Mathew 2009 Study 2.
Study characteristics | ||
Methods | Multicentre, R, DB, PC, cross‐over. Single dose to treat single attack. Washout between attacks ≥ 1 week Medication taken when PI mild and within 1 h of onset Assessments at 0, 0.5, 1, 1.5, 2, 4, 24, 48 h |
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Participants | Migraine ± aura (IHS 2004), aged 18 to 65 years, poor response to triptans with short half‐life. History: frequency of 1 to 8 per month, < 15 headache days monthly. Untreated severity ≥ mild Excluded: uncontrolled hypertension, cardio‐ or cerebrovascular disease N = 137 (131 for efficacy) F = 93% Mean age 40 years 27% without aura |
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Interventions | Sumatriptan 85 mg plus naproxen 500 mg, n = 134 Placebo, n = 133 Rescue medication allowed after 2 h if necessary (not specified) |
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Outcomes | Pain‐free at 2 h 24‐h sustained pain‐free Presence and relief of associated symptoms at 2 h 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 | Unclear risk | 50 to 200 participants per treatment arm |