Akpunonu 1995.
Methods | Multicentre, randomised, double‐blind, placebo‐controlled, parallel‐group. Single dose to treat single attack. Medication administered when migraine headache pain was of moderate or severe intensity Assessments by stopwatch and at discharge from emergency department (time not reported and may vary between participants) Rescue medication (excluding ergot derivatives) available after 90 minutes if headache relief not achieved Each participant provided with an open‐label 100 mg sumatriptan tablet to treat recurrence over the 24 h period after discharge |
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Participants | Aged 18 years or older, meeting IHS criteria for migraine (1988) with aura. At least 1‐year history of migraine. Participants with a frequency of tension headache of at least 15 days per month were excluded No concurrent use of monoamine oxidase inhibitors, lithium, or selective 5‐HT reuptake inhibitors No use of ergotamine within 24 h of study drug administration N = 136 Breakdown of participants by gender not reported Mean age not reported 100% with aura |
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Interventions | Sumatriptan 6 mg, n = 88 Placebo, n = 48 |
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Outcomes | Adverse events | |
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 reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported |
Study size | High risk | Treatment group 50 to 200 participants, placebo group < 50 participants |