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. Author manuscript; available in PMC: 2014 Sep 11.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Oct 6;(10):CD008039. doi: 10.1002/14651858.CD008039.pub2
Methods Randomised, double-blind, placebo-controlled, parallel-group. Single oral dose/attack (≥ 2 attacks treated)
Medication taken when migraine of moderate or severe intensity
Assessments at 0, 2, and 24 hours.
If moderate or severe headache persisted after 2 hours, rescue medication allowed (sumatriptan 100 mg or piroxicam 20 mg)
Participants Migraine with and without aura (IHS 1988). History: at least 12 month hx of migraine with/without aura, no more than 6 attacks/month. Untreated attacks ≥ moderate severity
Excluded participants with headaches usually needing bedrest, or ≥ 20% accompanied by vomiting
N = 124 (101 analysed)
M 18, F 83
Mean age 32 years
History of aura: not reported
Interventions Ibuprofen 400 mg, n = 35
Rofecoxib 25 mg, n = 33
Placebo, n = 33
Outcomes Headache relief at 2 hours
24 hour sustained relief
Use of rescue medication
Adverse events
Withdrawals
Notes Oxford Quality Score: R2, DB1, W1. Total 4
Note exclusions >10% lost to follow-up
Note: Headache relief not specifically defined
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes “random number tables”
Allocation concealment? Unclear Randomisation done by one investigator and responses evaluated by the other, but no details about method of concealment
Blinding?
All outcomes
Unclear Tablets had identical packets, but were not identical in appearance