STUDY SUMMARY: Meta-analysis of primary care trials
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.
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.
Do antibiotics benefit any subgroups?
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
WHAT’S NEW: Realistic evidence from realistic settings
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.
Symptoms >1 week are not a reason to prescribe
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.
How can you help your patient?
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.
- Saline irrigation. A 2007 Cochrane review of 8 chronic and recurrent sinusitis trials showed that nasal saline irrigation is effective for reducing symptoms of chronic and recurrent sinusitis.8 Although we do not have high-quality RCT data on saline nasal irrigation for treatment of acute sinusitis, nasal saline irrigation is harmless and inexpensive.
- What about nasal steroids? The evidence is equivocal, and the most recent high-quality RCT of nasal steroids showed no effect.9