Comparison of subcutaneous sumatriptan with usual acute treatments for migraine. French Sumatriptan Study Group.

246 migraine patients (International Headache Society definition, 1-6 severe attacks per month) were randomised into a multicentre, cross-over study comparing subcutaneous (s.c.) sumatriptan 6 mg administered by an auto-injector (Glaxo device) with usual acute migraine treatments. Patients were treated for 2 months or up to 12 attacks, and then crossed over to the alternative treatment for the same duration. Usual treatments were: analgesics (including combinations), 49%; ergotamine, 24%; NSAIDs 19%; DHE, 7%. Rescue medication was allowed 2 h after the first dose. Headache was assessed on a 4-point self-rating scale (0: none, 1: mild, 2: moderate, 3: severe). Other migraine symptoms were assessed as present or absent. Quality of life was assessed before the study and at the end of each treatment period. Two hundred and seventeen patients were eligible for the cross-over analysis. At 2 h post-dosing, an average of 78% of attacks per patient were successfully relieved (grade 3 or 2 to 1 or 0) by s.c. sumatriptan, compared with 34% for the usual treatments (p < 0.001) and 63% of attacks per patient were completely relieved (grade 0) by s.c. sumatriptan compared with 15% for the usual treatments (p < 0.001). Sumatriptan-treated patients used rescue medication for 19% of their attacks, compared to 59% for comparator drugs (p = 0.001). Results for patient preference were: s.c. sumatriptan, 85%; usual treatments, 10%; no preference, 5% (p < 0.001). Sumatriptan was significantly superior to comparator drugs for all other efficacy end-points (p < 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes