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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, three-arm, parallel-group, double-dummy. Single oral dose 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 asked to wait 2 hours before taking rescue medication
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 = 433
M = 66, F = 367
Mean age 42 years
Interventions Effervescent acetylsalicylic acid 1000 mg, n = 146
Sumatriptan 50 mg, n = 135
Placebo, n = 152
Outcomes Headache relief at 1 and 2 hours
Pain-free at 2 hours
24-hour sustained relief
Adverse events
Remission of associated symptoms: nausea, photophobia, phonophobia
Overall impression of study medication
Need for rescue medication
Notes Oxford Quality Score: R2, DB2, W1. Total = 5.
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes “Computer-generated randomisation list”
Allocation concealment? Unclear Not described
Blinding?
All outcomes
Yes “Matching effervescent or tablet placebo”