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Erschienen in:
01.10.2004 | Original Research Article
Short-Course, Low-Dose Oral Betamethasone as an Adjunct in the Treatment of Acute Infective Sinusitis
A Comparative Study with Placebo
Erschienen in: Clinical Drug Investigation | Ausgabe 10/2004
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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.