BUFFALO, N.Y. -- A new University at Buffalo study of treatments for children
with attention deficit hyperactivity disorder (ADHD) has found that combining
behavior modification therapy with medication is the most effective way to
improve the behavior of many ADHD children.In fact, when the two are combined,
the study showed, the amount of medication required to achieve the same results
as use of medication alone can be reduced by two-thirds.
"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
thebehavior 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.The University at Buffalo is a premier
research-intensive public university, the largest and most comprehensive campus in the
State University of New York.