A new study has found that Botox(R)
(Botulinum Toxin Type A) significantly reduces the number of days each
month that patients with a chronic form of migraine experience migraine
attacks. Migraine days declined by almost a third (26.9 percent) among the
patients treated with Botox injections, compared to increasing 6 percent in
patients who received placebo injections. The results will be presented on
June 23rd at the 48th Annual Meeting of the American Headache Society by
Frederick G. Freitag, D.O., associate director of the Diamond Headache
Clinic and lead investigator of the study.
"This new data adds to previous findings suggesting that Botox can be
efficacious in reducing the frequency of headache episodes in migraine
patients who suffer from frequent headaches," said Dr. Freitag. "For this
study, we excluded patients using a high quantity of acute pain medications
since this adds to the complexity of studying a preventive treatment, and
often contributes to the headache disorders. We were able to see
significant improvement in the Botox-treated patients compared to placebo
within one treatment cycle."
Chronic migraine is a progressive and highly disabling headache
disorder characterized by headaches that occur on 15 or more days each
month. It affects about 7 million Americans (approximately 2.4 percent of
the general population).(i) Botox is not approved by the U.S. Food and Drug
Administration (FDA) for the treatment of headache disorders but is
currently being further investigated as a prophylactic treatment in
migraine patients who suffer from frequent headaches.
For this placebo-controlled, randomized and double-blind study, 36
patients who had discontinued or limited their use of acute pain
medications during a 4-week baseline phase were randomized to receive one
treatment with either Botox (100 U using a fixed-dose, fixed site approach)
or placebo injections. The primary outcome measure was change in the number
of migraine days per month.
- At the end of the 4-month study, the number of days with migraine per
month declined by 26.9 percent among those treated with Botox, compared
to increasing 6 percent among placebo-treated patients (p