Department of Palliative Care and Rehabilitation Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA.
Cancer. 2010 Feb 1;116(3):766-74. doi: 10.1002/cncr.24751.
A significant response to placebo in randomized controlled trials of treatments for cancer-related fatigue (CRF) had been reported. A retrospective study was conducted to determine the frequency and predictors of response to placebo effect and nocebo effects in patients with CRF treated in those trials.
The records of 105 patients who received placebo in 2 previous randomized clinical trials conducted by this group were reviewed. The proportion of patients who demonstrated clinical response to fatigue, defined as an increase in Functional Assessment of Chronic Illness Therapy-Fatigue score of > or = 7 from baseline to Day 8, and the proportion of patients with a nocebo effect, defined as those reporting >2 side effects, were determined. Baseline patient characteristics and symptoms recorded using the Edmonton Symptom Assessment Scale (ESAS) were analyzed to determine their association with placebo and nocebo effects.
Fifty-nine (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. Commonly reported side effects were insomnia (79%), anorexia (53%), nausea (38%), and restlessness (34%). Multivariate analysis indicated that worse baseline (ESAS) sleep, appetite, and nausea were associated with increased reporting of the corresponding side effects.
Greater 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 CRF trials.
在癌症相关疲劳（CRF）的治疗随机对照试验中，报告了安慰剂的显著反应。进行了一项回顾性研究，以确定在这些试验中接受 CRF 治疗的患者对安慰剂效应和反安慰剂效应的反应频率和预测因素。
回顾了本研究小组进行的两项先前随机临床试验中接受安慰剂的 105 名患者的记录。确定了表现出疲劳临床反应的患者比例，定义为从基线到第 8 天疲劳功能评估慢性疾病治疗-疲劳评分增加≥7，以及报告≥2 种副作用的患者比例确定反安慰剂效应。分析了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，以确定它们与安慰剂和反安慰剂效应的关系。
59 名（56%）患者有安慰剂反应。基线焦虑和健康状况较差的子量表评分（单变量）和健康状况（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%）和不安（34%）。多变量分析表明，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。
参加 CRF 试验的晚期癌症患者中有一半以上有安慰剂反应。基线身体状况较差的评分与安慰剂反应相关。基线时出现特定症状的患者更有可能报告这些症状是药物的副作用。这些发现应在未来的 CRF 试验设计中加以考虑。
