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. Author manuscript; available in PMC: 2014 Sep 22.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Apr 14;(4):CD008042. doi: 10.1002/14651858.CD008042.pub2
Methods Participants recruited from 33 international neurology centres; in-patient based study
R, DB, three-period cross-over study; 18 h washout
One headache episode treated with each of two treatments
Participants IHS diagnosis of cluster headache
N = 157 randomised, 134 in efficacy analysis Mean age 41 ± 9 years
87% men Headache type: 72% episodic
Interventions Sumatriptan 6 mg, subcutaneous, n = 92
Sumatriptan 12 mg, subcutaneous, n = 88
Placebo, n = 88
Patients received 0.5 mL injection within 10 min of headache episode of at least moderate intensity
Rescue medication permitted after 15 min
Outcomes Primary: Pain relief to mild or none at 10 min on a five-point scale
Secondary: Headache relief at 5 and 15 min; pain-free at 15 min; associated symptoms; overall functional disability; adverse events/withdrawals; use of rescue medication
Notes Oxford Quality Score: 4 (R2, DB1, W1)
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Generated by computer
Allocation concealment? Unclear Not described
Blinding?
All outcomes
Unclear Not described