| Methods | Multicentre, randomised, double-blind, parallel-group. Medication taken up to three times at 2-hour intervals, if adequate relief not obtained, to treat a single migraine attack Rescue medication taken if no relief of symptoms after three doses of trial medication. Usual medication allowed if attack persisted 2 hours after second dose of trial medication Assessments at 0 and 2 hours. |
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| Participants | Aged 18-65 years, meeting IHS criteria for migraine. Excluded participants with tension headache. N = 227 M = 34, F = 193 Mean age 34 years |
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| Interventions | Lysine acetylsalicylate 1620 mg (equivalent to 900 mg aspirin) plus metoclopramide 10 mg, n = 112 Ergotamine 2 mg plus caffeine 200 mg, n = 115 |
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| Outcomes | No nausea or vomiting 2 hours after first intake Headache intensity (4-point categorical scale) Headache relief Complete resolution of headache Use of rescue medication Patients’ global evaluation of treatment |
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| Notes | Oxford Quality Score: R2, DB2, W1. Total = 5. | |
| Risk of bias | ||
| Item | Authors’ judgement | Description |
| Adequate sequence generation? | Yes | “Central randomisation list generated with SAS (PC version) 6.08” |
| Allocation concealment? | Unclear | Not described |
| Blinding? All outcomes |
Yes | “Maintained by providing an equivalent number of placebo sachets or capsules” |