S2BT56.
Methods | Multicentre, randomised, double‐blind, cross‐over. Single dose to treat each of 2 attacks. Medication administered at the onset of migraine attack Assessments at 30, 60, 90, and 120 mins, and 24 h after dosing Optional second dose (placebo for sumatriptan group and identical second dose of study medication for ergotamine + caffeine group) available after 30 mins if the participant had not obtained sufficient relief Alternative rescue medication available if relief still inadequate or for recurrence within 24 h (no mention of restriction on time gap between study medication and rescue medication) |
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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. No migraine prophylaxis containing ergotamine or prophylaxis which was likely to change dose during the study. No use of monoamine oxidase inhibitors, selective serotonin reuptake inhibitors, or lithium during the course of the study. N = 289 (251 for efficacy) M 41, F 210 (84%) Mean age 41 years Proportion with/without aura not reported |
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Interventions | Sumatriptan 25 mg (+ optional dose of placebo at 30 mins), n = 251 Ergotamine tartrate 2 mg + caffeine 100 mg (Cafergot) (+ optional second dose at 30 mins), n = 251 |
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Outcomes | Headache relief (at 1 and 2 h) Pain‐free (at 1 and 2 h) 24 h sustained headache relief Relief of functional disability at 2 h Use of rescue medication Withdrawals |
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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 | Low risk | Treatment groups > 200 participants |