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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Feb 15;2:CD009665. doi: 10.1002/14651858.CD009665
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
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%
Interventions Sumatriptan 6 mg, n = 76 (for efficacy)
Placebo, n = 40 (for efficacy)
Outcomes Headache relief (at 1 h)
Use of rescue medication
Adverse events
AE withdrawals
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