A study generating national attention that questions the use of certain drugs to help children suffering from migraine headaches included work from the University of Iowa’s College of Public Health.
The study found that two pills frequently prescribed to children to prevent migraines were no more effective than a placebo, even though the two drugs—amitriptyline and topiramate—prevent migraines in adults.
The evidence was so overwhelming researchers stopped the trial early. The results were published in the current issue of The New England Journal of Medicine.
The study was conducted by Cincinnati Children’s Hospital Medical Center and the UI College of Public Health’s Clinical Trials Statistical and Data Management Center. Christopher Coffey, director of the CTSDMC and professor of biostatistics in the UI’s College of Public Health, says the data management center served as the data coordinating center (DCC) for the study. Coffey says UI researchers entered and cleaned the data using a web-based data entry system developed and maintained at the DCC.
The UI researchers also had primary responsibility for all statistical aspects of the study and analyzing primary study data. They were responsible for all data management, safety monitoring, and clinical site monitoring activities for the study.
“The interpretation of these results is very challenging,” says Coffey, the lead statistician for the study. “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.
“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,” he says.