Monitoring of acute migraine attacks: placebo response and safety data.
In the course of evaluating the safety and efficacy of an investigational compound for acute migraine headaches, a large number of patients received placebo at a single site, offering the opportunity to characterize subjective and clinical physiologic responses of migraine patients to placebo in a controlled environment. In a single-site, double-blind, placebo-controlled study, 67 patients reported to the clinic while suffering a moderate to severe acute migraine headache and received oral placebo. For 6 hours after treatment, a continuous electrocardiogram (ECG) was performed, and headache severity, adverse events, and vital signs were recorded. Patients returned and repeated the procedure when free from pain. A headache was considered to be improved if its severity dropped to "mild" or "none." Twenty-five patients (37%; 95% CI: 26% to 50%) experienced headache improvement within 2 hours of receiving placebo, and 32 patients (48%: 36% to 60%) improved within 4 hours. There were no clinically important ECG changes during the migraine visit, and there were no clinically relevant differences in vital signs between the migraine and pain-free visits. Thus, a substantial placebo response occurs in migraine headache. Hemodynamic and ECG parameters are unchanged between migraine and pain-free states.
Jhee
S S
SS
California Clinical Trials, Beverly Hills, CA, USA.
Salazar
D E
DE
Ford
N F
NF
Fulmor
I E
IE
Sramek
J J
JJ
Cutler
N R
NR
D000208:Acute Disease; D000328:Adult; D004311:Double-Blind Method; D015716:Electrocardiography, Ambulatory; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology*; D010919:Placebos; D017366:Serotonin Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D018170:Sumatriptan / Q000009:adverse effects / Q000627:therapeutic use*
D010919:Placebos; D017366:Serotonin Receptor Agonists; D018170:Sumatriptan