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A recent randomized, placebo-controlled trial of adults with uncomplicated, acute rhinosinusitis was conducted to determine the incremental effect of amoxicillin treatment over symptomatic treatments for adults with acute rhinosinusitis.2
Study subjects (n = 166) were recruited from 10 community practices in Missouri between November 1, 2006, and May 1, 2009, and were randomized to receive either amoxicillin (1500 mg/ day) or placebo administered in 3 doses per day for a 10-day course. Patients also received symptomatic treatments for pain, fever, cough, and nasal congestion to use as needed. The primary end point of the study was improvement in disease-specific quality of life after 3 to 4 days of treatment assessed with the Sinonasal Outcome Test- 16 (minimally important difference of 0.5 units on a 0-3 scale).
Results showed that the mean change in Sinonasal Outcome Test-16 scores was not significantly different between groups on day 3 (decrease of 0.59 in the amoxicillin group and 0.54 in the control group; mean difference = 0.03 [95% CI, -0.12 to 0.19]). Additionally, there was no significant difference between groups on day 10 (mean difference = 0.01 [95% CI, -0.13 to 0.15]), but the groups differed at day 7, favoring amoxicillin (mean difference = 0.19 [95% CI, 0.024-0.35]). There was no statistically significant difference in reported symptom improvement at day 3 (37% for amoxicillin group vs 34% for control group; P = .67) or at day 10 (78% vs 80%, respectively; P = .71), whereas at day 7 more participants treated with amoxicillin reported symptom improvement (74% vs 56%, respectively; P = .02).
The authors concluded that among patients with acute rhinosinusitis, a 10-day course of amoxicillin, compared with placebo, did not reduce symptoms at day 3 of treatment.
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