[Efficacy and tolerance of an effervescent aspirin-metoclopramide combination in the treatment of a migraine attack. Randomized double-blind study using a placebo].
OBJECTIVE
A double blind, randomized, multicenter, parallel group study was carried out to compare the efficacy and tolerance of aspirin 900 mg-metoclopramide 10 mg effervescent association (AAM) with those of placebo in the treatment of acute migraine attack. All patients were selected according to the International Headache Society criteria.


METHODS
A total of 303 out-patients with an acute migraine attack were treated orally with either AAM (n = 152) or placebo (n = 151).


RESULTS
The aspirin-metoclopramide association was significantly more effective than placebo at relieving headache (principal criterion) within 2 h of treatment (54.3% versus 25.9% : p < 0.001), producing entire resolution of acute migraine attack (14.2% versus 5.3% : p = 0.017), reducing the percentage of patients requiring rescue medication (44.3% versus 63.2% : p = 0.001) and increasing the percentage of patients able to resume their usual activities (44.1% versus 22.1% : p = 0.003). AAM also provided more frequent relief from associated symptoms as compared with placebo (37.4% versus 22.1% : p = 0.006). The therapeutic efficacy was rated as good or excellent by 39.7% of patients in the AAM group compared with 20.7% in the placebo group (p < 0.001). Moreover 64.2% of AAM treated patients said they would be prepared to take the treatment again compared with 46.4% who received placebo (p < 0.001). The percentage of patients reporting adverse events was not different between the two treatments (20.4% AAM versus 18.5% placebo : p = 0.684). The most commonly reported symptoms were gastro-intestinal disorders. Similar number of gastralgia occurred with AAM (n = 4) and placebo (n = 3).


CONCLUSIONS
It is concluded that the aspirin-metoclopramide association may be used as a first intention treatment of acute migraine attack in out-patients.
Henry
P
P
Service de Neurologie, Hôpital Pellegrin Tripode, Bordeaux.
Hiesse-Provost
O
O
Dillenschneider
A
A
Ganry
H
H
Insuasty
J
J
D000284:Administration, Oral; D000328:Adult; D001241:Aspirin / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005194:Family Practice; D005260:Female; D006801:Humans; D008297:Male; D008787:Metoclopramide / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D010919:Placebos; D011795:Surveys and Questionnaires; D013607:Tablets
D004338:Drug Combinations; D010919:Placebos; D013607:Tablets; D008787:Metoclopramide; D001241:Aspirin
Efficacité et tolérance de l'association effervescente aspirine-métoclopramide dans le traitement de la crise de migraine sans aura. Essai randomisé en double aveugle contre placebo.