BOTOX and Chronic Migraine
Chronic migraine is a subtype of migraine headache. Chronic migraine affects approximately 2% of individuals in the United States. It is more difficult to treat and manage than episodic migraine. Chronic migraine imposes a significant burden on both the individual and society.
Chronic migraine is underdiagnosed. Data from the American Migraine Prevalence and Prevention (AMPP) study (Neurology 2008;71:559) showed that only 20% of chronic migraineurs obtain an accurate diagnosis. While neurologists (and headache medicine physicians specifically) are recognized as the experts for migraine, the AMPP study showed that individuals with chronic migraine had sought evaluation from numerous other types of providers, including chiropractors, allergists, dentists, psychologists, and physical therapists. While some of these providers may be able to assist in some aspects of disability related to chronic migraine, they are unsuitable for most in comprehensively diagnosing and treating the disease. This may account in part for the low rate of diagnosis of chronic migraine in these patients and the frequent diagnosis of conditions such as “sinus headaches,” “tension headaches,” “and stress headaches.”
Chronic migraine is undertreated. Likely related to the breadth of provider type as well as other reasons, most patients with chronic migraine do not obtain migraine-specific treatment. In the AMPP study fewer than one-third of patients obtained migraine-specific medications, whether for acute treatment or for disease prevention. Undesirable prescription non-migraine acute pain medications were used frequently, including opioids in 29% and butalbital (e.g. fioricet and fiorinal) in 15%.
The impact of chronic migraine on individuals is significantly greater compared to those with episodic migraine. Assessing patient disability using the Migraine Disability Assessment (MIDAS) questionnaire revealed that approximately 8% of those with chronic migraine missed at least 5 days of work or school over a three-month period of time; more than 50% missed at least 5 days of household work over the same period.
It is estimated that migraine disorders costs society $16 billion dollars per year in lost wages, worker productivity, and expenses related to medications, doctor visits, and emergency room visits.
Most simply, chronic migraine is a disorder characterized by more headache days than not. The headaches typically last at least four hours in duration when not treated with medication. The high headache frequency is present for at least three months. Many of the headaches should have migraine elements when untreated, such as one-sided throbbing pain, with nausea or vomiting, and associated with sensitivities to lights, sounds, or movements.
Ideally an individual will track their headache days accurately using a headache calendar. For those new patients who are uncertain of their exact headache frequency, I will ask how many completely pain-free days they experience, since this is often an easier number to remember. In my experience most patients underestimate their headache numbers, but pain-free days are more accurately recalled. A correct diagnosis of chronic migraine does not require that every headache is severe or disabling: the core feature is high frequency headaches.
BOTOX (onabotulinumtoxinA) is one type of migraine preventive agent. This is the same BOTOX that is used for cosmetic purposes, as well as for other neurological, urological, and ophthalmological conditions. BOTOX is an FDA-approved injectable product that is administered in a physician’s office for chronic migraine once every three months. While there are currently other types of botulinum toxin available (Myobloc, Dysport, and Xeomin) only BOTOX manufactured by Allergan is approved for treatment of chronic migraine. The mechanism by which BOTOX is effective for chronic migraine is currently unknown. It is unlikely related to the muscle or facial “paralysis” desired during cosmetic treatments.
My practice was a key site in one of the two principal clinical studies investigating BOTOX for chronic migraine. PREEMPT 1 and PREEMPT 2 (Phase 3 Research Evaluating Migraine Prophylaxis Therapy) enrolled 1384 patients who experienced an average of 20 headaches per month. Patients received two BOTOX or placebo (saline or salt water) injection treatments over a 12-week period, followed by an additional three active BOTOX treatments over the next 44-week period. Those patients who received BOTOX had fewer headache days per month when compared to the placebo group (8 to 9 fewer headache days/month with BOTOX versus 7 fewer headache days/month with placebo). It is important to note that even patients obtaining the placebo injections had fewer headache days per month overall.
Injections: BOTOX is administered in a unique injection pattern involving 31 different sites along the forehead muscles, temples, back of head, neck, and shoulders. A total of 155 units of BOTOX are injected. Since BOTOX is administered using a needle, patients should be aware that there may be injection discomfort during and after the procedure.
Side Effects: While BOTOX is generally well-tolerated it is not without side effects. The most common side effects are neck pain (9%), headache (5%), muscle weakness (4%), musculoskeletal stiffness (4%), and eyelid drooping (4%).
Speed of Onset: BOTOX for chronic migraine is effective, but it may not work quickly. The earliest response may be seen after approximately four weeks. In my clinical experience some patients may not respond after the first injection set. It has been my recommendation to obtain at least two and preferably three treatments of BOTOX to determine if the medication is helpful. As BOTOX is given every three months, it may require at least a six month trial period to determine if BOTOX works.
Insurance Coverage: BOTOX is usually covered by commercial insurance plans provided the patient has met certain requirements. Most insurance companies in North Carolina require that the patient has tried and failed to respond to at least three different recognized oral migraine preventive medications first. They also require that the condition of “medication-overuse headache” is absent. Medication-overuse headache is a complicating condition related to migraine, where overexposure to pain medications worsen the migraine disorder. Thus, those patients who are self-treating with over-the-counter pain medications most days of the week would not be immediately eligible for BOTOX treatment.
Expert Injectors: Because of the special injection pattern used, I recommend only appropriately trained providers administer the treatment. As one of the original injectors for Allergan, I have trained a number of neurologists around the state and country. Currently not all neurologists have had formal training for BOTOX injections for chronic migraine.
Clinical Studies: Headache Wellness Center (HWC) is currently participating in a clinical study using BOTOX for chronic migraine. The sponsor of the study is Allergan, the manufacturer of BOTOX. Our center is actively seeking individuals with frequent headaches who may qualify for the study. All evaluation, medication, and treatment would be provided without charge for those who qualify. Please contact our office to learn more about this opportunity.
Marshall C. Freeman, MD is the director of Headache Wellness Center (HWC) in Greensboro, NC. He is a board-certified neurologist in Adult Neurology, Neuromuscular Medicine, and Electrodiagnostic Medicine. He holds specialty certification in Headache Medicine by the United Council of Neurological Subspecialties. HWC is the oldest and longest continuously operating headache specialty practice in North Carolina, serving the headache population since 1990. HWC is actively accepting new patients. Visit www.HeadacheWellnessCenter.com or call 336-574-8000.