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Monitoring of Acute Migraine Attacks: Placebo Response and Safety Data
Author(s) -
Jhee Stanford S.,
Salazar Daniel E.,
Ford Neville F.,
Fulmor I. Edgar,
Sramek John J.,
Cutler Neal R.
Publication year - 1998
Publication title -
headache: the journal of head and face pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.14
H-Index - 119
eISSN - 1526-4610
pISSN - 0017-8748
DOI - 10.1046/j.1526-4610.1998.3801035.x
Subject(s) - migraine , placebo , medicine , headaches , anesthesia , placebo response , vital signs , acute migraine , adverse effect , clinical trial , surgery , alternative medicine , pathology
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.