Amoxicillin-clavulanate ineffective for suspected acute sinusitis

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Amoxicillin-clavulanate ineffective for suspected acute sinusitis

J Fam Pract. 2003 December;52(12):919-941

By

Eric A. Jackson, PharmD

BACKGROUND: Fifty percent of patients with acute sinusitis will have a viral infection and will not benefit from antibiotic therapy. This study evaluated the effect of a broad-spectrum antibiotic on adults with acute sinusitis diagnosed clinically in general practice.
POPULATION STUDIED: The investigators enrolled 252 adult patients over 4 winter seasons, recruited from general practices and the internal medicine and otolaryngology outpatient clinics of a university hospital in Basel, Switzerland. Clinical diagnosis was based on a history of repeated purulent nasal discharge and maxillary or frontal sinus pain for at least 48 hours but less than 1 month. Presence of pus under rhinoscopy was an initial inclusion criterion, but was dropped after the first winter season. After randomization, treatment groups were relatively well-matched for characteristics that would affect the outcomes of interest.
STUDY DESIGN AND VALIDITY: Eligible patients were consecutively enrolled and randomly assigned (with concealed allocation) to receive amoxicillin 875 mg/clavulanic acid 125 mg or matching placebo twice daily for 6 days. Patients also received a topical nasal decongestant and acetaminophen, and were allowed to use steam inhalation. Central randomization was stratified by treatment site in blocks of 6.
OUTCOMES MEASURED: The primary outcome was time to cure, defined as no days since the previous visit or interview during which symptoms restricted activity at home or work. Because 10% of recruited patients reported no restriction on activities, analysis of time to cure was repeated using a 10-point visual analog scale to describe degree of restriction on activity. Secondary outcomes included number of days during which symptoms restricted activity and frequency of adverse effects of antibiotics.
RESULTS: Using either definition of cure, there was no difference in the primary outcome (time to cure) between treatment groups. Cure rates for amoxicillin-clavulanate and placebo at 1 week (29.8% and 30.7%) and 2 weeks (76.6% and 74.0%) were similar for the 2 groups. The time to cure was also similar between antibiotic-treated and placebo-treated patients. There was no significant difference between the 2 treatment groups in the secondary outcome of number of days of restricted activity. However, at 1 week patients who took amoxicillin-clavulanate were almost 4 times more likely to have diarrhea (odds ratio=3.89; 95% confidence interval, 2.09–7.25).

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Amoxicillin-clavulanate ineffective for suspected acute sinusitis

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