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Clinical Drug Investigation
Published in: Clinical Drug Investigation 10/2004

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

Authors: Dr N. P. Ratau, J. R. Snyman, C. Swanepoel

Published in: Clinical Drug Investigation | Issue 10/2004

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Abstract

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.
Literature
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Meltzer EO, Orgel HA, Backhaus JW, et al. Intranasal flunisolide spray as an adjunct to oral antibiotic therapy for sinusitis. J Allergy Clin Immunol 1993; 92: 812–23PubMedCrossRef
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Yilmaz G, Varal B, Yilmas T, et al. Intranasal budesonide spray as an adjunct to oral antibiotic therapy for acute sinusitis in children. Eur Arch Otorhinolaryngol 2000; 257(5): 256–9PubMedCrossRef
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Williams JW, Aguilar C, Cornell J, et al. Antibiotics for acute maxillary sinusitis. Available in The Cochrane Library [database on disk and CD ROM]. Updated quarterly. The Cochrane Collaboration; issue 4. Oxford: Update Software, 2003
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Snyman JR, Sommers De K, van Wyk M, et al. Short course, low dose betamethasone therapy causes only marginal and transient hypothalamic pituitary adrenal axis suppression. Clin Drug Invest 2002; 21(7): 499–504CrossRef
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Young J, Bucher H, Tschudi P, et al. The clinical diagnosis of acute bacterial rhinosinusitis in general practice and therapeutic consequences. J Clin Epidemiol 2003; 56(4): 377–84PubMedCrossRef
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Dolor RJ, Witsell DL, Hellkamp AS, et al. Comparison of cefuroxime with or without intranasal fluticasone for the treatment of rhinosinusitis. JAMA 2001; 286: 3097–105PubMedCrossRef
Metadata
Title
Short-Course, Low-Dose Oral Betamethasone as an Adjunct in the Treatment of Acute Infective Sinusitis
A Comparative Study with Placebo
Authors
Dr N. P. Ratau
J. R. Snyman
C. Swanepoel
Publication date
01-10-2004
Publisher
Springer International Publishing
Published in
Clinical Drug Investigation / Issue 10/2004
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.2165/00044011-200424100-00003

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