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Botulinum Toxin Type A for
the Treatment of Headache: Pro
Andrew Blumenfeld, MD
Posted: December 2004  
Headache 2004;44:825-830

Introduction:  The use of botulinum toxin type A (BoNT-A) as a preventive headache treatment is increasing but remains controversial and the subject of much discussion. Several factors contribute to this discussion, the most important of which is the question of the evidence of its efficacy in headache prevention. The limited number of conclusive placebo-controlled trials has led to the challenge that the data do not differentiate a genuine treatment effect from a placebo response. Without doubt, an intensive neurologic consultation involving muscle palpation and injection of a high-profile treatment inevitably will create some element of placebo response. Questions also arise as to how the muscle-relaxing effects of BoNT-A could be relevant to the pathophysiology of migraine. To confound matters further, the cost of BoNT-A therapy is relatively high.

Should these issues rule out a role for BoNT-A in the long-term treatment of headache? Unfortunately, the current arsenal of preventive headache treatments is not replete with effective, proven, well-tolerated, low-cost pharmacotherapeutic agents. Patients are frequently dissatisfied with their treatment, and physicians need to explore new approaches if the overall burden of headache is to be meaningfully reduced.

I will briefly address the commonly raised objections to the use of BoNT-A as a preventive headache treatment, review the available evidence supporting the use of BoNT-A, and assess whether -- on the basis of efficacy, safety, and cost -- BoNT-A is a rational treatment choice.

Summary:  The evidence to date is sufficient to warrant serious consideration of BoNT-A as an effective, highly tolerable, long-term headache preventive, especially compared to the oral agents currently available. Results from controlled and open-label trials suggest prolonged improvement occurs in a sizeable proportion of patients, including those who have been refractory to other therapies. The duration of the observed pain relief in headache mirrors that seen in other disorders for which BoNt-A is administered, including CD and spasticity, and argues powerfully against a placebo effect. While the pharmacoeconomic aspects of BoNT-A treatment are still under investigation, there is growing evidence that BoNT-A reduces analgesic use, pharmacy costs, and expensive ER visits.