Short-course, low-dose oral betamethasone as an adjunct in the treatment of acute infective sinusitis : a comparative study with placebo.

OBJECTIVE: To assess the effect of a short course of low-dose oral corticosteroid used as an adjunct to antimicrobials in patients with acute infective sinusitis. STUDY DESIGN AND PATIENTS: Double-blind, randomised, placebo-controlled study including 42 patients with a clinical diagnosis of acute infective sinusitis. The study was performed at three primary healthcare sites in South Africa during the period January-November 2003. INTERVENTION: Two equal groups received either betamethasone 1mg orally (n = 21; the treatment group) or placebo tablets (n = 21; the placebo group) once a day in the morning for five consecutive days. All patients received amoxicillin-clavulanic acid 625mg orally, three times daily for 5 days. MAIN OUTCOME MEASURE: Patients rated symptoms on a daily symptom score card for 5 days and were examined by the investigator at diagnosis (day 0) and on the second visit (day 6).
RESULTS: Headache, facial pain, nasal congestion and dizziness improved significantly from baseline in the treatment group compared with the placebo group over 5 days of treatment (p = 0.028, p </= 0.047, p </= 0.04 and p </= 0.051, respectively). Percussion tenderness improved significantly (p = 0.049) and clearance of purulent secretions almost reached significance (p = 0.058) in the treatment group compared with the placebo group.
CONCLUSION: This study suggests a benefit of oral corticosteroid added to antimicrobial treatment of acute sinusitis and documents the first successful use of a short course of low-dose oral corticosteroid in patients with acute infective sinusitis.

RCT Entities:   Population Interventions Outcomes