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OTC Cold Medication Does Not Provide Temporary URI Symptom Relief, But May Help Young Children Sleep


  • In preschool children, do OTC cold medications provide greater temporary relief from URI symptoms than supportive care?

Clinical Bottom Lines

  1. In pre-school children (6 months to 5 years), OTC antihistamine-decongestant medications do not provide short-term relief of URI symptoms such as cough, runny nose or nasal congestion.
  2. The OTC medication may help a child fall asleep more quickly, but the NNT is 5 and the risks of side effects may not be worth this benefit.

Summary of Key Evidence

  1. Study is a multi-center, randomized, double-blinded clinical trial. 59 children were randomized into equal and similar control and treatment groups for a total of 175 dose responses.1
  2. Inclusion criteria were age 6 mo - 5 yrs, URI symptoms for less than 7 days, no asthma, no other meds (except Tylenol).
  3. OTC antihistamine-decongestant or placebo were given over next 48 hrs at parent's discretion (Q6 hrs, up to 4 total doses).
  4. Responses were defined as parent reported change in symptoms (runny nose, nasal congestion or cough) as well as sleep status at 2 hrs after medication/placebo dose.
  5. No difference in symptoms noted between OTC med and placebo.
  6. OTC med did have increased number of pts who were asleep 2 hrs after dose - NNT = 5.
  7. No report of adverse outcomes or medication side effects.

Additional Comments

  • It is important to note that the participants are those who were seen by a physician for their cold symptoms. Whether the results would be the same in those children who were not seen is unclear.
  • The study did not report the number of patients who declined to participate, nor did it report if any patients failed to complete the study.
  • The blinding between placebo and medication was careful and had same taste/appearance but did not mention if either contained alcohol in the formulation.
  • The increase in sleep may well have been due to the drowsiness from the antihistamine's anticholinergic effect.
  • There was no reporting of side effects or adverse reactions, but these may be serious considerations when treating a minor illness such as a URI.


  1. Clemens CJ, Taylor JA, Almquist JR, Quinn HC, Mehta A, Naylor GS. Is an antihistamine -decongestant combination effective in temporarily relieving symptoms of the common cold in preschool children? J Pediatr 1997;103,463-6.

CAT Author: Kristin McAdams, MD

CAT Appraisers: John Frohna, MD

Date appraised: October 28, 2005

Last updated November 27, 2005
Department of Pediatrics and Communicable Diseases
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