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Acute Migraine Treatment Guideline
Vincenza Snow, MD
7 October 2003 | Volume 139 Issue 7 | Pages 603-604
IN RESPONSE:
Dr. Marino provides a very interesting account of her journey toward achieving relief from her migraines. Happily, she has found a preventive therapy that is effective for her. Dr. Marino cites several reports on the use of botulinum toxin therapy in migraine headache and asks why it was not included in the evidence review for the American College of Physicians guidelines. First, I must point out that the College's guideline is based on an exhaustive systematic review of the evidence, performed under the auspices of U.S. Headache Consortium (1, 2). These evidence reviews covered published studies up until the year 1998. In addition, only trials that were judged to be well-designed randomized, controlled trials could be included (3). In order for a recommendation to be made, many such trials directly relevant to the recommendation had to yield a consistent pattern of findings. Thus, the study by Binder and associates (4) that Dr. Marino cites would necessarily be excluded from the review because of its design (nonrandomized, uncontrolled, open-label).
Since completion of our review, a single randomized, double-blind, controlled trial of the use of botulinum toxin type A in migraine prevention has been published (5). Silberstein and associates studied 123 patients with a history of 2 to 8 moderate to severe migraine attacks per month. Participants were randomly assigned to receive 25 U or 75 U of botulinum toxin type A injection or injection of vehicle control. The authors concluded that pericranial injection of 25 U safely and substantially reduced migraine frequency (at 3 months) and severity (at 2 and 3 months). Of interest, those treated with 75 U showed no significant effects. Even if this trial had been available at the time of our review, however, we could not make a recommendation on the basis of a single small study. Further large-scale randomized, controlled studies are needed to confirm these results, identify the most efficacious doses, and demonstrate long-term efficacy and safety.
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Author and Article Information
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From the American College of Physicians; Philadelphia, PA 19106.
1. Matchar DB, Young WB, Rosenberg JH, Pietrzak MP, Silberstein SD, et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management of acute attacks. 2000. Available at http://www.aan.com/professionals/practice/guidelines.cfm.
2. Ramadan NM, Silberstein SD, Freitag FG, Gilbert TT, Frishberg BM. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management for prevention of migraine. 2000. Available at http://www.aan.com/professionals/practice/guidelines.cfm.
3. McCrory DC, Matchar DB, Gray RN, Rosenberg JH, Silberstein SD. Evidence-based guidelines for migraine headache: overview of program description and methodology. 2000. Available at http://www.aan.com/professionals/practice/pdfs/gl0086.pdf.
4. Binder WJ, Brin MF, Blitzer A, Schoenrock LD, Pogoda JM. Botulinum toxin type A (BOTOX) for treatment of migraine headaches: an open-label study Otolaryngol Head Neck Surg. 2000;123:669-76. [PMID: 11112955].[Medline]
5. Silberstein S, Mathew N, Saper J, Jenkins S, the Botox Migraine Clinical Research Group. Botulinum toxin type A as a migraine preventive treatment Headache. 2000;40:445-50.[Medline]
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- Annals 2002 137: 840-849.
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