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 |