NEW YORK (Reuters Health) - Agave nectar - or placebo - are better than nothing for nighttime coughs in infants and toddlers, according to new findings published online October 27 in JAMA Pediatrics.
"For a condition that we don't have any other good treatment, especially for babies under age one, placebo seems to make a difference, and if there's a safe alternative that could make parents feel better and perhaps reduce unnecessary antibiotic prescribing that's something to consider," Dr. Ian Paul of Penn State College of Medicine in Hershey, the first author of the study, told Reuters Health in a telephone interview.
The US Food and Drug Administration has warned against the use of over-the-counter cough and cold medicines in children younger than 2, based on safety concerns and the fact that there is no proof of their efficacy, the researchers note in their report.
In 2007, Dr. Paul and his colleagues showed that honey was more effective than dextromethorphan or no treatment for nocturnal cough and sleep problems related to upper respiratory tract infection. However, they note, children younger than a year old should not be given honey, due to the risk of botulism.
Agave nectar has similar properties to honey, but with no known botulism risk, the researchers add. To investigate whether it might be helpful for treating cough, the researchers randomly assigned 125 children 2 to 47 months old presenting with non-specific cough for seven days or less to a dose of agave nectar, placebo, or no treatment 30 minutes before bedtime.
Parents completed a survey about their child's symptoms the night before the child enrolled in the study, and then on the subsequent night when the child was given agave, placebo or no treatment.
In each study group, the researchers found, parents rated all symptoms significantly improved in the second survey. For each symptom, improvements in the agave group and the placebo group were significantly better than for the no treatment group, aside from cough bothersomeness.
The researchers used pasteurized agave nectar with natural grape flavoring from Zarbee's, Inc., while the placebo consisted of grape-flavored water with caramel coloring.
"You can get plain agave nectar at pretty much every supermarket now," Dr. Paul said. "What made me think to try it in our study was I saw it in the supermarket."
Based on the findings, he added, pediatricians can think about advising parents to try agave nectar for children with cough. "It's something they can consider, as an alternative to telling parents to do nothing." The treatment "appears harmless," Dr. Paul said, and may make both parents and babies feel better.
Up to 38% of visits to primary care pediatricians by children one to five years old involve cough and cold, Dr. James A. Taylor and Dr. Douglas J. Opel of the University of Washington in Seattle note in an editorial accompanying the study. "These can be frustrating encounters for health care professionals because of the perception that the clinician has nothing to offer beyond reassurance," they add.
"If a placebo is of low cost, has no or minimal adverse effects, and the parent or patient is not deceived about the nature of the treatment," they write, "it seems largely irrelevant whether or not the benefit from a clinical encounter is because of a clinician's recommendation for the use of an evidence-based treatment or from a placebo effect."
They conclude: "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."
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