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Combined Epinephrine and Dexamethasone Therapy for Bronchiolitis?

This study did not show clear benefit for combination therapy with nebulized epinephrine and oral dexamethasone.

Researchers compared nebulized epinephrine and oral dexamethasone, alone and in combination, to placebo for treatment of moderately severe bronchiolitis in 800 full-term infants (age range, 6 weeks to 12 months) who presented to eight pediatric emergency departments in Canada with a first episode of wheeze associated with upper respiratory infection (the study definition of bronchiolitis). Patients were randomized to one of four treatment groups: nebulized epinephrine (2 doses of 3 mL in a 1:1000 solution) plus oral dexamethasone (1.0 mg/kg to a maximum of 10 mg, followed by 0.6 mg/kg once daily for 5 days), nebulized epinephrine plus oral placebo, nebulized placebo plus oral dexamethasone, or nebulized placebo plus oral placebo. Treating physicians were permitted to provide cointerventions after 90 minutes and to make admission decisions independently.

The rate of hospital admission within 7 days (the primary outcome) was 17% in the combination-therapy group, 24% in the epinephrine group, 26% in the dexamethasone group, and 26% in the placebo group. The rate of admission was reduced by 35% in the combination-therapy group compared with the placebo group (P=0.02), but when the analysis was adjusted for multiple comparisons, the reduction was no longer statistically significant (P=0.07). Eleven patients would need to be treated with combination therapy to prevent one hospital admission. Secondary outcomes, such as time to discharge (median, 4.6 vs. 5.3 hours) and symptom improvement, also were significantly better in the combination-therapy group than in the placebo group in unadjusted analysis, but most differences were not significant after adjustment for multiple comparisons. Adverse events were uncommon and not serious.

Comment: Multiple comparisons increase the likelihood of a statistically significant result by chance alone, so we can’t simply conclude that this combination therapy is better than placebo. By design, combination therapy was not directly compared to either agent alone, but the data suggest that such a comparison would not have shown combination therapy to be clearly superior to either agent alone. Prior studies have shown no benefit for steroids and mixed results, at best, for bronchodilators. As the authors state, this study should be considered exploratory; it is not a signal to adopt this combination therapy.

— Jill M. Baren, MD, MBE, FACEP, FAAP

Published in Journal Watch Emergency Medicine May 13, 2009

Citation(s):

Plint AC et al. Epinephrine and dexamethasone in children with bronchiolitis. N Engl J Med 2009 May 14; 360:2079.

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