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Placebo effect in the treatment of acute cough in infants and toddlers: a randomized clinical trial.

IMPORTANCE
Cough is one of the most common reasons why children visit a health care professional.


OBJECTIVES
To compare the effect of a novel formulation of pasteurized agave nectar vs placebo and no treatment on nocturnal cough and the sleep difficulty associated with nonspecific acute cough in infants and toddlers.


DESIGN, SETTING, AND PARTICIPANTS
In this randomized clinical trial performed in 2 university-affiliated outpatient, general pediatric practices from January 28, 2013, through February 28, 2014, children 2 to 47 months old with nonspecific acute cough duration of 7 days or less were studied. Surveys were administered to parents on 2 consecutive days, the day of presentation (when no medication had been given the prior evening) and the next day (when agave nectar, placebo, or no treatment had been administered to their child before bedtime) according to a partially double-blind randomization scheme.


INTERVENTIONS
A single dose of agave nectar, placebo, or no treatment administered 30 minutes before bedtime.


MAIN OUTCOMES AND MEASURES
Cough frequency, cough severity, cough bothersomeness, congestion severity, rhinorrhea severity, and cough effect on child and parent sleep.


RESULTS
Significant differences in symptom improvement were detected between the study groups (P < .05 for all, except P = .06 for cough bothersomeness), with agave nectar and placebo proving to be superior to no treatment, but no significant differences for any outcome were found when comparing agave nectar against placebo.


CONCLUSIONS AND RELEVANCE
In a comparison of agave nectar, placebo, and no treatment, a placebo effect was demonstrated, with no additional benefit offered by agave nectar. Health care professionals should consider the potential benefits and costs when recommending a treatment with only a placebo effect for infants and toddlers with nonspecific acute cough.


TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT01721395.