Penn State College of Medicine researchers have found that a placebo is more effective than no treatment or “watchful waiting” for young children’s cough symptoms. The results of the study, which are published in JAMA Pediatrics, also found that agave nectar is more effective than watchful waiting.
Coughs are one of the most common reasons for children to see a doctor. Although over-the-counter medications are available to treat coughs and colds in young children, there is little evidence to support them.
Because of this lack of evidence, as well as some safety concerns, the Food and Drug Administration (FDA) do not recommend the use of these over-the-counter medicines in children under 2 years old.
In 2008, as part of a voluntary change announced by the Consumer Healthcare Products Association, most manufacturers of these remedies included warnings on their product labels stating the medication should not be used in children under the age of 4 years.
However, in the absence of effective treatments for cough in young children, doctors report feeling pressured by parents to prescribe antibiotics, though these drugs do not affect the viruses that cause colds and coughs.
“Pediatricians typically tell parents, ‘Don’t give your child anything,’ or at most give them acetaminophen or ibuprofen,” says Dr. Ian Paul, professor of pediatrics. “We know sick children are miserable and can’t sleep, and parents are frustrated that they can’t do anything to help.”
A previous study from Dr. Paul and the Penn State team – the findings of which were replicated by other researchers – found that honey was more effective than a placebo for treating children’s coughs.
However, honey is associated with risks of infant botulism in children under the age of 1 year. For their new study, the researchers looked at agave nectar as a treatment for young children, which shares some properties with honey and has no known risk of infant botulism.
The researchers recruited 119 children aged 2-47 months from two general pediatric practices who had non-specific acute cough, night-time symptoms and who were ill for 1 week or less in total.
The children were given either commercially available grape-flavored agave nectar, grape-flavored water or no treatment. Details on cough frequency, cough severity and child and parent sleep quality were reported by the parents.
The study found that both agave nectar and the grape-flavored placebo improved cough symptoms more than no treatment and that there were no significant differences in effectiveness between the two.
In a small but significant subgroup of 30 children under the age of 1 year, however, agave nectar was more effective than the placebo. The researchers reported rare adverse results among both the agave nectar and placebo groups.
Dr. Paul describes the results:
“We found that placebo was better than doing nothing. For kids under age 1, for which there is no other option, the findings may be particularly important.
Perhaps this is a case where giving a placebo, such as agave nectar or sugar water, can help parents and their babies get through this annoying illness. This is a discussion that the pediatric community and parents are going to have to have.”
The researchers acknowledge that, because the study relies on parents reporting symptoms, there is an element of subjectivity in the results. However, they argue that this may not be a limitation of the study as “health care professionals and parents often make decisions based on subjective assessment of symptom severity.”