Clinical Question

Is high-dose amoxicillin/clavulanate (Augmentin) superior to standard-dose amoxicillin/clavulanate in adults with acute sinusitis?

Bottom Line

This study found no significant difference between the standard-dose and high-dose regimens of amoxicillin/clavulanate for treating acute sinusitis in adults. It is important to note that both doses are minimally superior to placebo. (Level of Evidence = 1b−)

Synopsis

The standard dosage of amoxicillin/clavulanate, 875/125 mg twice daily, is minimally more effective than placebo for treating acute sinusitis in adults. The investigators identified adults, 18 years or older, presenting to primary care offices with sinus symptoms consistent with currently accepted clinical criteria for acute bacterial sinusitis. Eligible patients randomly received (concealed allocation assignment) either a standard-dose regimen of amoxicillin/clavulanate, 875/125 mg, plus placebo twice daily for seven days, or a high-dose regimen of amoxicillin/clavulanate, 875/125 mg, plus amoxicillin, 875 mg twice daily for seven days. There was no placebo plus placebo group. Individuals masked to treatment group assignment assessed outcomes using a standard scoring tool for sinusitis at days 3 and 10. Complete follow-up occurred for 74.5% of patients on day 10.

Using intention-to-treat analyses, the primary outcome of a global rating of “a lot better” or “no symptoms” occurred in 44.3% of patients in the standard-dose group compared with 36.4% of patients in the high-dose group (nonsignificant difference of −7.9% favoring the standard-dose group). Because of the high dropout rate, the investigators assigned a negative outcome to everyone in the standard-dose group and a positive outcome to everyone in the high-dose group; the group difference in the primary outcome was still not significant.

Study design: Randomized controlled trial (double-blinded)

Funding source: Unknown/not stated

Allocation: Concealed

Setting: Outpatient (primary care)

Reference: Gregory J, Huynh B, Tayler B, et al. High-dose vs standard-dose amoxicillin plus clavulanate for adults with acute sinusitis: a randomized clinical trial. JAMA Netw Open. 2021;4(3):e212713.