TY - JOUR
T1 - Effectiveness of an antihistamine-decongestant combination for young children with the common cold
T2 - A randomized, controlled clinical trial
AU - Hutton, Nancy
AU - Wilson, Modena Hoover
AU - Mellits, E. David
AU - Baumgardner, Rosemary
AU - Wissow, Lawrence S.
AU - Bonuccelli, Catherine
AU - Holtzman, Neil A.
AU - DeAngelis, Catherine
N1 - Funding Information:
Drugs to treat upper respiratory tract infections are among the most commonly prescribed pharmaceuticals. Twenty-five percent of all drug recommendations reported to the National Ambulatory Medical Care Survey by pediatricians were in categories that included preparations for the common cold. 1 Supported by the General Pediatric Academic Development Program of the Robert Wood Johnson Foundation. Presented at the Joint Topic Session of the Ambulatory Pediatric Association, the American Pediatric Society, and the Society for Pediatric Research, April 30, 1987, Anaheim, Calif. Submitted for publication Jan. 23, 1989; accepted August 30, 1990. Reprint requests: Nancy Hutton, MD, Johns Hopkins Hospital, C.M.S.C. 144, 600 N. Wolfe St., Baltimore, MD 21205.
PY - 1991/1
Y1 - 1991/1
N2 - 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.
AB - 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.
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U2 - 10.1016/S0022-3476(05)81865-7
DO - 10.1016/S0022-3476(05)81865-7
M3 - Article
C2 - 1670783
AN - SCOPUS:0026067811
SN - 0022-3476
VL - 118
SP - 125
EP - 130
JO - The Journal of pediatrics
JF - The Journal of pediatrics
IS - 1
ER -