Methods | Multicentre, R, DB, PC and AC, four-way cross-over Four consecutive attacks treated with single doses of each test medication |
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Participants | “Simple” migraine (criteria of Soyka). Aged 18-70 years (included one patient aged 75 years). Prior attacks uniform with regard to headache intensity and duration N = 288 (completed 4 attacks M 55, F 233 Mean age 42 years |
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Interventions | Paracetamol 1000 mg Dihydroergotamine 2 mg Paracetamol + dihydroergotamine 1000/2 mg Placebo |
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Outcomes | Pain-free at 2 h Headache relief at 1 h and 2 h ≤ 50% pain relief at 1 h and 2 h Presence of nausea, vomiting, photophobia, phonophobia Use of rescue medication Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB1, W1. Total = 3 | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | “randomised order in the form of a Latin square” |
Allocation concealment? | Unclear | Not described |
Blinding? All outcomes |
Unclear | Not described |