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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, three-fold cross-over, double-dummy. Single oral dose per attack. Each participant treated three migraine attacks with different treatments Medication taken when migraine headache pain of moderate or severe intensity
Assessments at 0, 0.5, 1, 1.5, 2 and 24 hours.
If pain not controlled, participants encouraged to wait 2 hours before taking rescue medication Participants instructed to leave a minimum of 48 hours between consecutive study treatments to ensure that new attack and not migraine recurrence was being treated
Participants Aged 18-65 years, meeting IHS criteria for migraine with and without aura. At least 12-month history of migraine, with one to six attacks per month
N = 312
M = 59, F = 253
Mean age 38 years
Interventions Effervescent acetylsalicylic acid 1000 mg, n = 222
Ibuprofen 400 mg, n = 212
Sumatriptan 50 mg, n = 226
Placebo, n = 222
Outcomes Pain intensity at 0.5, 1, 1.5 and 2 hours
Nausea, vomiting, photophobia and phonophobia at same time points
Global assessment of medication on 4-point categorical scale
Use of ‘escape medication’
Time when headache disappeared
Recurrence within 24 hours
Adverse events
Notes Oxford Quality Score: R2, DB2, W1. Total = 5.
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes “Treatment was assigned by a predetermined randomisation code”
Allocation concealment? Unclear Not described
Blinding?
All outcomes
Yes Double dummy design