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Placebo-controlled clinical trials put children with asthma at risk

Enrolling children with asthma in the placebo arm of a clinical trial is common, harmful and ethically unjustified argue researchers from the University of Chicago and the National Institutes of Health (NIH) in the January 2004 issue of Pediatrics.

After a systematic review of all clinical asthma trials involving children in the United States published between 1998 and 2001, the researchers found that children with asthma were more than twice as likely to be harmed -- defined as forced to withdraw from the trial due to asthma exacerbation -- if they did not receive standard asthma therapy compared to children who received standard treatment.

Although established guidelines recommend anti-inflammatory medications for all children and adults with mild-persistent, moderate or severe asthma, 45 of the 70 published studies compared a drug against a placebo. All 45 studies involved subjects under the age of 18 and 14 of the studies involved only children.

"This is problematic," said study co-author Lainie Friedman Ross, M.D., Ph.D., associate professor of pediatrics and assistant director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. "These children have been exposed to unnecessary risks and harm because the very medication they depend on is being withheld from them during these studies."

The research also revealed serious concerns with current asthma practice. In only 18 of the 70 studies, those subjects with more than mild asthma were actually taking anti-inflammatory medications prior to joining the study. Although 22 of the studies required all subjects to begin or continue to take appropriate medications, 48 of the studies did not. In six trials, subjects who had been on appropriate anti-inflammatory therapy prior to the study were taken off these medications.

"Children aren't on medications before the study for a variety of reasons," Ross said. "It may be a lack of acces
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Contact: Catherine Gianaro
cgianaro@uchospitals.edu
773-702-6241
University of Chicago Medical Center
5-Jan-2004


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