Document Detail

Botulinum toxin type A (BOTOX) for treatment of migraine headaches: an open-label study.
MedLine Citation:
PMID:  11112955     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: The object of this clinical experience was to evaluate the correlation between pericranial botulinum toxin type A (BOTOX, Allergan Corp, Irvine, CA) administration and alleviation of migraine headache symptoms.
STUDY DESIGN AND SETTING: A nonrandomized, open-label study was performed at 4 different test sites. The subjects consisted of 106 patients, predominantly female, who either (1) initially sought BOTOX treatment for hyperfunctional facial lines or other dystonias with concomitant headache disorders, or (2) were candidates for BOTOX treatment specifically for headaches. Headaches were classified as true migraine, possible migraine, or nonmigraine, based on baseline headache characteristics and International Headache Society criteria. BOTOX was injected into the glabellar, temporal, frontal, and/or suboccipital regions of the head and neck. Main outcome measures were determined by severity and duration of response. The degrees of response were classified as: (1) complete (symptom elimination), (2) partial > or =50% reduction in headache frequency or severity), and (3) no response [neither (1) nor (2)]. Duration of response was measured in months for the prophylactic group.
RESULTS: Among 77 true migraine subjects treated prophylactically, 51% (95% confidence interval, 39% to 62%) reported complete response with a mean (SD) response duration of 4.1 (2.6) months; 38% reported partial response with a mean (SD) response duration of 2.7 (1.2) months. Overall improvement was independent of baseline headache characteristics. Seventy percent (95% confidence interval, 35% to 93%) of 10 true migraine patients treated acutely reported complete response with improvement 1 to 2 hours after treatment. No adverse effects were reported.
CONCLUSIONS: BOTOX was found to be a safe and effective therapy for both acute and prophylactic treatment of migraine headaches. Further research is needed to explore and develop the complete potential for the neuroinhibitory effects of botulinum toxin.
W J Binder; M F Brin; A Blitzer; L D Schoenrock; J M Pogoda
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery     Volume:  123     ISSN:  0194-5998     ISO Abbreviation:  Otolaryngol Head Neck Surg     Publication Date:  2000 Dec 
Date Detail:
Created Date:  2000-12-20     Completed Date:  2001-01-04     Revised Date:  2014-07-28    
Medline Journal Info:
Nlm Unique ID:  8508176     Medline TA:  Otolaryngol Head Neck Surg     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  669-76     Citation Subset:  IM    
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MeSH Terms
Acute Disease
Botulinum Toxins, Type A / pharmacology,  therapeutic use*
Middle Aged
Migraine Disorders / classification,  diagnosis,  drug therapy*,  prevention & control
Neuromuscular Agents / pharmacology,  therapeutic use*
Pain Measurement
Severity of Illness Index
Time Factors
Treatment Outcome
Reg. No./Substance:
0/Neuromuscular Agents; EC Toxins, Type A

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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