Roderick P Venekamp
Evid Based Med. 2012;17(6):e16
Introduction
Commentary on: Smith SR, Montgomery LG, Williams JW Jr. Treatment of mild to moderate sinusitis. Arch Intern Med2012;172:510–3.
Context
Acute rhinosinusitis (ARS) is a common reason for patients to visit a general practitioner (GP).[1,2] In general practice, diagnosing ARS is based on clinical signs and symptoms such as nasal congestion, reduction/loss of smell and facial pain/pressure. Although self-limiting in the majority of patients within 1– weeks, symptoms consistent with ARS can considerably impair daily functioning.[3]
Traditionally, ARS has been regarded as a bacterial infection of the paranasal sinuses. Therefore, numerous randomised controlled trials (RCTs) have been performed comparing antibiotic treatment with placebo for mild–moderate ARS. The present study provides an overview of systematic reviews and meta-analyses of these RCTs.
Methods
Smith and colleagues performed a literature search in PubMed and the Cochrane Collaboration Library for systematic reviews and meta-analyses published in the last decade of RCTs comparing antibiotics with placebo for patients with ARS. The main outcomes were the proportion of patients with cure or clinical improvement at 7–15 days of follow-up, rate of complications and recurrences, and adverse events.
Findings
Four meta-analyses comparing the effects of antibiotics with placebo were identified.[4–7] The proportion of patients with cure or clinical improvement at 7–15 days was statistically significantly higher in the antibiotic compared with placebo groups, but the differences were small. Cure or improvement rates were 64–80% in the placebo groups versus 71–90% in the antibiotic groups (risk differences: 7–14%). The rates of complications and recurrences did not differ between groups. Adverse events such as diarrhoea were 80% more common in the antibiotic compared with the placebo groups and were reported among 30–74% of patients treated with antibiotics.[6,7]
Commentary
The present study demonstrates that systemic antibiotics provide no clinically beneficial effects in patients with mild to moderate ARS by summarising the results of four meta-analyses of double-blind, placebo-controlled randomised clinical trials. Despite this convincing amount of evidence, antibiotics are prescribed very frequently in patients with ARS.[1,2] There is an urgent need to implement the overwhelming evidence into clinical practice, as current prescribing behaviour is accompanied by unnecessary side-effects and costs and doing so may enhance antimicrobial resistance.
Are antibiotics completely obsolete in ARS? The answer to this question is probably no. Antibiotics should still be considered in patients with a complicated course (ie, severe illness, immunocompromised patients). Moreover, current meta-analyses demonstrate that additional radiological assessment may lead to different results as compared to clinical diagnosis alone.[4,7] In an RCT conducted by Lindbaek and colleagues[8]among patients with ARS as confirmed by CT scanning, antibiotics appeared to be highly effective (NNT=3). Although no subsequent trial with CT scanning has been performed to reproduce the reported effects, the results suggest that there may be a subgroup among the broad population of patients with clinically diagnosed ARS that would benefit from antibiotics. As routine CT scanning is not feasible, identification of such a subgroup should be based on clinical signs and symptoms. This phenomenon has been recognised by Young and colleagues[7] who performed an individual patient data meta-analysis of 10 RCTs comparing antibiotic treatment with placebo in patients with clinically diagnosed ARS. Unfortunately, no predictors could be detected among common clinical signs and symptoms. Future studies should focus on identifying subgroups among the heterogeneous population of clinically diagnosed ARS that would benefit from antibiotic treatment. Unless the efficacy of such a tailored treatment regimen has been confirmed, a strong recommendation to GPs can be made to refrain from antibiotics and to treat patients with mild to moderate ARS symptomatically (decongestant nose drops and analgesics).
References
- Venekamp RP, Rovers MM, Verheij TJM, et al. Treatment of acute rhinosinusitis: discrepancy between guideline recommendations and clinical practice. Fam Pract 2012; doi: 10. 1093/fampra/cms022.
- Ashworth M, Charlton J, Ballard K, et al. Variations in antibiotic prescribing and consultation rates for acute respiratory infection in UK general practices 1995–2000. Br J Gen Pract 2005;55:603–8.
- Meltzer EO, Hamilos DL, Hadley JA, et al. Rhinosinusitis: establishing definitions for clinical research and patient care.J Allergy Clin Immunol 2004;114(Suppl):155–212.
- Ahovuo-Saloranta A, Borisenko OV, Kovanen N, et al. Antibiotics for acute maxillary sinusitis. Cochrane Database Syst Rev 2008;(2):CD000243.
- Falagas ME, Giannopoulou KP, Vardakas KZ, et al. Comparison of antibiotics with placebo for treatment of acute sinusitis: a meta-analysis of randomised controlled trials. Lancet Infect Dis 2008;8:543–52.
- Rosenfeld RM, Singer M, Jones S. Systematic review of antimicrobial therapy in patients with acute rhinosinusitis.Otolaryngol Head Neck Surg 2007;137(Suppl):S32–45.
- 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;371:908–14.
- Lindbaek M, Hjortdahl P, Johnsen UL. Randomised, double blind, placebo controlled trial of penicillin V and amoxycillin in treatment of acute sinus infections in adults. BMJ 1996;313:325–9.