Efficacy and Safety of 400 and 800mg Etodolac vs. 1,000mg Paracetamol in Acute Treatment of Migraine: A Randomized, Double-blind, Crossover, Multicenter, Phase III Clinical Trial

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dc.contributor.authorOzturk, Vesile
dc.contributor.authorErtas, Mustafa
dc.contributor.authorBaykan, Betul
dc.contributor.authorSirin, Hadiye
dc.contributor.authorOzge, Aynur
dc.date.accessioned2019-10-27T21:52:52Z
dc.date.available2019-10-27T21:52:52Z
dc.date.issued2013
dc.departmentEge Üniversitesien_US
dc.description.abstractAim: We aimed to determine the efficacy and safety of etodolac, in acute migraine attacks in comparison with paracetamol (acetaminophen). Methods: We designed a randomized, double-blind, crossover phase III clinical trial for patients diagnosed with migraine for at least 1year, according to ICHD-II criteria. Two hundred and twenty-nine adult patients having 2 to 8 attacks monthly from 17 centers were included. The patients were instructed to use 3 attack treatment packages consisting of 1,000mg paracetamol, 400mg etodolac, and 800mg etodolac on 3 migraine attacks of moderatesevere intensity each in a 3-month treatment period, interchangeably. Results: Any pain medication was used in 1,570 migraine attacks while study treatments were used in 1,047 attacks. The results for 1,000mg paracetamol, 400 mg etodolac, and 800 mg etodolac were as follows: response of headache at 2hours 44.9%, 48.3% and 46.1%; pain-free at 2hours 19.2%, 19.3% and 24.1%; sustained pain-free from 2 to 24hours 34.3%, 38.3% and 41.1%; relapse rates in 2 to 24hours 7.3%, 14.3% and 9.7%. There were no statistically significant differences between the groups regarding the headache response, pain-free, sustained pain-free, and relapse rates. Nausea, vomiting, phonophobia, or photophobia decreased similarly in all groups within 24hours of treatment administration. Drug-related adverse events were noted in 8 patients with 1,000mg paracetamol, in 9 patients with 400mg etodolac and in 9 patients for 800mg etodolac during the study. Comment: Our study showed that etodolac is a safe and effective alternative in acute migraine treatment and showed comparable efficacy to paracetamol 1,000mg. Etodolac may be considered as an alternative option for acute treatment of migraine.en_US
dc.description.sponsorshipNobel Ilacen_US
dc.description.sponsorshipThis study was supported by Nobel Ilac, San. Tic AS and the study audits and follow-up were carried out by Omega Research Group.en_US
dc.identifier.doi10.1111/j.1533-2500.2012.00572.xen_US
dc.identifier.endpage197en_US
dc.identifier.issn1530-7085
dc.identifier.issue3en_US
dc.identifier.pmid22730906en_US
dc.identifier.scopusqualityQ2en_US
dc.identifier.startpage191en_US
dc.identifier.urihttps://doi.org/10.1111/j.1533-2500.2012.00572.x
dc.identifier.urihttps://hdl.handle.net/11454/47758
dc.identifier.volume13en_US
dc.identifier.wosWOS:000315962200003en_US
dc.identifier.wosqualityQ2en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherWiley-Blackwellen_US
dc.relation.ispartofPain Practiceen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectmigraineen_US
dc.subjectetodolacen_US
dc.subjectparacetamol (acetaminophen)en_US
dc.subjectacute migraine treatmenten_US
dc.subjectrandomizeden_US
dc.subjectdouble-blinden_US
dc.subjectclinical trialen_US
dc.subjectcrossover designen_US
dc.titleEfficacy and Safety of 400 and 800mg Etodolac vs. 1,000mg Paracetamol in Acute Treatment of Migraine: A Randomized, Double-blind, Crossover, Multicenter, Phase III Clinical Trialen_US
dc.typeArticleen_US

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