S2WA4003.
Study characteristics | ||
Methods | Multicentre, R, DB, PC, parallel‐group. Single dose to treat single attack; several attacks treated over 12 weeks
Medication taken when PI ≥ moderate Assessments at 0, 4 h, for efficacy and adverse events, MSQ at baseline and after 12 weeks of treatment |
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Participants | Migraine ± aura (IHS 1988), aged 18‐65 years. History: > 12 months with frequency of 1‐6 per month and untreated severity ≥ moderate Excluded: previous use of triptan on > 3 occasions or had prescription for sumatriptan, ischaemic disease or symptoms, cardio‐ or cerebrovascular pathology, uncontrolled hypertension, epilepsy N = 168 F = 85% Mean age 39 years |
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Interventions | Naproxen sodium 275 mg, n = 81 Naratriptan 2.5 mg, n = 87 |
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Outcomes | Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double dummy" method |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Double dummy" method |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for |
Size | Unclear risk | 50‐200 participants in each treatment arm |