EMBARGOED FOR RELEASE: 3 P.M. (CT), MONDAY, OCTOBER 27, 2014
Media Advisory: To contact author Ian M. Paul, M.D., M.Sc., call Matt Solovey at 717-531-8606 or email email@example.com. To contact editorial author James A. Taylor, M.D., call Susan Gregg at 206-616-6730 or email firstname.lastname@example.org.
To place an electronic embedded link to this study in your story The link for this study will be live at the embargo time: http://archpedi.jamanetwork.com/article.aspx?doi=10.1001/jamapediatrics.2014.1609 and http://archpedi.jamanetwork.com/article.aspx?doi=10.1001/jamapediatrics.2014.2355.
Pasteurized agave nectar and placebo were both perceived to be better by parents for treating nighttime cough and the resulting sleep difficulty in infants and toddlers than doing nothing at all, according to a study published in JAMA Pediatrics.
Cough is a frequent symptom in children and one of the main reasons they visit a health care professional. Little evidence supports the use of over-the-counter medicine for acute cough. An alternative to treat cough is honey but children younger than 1 year are precluded from consuming honey because of concerns over infant botulism. Agave nectar has properties similar to honey but has not been associated with botulism.
Researchers Ian M. Paul, M.D., M.Sc., of the Penn State College of Medicine, Hershey, Penn., and colleagues compared treatment with agave nectar, placebo or no treatment at all on nighttime cough and the accompanying sleep disturbance in a group of 119 children who were randomized to one of the three treatment groups. The one-night study included children 2 to 47 months old who had nonspecific acute cough for seven days or less.
Study results indicate that agave nectar and placebo resulted in perceived symptom improvement by parents compared with no treatment, but agave nectar did not outperform placebo when a comparison was made between the two.
“Both physicians and parents want symptomatic relief for children with these common and annoying illnesses. The significant placebo effect found warrants consideration as health care providers and parents determine how best to manage the disruptive symptoms that occur in the setting of upper respiratory tract infections among young children. Placebo could offer some perceived benefit, although at a financial cost, while reducing inappropriate antibiotic prescribing,” the study concludes.
(JAMA Pediatr. Published online October 27, 2014. doi:10.1001/jamapediatrics.2014.1609. Available pre-embargo to the media at http://media.jamanetwork.com.)
Editor’s Note: An author made a conflict of interest disclosure. This study was funded by an unrestricted grant to the Penn State College of Medicine by Zarbee’s Inc. Please see article for additional information, including other authors, author contributions and affiliations, etc.
Editorial: Using the Placebo Effect to Treat Cold Symptoms in Children
In a related editorial, James A. Taylor, M.D., and Douglas J. Opel, M.D., M.P.H., of the University of Washington, Seattle, write: “Although the study intervention provided no more relief from cough symptoms than placebo, both treatments were statistically superior to no treatment. The investigators contend that these findings are indicative of a placebo effect.”
“Rather, what the investigators are observing in this study is a placebo effect in the parents who assessed outcomes in study children using a cough symptom questionnaire,” they continue.
“As investigators such as Paul and colleagues continue to evaluate pharmacologic treatments, perhaps we should also conduct research designed to identify other components of care (e.g., communication techniques and nonspecific treatments) that improve outcomes after visits to clinicians by children with cold symptoms, even if the improvement is simply caused by a placebo effect, as broadly characterized,” the authors conclude.
(JAMA Pediatr. Published online October 27, 2014. doi:10.1001/jamapediatrics.2014.2355. Available pre-embargo to the media at http://media.jamanetwork.com.)
Editor’s Note: Please see article for additional information, including other authors, author contributions and affiliations, etc.
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