Effectiveness of an antihistamine-decongestant combination for young children with the common cold: A randomized, controlled clinical trial

Nancy Hutton, Modena Hoover Wilson, E. David Mellits, Rosemary Baumgardner, Lawrence S. Wissow, Catherine Bonuccelli, Neil A. Holtzman, Catherine DeAngelis

Research output: Contribution to journalArticle

Abstract

We tested the hypothesis that antihistamine-decongestant combinations cause no clinically significant relief of the symptoms of upper respiratory tract infections in young children by randomly assigning 96 children to one of three treatment groups: antihistamine-decongestant, placebo, and no treatment. There were no differences among the three study groups in the proportion of children considered "better" overall by the parent 48 hours after the initial assessment (drug, 67%; placebo, 71%; no treatment, 57%; p=0.53). There were no differences among groups in individual or composite symptom score changes. Two thirds of parents whose children were eligible for the drug trial believed that their child needed medicine for cold symptoms. In the proportion of parents believing that their child needed medicine, there was no difference between those who consented to participate and those who refused. Parents who wanted medicine at the initial visit reported more improvement at follow-up, regardless of whether the child received drug, placebo, or no treatment. We conclude that there is no clinically significant improvement in symptoms of upper respiratory tract infection, including no significant placebo effect, in young children for whom an antihistamine-decongestant is prescribed.

Original languageEnglish (US)
Pages (from-to)125-130
Number of pages6
JournalThe Journal of pediatrics
Volume118
Issue number1
DOIs
StatePublished - Jan 1991

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Fingerprint Dive into the research topics of 'Effectiveness of an antihistamine-decongestant combination for young children with the common cold: A randomized, controlled clinical trial'. Together they form a unique fingerprint.

  • Cite this