Migraine with aura versus migraine without aura: pain intensity and associated symptom intensities after placebo.
OBJECTIVE
To compare the intensity of pain and associated symptoms after placebo administration in patients with migraine with aura and migraine without aura.


BACKGROUND
Studies that evaluate drugs used in the acute treatment of migraine ideally should include a placebo arm. The International Headache Society also recommends stratification according to age and sex but not by the presence versus absence of aura.


METHODS
The study was conducted as part of a placebo controlled randomized survey comparing four active drugs against placebo in the acute treatment of migraine. Patients were blinded as to treatment received. Placebo consisted of 10 mL of normal saline (0.9%) intravenously. Pain intensity was evaluated by a 10-point analogical-verbal scale. Nausea, photophobia, and phonophobia were evaluated by a four-point analogical-verbal scale. For statistical analysis, unpaired t-test with Welch correction was used.


RESULTS
After placebo administration, reduction of symptom intensity (pain, nausea, photophobia, and phonophobia) in patients with migraine without aura was significantly greater than that observed in patients with migraine with aura.


CONCLUSIONS
Our findings suggest that studies comparing placebo against an active drug should use stratification according to the presence versus absence of aura.
Bigal
Marcelo E
ME
Department of Neurology, Albert Einstein College of Medicine, Bronx, New York, USA.
Bordini
Carlos A
CA
Sheftell
Fred D
FD
Speciali
José G
JG
Bigal
Janaína O M
JO
D000328:Adult; D015982:Bias; D005260:Female; D006801:Humans; D008297:Male; D020325:Migraine with Aura / Q000150:complications / Q000188:drug therapy*; D020326:Migraine without Aura / Q000150:complications / Q000188:drug therapy*; D010147:Pain Measurement; D010919:Placebos / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
D010919:Placebos