Placebos Keep Pace With Some Migraine Medicines: Study


When it comes to preventing migraines in children, sugar pills may work just as well as some prescription medications, a new study suggests.

In the study published in the New England Journal of Medicine, placebo sugar pills were found to reduce the number of days children had migraines over a month’s time by half.

“The medication didn’t perform as well as we thought it would, and the placebo performed better than you would think,” said Scott Powers, the study’s lead author and a director of the Headache Center at Cincinnati Children’s Hospital, to the New York Times.

The study focused on two generic prescription drugs: topiramate, an anti-seizure medicine and amitriptyline, an antidepressant. Both are used for adult migraines as well and were linked to higher adverse effects.

“The fact that it shows that two of the most commonly used medications are no more effective than a placebo and have adverse effects makes a very clear statement,” said Leon Epstein, neurology chief at Ann & Robert Lurie H. Children’s Hospital of Chicago.

More than 350 children ages from eight to 17 years old participated in the study. They experienced 11 migraines on average in the month before the study. They were then randomly assigned to take either of the drugs or placebo pills daily for six months. At least half of the children achieved the study goal of reducing migraine frequency by half.

Powers said, in a statement to NBC, the results “really challenge what is typical practice today by headache specialists.”

Up to 10 percent of U.S. school-aged children have migraines. While over-the-counter anti-inflammatory medicines such as ibuprofen and acetaminophen can help reduce symptoms, the only government-approved migraine medication for kids is topiramate. Topiramate is known by the brand names Topamax and Quedexy and is only approved for children ages 12 and up.

Epstein said the study should lead neurologists to rely on other prevention strategies. He said he advises lifestyle changes such as more sleep and reducing stress, which can prevent migraines in teen patients.

Side effects from the drugs used in the study were common, including fatigue, dry mouth and forgetfulness. Almost one-third of the children taking topiramate had tingling sensations in their hands, arms, legs or feet. There was one suicide attempt in the topiramate group, another known side-effect of the drug.

Powers said that while the side effects were not unexpected, the drugs shouldn’t be “first-line prevention treatments” for children’s migraines.

Other experts were hesitant about giving up on drug treatment.

“Am I now going to feel obligated to tell patients that these drugs are no better than a placebo? No,” said Eugene R. Schnitzler, a professor of neurology and pediatrics at Loyola University Chicago Stritch School of Medicine. “I’ll simply say, ‘We have data in adults that it’s effective, but less convincing data in children and adolescents.’”

While the drugs were suggested to be ineffective for children in general, “that doesn’t mean for any one individual, a drug might not work,” said David Gloss, a neurologist and methodologist for the American Academy of Neurology.

Gloss and a team of physicians are revising the academy’s guidelines on pediatric migraines and are planning to assess nondrug approaches.

The National Institute of Neurological Disorders and Stroke and the National Institute of Child Health and Human Development paid for the study.