Dodick 2005.
| Methods | Multicentre, randomised, double‐blind, placebo controlled, parallel group. Single dose to treat up to 2 attacks Study medication to be taken within 15 minutes of pain becoming moderate or severe intensity. Headaches with moderate/severe intensity upon awakening were not to be treated Assessments made at 0, 0.25, 0.5, 1, 2 and 4 h Rescue medication permitted after 4 h |
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| Participants | Aged 18‐ 65 years, meeting IHS criteria for migraine (1988) with or without aura. At least 1 year history of migraine, with onset <50 years and 2 to 6 attacks/month. No prophylactics or non‐stable dose of SSRI within 2 months. No MAOI within 2 weeks. No analgesics, ergots or triptans within 24 h. Furthermore, no naratriptan within 36 h and no frovatriptan within 5 days. Excluded participants who had hypertension or any medical or physical condition that might put the patient at risk with exposure to zolmitriptan. N = 1869 (1868 for efficacy) M 248, F 1620 Mean age 41 years Without aura 56% |
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| Interventions | zolmitriptan 5 mg nasal spray, n = 935 (1745 attacks) placebo, n = 934 (1718 attacks) |
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| Outcomes | Headache relief (at 1, 2 and 4 h) Pain free (at 2 and 4 h) 24‐h sustained headache relief 24‐h sustained pain‐free Use of rescue medication Improvement in nausea, vomiting, photophobia, phonophobia Return to normal activities Adverse events |
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| 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 described |
| Allocation concealment (selection bias) | Unclear risk | not described |
| Blinding (performance bias and detection bias) All outcomes | Low risk | "matching placebo" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | drop‐outs described |
| Study size | Low risk | both groups >200 |