Practice Changer
Stop prescribing amoxicillin for acute rhinosinusitis. It’s unlikely to provide a speedier recovery than OTC remedies alone.1
Strength of recommendation
B: Based on a single high-quality randomized controlled trial.
ILLUSTRATIVE CASE
A 28-year-old man comes to your clinic after experiencing fatigue, purulent nasal discharge, and unilateral facial pain for nearly
10 days. Overall, he appears healthy, and you diagnose acute rhinosinusitis. You suggest OTC remedies for supportive care and wonder if a course of amoxicillin would speed his
recovery.
Each year, more than 30 million Americans—about one in seven adults—are diagnosed with sinusitis.2 No more than 2% of these cases are thought to be bacterial.3
CDC guidelines for the diagnosis of acute bacterial rhinosinusitis include symptoms that last seven or more days, with maxillary pain or tenderness in the face or teeth and purulent nasal secretions.4 Patients with symptoms lasting less than seven days are unlikely to have a bacterial infection. But the nonspecific signs and symptoms included in the CDC guidelines limit their usefulness in determining whether the cause of the sinusitis is bacterial or viral on clinical grounds alone.
Most cases of sinusitis spontaneously resolve
In patients with acute bacterial sinusitis, the American Academy of Otolaryngology–Head and Neck Surgery (AAO–HNS) guidelines advocate watchful waiting and symptom relief with nasal oxymetazoline, pseudoephedrine, and saline nasal irrigation.3 The rate of spontaneous resolution is high: 80% of patients with clinically diagnosed sinusitis improve without treatment within two weeks.1,5
Traditional decongestants and mucolytics have not demonstrated efficacy in resolving sinusitis, although rigorous evaluation is lacking. Other treatments, such as saline irrigation and intranasal corticosteroids, are of unclear benefit and need further study.6-8
Lack of evidence has done little to curtail antibiotic use
A previous PURL that was based on a meta-analysis of antibiotic treatment trials for sinusitis recommended that we stop prescribing antibiotics for adults with acute sinusitis unless their symptoms are severe.9,10 Yet antibiotics remain the mainstay of treatment.
Despite the AAO–HNS guidelines, evidence of spontaneous resolution, and accumulating data on the lack of efficacy of antimicrobials for sinusitis, 81% of patients diagnosed with acute sinusitis were given prescriptions for antibiotics, a study of primary care practices showed.11 Frequent use of antibiotics contributes to high rates of drug resistance, and adverse events related to antibiotic use account for an estimated 142,500 emergency department visits annually.12
STUDY SUMMARY
Little benefit from amoxicillin, even for severe cases
Garbutt and colleagues revisited the issue, randomizing 166 patients from 10 primary care practices to receive amoxicillin plus symptomatic treatment or placebo plus symptomatic treatment for acute rhinosinusitis.1
To be eligible for the study, patients had to be between the ages of 18 and 70, meet CDC diagnostic criteria for acute rhinosinusitis, and have moderate to very severe symptoms that were of seven- to-28-day duration and worsening or not improving, or of < 7-day duration but had worsened after an initial improvement. Exclusion criteria included complications from sinusitis, a history of allergy to penicillin or amoxicillin, antibiotic use in the past four weeks, comorbidities that impair immune function, cystic fibrosis, pregnancy, and mild symptoms.
Both groups had similar baseline characteristics, with participants who were predominantly white (79%) and female (64%). All the participants received a supply of symptomatic treatments: acetaminophen, guaifenesin, dextromethorphan, and sustained-release pseudoephedrine. The treatment group also received amoxicillin 1,500 mg/d, divided into three doses; the placebo group received identical-looking placebo pills.
Patients were assessed with the Sino-nasal Outcome Test-16 (SNOT-16), a validated measure that asks patients to assess both the severity and frequency of 16 sinus symptoms. SNOT-16 uses a 0-to-3 rating scale (0 = no problem; 3 = severe problem), with a clinically important difference of ≥ 0.5 on the mean score. The test was administered at enrollment and at days 3, 7, and 10. The disease-specific quality of life at day 3 was the primary outcome.
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 six-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 groups at days 3 and 10. On day 7, 74% of patients treated with amoxicillin self-