Placebo response in trials of drug treatments for cancer-related fatigue: a systematic review, meta-analysis and meta-regression.
Placebo response in trials of drug treatments for cancer-related fatigue: a systematic review, meta-analysis and meta-regression.
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DOI：
10.1136/bmjspcare-2019-002163
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发表时间：
2020-12
影响因子：
2.7
通讯作者：
Candy B
中科院分区：
文献类型：
--
作者：
Roji R;Stone P;Ricciardi F;Candy B
癌症相关性疲劳（CRF）是患者经历的最痛苦的症状之一。没有金标准的治疗方法，尽管已经测试了多种药物，但几乎没有有效性的证据。这些药物的随机对照试验（RCT）已经对安慰剂反应（PR）的存在或大小进行了评论。本系统综述的目的是确定缓解CRF药物RCT中PR的程度，并确定影响因素。纳入了旨在治疗CRF的RCT。使用安慰剂组基线和最终测量值之间的标准化平均变化（SMC）进行荟萃分析。为了探索可能与PR相关的因素（例如，人群或药物），进行了荟萃回归。使用修订后的科克伦工具评估偏倚风险。从3916篇引文中，确定了30项相关RCT。所有人都有局限性，这增加了他们产生偏见的风险。安慰剂组疲劳状态减轻的汇总SMC为−0.23（95%置信区间为−0.42至−0.04）。在荟萃回归分析的变量都没有统计学显着相关的PR。有一些证据，基于小样本的试验，在试验中的PR测试药物的CRF是不平凡的大小和统计学意义。我们建议研究人员在CRF中计划药物研究时应考虑实施替代试验设计，以更好地解释PR并减少对研究结果的影响。
Cancer-related fatigue (CRF) is one of the most distressing symptoms experienced by patients. There is no gold standard treatment, although multiple drugs have been tested with little evidence of efficacy. Randomised controlled trials (RCTs) of these drugs have commented on the existence or size of the placebo response (PR). The objective of this systematic review was to establish the magnitude of the PR in RCTs of drugs to relieve CRF and to identify contributing factors. RCTs were included in which the objective was to treat CRF. A meta-analysis was conducted using the standardised mean change (SMC) between baseline and final measurement in the placebo group. To explore factors that may be associated with the PR (eg, population or drug), a meta-regression was undertaken. Risk of bias was assessed using the revised Cochrane tool. From 3916 citations, 30 relevant RCTs were identified. All had limitations that increased their risk of bias. The pooled SMC in reduction in fatigue status in placebo groups was −0.23 (95% confidence intervals −0.42 to −0.04). None of the variables analysed in the meta-regression were statistically significant related to PR. There is some evidence, based on trials with small samples, that the PR in trials testing drugs for CRF is non-trivial in size and statistically significant. We recommend that researchers planning drug studies in CRF should consider implementing alternative trial designs to better account for PR and decrease impact on the study results.
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影响因子：
6.2
作者：
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Salanti, Georgia
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