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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, double-dummy, three-period, cross-over. Single oral dose of each treatment for each of three migraine attacks Assessments at 0 and 2 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 without aura. At least 12-month history of migraine, with age of onset before 50 years and two to six attacks permonth. Prophylaxis permitted if stable for ≥ 2 months
Excluded participants with other types of headache. Included participants with ‘slight’ migraine at baseline, but reported primary outcomes for those with ≥ moderate pain separately
N = 247 (198 treated three attacks and analysed for efficacy)
M = 57, F = 190
Mean age = 40 years
36.8% of randomised participants were taking prophylactic therapy
Interventions Aspirin 1000 mg, n = 198
Acetaminophen 400 mg plus codeine 25 mg, n = 198
Placebo, n = 198
Outcomes Headache relief at 2 hours
Pain-free at 2 hours
PI: 100 mm VAS
Mean PID at 2 hours (from baseline)
Relief of nausea and vomiting
Use of rescue medication
Patient preference for medication
Adverse events
Notes Oxford Quality Score: R1, DB2, W1. Total = 4
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear Not described
Allocation concealment? Unclear Not described
Blinding?
All outcomes
Yes Double-dummy design