Bousser 1993.

Methods	Multicentre, randomised, double‐blind, placebo‐controlled, cross‐over 2 consecutive early‐morning attacks treated when migraine headache pain was of moderate or severe intensity Single dose to treat each of 2 successive attacks with recommended second dose of study medication after 1 h for inadequate relief Assessments at 1, 2, 4, and 24 h after dosing Rescue medication available 2 h after initial dosing, provided it did not contain ergotamine
Participants	Aged 18 to 65 years, meeting IHS criteria for migraine (1988) with or without aura. At least 6‐month history of migraine (untreated severity ≥ moderate) with an average of 2 to 6 attacks per month, of which at least 2 were early‐morning migraine attacks. No ergot‐containing preparations were allowed within 24 h of taking study drugs N = 96 M 17, F 79 (82%) Mean age 41 years Proportion with/without aura not reported
Interventions	Sumatriptan 6 mg, n = 49 (41 for 1st attack efficacy) Placebo, n = 47 (40 for 1st attack efficacy)
Outcomes	Headache relief (at 1 h) and 2 h (1 h after optional 2nd dose) Pain‐free (at 1 h) and 2 h (1 h after optional 2nd dose) Presence of nausea and vomiting at 1 h Adverse events Withdrawals
Notes	Oxford Quality Score: R2, DB2, W1. Total = 5.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation code
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	Low risk	Study drug and placebo provided in identical syringes
Study size	High risk	Treatment groups < 50 participants