Cady 1998.
Methods | Multicentre, randomised, double‐blind, placebo‐controlled, parallel‐group. Single dose to treat single attack. Medication administered when migraine headache of moderate or severe intensity occurred within the first 4 h of a minimum 8 h work shift Assessments at 1 and 2 h after dosing Rescue medication (with the exception of ergotamine‐containing medications or sumatriptan) available after 2 h for intolerable pain Second dose of study medication available to treat recurrence in the workplace, provided no use of rescue medication had occurred |
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Participants | Aged 18 years or over, meeting IHS criteria for migraine (1988) with or without aura. At least 1‐year history of migraine (untreated severity ≥ moderate) with an average of 1 to 6 attacks per month. Participants had to have treated at last 1 disabling migraine in the workplace in the past 60 days, and had to be working 8‐hour (minimum) shifts at their jobs No monoamine oxidase inhibitors within 2 weeks of screening. No ergotamine‐containing medications or sumatriptan within 24 h, and no analgesics, antiemetics, or other acute migraine medications within 6 h of taking study medication. Participants were excluded if they had previously used sumatriptan (any formulation) N = 135 (132 for efficacy) M 20, F 112 (85%) Mean age 40 years Without aura 69% |
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Interventions | Sumatriptan 6 mg, n = 67 Placebo, n = 68 (65 for efficacy) |
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Outcomes | Use of rescue medication Adverse events Withdrawals |
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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 reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | Matching placebo |
Study size | Unclear risk | Treatment groups 50 to 200 participants |