The U.S. Food and Drug Administration announced last week that it has approved marketing of the first medical device to prevent migraine headaches — a decision based on evaluations of a clinical study out of Belgium that included just 67 participants. The FDA also looked at a 2,300-plus patient satisfaction study out of Belgium and France.
The product, Cefaly, is the first transcutaneous electrical nerve stimulation (TENS) device to be authorized for use before the onset of pain. Described as “a small, portable, battery-powered, prescription device that resembles a plastic headband worn across the forehead and atop the ears,” the Cefaly contains a self-adhesive electrode that is positioned in the center of the forehead. “The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches. The user may feel a tingling or massaging sensation where the electrode is applied,” according to the FDA’s March 11 news release.
“Cefaly provides an alternative to medication for migraine prevention,” and “may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks,” said Christy Foreman, the director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, in the release.
The European studies showed that the Cefaly does not completely prevent migraines or reduce the intensity of occurring migraines; those who used it, however, did experience fewer days of migraines per month and used less migraine attack medication.
Migraines affect 50 million Americans, writes Pamela Weintraub in “How to Handle Headaches” (Experience Life, April 2010). Of those, about 6 million people suffer migraines every day of their lives.
Many experts, including neurologist David Buccholz, MD, of John Hopkins University — who was interviewed by Weintraub — are researching approaches to prevent migraines before they start. Instead of using an electrode, however, Buccholz’s focus is on identifying dietary and environmental triggers, and using natural supplements for pain instead of prescription drugs, which often cause rebound headaches. (See “Dietary Triggers: Top 10 List” below for the top 10 foods/ingredients to avoid.)
Other strategies include seeing an acupuncturist, exercising regularly, getting the right amount of sleep, avoiding perfume and scented products, embracing stress-management techniques, and checking your home for fumes.
Taking supplements like riboflavin, butterbur, magnesium, coenzyme Q10, and feverfew can help support the brain and body before a headache begins. (For more information on these supplements, see “Natural Cures.”)
The key is to try to get to the root cause of the migraines — and to remember that each person is different. As pioneering functional-medicine doctor Mark Hyman, MD, explained in a December 2013 Experience Life article on functional medicine:
“You need to explore what is giving rise to those migraines,” says Hyman. “Conventional neurologists will diagnose you with a migraine based on your symptoms, but they don’t investigate the causes of those migraines.”
And, there are a variety of causes. For example, explains Hyman, one of his patients had migraines due to bacterial overgrowth in her small intestine. Another patient, who had been to the top headache clinics in the world, turned out to have a simple magnesium deficiency. Another had a gluten sensitivity that triggered her migraines. And yet another patient, who was approaching 40 and always experienced migraines right before her period, turned out to have an estrogen-progesterone imbalance.
Most neurologists don’t have the right model for treating these people, Hyman says, because they are treating only a symptom — pain — and not the root causes.
—”Functional Medicine: A Science Whose Time Has Come” by Catherine Guthrie
TELL US: Do you suffer from migraines? If so, what preventive methods have and haven’t worked for you? Comment below or tweet us @Experience.