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

Smith 2005.

Study characteristics
Methods Multicentre, R, DB, DD, parallel group. Single dose to treat single attack
Medication taken when pain ≥ moderate
Assessments at 0, 15 min intervals to 2 h, 30 min to 4 h, hourly to 24 h
Participants Migraine ± aura (IHS 2004), aged ≥ 18 years. History ≥ 1 year with 2 to 6 attacks per month, and able to tolerate oral triptan or ergot derivative
N = 972
F = 91%
Mean age 42 years
Without aura: > 70%
Interventions Sumatriptan 50 mg plus naproxen 500 mg, n = 251
Sumatriptan 50 mg, n = 229
Naproxen 500 mg, n = 250
Placebo, n = 242
Rescue medication allowed after 2 h if necessary (not specified)
Outcomes Headache relief at 1 and 2 h
Pain‐free at 2 h
24‐h sustained headache relief
24‐h sustained pain‐free
Presence and relief of functional disability at 2 h
Presence and relief of associated symptoms at 2 h
Use of rescue medication
AEs
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 described
Allocation concealment (selection bias) Unclear risk Not described
Blinding (performance bias and detection bias)
All outcomes Low risk DD method, with sumatriptan encapsulated
Incomplete outcome data (attrition bias)
All outcomes Low risk Drop‐outs described
Study size Low risk > 200 participants per treatment arm