title: A double-blind study of subcutaneous dihydroergotamine vs subcutaneous sumatriptan in the treatment of acute migraine.
abstract: OBJECTIVE
  To 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.
  
  
  METHODS
  Double-blind, randomized trial with parallel treatment arms.
  
  
  METHODS
  Clinics and private neurology practices.
  
  
  METHODS
  Patients of either sex, with migraine with or without aura, between the ages of 18 and 65 years.
  
  
  METHODS
  Patients 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.
  
  
  METHODS
  Relief of head pain and recurrence of successfully treated headache.
  
  
  RESULTS
  There 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).
  
  
  CONCLUSIONS
  Both sumatriptan and dihydroergotamine were effective in aborting migraine headaches. Headache recurrence was two and a half time as likely with sumatriptan as with dihydroergotamine.
authors.affiliation: Palm Beach Headache Center, Fla, USA.
authors.forename: P
authors.initials: P
authors.lastname: Winner
authors.forename: O
authors.initials: O
authors.lastname: Ricalde
authors.forename: B
authors.initials: B
authors.lastname: Le Force
authors.forename: J
authors.initials: J
authors.lastname: Saper
authors.forename: B
authors.initials: B
authors.lastname: Margul
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000627:therapeutic use*; D004087:Dihydroergotamine / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D011446:Prospective Studies; D012008:Recurrence; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D018170:Sumatriptan / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D018712:Analgesics, Non-Narcotic; D017366:Serotonin Receptor Agonists; D004087:Dihydroergotamine; D018170:Sumatriptan