AHS: Botox (Botulinum Toxin Type A) Injections Effective for Migraine and Chronic Daily Headache
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AHS: Botox (Botulinum Toxin Type A) Injections Effective for Migraine and Chronic Daily Headache

By Bruce Sylvester

Special to DG News

SEATTLE, WA -- June 23, 2002 - Botox (botulinum toxin type A ) injections given every three months appear to prevent up to 92 percent of debilitating headaches in patients who do not respond to other medications, researchers reported here June 21 at the annual meeting of the American Headache Society.

"The side-effects of current medications used for migraine can have difficult side-effects. Now we have a new treatment for severe headache without those problems. It is an important development," said Stephen Silberstein, MD, president of the American Headache Society and professor of neurology at Thomas Jefferson Medical School in Philadelphia, Pennsylvania.

Though not yet approved for headache treatment, Botox was approved by the Food and Drug Administration (FDA) for other medical uses.
Migraine headaches affect about 17 percent of women and 6 percent of men in the United States. About 5 percent of the population has chronic daily headache.

"Migraine is the leading cause of disability in the world, measured by days missed from work and sufferering among working-age people," said lead researcher Todd Troost, MD, professor of neurology at Wake Forest University Medical School in Winston-Salem, North Carolina,. "Botox therapy is safe, effective and essentially carries no risk as a treatment for headache sufferers. It will permit many patients to get completely off all other medications and avoid their side effects. And if a patient rarely has to take an acute medication for a severe migraine, we have found that prior Botox therapy will enhance the potency."

Botox partially paralyzes muscles for about three months. For headaches, it is injected into muscles around the eyes, forehead and sometimes the jaw. Patients whose headaches involve the entire head get additional injections in the upper back of the neck and the shoulders.

Dr. Troost and his team of investigators evaluated 101 women and 33 men with migraine headaches, tension headaches or headaches happening at least 15 days a month. A majority of the patients had been treated unsuccessfully with at least three other headache medications.

The subjects received one to four Botox treatments at intervals of three months, with doses of 30-200 U for chronic daily headache and 15-240 U for migraine. Two months following each treatment, they described the results by using a five-point scale, with 1 describing no improvement, and 5 describing excellent effect.

Eighty-four percent of the subjects reported improvement. Of those who had four treatments, 92 percent reported improvements with a mean score of 4.3 for the group. Clinical improvement was seen in 77 percent, 94 percent, 90 percent and 92 percent of patients for treatments 1 to 4, respectively. The researchers observed no gender differences in response to treatment and no adverse events.

"There are significant improvements that appear to be progressive and may also be cumulative," said Dr. Troost. "I tell patients that it is important not give up if it has only a mild effect the first time. The second or third time it really seems to work better."

Dr. Troost said that patients with debilitating headaches often do not get results from medications designed to treat acute attacks. As a result, they often misuse over-the-counter and prescription pain medications. "Botox now offers an alternative to daily medication for frequent migraine sufferers, and it is a safe way for them to get off dangerous pain pills, prescribed and over-the-counter, that these patients use in excessive amounts," he said.

Dr. Troost said that FDA-testing of Botox for headaches has begun and should, supported by his findings, move forward, "so that the FDA will eventually approve Botox as a recognized effective therapy for headache".

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