Sheffield Institute for Translational Neuroscience, Sheffield, UK.
Academic Department of Neurosciences, Sheffield Teaching Hospitals, NHS Trust, Sheffield, UK.
Acta Neurol Belg. 2019 Jun;119(2):257-264. doi: 10.1007/s13760-019-01143-1. Epub 2019 Apr 19.
Nocebo refers to the adverse events (AEs) experienced when taking a placebo drug and is believed to be a centrally mediated process. We sought to examine the AEs following placebo administration in Randomised Controlled Trials (RCTs) for Myasthenia Gravis (MG) patients. A systematic literature search was performed on Medline and Web of Science for RCTs for MG pharmacological treatments. We assessed the number of placebo-treated patients reporting at least one AE and the number of dropouts because of AEs. Data were extracted from six RCTs fulfilling the search criteria. Four out of five placebo-treated participants (80.1%) reported at least one AE and one in 40 (2.4%) discontinued placebo treatment because of AE. All patients participating in the MG trials reported similar AEs independent of the study arm to which they belonged (placebo or active treatment). This meta-analysis demonstrates a low nocebo dropout rate in MG compared to central nervous system disorders.
“安慰剂效应”是指在服用安慰剂时所经历的不良反应（AE），被认为是一种中枢介导的过程。我们试图在随机对照试验（RCT）中检查重症肌无力（MG）患者服用安慰剂后的不良反应。对 Medline 和 Web of Science 进行了系统的文献检索，以寻找用于治疗 MG 的药理学 RCTs。我们评估了至少报告一种 AE 的安慰剂治疗患者数量和因 AE 而退出的患者数量。从符合检索标准的六项 RCT 中提取数据。五名安慰剂治疗的参与者中有四名（80.1%）报告了至少一种 AE，其中一人（2.4%）因 AE 而停止了安慰剂治疗。所有参加 MG 试验的患者报告了相似的不良反应，无论他们属于哪个研究组（安慰剂或活性治疗）。这项荟萃分析表明，与中枢神经系统疾病相比，MG 的安慰剂脱落率较低。
