Cincinnati, OH—What started out as a study to determine which commonly prescribed medications were most effective in preventing migraines in children and teens had unexpected results.

The report published recently in The New England Journal of Medicine found no significant differences among amitriptyline, topiramate, and placebo in reducing headache days or related disability.

“The study was intended to demonstrate which of the commonly used preventive medications in migraine was the most effective. What we found is that we could prevent these headaches with either a medication or a placebo,” explained senior author Andrew Hershey, MD, PhD, co-director of the Cincinnati Children‘s Headache Center. “This study suggests that a multi-disciplinary approach and the expectation of response is the most important, not necessarily the prescription provided.”

The Childhood and Adolescent Migraine Prevention (CHAMP) study was conducted at 31 sites in the United States, with Cincinnati Children‘s serving as the Clinical Coordinating Center for the study and the Clinical Trials Statistical and Data Management Center at the University of Iowa serving as the Data Coordinating Center.

The 24-week clinical trial included 328 eligible patients and used a clinically meaningful endpoint of a 50% or greater reduction in headache days from the 28 days prior to randomization to the final 4 weeks of the study.

Results indicate that 61% of those on a placebo saw the days they had a headache reduced by 50% or more.

For the two medication groups, meanwhile, 52% of participants taking amitriptyline and 55% of those on topiramate reached that level of reduced headache days. The responder rates were not statistically different among the three groups, study authors point out.

On the other hand, they note, compared to the group given the placebo, those on the two active drugs had a significantly higher rate of side effects, including fatigue, dry mouth and, in three cases, mood alteration. Most notably, 31% of those on topiramate had paresthesia—a “pins and needles” tingling in the hands, arms, legs or feet, according to the results.

Study authors suggest the results raise questions about the best way to prevent migraines, particularly since prescribing a placebo without patient knowledge is ethically questionable. Yet they add that the expectation of responding to a medication could override the actual biochemical and pharmacologic changes that are thought to occur with pharmacotherapy.

“Our national team was hoping to develop evidence to drive the choice by medical providers of the first line prevention medication for helping youth with migraine, but the data showed otherwise,” emphasized first author Scott Powers, PhD, pediatric psychologist and co-director of the headache center at Cincinnati Children‘s. “We see this as an important opportunity for health care providers, scientists, children, and families because our findings suggest a paradigm shift. First line prevention treatment will involve a multidisciplinary team approach and focus on non-pharmacological aspects of care. The good news is we can help children with migraines get better.”

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