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A Critical Review of Clinical Trials Between 1950 and 1991

Michael B. H. Smith, MB, FRCPC; William Feldman, MD, FRCPC

JAMA. 1993;269(17):2258-2263.

Abstract
Objective.
—To determine whether over-the-counter cold medications have been shown to be effective in relieving symptoms in children, adolescents, and adults.

Data Sources.
—The MEDLINE database using the key words combined with medications and research and review articles. Articles were retrieved if they were written in English and published between January 1950 and January 1991.

Study Selection.
—Articles were selected if they described a controlled clinical trial on the treatment of the common cold. Forty-eight percent of 106 articles met the selection criteria, and these were grouped by age into child studies (<5 years old and <12 years old) and adolescent (aged 12 years and older)/adult studies.

Data Extraction.
—Each article was scored on 11 criteria to determine scientific validity. Those articles scoring above 70% were included in the final analysis. Two authors independently scored a sample of articles to determine interrater reliability.

Data Synthesis.
—Very few studies have been performed on children. Of those, two done on preschool children demonstrated no symptom relief, whereas two done on older children showed some benefit. In the adolescent/adult studies, chlorpheniramine maleate, pseudoephedrine hydrochloride, oxymetazoline hydrochloride, phenylpropanolamine hydrochloride, ipratropium bromide, and atropine methonitrate all improved nasal symptoms. Combination therapy (using an antihistamine-decongestant mix) was shown to relieve a variety of symptoms.

Conclusions.
—No good evidence has demonstrated the effectiveness of over-the-counter cold medications in preschool children. Furthur studies are required to clarify the role of these medications in children. Certain single over-the-counter medications and combinations have been shown to reduce cold symptoms in adolescents and adults.

(JAMA. 1993;269:2258-2263)

Author Affiliations
From the Division of Pediatric Medicine, Izaak Walton Killam Children's Hospital, Halifax, Nova Scotia (Dr Smith), and Division of General Pediatrics, Hospital for Sick Children, Toronto, Ontario (Dr Feldman).

Footnotes
Presented at the 31st annual meeting of the Ambulatory Pediatric Association, New Orleans, La, May 1, 1991.

Reprints not available.

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