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BOTOX(r) IS FOUND TO PROVIDE IMMEDIATE AND LONG-TERM RELIEF FOR MIGRAINE HEADACHES

A patient study carried out at different locations confirms Botulinum toxin type A is effective in treating painful migraines without adverse side effects

NEW ORLEANS -- Migraines are characterized by pain in the head (usually unilateral), vertigo, nausea vomiting, photophobia, and scintillating appearances of light. This debilitating disorder affects 17 percent of all women and six percent of men. Current treatments for this disorder have limited benefit and are often accompanied by significant side effects. A consensus exists in the medical community that an acute and long-acting, well-tolerated therapy is needed.

Botulinum toxin type A ( BOTOX(r) ) has been used by ophthalmologists and neurologists since 1980 to treat lazy eye, eye spasms, and certain other neurologic disorders. More recently, cosmetic dermatologists have been using it to treat the muscles used for facial expression. The presenting researcher of this study had found a correlation between BOTOX(r) injections into the pericranium. As a follow-up, a team of physician-researchers established an unblinded, open-labeled study to determine whether this correlation was meaningful and could be replicated at different medical treatment facilities.

The authors of the study, "Botulinum Toxin Type A for Treatment of Migraine Headaches: An Open Label Assessment" are William J. Binder, MD, FACS, University of California, Los Angeles; Mitchell Brin, MD, Mt. Sinai Medical Center, New York, NY; Andrew Blitzer, MD, FACS, College of Physicians and Surgeons, Columbia University, New York, NY; and Larry Schoenrock, MD, University of California-San Francisco.

The study results were presented before the American Academy of Otolaryngology--Head and Neck Surgery Foundation Annual Meeting and Oto Expo being held September 26-29, at the Ernest N. Morial Convention Center in New Orleans, LA. At the gathering, the Academy's 11,000 members will have the opportunity to hear the latest research in the diagnosis and treatment of disorders of the ear, nose, throat, and related structures of the head and neck.

Methodology:

Headache patients were identified through cosmetic surgery, movement disorder/dystonia, and otolaryngology clinics. After a review of their clinical histories, they were classified into three groups: migraine, possible migraine, and non-migraine patients. BOTOX(r) was injected into glabellar, temporalis, frontalis, and suboccipital regions of the forehead and neck. Response was scored as complete elimination of headaches, partial improvement (at least 50 percent reduction in frequency or severity of headaches), and non-responders (less than 50 percent reduction in frequency or severity of headaches or lost to follow-up).

In this trial, 100 patients and 110 treatments were involved. The average age of the patients was 43.9 years; eleven of the subjects were male, 89 were women (women in the trial were slightly older than men).

Results:

The study revealed:

Following the administration of the 110 treatments, the researchers found 58 (50.4 percent) of the treatments resulted in complete improvement, 37 (32.2 percent) caused partial improvement, and 15 (17.4 percent) had no response.

Ninety-seven of the 100 patients received the injections. Of that group, 75 patients were diagnosed as true migraine, 15 as possible migraine, and seven as non-migraine. Of the 75 true migraine patients, there were 39 complete responders, 29 partial responders, and seven non-responders.

The average benefit of the BOTOX(r) injections was 4.1+ 2.6 months for complete responders and 2.7+ 1.1 months for partial responders. Of 13 patients who reported acute migraine or possible migraine, eight experienced a complete benefit within 1 to 2 hours.

Adverse effects were limited to transient local pain at the injection site and ecchymosis (a purple patch on the skin).

Conclusion:

The findings recommend BOTOX(r) as a safe, effective, therapeutic agent for the treatment of migraine.

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Editor's Note: For a copy of this study or an interview with Dr. Binder, contact Ken Satterfield at 703-519-1563 (through 9-21); 9/23-29, call the Annual Meeting Â鶹´«Ã½room at 504-670-5409.