Department of Neurology and Neurosurgery, Russian State Medical University, Moscow, Russia.
Epilepsy Behav. 2010 Jan;17(1):64-9. doi: 10.1016/j.yebeh.2009.10.007. Epub 2009 Nov 17.
This meta-analysis of published, randomized, controlled trials (RCTs) of antiepileptic drugs in adults with focal drug-resistant epilepsy was performed to estimate a mean placebo effect, to evaluate variability in placebo response rates, to investigate associations between placebo effect rates and study characteristics, and to determine whether there were changes in placebo response rates over recent years in RCTs (so-called "placebo drift"). One hundred ninety-eight potentially appropriate studies were identified after MEDLINE search and carefully reviewed. Twenty-seven RCTs (with 5662 randomized patients, including 1887 patients in placebo arms) were included in the meta-analysis. A random effects meta-analytic model estimated the pooled placebo response at 12.5% (95% CI: 10.03-14.94%). A statistically significant correlation between baseline median seizure frequency and placebo response rates was not observed. "Placebo drift" was not considered statistically significant.
本研究对已发表的成人局灶性耐药性癫痫的抗癫痫药物随机对照试验（RCT）进行了荟萃分析，旨在估计平均安慰剂效应，评估安慰剂反应率的变异性，研究安慰剂效应率与研究特征之间的关系，并确定近年来 RCT 中安慰剂反应率是否发生变化（所谓的“安慰剂漂移”）。在 MEDLINE 搜索后仔细审查，确定了 198 项潜在合适的研究。27 项 RCT（共 5662 名随机患者，包括 1887 名安慰剂组患者）纳入荟萃分析。随机效应荟萃分析模型估计， pooled placebo response 为 12.5%（95% CI：10.03-14.94%）。基线中位数发作频率与安慰剂反应率之间未观察到统计学上显著相关性。“安慰剂漂移”未被认为具有统计学意义。
