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Nocebo response in human models of migraine: A systematic review and meta-analysis of randomized, double-blind, placebo-controlled, two-way crossover trials in migraine without aura and healthy volunteers

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@article{1ebc75defc1a4b329c3e4d5c30ce4431,
title = "Nocebo response in human models of migraine: A systematic review and meta-analysis of randomized, double-blind, placebo-controlled, two-way crossover trials in migraine without aura and healthy volunteers",
abstract = "BACKGROUND: 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.OBJECTIVE: 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.METHODS: 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.RESULTS: 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%, I2 = 50.8%). The incidence of delayed headache was 25.9% (95% CI = 18.5-34.1%, I2 = 18.9%). For healthy volunteers, the incidence of migraine attacks after placebo was 0.5% (95% CI = 0.0-3.6%, I2 = 0.0%) while the incidence of delayed headache was 10.5% (95% CI = 4.8-17.6%, I2 = 45.2%).CONCLUSION: 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%.",
author = "Hashmat Ghanizada and Afrim Iljazi and H{\aa}kan Ashina and Do, {Thien Phu} and Al-Karagholi, {Mohammad Al-Mahdi} and Amin, {Faisal Mohammad} and Messoud Ashina",
year = "2021",
doi = "10.1177/0333102420970489",
language = "English",
volume = "41",
pages = "99--111",
journal = "Cephalalgia",
issn = "0333-1024",
publisher = "Wiley-Blackwell Publishing Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - Nocebo response in human models of migraine

T2 - A systematic review and meta-analysis of randomized, double-blind, placebo-controlled, two-way crossover trials in migraine without aura and healthy volunteers

AU - Ghanizada, Hashmat

AU - Iljazi, Afrim

AU - Ashina, Håkan

AU - Do, Thien Phu

AU - Al-Karagholi, Mohammad Al-Mahdi

AU - Amin, Faisal Mohammad

AU - Ashina, Messoud

PY - 2021

Y1 - 2021

N2 - BACKGROUND: 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.OBJECTIVE: 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.METHODS: 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.RESULTS: 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%, I2 = 50.8%). The incidence of delayed headache was 25.9% (95% CI = 18.5-34.1%, I2 = 18.9%). For healthy volunteers, the incidence of migraine attacks after placebo was 0.5% (95% CI = 0.0-3.6%, I2 = 0.0%) while the incidence of delayed headache was 10.5% (95% CI = 4.8-17.6%, I2 = 45.2%).CONCLUSION: 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%.

AB - BACKGROUND: 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.OBJECTIVE: 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.METHODS: 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.RESULTS: 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%, I2 = 50.8%). The incidence of delayed headache was 25.9% (95% CI = 18.5-34.1%, I2 = 18.9%). For healthy volunteers, the incidence of migraine attacks after placebo was 0.5% (95% CI = 0.0-3.6%, I2 = 0.0%) while the incidence of delayed headache was 10.5% (95% CI = 4.8-17.6%, I2 = 45.2%).CONCLUSION: 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%.

U2 - 10.1177/0333102420970489

DO - 10.1177/0333102420970489

M3 - Review

C2 - 33241720

VL - 41

SP - 99

EP - 111

JO - Cephalalgia

JF - Cephalalgia

SN - 0333-1024

IS - 1

ER -

ID: 62085330