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. 2014 May 21;2014(5):CD008616. doi: 10.1002/14651858.CD008616.pub2

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
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%
Interventions zolmitriptan 5 mg nasal spray, n = 935 (1745 attacks)
placebo, n = 934 (1718 attacks)
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
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