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


METHODS
Randomized, double-blind, placebo-controlled trial.


METHODS
Four pediatric offices in the Seattle, Wash, area.


METHODS
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.
Clemens
C J
CJ
Department of Pediatrics, University of Washington, Seattle, USA.
Taylor
J A
JA
Almquist
J R
JR
Quinn
H C
HC
Mehta
A
A
Naylor
G S
GS
D001977:Brompheniramine / Q000627:therapeutic use*; D002675:Child, Preschool; D003139:Common Cold / Q000188:drug therapy*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D008297:Male; D010656:Phenylephrine / Q000627:therapeutic use*; D010665:Phenylpropanolamine / Q000627:therapeutic use*; D054199:Pseudoephedrine; D013997:Time Factors
D004338:Drug Combinations; D006634:Histamine H1 Antagonists; C007484:brompheniramine, pseudoephedrine drug combination; D010656:Phenylephrine; D010665:Phenylpropanolamine; D054199:Pseudoephedrine; D001977:Brompheniramine