There was no statistically significantly difference in SNOT-16 scores between the amoxicillin and placebo groups on Days 3 and 10. On Day 7, there was a small statistically significant improvement in the amoxicillin group, but it did not reach the level of clinical importance (≥0.5) based on SNOT-16’s mean score.
The authors also asked participants to retrospectively assess symptom change since enrollment on a 6-point scale. Those who reported that their symptoms were “a lot better” or “absent” were characterized as significantly improved. The results correlated with the data from the SNOT-16, showing no difference between the amoxicillin and control group at Days 3 and 10. On Day 7, 74% of patients treated with amoxicillin self- reported significant improvement in symptoms since the start of the study, vs 56% in the control group. The number needed to treat was 6 (95% confidence interval, 3-34; P= .02) for a reduction in symptoms at Day 7.
Patients in both groups had similar rates of absenteeism, inability to perform usual activities, relapse and recurrence, and use of additional health care. Satisfaction with treatment was similar, as well.
No serious adverse effects occurred. Both groups reported similar frequencies (<10%) of nausea, diarrhea, abdominal pain, or vaginitis.
WHAT’S NEW: Even severe sinusitis resolves without antibiotics
Previous studies recommended foregoing antibiotics for acute sinusitis, except when symptoms are severe. This study—in which more than half (52%) of patients in each group had symptoms rated severe or very severe—found no benefit to adding amoxicillin to supportive treatments.1 Antibiotics did not shorten the duration of illness, prevent relapse and recurrence, or improve satisfaction with treatment. The researchers found a statistically significant difference between groups on Day 7 of 0.19 points, but no clinically meaningful difference (≥0.5) based on the SNOT-16 mean score.
CAVEATS: Guidelines, risk of complications may give reason to pause
The 2012 Infectious Diseases Society of America guidelines recommend amoxicillin with clavulanic acid as empiric therapy for acute bacterial rhinosinusitis.7 The findings of the study by Garbutt et al—conducted at a time when the incidence of beta-lactamase-producing organisms was low and amoxicillin was the treatment of choice—suggest otherwise.
Serious complications of sinusitis, such as brain abscess, periorbital cellulitis, and meningitis, can occur, however. Patients who deteriorate clinically or develop high fever or severe headache require close follow-up, which may include further diagnostic evaluation or consultation with an otolaryngologist. Evidence is lacking as to whether antibiotics prevent such complications.5
CHALLENGES TO IMPLEMENTATION: Managing patient expectations
Many patients with symptoms of acute rhinosinusitis think they need an antibiotic. Managing their expectations and providing instructions about supportive treatments are time consuming and may be difficult.
Nonetheless, we’re optimistic: We think that most patients today are aware of the problems associated with antibiotic resistance and wary of “superbugs,” and will therefore be receptive to this practice change. Physicians can help by reminding patients of the adverse effects of antibiotics and the natural course of rhino-sinusitis, as well as by offering symptomatic treatments.
Acknowledgement
The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.
