By Ejaz Shamim
Potential migraine remedies are getting much public attention recently. A fellow neurologist called monoclonal antibody therapy “the most hopeful thing on the horizon” for migraine sufferers, while a writer touted designer drugs as the first “specifically designed to prevent” migraines. But despite their promise, many have not been approved by the Food and Drug Administration.
We will not likely develop a migraine cure in the near future, but we may not need designer drugs, or any drugs, to prevent migraines in many sufferers. Two remedies already approved by the FDA could help chronic migraine sufferers more immediately and effectively than any new treatments being promoted while promising fewer toxic side effects than other existing remedies. Preliminary results from ongoing studies offer real hope for Botox and magnetic stimulation as treatment options.
Why is this important? Because about 36 million people suffer from migraines in the U.S. with almost half of those suffering from chronic migraines, defined as more than 15 per month. Migraines occur most often in people ages 35-55, but even young athletes such as Braden Holtby, 26, of the Capitals and Wizards point guard John Wall, 25, are afflicted.
Researchers struggle to identify preventative techniques in part because we don’t know precisely what causes migraines. Certainly stress, poor sleep habits, dietary choices and hormonal changes are aggravating factors.
We also struggle to treat migraines. Many approved daily medications can lead to dependency and can have side effects including liver problems, kidney stones and low blood pressure.
The FDA approved Botox for the treatment of chronic migraines in 2010. Experts think Botox helps prevent migraines by relaxing muscles around the head when administered every three months. Most experts agree this treatment benefits some patients, but established data only exist on Botox’s impact over one year.
Our clinical trial is the first long-term Botox study. We are examining how effective and safe Botox is in treating chronic migraines over two years. Results through 24 weeks show that patients experienced a decline in monthly headache days (an average dip of 8) and moderate to severe headache days (6.7). Patients also performed better on a test measuring pain, fatigue, stress and ability to carry out typical tasks. They have reported only rare, small-scale side effects, including neck discomfort, muscle weakness and droopy eyelids.
The second technique we study is the magnetic stimulation study, using a SpringTMS device. Magnetic stimulation shows benefits with no side effects. After at least three months, 25 of the 29 participants at one research site reported using fewer headache medicines, 22 reported less intense and less frequent pain, and 20 reported fewer headache days.
The SpringTMS uses a magnetic pulse created by sending an electrical current through a wire and directing it to the back of the head, where we think the electrical activity leading to migraines originates. Cleared by the FDA in 2014, the device is a breakthrough in preventing migraines for chronic sufferers.
We expect final results for both studies later this year. Although it’s too early to draw firm conclusions, preliminary results suggest we have credible answers for chronic migraine sufferers much sooner than any new drug could provide.
Dr. Ejaz A. Shamim, a neurologist with Mid-Atlantic Permanente Medical Group (MAPMG) in the Washington, D.C., area, serves as the local principal investigator for the COMPEL Botox and ESPOUSE SpringTMS study sites in the Washington/Baltimore area.
