Methods | Multicentre, randomised, double-blind, placebo-controlled, parallel-group. Single dose to treat single attack Medication administered to treat the next moderate or severe migraine that occurred in the workplace during the first 4 h of an 8 h workday Assessments at 10, 20, 30, 40, 50, 60, 90, and 120 minutes after dosing Rescue medication (excluding ergotamine, ergot-containing medications or other suma- triptan preparations) available after 2 h if needed |
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Participants | Aged 18 to 65 years, 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, and at least 1 debilitating migraine treated in the workplace within 2 months of study enrolment Participants were required to be employed outside their homes, work a minimum of an 8 h shift, and be willing to self treat a migraine at work with an injection Participants were excluded if they were currently receiving monoamine oxidase inhibitors or had previously taken sumatriptan Participants were not to have taken any analgesics, antiemetics, or other acute migraine medications within 6 h before use of study medication 140 treated a preliminary attack in clinic N = 119 treated attack in workplace (116 for efficacy) M 14, F 105 (88%) Mean age 40 years Without aura 73% |
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Interventions | Sumatriptan 6 mg, n = 76 (for efficacy) Placebo, n = 40 (for efficacy) |
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Outcomes | Headache relief (at 1 h) Use of rescue medication Adverse events AE withdrawals |
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Notes | Oxford Quality Score: R1, DB2, W0. Total = 3. | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Low risk | Patients assigned a treatment number in chronological order as they were screened, each treatment number corresponded to a number on the label of unassigned trial medication |
Blinding (performance bias and detection bias) All outcomes |
Low risk | Matching placebo; identical packaging and double-blind medication labels |
Study size | High risk | Treatment group 50 to 200 participants, placebo group < 50 participants |