Is an antihistamine-decongestant combination effective in temporarily relieving symptoms of the common cold in preschool children?,☆☆,

Presented in part at the 36th Annual Meeting of the Ambulatory Pediatric Association, May 10, 1996, Washington, D.C.
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Abstract

Objective: To determine whether an antihistamine-decongestant combination (ADC) is superior to placebo in temporarily relieving symptoms of upper respiratory tract infection (URI) in preschool children.

Design: Randomized, double-blind, placebo-controlled trial.

Setting: Four pediatric offices in the Seattle, Wash., area.

Participants: Children 6 months through 5 years of age with a URI of less than 7 days' duration.

Methods: Children were randomly assigned to receive an ADC (brompheniramine maleate–phenylpropanolamine hydrochloride) or placebo as needed for URI symptoms. Two hours after each dose of study medication, changes in the child”s runny nose, nasal congestion, cough, and sleep status were assessed by means of a standardized questionnaire.

Results: A total of 175 responses were recorded for 59 patients. There were no statistically significant differences in symptom improvement between the ADC and the placebo group (runny nose, p = 0.48; nasal congestion, p = 0.94; cough, p = 0.66). However, the proportion of children asleep 2 hours after receiving the ADC was significantly higher than the proportion receiving placebo (46.6% vs 26.5%; p = 0.01). Results were unchanged after control for the correlated nature of repeated responses, age, symptom duration, use of acetaminophen, time that the medication was given, and parental desire for medication.

Conclusions: The ADC was equivalent to placebo in providing temporary relief of URI symptoms in preschool children. However, the ADC did have significantly greater sedative effects than did placebo. (J Pediatr 1997;130:463-6)

Section snippets

METHODS

From April 1995 through March of 1996, patients were recruited from four private pediatric practices in the Seattle, Wash., area. Eligible patients were children 6 months through 5 years of age seen in participating physicians' offices with a diagnosis of an upper respiratory tract infection of less than 7 days' duration. Children were excluded if they had a history of asthma or allergies and, at the time of diagnosis, were currently or subsequently taking any prescribed medication.

After

RESULTS

A total of 175 responses were recorded on 59 patients. Twenty-eight patients (90 responses) received the ADC, whereas 31 patients (85 responses) received placebo. The ADC and placebo groups were comparable with regard to age, duration of symptoms, and whether the parent felt that the child needed medicine for his or her URI (Table I).

. Characteristics of ADC and placebo groups

VariableADC (n = 28)Placebo (n = 31)
Age (mo) *23.7 (15.3)30.1 (15.8)
Female gender1318
Duration of symptoms (days) *3.2

DISCUSSION

To our knowledge, this is the first study in the literature that examines the efficacy of an ADC in temporarily relieving symptoms of the common cold in preschool children. Despite widespread use, our data indicate that an ADC is no more effective than placebo. However, those children who receive an ADC are significantly more likely to fall asleep within 2 hours than those receiving placebo. Our results remained unchanged after control for a number of potentially confounding factors.

These data,

Acknowledgements

We thank Theresa McRorie, PharmD, for assistance in making placebo; Danette Glassey, MD, and Julie Ellner, MD, for their help in patient enrollment; Robert Platt, PhD, for assistance in data analysis; and Michelle Bugge for technical assistance.

References (16)

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From the Department of Pediatrics, University of Washington, Seattle.

☆☆

Reprint requests: Conrad J. Clemens, MD, MPH, Pediatric Teaching Service, Moses Cone Memorial Hospital, 1200 N. Elm St., Greensboro, NC 27401-1020.

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