Prescribed medications are no more effective than a sugar pill when used to prevent migraines in children and teens.
[Photo: Dr. Chris Coffey]
A study published October 27 in The New England Journal of Medicine shows 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,” says Dr. Andrew Hershey, co-director of the Cincinnati Children’s Headache Center and senior author of the study. “This study suggests that a multi-disciplinary approach and the expectation of response is the most important, not necessarily the prescription provided.”
Researchers conducted the Childhood and Adolescent Migraine Prevention (CHAMP) study at 31 sites in the United States.
Cincinnati Children’s served as the Clinical Coordinating Center (CCC) for the study, and was responsible for all clinical oversight activities. The Clinical Trials Statistical and Data Management Center (CTSDMC) at the University of Iowa served as the Data Coordinating Center for the study. It had primary responsibility for data management, implementing the electronic data capture system, and all statistical aspects of the study.
“The interpretation of these results is very challenging. In most situations, trials that fail to show benefit of an intervention do so because study participants do not improve. That was not the situation here. A majority of all study participants improved, regardless of their assigned treatment group,” says Dr. Chris Coffey, director of the CTSDMC and professor of biostatistics in the University of Iowa’s College of Public Health, and lead statistician for the study. “Further research is needed to better understand the results and to determine what future strategies might optimize the treatment of headaches in these childhood and adolescent populations.”
The results raise questions about the best way to prevent migraines, particularly given that it’s unethical to prescribe a placebo without the patient’s knowledge, according to the authors. They add it is likely the expectation of responding to a medication may override the actual biochemical and pharmacological changes that are thought to occur with pharmacotherapy.