Danish Headache Center, Department of Neurology, 70590Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Cephalalgia. 2021 Jan;41(1):99-111. doi: 10.1177/0333102420970489. Epub 2020 Nov 26.
Human models of migraine have been used for the past 30 years to test putative 'trigger' molecules and ascertain whether they induce migraine attacks in humans. However, nocebo effects using this model have never been systematically explored.
To assess the nocebo response rate in randomised clinical trials conducted at the Danish Headache Center, and in which human models of migraine were used.
In this systematic review and meta-analysis, we searched PubMed for studies of human models of migraine with a randomised, double-blind, placebo-controlled, two-way crossover design that included data on the incidence of migraine attacks or headache after infusion of placebo. A total of 943 articles were screened by title and abstract. Of these, 27 studies met the inclusion criteria (published between 1994 and 2020) and were included in the qualitative and quantitative analysis. We performed a random effects meta-analysis for the incidence of migraine attacks or delayed headache after placebo infusion.
Twenty-seven studies were eligible for inclusion: 12 studies reported data for adults with migraine (n = 182), whereas 16 studies reported data on healthy volunteers (n = 210). For adults with migraine, the incidence of migraine attacks after placebo was 8.1% (95% CI = 2.5-15.5%, I = 50.8%). The incidence of delayed headache was 25.9% (95% CI = 18.5-34.1%, I = 18.9%). For healthy volunteers, the incidence of migraine attacks after placebo was 0.5% (95% CI = 0.0-3.6%, I = 0.0%) while the incidence of delayed headache was 10.5% (95% CI = 4.8-17.6%, I = 45.2%).
The nocebo response in randomised, placebo-controlled two-way crossover trials with intravenous infusions of placebo in migraine is negligible. Future studies using human models of migraine can be conducted by assuming a nocebo response rate of 15.5%.
在过去的 30 年中，人们一直在使用偏头痛模型来测试推测的“触发”分子，并确定它们是否会在人类中引发偏头痛发作。然而，使用该模型的反安慰剂效应从未被系统地探索过。
评估在丹麦头痛中心进行的、使用偏头痛人类模型的随机临床试验中的反安慰剂反应率。
在这项系统评价和荟萃分析中，我们在 PubMed 上搜索了使用随机、双盲、安慰剂对照、双向交叉设计的偏头痛人类模型研究，这些研究包括在输注安慰剂后偏头痛发作或头痛的发生率数据。通过标题和摘要筛选了 943 篇文章。其中，27 项研究符合纳入标准（发表于 1994 年至 2020 年之间），并纳入了定性和定量分析。我们对安慰剂输注后偏头痛发作或延迟性头痛的发生率进行了随机效应荟萃分析。
27 项研究符合纳入标准：12 项研究报告了偏头痛成人的数据（n=182），而 16 项研究报告了健康志愿者的数据（n=210）。对于偏头痛成人，安慰剂后偏头痛发作的发生率为 8.1%（95%CI=2.5-15.5%，I=50.8%）。延迟性头痛的发生率为 25.9%（95%CI=18.5-34.1%，I=18.9%）。对于健康志愿者，安慰剂后偏头痛发作的发生率为 0.5%（95%CI=0.0-3.6%，I=0.0%），而延迟性头痛的发生率为 10.5%（95%CI=4.8-17.6%，I=45.2%）。
在偏头痛静脉输注安慰剂的随机、安慰剂对照双向交叉试验中，反安慰剂反应可忽略不计。未来使用偏头痛人类模型的研究可以假设反安慰剂反应率为 15.5%。
Zotero 插件