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Efficacy and Safety of 400 and 800 mg Etodolac vs. 1,000 mg Paracetamol in Acute Treatment of Migraine: A Randomized, Double‐blind, Crossover, Multicenter, Phase III Clinical Trial
Author(s) -
Öztürk Vesile,
Ertaş Mustafa,
Baykan Betül,
Şirin Hadiye,
Özge Aynur
Publication year - 2013
Publication title -
pain practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.899
H-Index - 58
eISSN - 1533-2500
pISSN - 1530-7085
DOI - 10.1111/j.1533-2500.2012.00572.x
Subject(s) - medicine , crossover study , etodolac , migraine , double blind , clinical trial , anesthesia , randomized controlled trial , multicenter study , surgery , pharmacology , placebo , alternative medicine , pathology
Aim: 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 1 year, 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 1,000 mg paracetamol, 400 mg etodolac, and 800 mg etodolac on 3 migraine attacks of moderate–severe 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 1,000 mg paracetamol, 400 mg etodolac, and 800 mg etodolac were as follows: response of headache at 2 hours 44.9%, 48.3% and 46.1%; pain‐free at 2 hours 19.2%, 19.3% and 24.1%; sustained pain‐free from 2 to 24 hours 34.3%, 38.3% and 41.1%; relapse rates in 2 to 24 hours 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 24 hours of treatment administration. Drug‐related adverse events were noted in 8 patients with 1,000 mg paracetamol, in 9 patients with 400 mg etodolac and in 9 patients for 800 mg 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 1,000 mg. Etodolac may be considered as an alternative option for acute treatment of migraine.