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. 2016 Apr 20;2016(4):CD008541. doi: 10.1002/14651858.CD008541.pub3

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
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
Interventions Sumatriptan 85 mg plus naproxen 500 mg, n = 134
Placebo, n = 133
Rescue medication allowed after 2 h if necessary (not specified)
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
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