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. Author manuscript; available in PMC: 2014 Sep 13.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Apr 14;(4):CD008041. doi: 10.1002/14651858.CD008041.pub2
Methods Multicentre, randomised, double-blind, placebo-controlled, two-period cross-over. Single oral dose of each medication for each of two attacks
Medication administered when migraine headache pain of moderate or severe intensity
Assessments at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, and 6 hours post-treatment
If pain not controlled, participants asked to wait 2 hours before taking rescue medication
Participants Aged > 18 years, meeting IHS criteria for migraine with and without aura. At least 12-month history of migraine, with one to six attacks per month within previous three months
Excluded participants who vomited during the majority of their migraine attacks
Excluded participants who regularly used NSAIDs or other drugs that could interact with trial medications
N = 101 (73 treated two attacks and analysed for efficacy)
M = 11, F = 90
Mean age 44 years
Interventions Mouth-dispersible aspirin 900 mg, n = 73
Placebo, n = 73
Outcomes Headache relief at all assessment time points
Pain-free at all assessment time points
PI: standard 4-point scale
Functional disability: standard 4-point scale
Presence/absence of associated symptoms
Headache recurrence at 24 hours
Use of rescue medication
Participants’ and investigators’ global assessments
Palatability and convenience of study medication
Notes Oxford Quality Score: R1, DB2, W1. Total score = 4.
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear Not described
Allocation concealment? Unclear Not described
Blinding?
All outcomes
Yes “Placebo tablets formulated and manufactured to be indistinguishable from aspirin tablets, with respect to appearance, taste and dispersion in mouth”