Brandes 2007 Study 1.
Study characteristics | ||
Methods | Multicentre, R, DB, PC, parallel group. Single dose to treat single attack Medication taken when PI ≥ moderate Assessments at 0, 0.5, 1, 1.5, 2, then hourly to 24 h |
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Participants | Migraine ± aura (IHS 2004), aged 18 to 65 years. History: > 6 months with frequency of 2 to 6 per month and untreated severity ≥ moderate Excluded: uncontrolled hypertension, cardio‐ or cerebrovascular disease, using MAOI, ergot, SJW, or NSAID N = 1461 F = 86% Mean age 40 years 72% without aura |
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Interventions | Sumatriptan 85 mg plus naproxen 500 mg, n = 370 (364 analysed for efficacy) Sumatriptan 85 mg, n = 365 (361 for efficacy) Naproxen 500 mg, n = 361 (365 for efficacy) Placebo, n = 365 (360 for efficacy) Rescue medication allowed after 2 h if necessary (as prescribed by physician but not ergot‐containing, serotonin agonist, or NSAID‐containing medications) |
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Outcomes | Headache relief at 2 h Pain‐free at 2 h 24‐h sustained headache relief 24‐h sustained pain‐free Presence and relief of associated symptoms at 2 h Presence and relief of functional disability at 2 h (from Landy 2007) Use of rescue medication AEs Withdrawals |
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Notes | Oxford Quality Score: R1, DB1, W1. Total = 3 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐outs described |
Study size | Low risk | > 200 participants per treatment arm |