Objective: To determine the relative adverse symptomatic effects and benefits of therapy with oral corticosteroids at doses of 2 mg/kg vs 1 mg/kg daily in children with acute exacerbations of asthma.
Methods: Using a questionnaire that addressed symptoms, we conducted a prospective study of the adverse effects and benefits of therapy with prednisone or prednisolone at two dose levels in 86 children who were 2 to 16 years of age with mild persistent asthma during an acute exacerbation and were unresponsive to therapy with inhaled steroids and beta-adrenergic agents. Parents and physicians were blinded to the dose level. Children were assigned to either of the two doses by random allocation. Behavioral side effects were assessed via a questionnaire administered by a physician. Benefits were measured by the resolution of asthma symptoms (cough, shortness of breath, and wheeze) at the completion of the treatment with oral steroids.
Results: Behavioral side effects, particularly anxiety (p < 0.02) and aggressive behavior (p < 0.002), were twice as common in patients receiving a dose of 2 mg/kg/d. Benefits were comparable in the two groups. The number needed to harm (ie, the number of patients receiving experimental treatment that would lead to one additional person being harmed vs patients receiving standard treatment) was 6.1 for anxiety, 8.6 for hyperactivity, and 4.8 for aggressive behavior.
Conclusions: Because the adverse side effects were greater at the higher dose but the benefits were comparable, we recommend using an oral corticosteroid dose of 1 mg/kg daily for children with mild persistent asthma who present with an acute exacerbation of asthma.