Botox ingredient has limited effect on headaches: study

NEW YORK Wed Apr 25, 2012 4:15pm EDT

A sample of Botox is seen at the Long Island Plastic Surgical Group at the Americana Manhasset luxury shopping destination in Manhasset, New York September 30, 2010. REUTERS/Shannon Stapleton

A sample of Botox is seen at the Long Island Plastic Surgical Group at the Americana Manhasset luxury shopping destination in Manhasset, New York September 30, 2010.

Credit: Reuters/Shannon Stapleton

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NEW YORK (Reuters Health) - The main ingredient in Botox may be modestly helpful for people with chronic migraines, a new report suggests, but the wrinkle treatment doesn't seem to offer much relief for those whose headaches are less frequent.

Patients who started out having headaches almost daily reported two fewer headaches per month when they were given injections of botulinum toxin A. They also had more side effects, including weak muscles and a stiff neck.

The medication is marketed under multiple brands, but Allergan's Botox is the best known. Botox is used to treat a range of conditions, including migraines and excessive sweating.

"The effect these appear to be having on migraine headaches is small -- it only reduces headaches by a couple of days a month," said Dr. Jeffrey Jackson, the study's lead researcher, from the Medical College of Wisconsin in Milwaukee.

That's "really, really modest," he told Reuters Health.

Still, it's possible that some chronic migraine patients will benefit from injections much more than others, he said.

For their new analysis, he and his colleagues looked back at 27 studies in which more than 5,000 headache patients were randomly assigned to get botulinum toxin A injections in the head and neck or an injection of a drug-free placebo. The study was published on Tuesday in the Journal of the American Medical Association.

The initial trials varied widely in their use of the drug, with researchers injecting the medication into any of four to 58 spots, either at a single time or at three different times a few months apart.

Most trials allowed patients to use other headache medication in addition to the injections.

Study participants with chronic headaches or chronic migraines initially reported having 17 to 20 headaches per month, on average. Twelve weeks or more after getting botulinum toxin A injections, that had dropped by an average of two monthly headaches, compared to patients getting the placebo.

In people with fewer migraines to begin with -- six per month, on average -- the drug injections didn't seem to provide any change in headache frequency. The findings were consistent regardless of patients' age as well as the botulinum toxin A dose and injection strategy used.

IMPACT STILL SIGNIFICANT

About half of study participants experienced side effects during the trials. People randomly assigned to receive the active drug injections were 25 percent more likely to report any type of side effect. Muscle weakness was nine times more common in those patients, and neck pain or stiffness was reported three to five times more often than in the placebo groups.

Botox is approved by the U.S. Food and Drug Administration to treat chronic migraines -- but not for less-frequent "episodic" headaches, a spokesperson for Allergan noted.

Headache researcher Dr. Vincent Martin, from the University of Cincinnati, said doctors have known for years that Botox doesn't help people with less-frequent headaches -- and the new review "gives a more definitive conclusion" on that.

But given that Botox is the only FDA-approved treatment for chronic migraines -- the most disabling type of headache -- its effect in those patients is not insignificant, said Martin, who wasn't involved in the new study.

"It's a very important treatment for many people with chronic migraine -- not for everyone," he told Reuters Health.

The drug costs nearly $1,000 for the dose used in chronic migraine patients, and injections aren't typically covered by insurance, according to Jackson.

He said the study had no outside funding source and wasn't linked to any companies that make botulinum toxin A products.

Dr. Mitchell Brin, Allergan's Chief Scientific Officer for Botox, pointed out that previous studies have suggested people with chronic migraines who are prescribed the drug also tend to have shorter-lasting migraines on the days when they still have headaches.

The difference equaled about 40 fewer hours per month of pain, compared to patients given placebo injections, he said.

That's "quite meaningful," Brin told Reuters Health. "The impact on their lives is quite significant."

Martin agreed that doctors often take into account more than just headache frequency when they prescribe the injections.

"Just looking at headache days per month may not tell the whole story," he said.

(Editing by Christine Soares, Michele Gershberg and Gunna Dickson)

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