Maintenance of Blinding in Clinical Trials and the Implications for Studying Analgesia Using Cannabinoids.
Maintenance of Blinding in Clinical Trials and the Implications for Studying Analgesia Using Cannabinoids.
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DOI：
10.1089/can.2016.0016
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发表时间：
2016
影响因子：
3.8
通讯作者：
Marcotte TD
中科院分区：
文献类型：
--
作者：
Wilsey B;Deutsch R;Marcotte TD
镇痛药临床试验的设计总是涉及安慰剂和活性研究药物之间的比较。假设治疗效果可以通过从使用活性研究药物获得的应答中减去安慰剂应答来近似。然而，大麻素的精神活性可能会暴露它们的存在，并导致对疼痛缓解的期望和/或条件反射。例如，研究参与者倾向于相信大麻对他们的病情有益，如果他们要准确地识别积极的治疗，因为它的精神活性，他们可能更倾向于报告积极的影响。这可能导致对大麻素功效的错误假设。在研究的设计阶段，需要实施旨在抵制揭盲的方法。在临床试验期间，询问参与者他们认为自己接受了哪种治疗也很重要。当治疗猜测的准确性与随机猜测（估计正确率为50%）没有显著差异时，可认为保留设盲。在研究完成后，使用统计方法，如回归和中介分析是值得考虑的，看看精神活性的影响是否会使结果产生偏差。
The design of analgesic clinical trials invariably involves a comparison between placebo and active study medication. An assumption is made that treatment effects can be approximated by subtracting the response to placebo from that attained with the use of active study medication. However, the psychoactivity of cannabinoids may unmask their presence and lead to an expectation and/or conditioning of pain relief. For example, study participants biased toward the belief that cannabis is beneficial for their condition might be more inclined to report positive effects if they were to accurately identify the active treatment because of its psychoactivity. This may lead to incorrect assumptions regarding the efficacy of a cannabinoid. Methodologies designed to counteract unmasking need to be implemented in the design phase of a study. During the clinical trial, it is also important to query participants as to which treatment they believe they have received. Blinding can be considered to be preserved when the accuracy of treatment guesses is not considerably different than random guessing, which is estimated to be correct 50% of the time. After a study has been completed, the use of statistical methodologies such as regression and mediation analysis are worthy of consideration to see whether psychoactive effects biased the results.
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DOI：
10.1038/npp.2008.120
发表时间：
2009-02
期刊：
Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology
影响因子：
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作者：
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影响因子：
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作者：
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通讯作者：
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影响因子：
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作者：
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通讯作者：
Dworkin, Robert H.
DOI：
10.1016/j.cct.2003.10.016
发表时间：
2004-04-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
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作者：
Bang, HJ;Ni, LY;Davis, CE
通讯作者：
Davis, CE
影响因子：
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作者：
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