NDLI: Effect of Amoxicillin-Clavulanate in Clinically Diagnosed Acute Rhinosinusitis: A Placebo-Controlled, Double-blind, Randomized Trial in General Practice

Content Provider	JAMA Network
Author	Bucher, Heiner C. Tschudi, Peter Young, James Périat, Pierre Welge-Lüssen, Antje Züst, Hansjörg Schindler, Christian
Copyright Year	2003
Abstract	Background: Acute rhinosinusitis is one of the most common reasons for prescribing antibiotics in primary care. However, it is not clear whether antibiotics improve the outcome for patients with clinically diagnosed acute rhinosinusitis. We evaluated the effect of a combination product of amoxicillin–potassium clavulanate on adults with acute rhinosinusitis that was clinically diagnosed in a general practice setting. Methods: We conducted a randomized, placebo-controlled, double-blind trial with 252 adults recruited at 24 general practices and 2 outpatient clinics. Each patient had a history of purulent nasal discharge and maxillary or frontal pain for at least 48 hours. Patients were given amoxicillin, 875 mg, and clavulanic acid, 125 mg, or placebo twice daily for 6 days. Main outcome measures were time to cure (primary outcome), number of days during which rhinosinusitis restricted activities at home or work, and frequency of adverse effects (secondary outcomes). Results: The adjusted hazard ratio for the effect of amoxicillin-clavulanate was 0.99 (95% confidence interval [ CI], 0.68-1.45) on time to cure and 1.28 (95% CI, 0.80-2.05) in the prespecified subgroup of patients with a positive rhinoscopy result. At 7 days the mean difference between amoxicillin-clavulanate and placebo was −0.29 (95% CI, −0.93 to 0.34) in the number of days with restrictions due to rhinosinusitis and −0.60 (95% CI, −1.41 to 0.21) in patients with a positive rhinoscopy result. At 7 days patients who took amoxicillin-clavulanate were more likely to have diarrhea (odds ratio, 3.89; 95% CI, 2.09-7.25). Conclusions: Adult patients in general practice with clinically diagnosed acute rhinosinusitis experience no advantage with antibiotic treatment with amoxicillin-clavulanate and are more likely to experience adverse effects.
Ending Page	1798
Starting Page	1793
Page Count	6
File Format	PDF HTM / HTML
ISSN	00039926
DOI	10.1001/archinte.163.15.1793
Issue Number	15
Journal	Archives of Internal Medicine
Volume Number	163
Language	English
Publisher	American Medical Association
Publisher Date	2003-08-11
Access Restriction	Open
Subject Keyword	amoxicillin-potassium clavulanate combination acute sinusitis sinusitis adverse effects antibiotics diarrhea amoxicillin potassium clavulanate endoscopy of nose pain purulent rhinitis primary outcome measure
Content Type	Text
Resource Type	Article
Subject	Internal Medicine

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