Science & Enterprise subscription

Please share Science & Enterprise

RSS
Follow by Email
Facebook
Facebook
Google+
Twitter
Visit Us
LinkedIn

Affiliations

Preventive Drugs Offer No Benefit for Children’s Migraine

Headache graphic

(Gerd Altmann, Pixabay)

28 October 2016. A clinical trial testing drugs for depression and seizures, but sometimes prescribed to prevent migraines, shows the drugs to be no better than a placebo in preventing migraines among children. Findings from the study, led by Andrew Hershey, co-director of the headache clinic at Cincinnati Children’s Hospital in Ohio, appear in yesterday’s (27 October) issue of the New England Journal of Medicine.

Migraine is a neurological syndrome causing severe headaches along with nausea, vomiting, and extreme sensitivity to light and sound. In some cases, migraines are preceded by warning episodes called aura including flashes of light, blind spots, or tingling in arms and legs. Migraine Research Foundation says children generally experience fewer and shorter migraine attacks than adults, but childhood migraine can be just as disabling and can seriously affect the child’s quality of life.

Hershey and colleagues, including biomedical statisticians from University of Iowa, are seeking better guidelines for medications to treat migraines in children. The authors note that more than 6 million children in the U.S. have migraines, but FDA has yet to approve migraine medications for children younger than the age of 12. A previous survey showed the drugs amitriptyline and topiramate were often prescribed to prevent migraines among children.

Amitriptyline is an established medication given as a tablet to treat depression, marketed as the brand names Elavil and Vanatrip, and also available in generic form. The drug works by altering the balance of the neurotransmitter serotonin in the brain, associated with migraines. Topiramate is given as a tablet or capsule approved to treat seizures like those experienced with epilepsy, and is available as the brand name drug Topamax and in generic form. While the precise mechanism of topiramate is not known, the drug is believed to block channels that promote neurotransmitter activity supporting migraines.

The clinical trial enrolled 328 children and adolescents age 8 to 17 experiencing migraines, at 31 sites in the U.S. In this late-stage trial, some 40 percent of participants were randomly assigned to receive either amitriptyline (132) or topiramate (130), while the remaining 20 percent (66) received a placebo. The study team looked primarily at the frequency of headaches experienced by participants, with an efficacy target of 50 percent or greater reduction in the number of days with headaches over a 4-week period, compared to a similar period before the trial. Investigators also tracked related efficacy measures as well as adverse effects.

The results show a majority of participants receiving amitriptyline (52%) and topiramate (55%) met the target of reducing the number of headache days by half or more. But the findings show 61 percent of placebo recipients also reduced their number of headache days by half or more over 4 weeks, with the differences among the three groups not large enough to be statistically reliable.

In addition, participants receiving the active drugs were more likely to experience adverse side effects. From 25 to 30 percent of the amitriptyline recipients reported dry mouth or fatigue, while 31 percent topiramate experienced paresthesia — “pins-and-needles” tingling in hands or feet, which were more frequent occurrences than among placebo recipients. More seriously, 3 participants receiving amitriptyline reported altered moods and 1 individual in the topiramate group attempted suicide.

The authors conclude the prescribed drugs were no more likely than a placebo to reduce headaches and disability from migraine among children, with the reports of adverse effects from the drugs making them even more problematic.  “The study was intended to demonstrate which of the commonly used preventive medications in migraine was the most effective,” says Hershey in a Cincinnati Children’s statement. “What we found is that we could prevent these headaches with either a medication or a placebo. Hershey adds, “that a multi-disciplinary approach and the expectation of response is … most important, not necessarily the prescription provided.”

Read more:

*     *     *

Please share Science & Enterprise ...

Comments are closed.