"One of the major findings of the study is that when using behavior modification, you can get away with tiny, tiny doses of medication, much lower than previously thought," said ADHD researcher William E. Pelham, Jr., University at Buffalo Distinguished Professor in the Department of Psychology, UB College of Arts and Sciences and UB School of Medicine and Biomedical Sciences.
The study is the first to test the effectiveness of a new drug treatment, a methylphenidate (MPH) patch. Methylphenidate is the stimulant used in pill form by ADHD drugs Concerta and Ritalin.
The study is published in the May issue of Experimental and Clinical Psychopharmacology. It was funded by a grant from Noven Pharmaceuticals. Shire Pharmaceuticals Group, which purchased the rights to the MPH patch from Noven, will seek FDA approval for the MPH patch in 2006.
Twenty-seven children with ADHD, ages 6 to 12, participated in the study, conducted at the University at Buffalo's Summer Treatment Program for children with ADHD. Pelham and co-researchers assessed the effects of behavior modification, the MPH patch and a placebo on the children in classroom and organized play settings, and through use of parental behavior ratings.
The researchers found that when used alone, the MPH patch and behavior modification therapy were equally effective treatments. The MPH patch was effective in all doses tested, with few reports of side effects and good wear characteristics.
Combined treatment -- using a very low dose of the MPH patch with behavior modification -- was superior to either treatment alone, however.
"The patch used with behavior modification caused the greater amount of improvement in the
behavior of the children," says Pelham, who helped develop Concerta and who has conducted many other trials involving other stimulant drugs.
Significantly, the study also found that with combined treatment children required much lower doses of medication -- as much as 67 percent lower -- to achieve the same effects as high doses of medication used alone.
Lower dosages of medication lowers the risk of long-term drug side effects, which studies have shown to include loss of appetite and stunting of growth, Pelham points out. "Long-term side effects of ADHD drugs are almost always related to dosage," he says. "If you want to lower a child's dosages daily and throughout their lifetime, the best way to do that is to combine the medication with behavior modification."
According to Pelham, the MPH patch's dosage flexibility potentially makes it ideal for administering lower dosages of methylphenidate in combination with behavior modification. The MPH patch can be applied to a child for short periods during the course of the day. The most commonly used pill forms of methylphenidate, which last for 12 hours, do not offer such flexibility, Pelham says.
"The patch enables users to use less medication for short time periods, and that's good in my opinion," Pelham says. "I think parents are becoming more concerned about the safety of medications than they have been in the past."
The study is the first comparison study of medication and behavior modification to control for the presence and absence of behavior modification that is received by a child daily from parents, teachers, siblings or peers, according to Pelham. As such, the study is the first to accurately isolate the effects of medication and behavior modification treatments, Pelham says.
"There's so much behavior modification that goes on naturally in the world that unless you do a study where you guarantee that all of it is taken away you underestimate the effect of behavior modification because it's always there," Pelham says.
"This study shows that when you control for those outside factors, you get effects of behavior modification that are just as big as high doses of medication."
The study's results, Pelham says, should send a clear message to parents of children with ADHD. "You definitely should be using behavior modification," he says. "You'll be giving your children much lower doses of medication over their lifetimes if you combine behavior modification with medication."
The study's co-investigators were Lisa Burrows-MacLean, Elizabeth M. Gnagy, Gregory A. Fabiano, Erika K. Coles, Katy E. Tresco, Anil Chacko, Brian T. Wymbs, Amber L. Wienke, Kathryn S. Walker and Martin T. Hoffman from the UB Center for Children and Families.
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