Headaches are as common in young people as they are in adults. But according to the results of two new studies published in JAMA Pediatrics, there is no clear evidence that drugs used to treat headaches and migraine in adults are any more effective than a placebo when given to children and teens.
In the first study, researchers at the Medical College of Wisconsin in Milwaukee conducted an analysis of 21 clinical trials assessing prevention treatments to reduce the frequency or severity of headaches in children and adolescents.
All but one of the studies focused on episodic migraines (migraines that occur less than 15 times a month), with one study involving chronic headaches (15 times or more a month).
What they found was that drugs like topiramate (marketed as Topamax) and trazodone (Oleptro and Desyrel) were effective in treating childrens’ migraine, other commonly used drugs, such as flunarizine (Sibelium), propranolol (Inderal) and valproate, were no more effective than a placebo.
Children taking a placebo, or sham medicine, reduced their migraines by an average of about three headaches a month.
The second study focused on trials involving children given a commonly used class of drugs called triptans, which are used to treat adult migraine. As with the headache prevention study, Food and Drug Administration researchers found that placebos were often just as effective in relieving pediatric headaches, with up to 58 percent of patients receiving sugar pills experiencing pain relief within two hours of treatment.
Although the reasons for the high placebo response rates are unclear, researchers think it might be due to the shorter duration of migraine attacks in adolescents, who may also have different types of migraines than adults.
“These studies clearly demonstrate why we cannot assume what works in adults will work in kids and why children need their own studies,” said William Rodriguez, Pediatric Science Director of the FDA’s Office of Pediatric Therapeutics, in an e-mail to Bloomberg News.
“There are many — over 50 percent in most studies — of children who do not need a drug for the migraine to resolve in a couple of hours. Drug therapy appears to be effective in a certain subset of children with migraine.”
According to researchers, migraines occur throughout childhood and adolescence, with prevalence increasing with age; from 3 percent of preschool children, to 11 percent of elementary school kids, and 23 percent of high school students.
Among children, they note, more boys than girls have migraines, but that is reversed after puberty. Eight million children in the U.S are estimated to suffer from migraines.
What stood out for researchers in both studies was not only the need for more investigation into the treatment of migraines in children and teens, but also a better understanding of the use of adult migraine medicines in kids and the role placebos have in helping them.
“Pediatric clinical trials are different than trials conducted in adults for many reasons. One of the issues is that a failed pediatric trial seldom motivates a sponsor to conduct additional pediatric trials,” said Dr. Rodriguez. “This is in contrast to what happens with failed adult trials. It has to do with the fact the sponsor is usually much more interested in the adult market as the pediatric populations with diseases are small.”
Researchers at the Medical College of Wisconsin say further studies with placebo controls would enhance the likelihood of more successful management of migraines and avoid the “therapeutic futility” of using medicines in patients who are unlikely to respond.
“All the drugs in our analysis have been found effective in adults with migraine headaches, but few were beneficial among children,” they wrote. “This suggests there may be something different about pediatric migraines or that the response to treatment differs between children and adults.”