The Journal of the American Medical Association has featured a randomised controlled trial evaluating the incremental effect of amoxicillin treatment over symptomatic treatments for adults with clinically diagnosed acute rhinosinusitis.
The study involved a total of 166 adults with uncomplicated, acute rhinosinusitis recruited from 10 community practices in Missouri. Patients were randomised to a 10-day course of either amoxicillin (500 mg three times a day, n=85, 51%) or placebo (n=81, 49%) administered in 3 doses per day. All patients received a 5- to 7-day supply of symptomatic treatments for pain, fever, cough, and nasal congestion to use as needed. The primary outcome 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). Secondary outcomes included the patient's retrospective assessment of change in sinus symptoms and functional status, recurrence or relapse, and satisfaction with and adverse effects of treatment.
Outcomes were assessed by telephone interview at days 3, 7, 10, and 28.
The following results were reported:
• The mean change in Sinonasal Outcome Test-16 scores was not statistically significantly different between groups on day 3 (decrease of 0.59 in the amoxicillin group and 0.54 in the control group; mean difference between groups of 0.03 [95% CI, −0.12 to 0.19]) and on day 10 (mean difference between groups of 0.01 [95% CI, −0.13 to 0.15]), but differed at day 7 favoring amoxicillin (mean difference between groups of 0.19 [95% CI, 0.024 to 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 = 0.67) or at day 10 (78% vs 80%, respectively; P = 0.71), whereas at day 7 more participants treated with amoxicillin reported symptom improvement (74% vs 56%, respectively; P = 0.02).
• No serious adverse events occurred.
The researchers concluded that “evidence from this study suggests that treatment with amoxicillin for 10 days offers little clinical benefit for most patients with clinically diagnosed uncomplicated acute rhinosinusitis. However, it is important to note that patients with symptoms indicative of serious complications were excluded from this trial and likely need a different management strategy.”