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Posted by Ted ( on September 18, 2000 at 15:04:03:

In Reply to: migraine headaches posted by L. Balfanz on September 18, 2000 at 14:31:34:

This is a cluster headache forum, which is a different condition than migraines. There are many people here who have both however. I provided a link to Elaine and Todd's site which has a message board for migraine sufferers as well. Also, I'm pasting an article for you from Medscape (written last year) on botox and migraines. I hope this helps you:

Medical Tribune
Botulinum Toxin Found To Prevent Migraines
Roberta Friedman
[Medical Tribune 40(13):17, 1999. ]


Injecting botulinum toxin into the muscles of the head can reduce the frequency of migraines in both men and women, according to two studies presented at the recent annual meeting of The American Association for the Study of Headache in Boston.

In the first study, a one-time dose of 25 units of botulinum toxin type A (Botox, Allergan) reduced the frequency of migraines and the severity of pain, associated vomiting and the use of pain medications for up to three months after the injections, reported Joel R. Saper, M.D, director of the Michigan Head Pain and Neurological Institute in Ann Arbor, and a clinical professor of neurology at Michigan State University in East Lansing.

In another study, 51 percent of 96 patients reported complete improvement of their migraine pain, according to researchers at the University of California in Los Angeles.

Botulinim toxin's effects on migraine were discovered by accident when women who received the injections to treat facial wrinkles "came back and told their doctors that their headaches were gone, in addition to their wrinkles," said co-author Stephen Silberstein, M.D., a professor of neurology and director of the headache center at the Thomas Jefferson University School of Medicine in Philadelphia.

In the 12-center double-blind, trial, 123 migraine patients-most of them women, with a mean age of 44-were randomized to placebo (41 patients), 25 units (42 patients) or 75 units (40 patients) of botulinum toxin. The toxin was injected symmetrically into the glabellar, frontalis and temporalis muscles. The subjects, on average, had histories of two to eight moderate-to-severe migraines per month.

The 25-unit treatment reduced the frequency of moderate to severe attacks during the second and third months of the trial, according to the researchers. The frequency of mild to severe migraine was reduced in the third month. The 25-unit dose also reduced the number of days other medications were used for acute migraine in the second month, reduced headache-associated days of vomiting in the second month and improved the patient global assessment scores in the second month.

The 75-unit treatment resulted in significantly more treatment-related side effects than placebo, and yielded significantly better global assessment scoring.

The side effect reported was eyelid drooping, according to co-investigator Jack Klapper, M.D., a neurologist at the Colorado Neurology and Headache Center in Denver. "With improved technique, that would improve," he said. "But there is no weight gain, no drowsiness, no GI side effects, and you don't have to do blood work. So, in terms of side effects, [Botox] is actually superior," he added.

In general, botulinum toxin was as effective as standard preventive medications such as divalproex sodium (Depakote, Abbott Laboratories) and gabapentin (Neurontin, Parke-Davis), according to Dr. Klapper. "The only drawback [with Botox] is that you have to repeat it every three months," he said. "The 25-unit dose was clearly the correct dose in this study," he added.

But the researchers still do not know why botulinum toxin works.

"That Botox could help headache is surprising, because we believe that headaches of the type we are treating are primarily central [brain] in origin," Dr. Saper said. "We have not considered Botox to work centrally. Botox paralyzes skeletal muscle, and, therefore, in general, reduces symptoms from conditions that cause muscle spasm.

"The speculation is-in some way not yet known-that Botox may work in the brain, and make its way there down the nerve circuits," Dr. Saper added. "Also, a central-peripheral loop may be required in some cases of headache to sustain the pain, which Botox may interrupt. Or, there are other mechanisms of migraine that we don't yet understand, in which Botox would be influential."

Another researcher team presented the results of an open-label study. A total of 96 chronic migraine patients were given an average dose of 25 units of botulinum toxin, according to William Binder, M.D., an assistant clinical professor at the University of California, Los Angeles, and a plastic and reconstructive surgeon at the Cedars-Sinai Medical Center.

Forty-nine of the patients reported complete improvement of their migraine pain, 27 patients experienced partial improvement, and 20 showed no response to the toxin.

Marvin Hoffert, M.D., director of the pain and headache program at the Northwest Neuroscience Institute in Seattle, suspects that botulinum toxin has an indirect action on the muscle tension components of migraine headaches. "You can settle down a migraine with lessened muscle tension," he said.

Mark Gostine, M.D., president of the Michigan Pain Consultants in Grand Rapids, was surprised that the toxin was effective. "It probably worked in a subgroup [of patients] with muscle tension headaches," he said.

Dr. Saper himself took a cautious approach to the multi-center study results. "This data is valid, but I'm cautious about overinterpreting the available results," he said. "We don't nearly have enough people to draw sweeping conclusions. I believe that the ultimate data on whether Botox works or does not remains to be determined by continued research."

Dr. Klapper pointed out that Botox will be more cost effective for some patients than for others. "If a patient has one migraine a month and responds to over-the-counter medications, it may not be worth it," he said. "But if a patient has frequent headaches, and is not responding to the triptans, which cost $18 a pill and $36 a shot, then you would do a cost-benefit analysis," he said.

So far, researchers do not know of any potential long-term dangers with the treatment, according to Dr. Klapper "It remains to be seen," he said. "But Botox is used long-term in other conditions, so its safety has been proven."

The agent is now in Phase III testing for the migraine indication.

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