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No Proof Drugs Ease Kids' Migraines: Study
Date:1/28/2013

e more effective than a sugar pill.

But the evidence supporting each of these drug's effectiveness was "limited," and the team concluded there was generally insufficient data concerning pediatric migraine patients to draw firm conclusions.

"It's very discouraging," said Jackson. "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."

Also disturbing is that "these medicines are kind of nasty," he added. "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."

Migraine prevalence increases with age, from 3 percent of preschool children to 11 percent of elementary school kids and 23 percent of high school students, according to background information in the study.

For the pediatric migraine treatment analysis, Dr. William Rodriguez, a pediatrician in the FDA's Office of Pediatric Therapeutics, and colleagues reviewed all relevant data submitted to the FDA between 1999 and 2011 regarding five drugs previously approved for adult migraine treatment. Those drugs included: sumatriptan succinate nasal spray, zolmitriptan, eletriptan hydrobromide, almotriptan malate and rizatriptan benzoate pills.

Seven reviewed studies had been conducted according to rigorous, randomized, placebo-controlled standards, and involved patients between 12 and 17 years old 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.

As with the headache prevention study, the FDA review found that placebos were often effective in relieving pediatric headaches, with roughly 53 to 58 percent of sugar pill patients experiencing pain relief within two hours of treatment.

The authors co
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