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. 2013 Oct 20;2013(10):CD009455. doi: 10.1002/14651858.CD009455.pub2

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
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
Interventions Naproxen sodium 275 mg, n = 81
Naratriptan 2.5 mg, n = 87
Outcomes Adverse events
Withdrawals
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