Benylin

Paul IM, Yoder KE, Crowell KR, et al. Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. Pediatrics 2004; 114:e85-e90.

* CLINICAL QUESTION

Do cough suppressants improve the sleep of children with respiratory infections, or the sleep of their parents?

* BOTTOM LINE

In this single-dose study, placebo worked just as well as either dextromethorphan or diphenhydramine to decrease cough frequency or severity for children. Also, the active drugs provided no additional benefit on parents' report of their own or their child's sleep.

This is both bad news and good news. The bad news is that these drugs don't work any better than placebo (which, actually, was reported to work pretty well). The good news is that when parents feel the need to do something when their child has a cold, all products work equally well. (LOE=1b-)

* STUDY DESIGN

Randomized controlled trial (double-blinded)

* SETTING

Outpatient (primary care)

* SYNOPSIS

When a young child coughs at night, parents don't get much sleep. Although the American Academy of Pediatrics recommends against antitussives because of their lack of demonstrated benefit, these products fly off pharmacy shelves in the winter months.

This study identified 100 children experiencing rhinitis and cough symptoms for 1 week or less, who didn't have asthma or allergies; in other words, children with a cold. The average age was slightly older than 4 years (range=2-16 years). The children were randomized (allocation concealment uncertain) to receive a single dose of placebo, diphenhydramine (Diphen), or dextromethorphan (Benylin), for the single night of the study.

Using a 7-point Likert scale, parents were asked to rate the effect of treatment on the child's cough frequency, as well as the effect on their own sleep and that of the child. As compared with ratings obtained for the night before the study night, parents overall reported a significant decrease in cough frequency and severity (from "somewhat" to "occasional" on the descriptive scale). The combined symptom score decreased from 19.8 to 8.9 (of a possible 30) with any treatment (P<.01). Parents also reported a significant improvement in both their sleep and their childrens' sleep. However, the results were not different whether the child was treated with either drug or placebo. Adverse effects were reported equally in all 3 study groups. The study had the power to find a 1-point change in scores of the 3 arms, if one truly existed.

COPYRIGHT 2004 Dowden Health Media, Inc.
COPYRIGHT 2004 Gale Group