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Botox Best for People With Most Severe, Frequent Headaches PHILADELPHIA, PA -- June 27, 2005 -- Researchers today reported they have found that regular injections of the anti-wrinkle drug Botox® are particularly effective in reducing migraine attacks in sufferers with the most frequent, most disabling headaches, with fewer side effects than other migraine prevention medications. The multi-center study from the Mayo Clinic in Arizona is being presented at the 47th Annual Scientific Meeting of the American Headache Society (AHS). More than 4 million Americans suffer from migraine headaches 15 or more days per month. Following the Botox injections, on average patients had fewer than half the number of headache attacks they had prior to therapy. The randomized, double-blind, placebo-controlled study found that injections of botulinum toxin type A (Botox) not only reduced the frequency of migraine headaches in those who had frequent migraines, but significantly reduced the amount of other medications they took to combat migraine pain. The injections are given once every three months, whereas most preventive medication is taken orally every day. "We've been studying Botox for the prevention of migraine attacks for several years, and now we're learning that it appears to be most effective in patients who suffer almost every day, and experience significant disability as a result, including missing school, work and social events," said David W. Dodick, MD, consultant in neurology at Mayo Clinic in Arizona and professor of neurology at Mayo Clinic College of Medicine. "The worse their headaches, the more frequent the attacks, the more medicine they have to take to combat the pain, the better Botox seems to work." "Botox appears to prevent the activation of the trigeminal nerve, which is very important in migraine," he said. "It seems to work best when the sensory nerves are more easily activated, such as in patients with frequent headaches." "The evidence points to Botox being cost effective, too," said Fred Freitag, DO, associate director of the Diamond Headache Clinic, Chicago. "We saw a substantial reduction among these patients in medication use. This parallels the clinical experience that also shows a decrease as well in visits to the doctor's office or emergency room for treatment. It was rather impressive." At the AHS meeting, Drs. Dodick and Freitag are presenting information tracking different data on the same patient population -- 228 people who get migraine headaches more than 15 days a month, who were not using preventive medication. The people were randomly divided into two groups: 117 received Botox injections and 111 received injections of a placebo saline solution (salt water) with no medication. The study was blinded, so that neither the treating physicians nor the patients knew whether Botox or saline was being administered. Patients in the 11-month study received injections every 90 days, or three treatments in all. In each treatment, patients received from 10 to 25 injections in the head, neck and shoulders, depending on the location of the pain. Mayo Clinic Data Dr. Dodick's group analyzed how often the migraine attacks occurred, as well as their severity. Two months after the study began, researchers found there was a significant difference between the Botox and saline groups in frequency of attacks. Patients who received Botox on average experienced a 55 percent reduction in the frequency of their headaches. Before the study, people in the Botox group had averaged 14 migraine attacks a month or 24 days of headache, whereas after treatment, they experienced an average of 6 migraine attacks a month. The reduction in headache frequency held steady through the remainder of the study. Patients in the saline group experienced a 35 percent reduction of headaches on average. Before the study, people in the saline group experienced headaches an average of 12.9 migraine attacks a month, whereas after treatment, their headache frequency decreased to 8.4 attacks a month. "Studying Botox to treat patients with the most frequent migraines will be a focus of future research studies in an attempt to confirm these preliminary findings," said Dr. Dodick. Diamond Headache Clinic Dr. Freitag's group analyzed the use of other headache pain medication in the Botox and saline groups. Those in the Botox group consistently used significantly less over-the-counter and prescription medication than did those in the saline group, and the amount of pain medication used continued to decrease during the course of the study. At about eight months into the study: Patients in the Botox group were using pain medication an average of 6.2 days a month, compared to an average of 15.5 days a month before the study began, a 60 percent reduction; and Patients in the saline group were using pain medication an average of 8.8 days a month, compared to an average of 13.5 days a month before the study began, a 35 percent average reduction. Researchers also noted that people in the Botox group made fewer visits to the clinic or emergency room then they had before the study began. Five patients dropped out of the study due to side effects, including temporary burning sensation or pain, slight muscle weakness or bruising at the site of the injection. Preventive medication typically does not eliminate migraine attacks, but may reduce the frequency and severity of the attacks. "We aren't at the point of achieving headache-free status with Botox in the chronic headache population, but we are at the point of far fewer headaches," said Dr. Freitag. Botox is not approved by the Food and Drug Administration (FDA) to treat headaches, but the study being presented at the AHS is one of several that the FDA has discussed with the study sponsor in preparation for future trials of Botox. Botox is FDA-approved for the treatment of blepharospasm (eyelid spasm), strabismus (crossed eyes), cervical dystonia (painful neck spasms) and wrinkles between the eyebrows. In 1992, a Los Angeles plastic surgeon was the first to notice that Botox seemed to prevent migraine attacks. Patients whose wrinkles he was treating with Botox told him that they were getting fewer migraines. Co-authors of the paper Dr. Dodick is presenting at the AHS meeting are Alexander Mauskop, MD, New York., New York; Arthur H. Elkind, MD, Mt. Vernon, New York; Ronald DeGryse, MA., MS., Irvine, California; Mitchell F. Brin, MD, Irvine, California, and Stephen D. Silberstein, MD, Philadelphia, Pennsylvania. Co-authors of the paper Dr. Freitag is presenting at the AHS meeting are Peter J. McAllister, MD, Fairfield, Connecticut; Brian Freund, MD, Pickering, Ontario; Marvin Schwartz, MD, Pickering, Ontario; Ronald DeGryse, MA, MS, Irvine, and Rich Barron, MS, Irvine, California. SOURCE: The American Headache Society E-mail this page to a friend or colleague! To print, use this version