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Stop prescribing antibiotics for adults with a clinical diagnosis of acute sinusitis, unless the patient has severe symptoms. Antibiotics have little if any positive effects on the severity and duration of symptoms, and they cause adverse effects and create unnecessary expense.
Strength of recommendation
A: Based on a meta-analysis of 9 randomized trials in primary care practice.
Young J, De Sutter A, Merenstein D, et al. Antibiotics for adults with clinically diagnosed acute rhinosinusitis: a meta-analysis of individual patient data. Lancet. 2008;371:908-914.1
A 23-year-old woman presents to your office with a 1-week history of cough, purulent nasal discharge, and unilateral facial pain. You diagnose acute sinusitis.
Should you prescribe an antibiotic?
No. Yet it’s no wonder that most adults treated for acute sinusitis leave the doctor’s office with a prescription for antibiotics. Until the publication of the meta-analysis by Young and colleagues1 featured in this PURL, we have lacked A-level evidence from studies conducted in realistic settings—like your practice and ours.
Review of serial data from the National Ambulatory Medical Care Surveys (NAMCS) from 1999 through 2005 does show a slight downward trend in antibiotic prescribing for acute sinusitis: 1999-2002 data showed that 83% of cases of acute sinusitis were treated with an antibiotic.2 Data from the 2004 and 2005 NAMCS reveal that family physicians prescribed antibiotics for 80% of patients with acute sinusitis in 2004 and 76% of patients in 2005 (S. Medvedev, unpublished data, NAMCS database, March 2008).
Is this continued high rate of antibiotic prescribing justified?
Do antibiotics improve symptoms and shorten the duration of illness or not?
These questions are important, obviously, not only because of the high rate of prescribing but also because sinusitis is one of the most common diagnoses: approximately 20 million cases annually in the United States, or about 21% of all outpatient antibiotic prescriptions for adults.2
Before we discuss the evidence that is summarized in the excellent meta-analysis by Young and colleagues,1 let’s acknowledge that acute sinusitis is undeniably a diagnostic dilemma. Distinguishing bacterial from viral infection is nearly impossible on clinical grounds because the symptoms are so similar. A litany of identical upper respiratory symptoms accompanies both viral and bacterial sinus infections. Purulent nasal secretions, maxillary facial pain (especially with unilateral predominance), maxillary tooth pain (which is uncommon with sinus infection), altered sense of smell, and worsening illness after improvement constitute the short list of signs and symptoms that has some predictive value, but even the presence of all of these is not a terrific predictor of bacterial sinus infection. Plain x-rays have low accuracy in distinguishing viral from bacterial infection. Computed tomography (CT) sinus scans are better but far from perfect, are not readily available in practice, and are expensive.
Treating 15 patients with an antibiotic to possibly benefit 1 patient after 2 weeks does not seem like a good idea when one considers cost and complications
How effective are antibiotics for patients diagnosed not by sinus x-rays or CTs, but by signs and symptoms—as we typically do in daily practice?
A meta-analysis3 of 13 randomized controlled trials (RCTs) found that sinusitis improved without antibiotics, but it included trials in which patients were recruited based on results of imaging studies and cultures, which are not normally used in primary care clinical practice. That study compared antibiotic treatment to placebo for acute uncomplicated sinusitis; 35% of placebo-treated patients were clinically cured by 7 to 12 days and 73% were improved after 7 days. Antibiotic therapy increased cure rates by 15% and improvement rates by 14%, yielding a number needed to treat of 7 to achieve 1 additional positive outcome at 7 days.
Young and colleagues1 aggregated and analyzed individual patient-level data from all known placebo-controlled, randomized, antibiotic treatment trials of adults with clinical symptoms of acute sinusitis that were conducted in primary care settings. They excluded trials that used imaging or bacterial culture as part of patient recruitment.
Studies were included that allowed the use of concomitant medication such as nonsteroidal anti-inflammatory drugs, decongestants, or nasal steroids, as long as patients in both groups had access to the same medications. All trials excluded patients with severe symptoms such as high fever, periorbital swelling or erythema, or intense facial pain, important exclusions that we will discuss below.
The current recommendation to use antibiotics if illness lasts more than 1 week was based on expert opinion, not clinical trials
They identified 10 such studies and completed an intent-to-treat analysis of the 9 double-blind trials for which patient level data were available. Using individual data from 2547 patients, the odds ratio for an overall antibiotic treatment effect was 1.37 (95% confidence interval, 1.13-1.66), with a number needed to treat (NNT) of 15.
This finding means that 15 patients needed to be given an antibiotic for 1 additional patient to be cured at 8 to 15 days after treatment commenced. Using statistical modeling, they determined that 64% of patients treated with placebo were cured at 14 days compared with 70% given an antibiotic. One patient out of 1381 treated with placebo experienced a serious complication, a brain abscess.
The investigators also analyzed the prognostic value of specific signs and symptoms to answer the question: Is there any subgroup of patients who might benefit more from antibiotic treatment?
Duration. Patients with a longer duration of symptoms, more severe symptoms, or increased age took longer to cure, but were no more likely to benefit from antibiotic treatment than other patients.
Symptoms, such as a previous common cold, pain on bending, unilateral facial pain, tooth pain, and purulent nasal discharge did not have any prognostic value.
Only one sign—purulent discharge noted in the pharynx on examination—was associated with a higher likelihood of benefit from treatment with antibiotics, but the NNT was still 8 in this group. Patients with symptoms for 7 days or longer were no more likely to respond to antibiotics than those with symptoms for fewer than 7 days.1
We believe this meta-analysis provides a high level of evidence against routine treatment of sinusitis with antibiotics in primary care practice. Treating 15 patients with an antibiotic to possibly benefit 1 patient 2 weeks after treatment commences does not seem like a good idea when one considers the cost and complications of antibiotic use. Diarrhea and other adverse outcomes are 80% more common among patients with sinusitis who are treated with an antibiotic compared with placebo.3 As noted above, prior meta-analyses of antibiotic treatment for acute sinusitis have been more encouraging than this meta-analysis, with a number needed to treat of 7, but those meta-analyses are clearly overly optimistic for the results one will achieve in primary care practice using clinical signs and symptoms to diagnose acute sinusitis.3,4 Unlike the Young study, they included trials in specialty clinics with CT scans and sinus puncture and culture used for the diagnostic standard.
One very important new finding in this meta-analysis that should change practice is that the duration of illness did not predict a positive response to antibiotics.
Current national recommendations are to use an antibiotic for patients with a duration of illness longer than 1 week, as these patients are presumably more likely to have a bacterial infection.5-7 However, that recommendation had been based on expert opinion, not on data from clinical trials. A longer duration of symptoms should not be a reason to prescribe an antibiotic for sinusitis symptoms.
What to do, then, for patients with acute sinusitis? Treat the symptoms, which means recommending pain medication for facial pain or headache and saline nasal spray for the nasal discharge, not antibiotics or nasal corticosteroids. Side effects will be fewer and costs will be lower.
A very important caveat to our recommendation is that seriously ill patients must be managed differently. Very infrequently a patient develops a serious complication of acute sinusitis such as brain abscess, periorbital cellulitis, or meningitis. Therefore, seriously ill patients with signs and symptoms of acute bacterial sinusitis, such as high fever, periorbital erythema or edema, severe headache, or intense facial pain must be carefully evaluated and treated with great caution and close follow-up. These patients should be referred immediately for consultation with an otolaryngologist.
Saline nasal spray and pain medications lead to fewer side effects and lower cost
Of course, mildly ill patients today may become quite ill tomorrow, so always provide advice to patients to return if they are getting worse, a good clinical practice for any condition that is usually benign but occasionally serious.
Patients who have prolonged or recurrent sinusitis symptoms need further evaluation for other diagnoses such as allergies, cystic fibrosis, fungal sinus infection, and other illnesses associated with immune compromise. These complicated patients benefit from consultation with an otolaryngologist who has a specific interest in chronic and recurrent sinusitis, and perhaps consultation from an infectious disease specialist as well.
Some patients may be accustomed to receiving an antibiotic prescription for their “sinus infections” and may resist conservative management. It may be difficult to convince them that antibiotics won’t make a difference when they attribute past resolution of symptoms to antibiotics.
Take enough time to educate your patients on the natural course of illness, the positive benefits of nasal saline, and the reasons not to use unnecessary antibiotics (eg, they are not effective, have potential adverse effects, and can contribute to future antibiotic resistance); this effort will save you time in future visits.10 A “just in case you don’t get better” prescription to be filled only if the patient is not improving in the next few days is about 50% effective in reducing antibiotic usage for upper respiratory infections.11
Giving a prescription to be filled only if the patient does not improve is about 50% effective in reducing antibiotic usage
We acknowledge Sofia Medvedev of the University HealthSystem Consortium (UHC) in Oak Brook, IL for analysis of the National Ambulatory Medical Care Survey data.
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.
PURLs methodology This study was selected and evaluated using FPIN’s Priority Updates from the Research Literature (PURL) Surveillance System methodology. The criteria and findings leading to the selection of this study as a PURL can be accessed at www.jfponline.com/purls.
Sarah-Anne Schumann, Department of Family Medicine, The University of Chicago.
John Hickner, Department of Family Medicine, The University of Chicago.