Cefaly: Natural Migraine Treatment
About 10 percent of all people complain of migraines, according to the U.S. National Institutes of Health, with women affected three times as much as men. Symptoms include intense headaches, nausea and photosensitivity.
The Cefaly, is a battery-powered TENS (transcutaneous nerve stimulation system) unit, which is a headband that delivers mild electrical stimulation to the wearer’s nerves. Although other TENS units are marketed for pain relief, this Belgian-made device, was approved in 2014 by the U.S. Food and Drug Administration for marketing as a way to prevent migraines. The bands stimulator delivers mild electrical currents to the trigeminal nerve branches in the wearer’s forehead. Agency spokespersons explained at the time that these nerves are linked to migraines.
The device is available by prescription for people that are 18 years old or older. Users are cautioned to wear it once per day for no more than 20 minutes. “Cefaly provides an alternative to medication for migraine prevention,” said Christy Foreman, director of the FDA’s Office of Device Evaluation in a prepared statement. “This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.”
During a trial study, 67 adults wore either the Cefaly or a fake device were randomized to wear either the Cefaly device or a fake that served as a placebo. Researchers determined that the number of headaches that 38% of the people that were stimulated had suffered monthly were cut in half as opposed to 12 percent of the people that wore the fake. STX-Med, which is the company that manufactures the device, surveyed 2,000 users in Europe and reported that most of them were satisfied with its effects. About 4 percent of them reported suffering from adverse effects.
There were no serious adverse effects reported in the study or another one previously conducted in France and Belgium, according to information from the FDA. The agency added that 53 percent of those that used the device indicated they were satisfied with it. Common complaints were mild discomfort, sleepiness and a headache after using the device.
Researchers from New York University claimed that the device’s results were comparable to the results from oral medication.