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 |