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

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
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
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)
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
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