Calhoun 2014.
Study characteristics | ||
Methods | Single centre, R, DB, PC, cross‐over study 4 non‐menstrual migraines treated with single dose of study medication (4 sumatriptan plus naproxen, 1 placebo, in random order), within 30 min of onset of headache or neck pain, and only if preceding day was free of both headache and neck pain | |
Participants | Episodic migraine ± aura (IHS 2004), aged 18 to 55 years. 1‐year history, with 2 to 7 attacks per month in previous 3 months, able to recognise in mild pain stage. Preventive medication stable for previous 2 months and throughout study
Excluded: ≥ 8 migraine attacks per month or > 15 days per month of headache or neck pain, uncontrolled hypertension, cardio‐ or cerebrovascular disease, peripheral vascular disease, using MAOI, ergot, SJW N = 43 F = 95% Mean age 36 years |
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Interventions | Sumatriptan 85 mg plus naproxen 500 mg, n = 43
Placebo n = 43 Rescue medication allowed with open label sumatriptan plus naproxen or other approved medication after 2 h for inadequate response |
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Outcomes | Pain‐free at 2 h 24‐h sustained pain‐free Adverse events |
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Notes | Oxford Quality Score: R2, DB1, W0. Total = 3 Authors were contacted to find out what denominator was used to calculate response rate, but the information was not provided |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Study drug and placebo were dispensed based on a randomization code" |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Method to maintain blinding not described: "blister pack containing 4 pills", but unclear if pills were identical |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Results reported for ITT population, but it was unclear whether the denominator used to calculate per cent response was participants or headache episodes (each participant was asked to treat 4 episodes) |
Study size | High risk | < 50 participants per treatment arm |