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Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial

Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial
Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial
Context Acute sinusitis is a common clinical problem that usually results in a prescription for antibiotics but the role of antibiotics is debated. Anti-inflammatory drugs such as topical steroids may be beneficial but are underresearched.

Objective To determine the effectiveness of amoxicillin and topical budesonide in acute maxillary sinusitis.

Design, Setting, and Patients A double-blind, randomized, placebo-controlled factorial trial of 240 adults (aged 16 years) with acute nonrecurrent sinusitis (had 2 diagnostic criteria: purulent rhinorrhea with unilateral predominance, local pain with unilateral predominance, purulent rhinorrhea bilateral, presence of pus in the nasal cavity) at 58 family practices (74 family physicians) between November 2001 and November 2005. Patients were randomized to 1 of 4 treatment groups: antibiotic and nasal steroid; placebo antibiotic and nasal steroid; antibiotic and placebo nasal steroid; placebo antibiotic and placebo nasal steroid.

Intervention A dose of 500 mg of amoxicillin 3 times per day for 7 days and 200 µg of budesonide in each nostril once per day for 10 days.

Main Outcome Measures Proportion clinically cured at day 10 using patient symptom diaries and the duration and severity of symptoms.

Results The proportions of patients with symptoms lasting 10 or more days were 29 of 100 (29%) for amoxicillin vs 36 of 107 (33.6%) for no amoxicillin (adjusted odds ratio, 0.99; 95% confidence interval, 0.57-1.73). The proportions of patients with symptoms lasting 10 or more days were 32 of 102 (31.4%) for topical budesonide vs 33 of 105 (31.4%) for no budesonide (adjusted odds ratio, 0.93; 95% confidence interval, 0.54-1.62). Secondary analysis suggested that nasal steroids were significantly more effective in patients with less severe symptoms at baseline.

Conclusion Neither an antibiotic nor a topical steroid alone or in combination was effective as a treatment for acute sinusitis in the primary care setting.
0098-7484
2487-2496
Williamson, I.G.
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Rumsby, K.
2002ee8a-32ac-4119-869d-ed35164c3b51
Benge, S.
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Moore, M.
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Smith, P.W.
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Cross, M.
c2d9d649-a1b3-41c8-b21c-5f94a09b432d
Little, P.
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Williamson, I.G.
12381296-edbf-4ac5-969b-dcb559c22f27
Rumsby, K.
2002ee8a-32ac-4119-869d-ed35164c3b51
Benge, S.
7ab4ae07-7bb4-4be5-870a-970ab831a15a
Moore, M.
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Smith, P.W.
961a01a3-bf4c-43ca-9599-5be4fd5d3940
Cross, M.
c2d9d649-a1b3-41c8-b21c-5f94a09b432d
Little, P.
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Williamson, I.G., Rumsby, K., Benge, S., Moore, M., Smith, P.W., Cross, M. and Little, P. (2007) Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial. JAMA, 298 (21), 2487-2496. (doi:10.1001/jama.298.21.2487). (PMID:18056902)

Record type: Article

Abstract

Context Acute sinusitis is a common clinical problem that usually results in a prescription for antibiotics but the role of antibiotics is debated. Anti-inflammatory drugs such as topical steroids may be beneficial but are underresearched.

Objective To determine the effectiveness of amoxicillin and topical budesonide in acute maxillary sinusitis.

Design, Setting, and Patients A double-blind, randomized, placebo-controlled factorial trial of 240 adults (aged 16 years) with acute nonrecurrent sinusitis (had 2 diagnostic criteria: purulent rhinorrhea with unilateral predominance, local pain with unilateral predominance, purulent rhinorrhea bilateral, presence of pus in the nasal cavity) at 58 family practices (74 family physicians) between November 2001 and November 2005. Patients were randomized to 1 of 4 treatment groups: antibiotic and nasal steroid; placebo antibiotic and nasal steroid; antibiotic and placebo nasal steroid; placebo antibiotic and placebo nasal steroid.

Intervention A dose of 500 mg of amoxicillin 3 times per day for 7 days and 200 µg of budesonide in each nostril once per day for 10 days.

Main Outcome Measures Proportion clinically cured at day 10 using patient symptom diaries and the duration and severity of symptoms.

Results The proportions of patients with symptoms lasting 10 or more days were 29 of 100 (29%) for amoxicillin vs 36 of 107 (33.6%) for no amoxicillin (adjusted odds ratio, 0.99; 95% confidence interval, 0.57-1.73). The proportions of patients with symptoms lasting 10 or more days were 32 of 102 (31.4%) for topical budesonide vs 33 of 105 (31.4%) for no budesonide (adjusted odds ratio, 0.93; 95% confidence interval, 0.54-1.62). Secondary analysis suggested that nasal steroids were significantly more effective in patients with less severe symptoms at baseline.

Conclusion Neither an antibiotic nor a topical steroid alone or in combination was effective as a treatment for acute sinusitis in the primary care setting.

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Published date: 5 December 2007

Identifiers

Local EPrints ID: 49385
URI: http://eprints.soton.ac.uk/id/eprint/49385
ISSN: 0098-7484
PURE UUID: fcd55d1e-4559-4cbc-a3f5-5f549befca13
ORCID for K. Rumsby: ORCID iD orcid.org/0000-0002-8573-3718
ORCID for M. Moore: ORCID iD orcid.org/0000-0002-5127-4509
ORCID for P.W. Smith: ORCID iD orcid.org/0000-0003-4423-5410

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Date deposited: 06 Nov 2007
Last modified: 23 Jul 2022 01:54

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Contributors

Author: I.G. Williamson
Author: K. Rumsby ORCID iD
Author: S. Benge
Author: M. Moore ORCID iD
Author: P.W. Smith ORCID iD
Author: M. Cross
Author: P. Little

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