Methods | Multicentre, randomised, double-blind, placebo-controlled, cross-over. Single dose to treat each of 4 consecutive attacks (3 with sumatriptan, 1 with placebo) Medication administered when migraine headache pain was of moderate or severe intensity Assessments at 0.5, 1, and 1.5 h after dosing Rescue medication available after 1.5 h |
|
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) No ergotamine or analgesics containing opioid derivatives within 24 h, or simple analgesics or antiemetics within 6 h of taking study medication Each treatment separated by a pain-free interval of at least 24 h N = 170 (of which 120 treated all 4 attacks) M 15, F 155 (91%) Mean age 41 years Proportion with/without aura not reported |
|
Interventions | Sumatriptan 6 mg, n = 166 (128 treating first attack with moderate or severe baseline pain intensity) Placebo, n = 144 (42 treating first attack with moderate or severe baseline pain intensity) |
|
Outcomes | Headache relief (at 1 h) Pain-free (at 1 h) 24 h sustained headache relief 24 h sustained pain-free Improvement in nausea, vomiting, photophobia, and phonophobia at 1 h Improvement in functional disability at 1 h Use of rescue medication Adverse events Withdrawals |
|
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 | Placebo injections designed to match the active dose |
Study size | High risk | Treatment group 50 to 200 participants, placebo group < 50 participants |