Monitoring of Acute Migraine Attacks: Placebo Response and Safety Data
Version of Record online: 21 MAY 2003
Headache: The Journal of Head and Face Pain
Volume 38, Issue 1, pages 35–38, January 1998
How to Cite
Jhee, S. S., Salazar, D. E., Ford, N. F., Fulmor, I. E., Sramek, J. J. and Cutler, N. R. (1998), Monitoring of Acute Migraine Attacks: Placebo Response and Safety Data. Headache: The Journal of Head and Face Pain, 38: 35–38. doi: 10.1046/j.1526-4610.1998.3801035.x
- Issue online: 21 MAY 2003
- Version of Record online: 21 MAY 2003
- Accepted for publication June 25,1997.
- Cited By
- ambulatory electrocardiography;
- clinical trials
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% Cl: 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.