药物”“副作用”及相关术语。如果研究对象是人类、使用了活性药物、与常规护理或无干预相比实施了旨在影响副作用报告的简短心理干预且采用了随机对照设计，则这些研究符合纳入标准。由于文献的异质性，我们采用了叙述性综合分析，并使用GRADE方法评估证据质量。我们的数据库搜索以及对纳入研究参考文献部分的补充搜索共检索到50140条引文。经过筛选、全文评审和手动参考文献检索后，纳入了27项研究。研究和证据的质量被判定为低。最强且最一致的效应来自省略副作用信息，尽管令人惊讶的是，淡化副作用并未影响副作用报告。其他技术，包括启动、分散注意力和改变对品牌的认知，产生了混合结果。简短心理干预可以影响对活性药物的副作用报告。目前研究正在探索在坚持知情同意的同时淡化副作用的新方法，但需要有合适对照组的更大规模的验证性试验。该领域的文献通过更详细的研究报告将得到改善。
