Expectancy in placebo-controlled trials of psychedelics: if so, so what?
Expectancy in placebo-controlled trials of psychedelics: if so, so what?
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DOI：
10.1007/s00213-022-06221-6
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发表时间：
2022-10
影响因子：
3.4
通讯作者：
Rucker, James
中科院分区：
文献类型：
--
作者：
Butler, Matt;Jelen, Luke;Rucker, James
现代迷幻药的研究仍处于早期阶段，迷幻药最终引入临床实践仍存在疑问。在这篇文章中，我们讨论了致盲和预期在迷幻试验中的作用，并将其置于更广泛的历史和当代背景下，在医疗保健的其他领域进行试验。我们认为，不成熟和不加批判的宣传（“炒作”）的迷幻药作为药物不仅是误导，而且直接影响参与者的预期正在进行的迷幻药试验。我们认为，虽然致幻剂试验可能会显着高估治疗效果的设计，由于揭盲和预期效应，这不是一个独特的情况。安慰剂对照的随机对照试验并不完全适合所有的治疗方法，盲法的问题不应该自动取消药物的许可决定。我们建议，在迷幻药试验中可以（实际上已经）采取简单的实际措施，以部分减轻预期和揭盲的影响，例如独立评分员和活性安慰剂。我们简要地建议其他替代试验方法，可用于支持RCT结果，如自然研究。我们的结论是，当代安慰剂对照随机对照试验的致幻剂的结果不应被驳回，由于设计的不完善，也不应采取早期数据作为有效性的有力证据。
Modern psychedelic research remains in an early phase, and the eventual introduction of psychedelics into clinical practice remains in doubt. In this piece, we discuss the role of blinding and expectancy in psychedelic trials, and place this in a broader historical and contemporary context of blinding in trials across the rest of healthcare. We suggest that premature and uncritical promotion (‘hype’) of psychedelics as medicines is not only misleading, but also directly influences participant expectancy in ongoing psychedelic trials. We argue that although psychedelic trials are likely to significantly overestimate treatment effects by design due to unblinding and expectancy effects, this is not a unique situation. Placebo-controlled RCTs are not a perfect fit for all therapeutics, and problems in blinding should not automatically disqualify medications from licencing decisions. We suggest that simple practical measures may be (and indeed already are) taken in psychedelic trials to partially mitigate the effects of expectancy and unblinding, such as independent raters and active placebos. We briefly suggest other alternative trial methodologies which could be used to bolster RCT results, such as naturalistic studies. We conclude that the results of contemporary placebo-controlled RCTs of psychedelics should neither be dismissed due to imperfections in design, nor should early data be taken as firm evidence of effectiveness.
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影响因子：
7.2
作者：
Boutron, I;Tubach, F;Ravaud, P
通讯作者：
Ravaud, P
DOI：
10.1136/jnnp-2021-326924
发表时间：
2021-11
期刊：
Journal of neurology, neurosurgery, and psychiatry
影响因子：
--
作者：
Butler M;Tamborska A;Wood GK;Ellul M;Thomas RH;Galea I;Pett S;Singh B;Solomon T;Pollak TA;Michael BD;Nicholson TR
通讯作者：
Nicholson TR
影响因子：
4.4
作者：
Krauss, Alexander
通讯作者：
Krauss, Alexander
影响因子：
11
作者：
Burke, Matthew J.;Romanella, Sara M.;Santarnecchi, Emiliano
通讯作者：
Santarnecchi, Emiliano
影响因子：
4.1
作者：
Carhart-Harris, Robin L.;Roseman, Leor;Kaelen, Mendel
通讯作者：
Kaelen, Mendel