As you may know by now, Botox (onabotulinum toxin A) was approved by the FDA in October of 2010 for the treatment of chronic migraine. The IHS definition of chronic migraine requires the existence of migraine symptoms, with total headache days greater than 14 days each month for the previous three months. Most patients with chronic migraine have very close to continuous, if low grade, daily headache. The benefit in controlled trials was evident even in the absence of other treatments for migraine (such as treatment of medication overuse and caffeine related headache) or a general treatment program through a headache clinic.
At the North Carolina Comprehensive Headache Clinic, we have administered approximately 800 doses of Botox for migraine since 1993 with no serious complications. The treatment has been well tolerated, and when combined with general measures to treat chronic migraine, we have found it to be clinically useful. The selection criteria here is strict. Other headache syndromes must be excluded (hemicrania continua, primary thunderclap headache, new persistent daily headache, cluster headache, hypnic headache, intracranial hypotension and intracranial hypertension, and secondary headaches). Before recommending Botox, in the past we have treated medication overuse and prescribe preventive medications tailored to the patient’s symptoms, along with a wellness program, before recommending Botox.
The patient with chronic migraine and significant psychiatric co-morbidities has long presented special diagnostic challenges, followed by management difficulties. In patients whose psychiatric condition is sufficiently serious to require ongoing psychiatric care, the use of additional psychotropic medications to treat chronic migraine as a separate condition often provides few options at considerably increased risk of complications, and clear increase in management complexity. Serotonin syndrome, assessment of suicide risk, inadvertent overdosage, automobile accidents, and increase in metabolic complications (particularly weight gain) have previously significantly limited safe options for these patients.
Of all the groups of headache patients we see, we believe that the FDA approval of Botox will most benefit the care and management of the patient with chronic migraine and psychiatric co-morbidities.
For long-term management, Botox is administered only once every three months, which significantly reduces the total burden of Headache Clinic visits for the patient, and allows psychotropic medication to be selected on the basis of optimal management of the psychiatric condition alone.
. Much that we do could be confined to self-directed instructions or our Web-based information on self-care. Recommendations for adding pharmaceutical treatment can be suggested to the treating psychiatrist to use or not, as they find appropriate to the overall psychiatric program of care.
It is important to note that Botox has not been shown to benefit patients whose headache occurs less than 15 days/month.
While we find that many patients with chronic headache “under count” their headche days, often because they do not wish to be seen as complaining of “normal” daily headache. On the other hand, we are concerned that patients with true episodic migraine occurring less that 15 days/month will over count in hopes of obtaining Botox coverage. However, we feel it is well established that patients with intermittent migraine will not benefit from Botox. Possibly, this is because Botox suppresses the processes that produce migraine transformation over time, such as classical conditioning and kindling, thus allowing chronic migraine to be converted back to a more manageable intermittent migraine. It is also important to note that Botox carries a black box warning and that patients should be selected appropriately.
There are other neurologists in the area who are experienced in the use of Botox and in headache diagnosis and treatment who can be accessed through the Allergan web site or through the American Council on Headache Education. Appointments for evaluation can be made though the link to the office.
Charles Matthews M.D.
Director, the North Carolina Comprehensive Headache Clinic