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Jefferson Neurologists Find Botulinum Toxin Type A Treatment Effective for Chronic Daily Headache Sufferers with Migraine

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Neurologists at Thomas Jefferson University Hospital, Philadelphia, have had success in preventing and treating Chronic Daily Headache, or CDH, in migraine sufferers with injections of botulinum toxin type A, popularly known as “Botox.”

As part of multi-site studies, Jefferson neurologists tested botulinum toxin type A for the treatment of CDH.  In one of the studies, investigators found that after three doses of botulinum toxin type A, nearly 60 percent of CDH patients with a history of migraine headache were able to cut their rate of headache by about 50 percent by being treated with the drug in areas of the face, head and neck. This represents a significant improvement for many patients who are frustrated by the ineffectiveness and rigid medication schedules of conventional treatment options. The study was sponsored by Allergan, Inc. and presented on April 14 at the American Academy of Neurology (AAN) meeting in Miami Beach.

The frequency of headaches is essential in defining CDH. “The diagnosis of CDH is used in patients who have 15 or more ‘headache days’ in a 30-day period,” said Stephen Silberstein, M.D., professor of neurology at Jefferson Medical College of Thomas Jefferson University. Dr. Silberstein, who is director of the Jefferson Headache Center at Thomas Jefferson University Hospital, was a co-investigator of the study.

“CDH affects approximately four percent of the world population and is associated with obesity, snoring, depression, anxiety, and acute medication overuse,” said Dr. Silberstein.

CDH sufferers are likely to have family, social and occupational problems, which serve to perpetuate the headache cycle. Most patients with CDH also have occasional— and sometimes frequent— migraine headaches, marked by sharp pain and often accompanied by nausea, vomiting and visual disturbances. These migraines can occur at intervals from a few days to a few months apart.

Patients in the study participated in a 30-day screening program, and then began receiving quarterly injections. Participants were assessed every 30 days for 9 months, for a total of 3 treatment cycles. A subgroup of 228 participants not taking concomitant prophylactic medications was further analyzed: 117 patients received botulinum toxin type A and 111 received a placebo.

Researchers measured the difference between the baseline number of headaches and the rate after treatment. The average number of headaches per 30 days at baseline was about 14 for the group receiving botulinum toxin type A, and 13 for the placebo group. After two injection sessions, the average patient receiving botulinum toxin type A had nearly eight headaches less per cycle, compared to only 4.5 less headaches for the placebo group. Yet after the third treatment cycle, a notable difference became apparent. The group receiving botulinum toxin type A injections experienced on average a total of 4.2 headaches per 30 days, compared to about twice that number in the placebo group.  

To date, treatment of CDH with migraine using botulinum toxin type A is considered an “off label” use of the drug and so is not always covered by standard health insurance plans. Patients who pay for their own treatments can expect to pay $500 to $900 per cycle. Side effects of the medication includes a slight risk of temporary drooping of the skin near the site of injection. Dr. Silberstein noted that another–often desirable–side effect is “loss of wrinkles.”  The drug appears to work by reducing muscle contractions and possibly blocking pain-transmitting chemicals.

The Jefferson Headache Center at Thomas Jefferson University Hospital is a multidisciplinary tertiary care facility that specializes in the treatment of patients with all types of head pain, regardless of etiology.  The Center's goals are to diagnose patients in an accurate and timely fashion, and to develop individualized treatment programs to reduce the frequency and intensity of headaches, thereby enabling patients to return to a normal and active lifestyle.



Media Only Contact:
Jeffrey A. Baxt
Thomas Jefferson University Hospital
Phone: 215-955-6300

Published: 4-14-2005