Methods | Multicentre, randomised, double-blind (double-dummy), placebo-controlled, parallel-group. Single oral dose Medication taken when migraine of moderate or severe intensity Assessments at 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, and 4 hours If pain not controlled, participants asked to wait 2 hours before taking rescue medication (of participant’s choice) |
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Participants | Migraine with and without aura (IHS 1988). History: attack at least once every 2 months during past year. Untreated attacks ≥ moderate severity N = 1559 M 306, F 1249 Mean age 38 years History of aura: 21% |
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Interventions | Ibuprofen 2 × 200 mg, n = 669 Paracetamol + aspirin + caffeine 2 × 250/250/65 mg, n = 669 Placebo, n = 221 |
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Outcomes | Pain-free at 2 hours Presence of nausea, vomiting, photophobia, phonophobia Adverse events Withdrawals |
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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 method |