January 29, 2013
No Evidence That Adult Drugs Work For Migraines In Children And Teenagers
Lawrence LeBlond for redOrbit.com - Your Universe Online
It is well-known that children and teens can suffer from debilitating migraines as much as adults do. And many of these younger sufferers are often prescribed the same drugs and doses that adults receive for their pulse-pounding headaches. But two recent reviews of pediatric migraine research are digging up some troubling news.
The first review (a migraine-treatment analysis), conducted by the US Food and Drug Administration (FDA), states that a drug-free placebo prevents migraines in children and teens just as well as most headache medicines, or even better.
D. William Rodriguez, a pediatrician in the FDA´s Office of Pediatric Therapeutics, reviewed all relevant data submitted to the FDA between 1999 and 2011 regarding five drugs approved for adult migraine treatment: sumatriptan succinate nasal spray, zolmitriptan, eletriptan hydrobromide, almotriptan malate and rizatriptan benzoate pills.
In all, seven studies were reviewed that involved patients between 12 and 17 years of age, and who had a history of migraines lasting at least four hours per incident. Most of the participants were white, and the studies included slightly more girls than boys overall.
The FDA review found that between 53 and 58 percent of patients who took a placebo experienced pain relief within two hours.
The authors noted that the strength of the observed placebo effect made it difficult to gauge the effectiveness of prescription treatments, and also noted that no trials were conducted between 1999 and 2003 that showed any drug effectiveness among adolescents.
The team also suggested that design changes should be implemented for future studies to help clarify matters. These studies should distinguish between children who have short-lasting migraine and those with longer ones, and perhaps between those who respond quickly to placeboes and those who do not.
"These studies clearly demonstrate why we cannot assume what works in adults will work in kids and why children need their own studies," noted Rodriguez.
The migraine-prevention review, conducted by the Medical College of Wisconsin in Milwaukee, analyzed 21 previous studies (dating up to mid-2012) that included male and female patients up to age 18. The review was led by Wisconsin´s professor of medicine, Dr. Jeffrey Jackson.
In that review, Jackson and colleagues found that 20 of the studies focused on “episodic migraine,” where migraines occur fewer than 15 times per month. Only one study looked at “chronic headaches,” occurring 15 or more times per month.
All of the studies had either compared two or more migraine medications or a single drug´s effectiveness in reducing headache frequency and severity against that of a placebo. These treatments included anti-epileptic medications, antidepressants, antihistamines, calcium channel blockers, blood pressure control meds, and non-steroidal anti-inflammatory drugs.
This review also found that, to a large degree, placeboes were more widely effective in controlling pediatric headaches than were prescription drugs. The placeboes reduced occurrence of migraine from an average of six per month to fewer than three per month.
However, there still remained limited evidence supporting the effectiveness of these drugs, and there could be no firm conclusions based on insufficient data from past pediatric studies.
"It's very discouraging," Jackson said, according to US News correspondent Alan Mozes. "I was rather shocked to see, quite frankly, how few studies were done among children with headaches, and that the handful of studies we have suggest that the benefits of these drugs, if any, aren't really big."
He also said that these medicines are particularly nasty. "Some cause dry mouth, or fatigue, or problems with concentrating. They're not really medicines you would want your vibrant teen to be on if they're not working."
"Parents should be aware that our medication choices aren't as good as they should be," Dr. Jennifer Bickel, a neurologist and headache specialist at Children's Mercy Hospitals and Clinics in Kansas City, Missouri, told Genevra Pittman at Reuters Health.
It´s a shame that doctors have to rely on headache drugs made for adults, she noted, as there has been no research on migraine treatment and prevention in children and teenagers.
Those adult medicines are "not a miracle cure," said Bickel, who was not involved in either review.
According to background data in the study, migraine prevalence increases with age. In preschool children, the prevalence is about 3 percent, rising to 11 percent in elementary school children and 23 percent in high school students.
The results of both reviews have been published in the online edition of JAMA Pediatrics on Jan. 28, 2013.