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Injections of botulinum toxin, best known as a wrinkle treatment, are now being used increasingly to prevent chronic migraine sufferers. Scientific data are mixed, but two large recent studies show Botox can reduce the number of headache days in chronic sufferers.

Migraine headache is a debilitating neurological condition that manifests itself as an intense throbbing pain on one or both sides of the head, according to the Migraine Research Foundation, a New York nonprofit. Some 14 million people experience migraine attacks nearly every day, and attacks typically last from four to 72 hours, according to the foundation. The causes of migraines aren't fully understood, and oral medications—while helpful for some—leave others still suffering, doctors say.

Botulinum toxin is a bacterial protein that scientists say blocks chemicals responsible for muscle contractions and pain. Botox—a form of the toxin sold by Allergan Inc. of Irvine, Calif.—was approved this fall as a migraine treatment by the U.S. Food and Drug Administration. It is approved to treat chronic migraine sufferers, defined as people who suffer from headaches on 15 or more days per month with headaches lasting four hours a day or longer.

If patients are overusing other medications due to chronic headache pain, he adds, it is important to discontinue those medications before beginning Botox because the medication overuse can actually make the headaches worse. Other physicians say Botox treatments will help patients discontinue medication overuse on their own.Allergan, whose Botox drug is the only botulinum toxin FDA-approved to treat migraines, recommends an injection regime of 31 shots a session in seven separate locations on the head, neck and shoulders. Costs per session range from $1,000 to $1,500 or more, and are sometimes covered by insurance. The shots should be repeated every three months, Allergan says.

"What I tell my patients is that Botox is probably the most well-studied therapy for chronic migraine, and has the best evidence" of efficacy, says Sheena K. Aurora, director of the Swedish Pain and Headache Center in Seattle and a principal investigator on two recent Allergan-funded studies. Chronic migraine sufferers are a poorly studied patient group, she adds, because their condition is so hard to treat that most pharmaceutical companies exclude them from migraine studies altogether.

Other physicians, such as Joel Saper, director of the Michigan Headache & Neurological Institute in Ann Arbor, who has participated in an Allergan-funded study, are more cautious. Botox "does not help everybody," Dr. Saper says. "It may not even help most everyone. But it does in my personal anecdotal experience help some people."

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