Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial.
Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-017-1964-x
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发表时间：
2017-05-25
期刊：
影响因子：
2.5
通讯作者：
Davis RB
中科院分区：
文献类型：
--
作者：
Ballou S;Kaptchuk TJ;Hirsch W;Nee J;Iturrino J;Hall KT;Kelley JM;Cheng V;Kirsch I;Jacobson E;Conboy L;Lembo A;Davis RB
根据定义，安慰剂药物由对症状没有生理影响的非活性成分组成。尽管如此，随机对照试验（RCT）和临床环境中的安慰剂给药已被证明对许多身体和心理疾病有显着影响。直到最近，传统观点还认为，患者必须相信安慰剂药片实际上含有（或者至少可能含有）活性药物，才能引起对安慰剂的反应。然而，最近的几项随机对照试验，包括患有肠易激综合征（IBS）、慢性腰痛和阵发性偏头痛的患者，已经证明接受开放标签安慰剂（OLP）的个体仍然可以经历症状改善，并从诚实描述的安慰剂治疗中受益。本文描述了一种创新的多学科试验设计 (n = 280)，试图复制和扩展早期 IBS OLP 研究。目前的研究将比较 OLP 与双盲安慰剂 (DBP) 给药，这是通过比较 DBP 和薄荷油的嵌套双盲 RCT 来实现的。该研究还检查了 OLP 可能的遗传和心理预测因素，并试图通过对随机选择的亚组进行一系列广泛访谈，更好地了解参与者对 OLP 和 DBP 的体验。 OLP 治疗是一种在道德上利用安慰剂效应的新策略。它有可能重新构建安慰剂理论，并影响医生如何优化常见主观症状的观察和等待策略。本研究旨在通过首次比较 OLP 和 DBP 给药方式，大幅扩展我们对 OLP 的了解。该研究采用独特的多学科方法，还探讨了 OLP 的遗传、心理和经验维度。本文最后对试验的“文化”以及 OLP 的潜在机制和伦理影响进行了广泛的讨论。 ClinicalTrials.gov，标识符：NCT02802241。注册于 2016 年 6 月 14 日。本文的在线版本 (doi:10.1186/s13063-017-1964-x) 包含补充材料，可供授权用户使用。
Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo. However, several recent RCTs, including patients with irritable bowel syndrome (IBS), chronic low back pain, and episodic migraine, have demonstrated that individuals receiving open-label placebo (OLP) can still experience symptomatic improvement and benefit from honestly described placebo treatment. This paper describes an innovative multidisciplinary trial design (n = 280) that attempts to replicate and expand upon an earlier IBS OLP study. The current study will compare OLP to double-blind placebo (DBP) administration which is made possible by including a nested, double-blind RCT comparing DBP and peppermint oil. The study also examines possible genetic and psychological predictors of OLP and seeks to better understand participants’ experiences with OLP and DBP through a series of extensive interviews with a randomly selected subgroup. OLP treatment is a novel strategy for ethically harnessing placebo effects. It has potential to re-frame theories of placebo and to influence how physicians can optimize watch-and-wait strategies for common, subjective symptoms. The current study aims to dramatically expand what we know about OLP by comparing, for the first time, OLP and DBP administration. Adopting a unique, multidisciplinary approach, the study also explores genetic, psychological and experiential dimensions of OLP. The paper ends with an extensive discussion of the “culture” of the trial as well as potential mechanisms of OLP and ethical implications. ClinicalTrials.gov, identifier: NCT02802241. Registered on 14 June 2016. The online version of this article (doi:10.1186/s13063-017-1964-x) contains supplementary material, which is available to authorized users.