Botulinum Toxin for Migraines

Headaches have hundreds of potential causes and are one of the more painful common conditions that bring patients to primary care doctors and neurologists. Migraine headaches affect about 29.5 million people in the United States. Women are three times more likely to suffer from them than men. They are more prevalent among people between 20 and 45 years old and are a leading cause of work absenteeism and reduced work productivity. The direct and indirect cost of migraines to the economy is estimated at $50 billion a year.

Using botulinum toxin injections is a controversial treatment to prevent migraine headaches. Reports in the scientific literature (including retrospective case series, uncontrolled and nonblinded studies, small controlled trials and case reports) suggest botulinum reduces migraines in some patients.

However, recently several larger and randomized, double-blind, placebo-controlled clinical trials that were differently designed do not favor botulinum toxin as a treatment. A clinical trial entitled “A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients with Frequent Headaches” is currently underway.

Today some clinicians use botulinum toxin injections trying to manage patients who have severe and frequent migraines. Given the varying clinical experiences reported, one of the criteria proposed for doctors to select patients for this treatment is their failure to respond to other migraine treatments; but each migraine sufferer is unique.

Doctors considering botulinum toxin therapy for a migraine patient should take a thorough review of the patient´s clinical history; conduct an in-depth physical examination; perform or review diagnostic studies; consider past and current treatments and the patient´s responses to them; and consider any co-morbid illnesses or conditions.

Until the results of the current and future clinical trials of botulinum toxin for migraine headache prevention can provide definitive answers about its efficacy and safety, doctors should use it on a case-by-case basis. Only an individualized approach allows the doctor to balance all the considerations when using botulinum toxin. For now, doctors should carefully preselect patients who might potentially benefit from the therapy until further evidence-based research deepens our understanding about its clinical use.

Unless plan language specifically excludes this treatment, case managers should be aware of the evolving nature of botulinum toxin injections for migraines and that it needs case-by-case consideration. This makes it a good candidate for review by an independent review organization with a physician panel up-to-date on the latest medical literature about the treatment.