小脑性共济失调中的反安慰剂效应：安慰剂对照临床试验的系统评价和荟萃分析。
Nocebo in cerebellar ataxia: A systematic review and meta-analysis of placebo-controlled clinical trials.
机构信息
Academic Department of Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, UK; Sheffield Institute for Translational Neuroscience, Sheffield, UK.
Academic Department of Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, UK.
出版信息
J Neurol Sci. 2019 Jun 15;401:112-117. doi: 10.1016/j.jns.2019.04.039. Epub 2019 Apr 30.
INTRODUCTION
Nocebo, the negative counterpart of the placebo phenomenon results in the induction of adverse events (AEs) following the administration of an inert substance. Nocebo has been demonstrated to be associated with low treatment compliance in clinical trials, thus affecting treatment outcomes. This study sought to determine the prevalence of nocebo in cerebellar ataxia.
METHODS
A systematic literature search was conducted on Pubmed for randomized controlled trials (RCTs) for cerebellar ataxia treatments. The number of drug-related AEs and the number of withdrawals due to drug intolerance in the placebo group were statistically analysed.
RESULTS
The literature search identified 214 studies, of which 6 studies fulfilled the inclusion criteria. Approximately 1 in 20 (4.8%) placebo-treated patients withdrew treatment due to AEs and approximately 1 in 7 (13.8%) placebo-treated participants reported at least one AE. Participants in cerebellar ataxia trials reported similar AEs across both treatment groups (active and placebo).
CONCLUSION
Our results demonstrate that the nocebo effect in cerebellar ataxia is amongst the lowest in neurological diseases.
简介
“反安慰剂效应”是安慰剂效应的负面表现，在给予惰性物质后会导致不良事件（AE）的发生。反安慰剂效应已被证明与临床试验中的低治疗依从性有关，从而影响治疗结果。本研究旨在确定小脑性共济失调中反安慰剂的发生率。
方法
在 Pubmed 上对小脑性共济失调治疗的随机对照试验（RCT）进行了系统的文献检索。对安慰剂组中与药物相关的 AE 数量和因药物不耐受而停药的数量进行了统计学分析。
结果
文献检索共确定了 214 项研究，其中 6 项研究符合纳入标准。大约每 20 名（4.8%）接受安慰剂治疗的患者中有 1 名因 AE 而停止治疗，大约每 7 名（13.8%）接受安慰剂治疗的参与者报告至少有 1 项 AE。小脑共济失调试验的参与者在两组治疗中（主动和安慰剂）报告了类似的 AE。
结论
我们的研究结果表明，小脑性共济失调中的反安慰剂效应在神经疾病中是最低的之一。
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