Placebo and nocebo effects in randomized double-blind clinical trials of agents for the therapy for fatigue in patients with advanced cancer.
Placebo and nocebo effects in randomized double-blind clinical trials of agents for the therapy for fatigue in patients with advanced cancer.
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DOI：
10.1002/cncr.24751
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发表时间：
2010-02-01
期刊：
影响因子：
6.2
通讯作者：
Bruera, Eduardo
中科院分区：
文献类型：
--
作者：
de la Cruz, Maxine;Hui, David;Parsons, Henrique A.;Bruera, Eduardo
我们以前曾报道过在治疗癌症相关疲劳（CRF）的随机对照试验中对安慰剂的显著反应。我们进行了一项回顾性研究，以确定在这些试验中接受治疗的CRF患者对安慰剂效应和反安慰剂效应反应的频率和预测因素。我们回顾了在我们组进行的两项先前随机临床试验中接受安慰剂的105例患者的记录，并确定了对疲劳表现出临床应答的患者比例，定义为FACIT-F评分从基线到第8天增加7分或更高，以及具有反安慰剂效应的患者比例，定义为报告>2个副作用的患者。分析基线患者特征和使用埃德蒙顿症状评估量表（ESAS）记录的症状，以确定其与安慰剂和反安慰剂效应的相关性。59例（56%）患者有安慰剂应答。更差的基线焦虑和幸福子量表评分（单变量）和幸福（多变量）与安慰剂反应显著相关。常见的副作用包括失眠（79%）、厌食（53%）、恶心（38%）和坐立不安（34%）。多变量分析显示，基线（ESAS）睡眠、食欲和恶心较差与相应副作用的报告增加相关。在CRF试验中，超过一半的晚期癌症患者有安慰剂反应。较差的基线身体健康评分与安慰剂反应相关。在基线时出现特定症状的患者更有可能将这些报告为药物的副作用。在未来CFR试验的设计中应考虑这些结果。
We have previously reported significant response to placebo in randomized controlled trials of treatments for cancer related fatigue (CRF). We conducted a retrospective study to determine the frequency and predictors of response to placebo effect and nocebo effect in patients with CRF treated in those trials. We reviewed the records of 105 patients who received placebo in two previous randomized clinical trials conducted by our group and determined the proportion of patients who demonstrated clinical response to fatigue, defined as an increase in FACIT-F score of 7 or greater from baseline to day 8, and the proportion of patients with a nocebo effect, defined as those reporting >2 side effects. Baseline patient characteristics and symptoms recorded using the Edmonton Symptom Assessment Scale (ESAS) were analyzed to determine their association with placebo and nocebo effects. 59 (56%) patients had a placebo response. Worse baseline anxiety and well-being subscale score (univariate) and well-being (multivariate) were significantly associated with placebo response. Common side effects reported were insomnia (79%), anorexia (53%), nausea (38%) and restlessness (34%). Multivariate analysis showed that worse baseline (ESAS) sleep, appetite, and nausea were associated with increased reporting of the corresponding side effects. More than half of advanced cancer patients enrolled in CRF trials had a placebo response. Worse baseline physical well-being score was associated with placebo response. Patients experiencing specific symptoms at baseline were more likely to report these as side effects of the medication. These findings should be considered in the design of future CFR trials.
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影响因子：
1.7
作者：
Bruera, E;Neumann, C;Quan, H
通讯作者：
Quan, H
影响因子：
3
作者：
Brown, WA
通讯作者：
Brown, WA
影响因子：
5.6
作者：
Montgomery, SA
通讯作者：
Montgomery, SA
DOI：
10.1001/jama.1955.02960340022006
发表时间：
1955-01-01
影响因子：
120.7
作者：
BEECHER, HK
通讯作者：
BEECHER, HK
影响因子：
7.4
作者：
Pollo, A;Amanzio, M;Benedetti, F
通讯作者：
Benedetti, F