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Arch Neurol Chicago · Feb 1996
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialA double-blind study of subcutaneous dihydroergotamine vs subcutaneous sumatriptan in the treatment of acute migraine.
- P Winner, O Ricalde, B Le Force, J Saper, and B Margul.
- Palm Beach Headache Center, Fla, USA.
- Arch Neurol Chicago. 1996 Feb 1;53(2):180-4.
ObjectiveTo assess the efficacy and tolerability of subcutaneous dihydroergotamine mesylate (DHE-45) vs subcutaneous sumatriptan succinate (Imitrex) for the treatment of acute migraine with or without aura.DesignDouble-blind, randomized trial with parallel treatment arms.SettingClinics and private neurology practices.SubjectsPatients of either sex, with migraine with or without aura, between the ages of 18 and 65 years.InterventionsPatients with moderate or severe head pain were randomized to receive either 1 mg of subcutaneous dihydroergotamine mesylate or 6 mg of subcutaneous sumatriptan succinate. Patients rated head pain, functional ability, nausea, and vomiting at baseline and at 0.5, 1, 2, 4, and 24 hours after the injection. Presence or absence of headache at 3 hours was calculated from collected data. If pain persisted after 2 hours, a second injection of the same study medication was allowed, and self-ratings were repeated 30 and 60 minutes later. Follow-up data were collected at 24 hours.Main Outcome MeasuresRelief of head pain and recurrence of successfully treated headache.ResultsThere were 295 evaluable patients. At 2 hours, 73.1% of the patients treated with dihydroergotamine and 85.3% of those treated with sumatriptan had relief (P = .002). There was no statistical difference in headache relief between the groups at 3 or 4 hours. Headache relief was achieved by 85.5% of those treated with dihydroergotamine and by 83.3% of those treated with sumatriptan by 4 hours. By 24 hours 89.7% of dihydroergotamine-treated patients and 76.7% of sumatriptan-treated patients had relief (P = .004). Headache recurred within 24 hours after treatment in 45% of the sumatriptan-treated patients and in 17.7% of the dihydroergotamine-treated patients (P < or = .001).ConclusionsBoth sumatriptan and dihydroergotamine were effective in aborting migraine headaches. Headache recurrence was two and a half time as likely with sumatriptan as with dihydroergotamine.
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