Are antibiotics beneficial for patients with sinusitis complaints?

,

Original Research

Are antibiotics beneficial for patients with sinusitis complaints?

J Fam Pract. 2005 February;54(2):144-151

By

Dan Merenstein, MD

A randomized double-blind clinical trial

PDF Download

References

1. Leggett JE. Acute sinusitis. When—and when not—to prescribe antibiotics. Postgrad Med 2004;115(1):13-19.

2. Lau J, et al. Diagnosis and treatment of acute bacterial rhinosinusitis. Evidence Report #9. Rockville, Md: Agency for Health Care Policy and Research; 1999.

3. Brooks I, Gooch WM, 3rd, Jenkins SG, et al. Medical management of acute bacterial sinusitis. Recommendations of a clinical advisory committee on pediatric and adult sinusitis. Ann Otol Rhinol Laryngol Suppl 2000;182:2-20.

4. Williams JW, Jr, Holleman DR, Jr, Samsa GP, Simel DL. Randomized controlled trial of 3 vs 10 days of trimethoprim/sulfamethoxazole for acute maxillary sinusitis. JAMA 1995;273:1015-1021.

5. Williams JW, Jr, Simel DL. Does this patient have sinusitis? Diagnosing acute sinusitis by history and physical examination. JAMA 1993;270:1242-1246.

6. Williams JW, Jr, Simel DL, Roberts L, Samsa GP. Clinical evaluation for sinusitis. Making the diagnosis by history and physical examination. Ann Intern Med 1992;117:705-710.

7. Wald ER, Chiponis D, Ledesma-Medina J. Comparative effectiveness of amoxicillin and amoxicillin-clavulanate potassium in acute paranasal sinus infections in children: a double-blind, placebo-controlled trial. Pediatrics 1986;77:795-800.

8. van Duijn NP, Brouwer HJ, Lamberts H. Use of symptoms and signs to diagnose maxillary sinusitis in general practice: comparison with ultrasonography. BMJ 1992;305:684-687.

9. Alho OP, Ylitalo K, Jokinen K, et al. The common cold in patients with a history of recurrent sinusitis: increased symptoms and radiologic sinusitislike findings. J Fam Pract 2001;50:26-31.

10. Berg O, Carenfelt C. Analysis of symptoms and clinical signs in the maxillary sinus empyema. Acta Otolaryngol 1988;105:343-349.

11. Okuyemi KS, Tsue TT. Radiologic imaging in the management of sinusitis. Am Fam Physician 2002;66:1882-1886.

12. Engels EA, Terrin N, Barza M, Lau J. Meta-analysis of diagnostic tests for acute sinusitis. J Clin Epidemiol 2000;53:852-862.

13. Poole MD. A focus on acute sinusitis in adults: changes in disease management. Am J Med 1999;106:38S-47S;discussion 48S-52S.

14. Desrosiers M, Frankiel S, Hamid QA, et al. Acute bacterial sinusitis in adults: management in the primary care setting. J Otolaryngol 2002;31 Suppl 2:2S2-14.

15. Lindbaek M. Acute sinusitis: guide to selection of anti-bacterial therapy. Drugs 2004;64:805-819.

16. De Sutter AI, De Meyere MJ, Christiaens TC, Van Driel ML, Peersman W, De Maeseneer JM. Does amoxicillin improve outcomes in patients with purulent rhinorrhea? J Fam Pract 2002;51:317-323.

17. Bucher HC, Tschudi P, Young J, et al. BASINUS (Basel Sinusitis Study) Investigators Effect of amoxicillin-clavulanate in clinically diagnosed acute rhinosinusitis: a placebo-controlled, double-blind, randomized trial in general practice. Arch Intern Med 2003;163:1793-1798.

18. Varonen H, Kunnamo I, Savolainen S, et al. Treatment of acute rhinosinusitis diagnosed by clinical criteria or ultrasound in primary care. A placebo-controlled randomised trial. Scand J Prim Health Care 2003;21:121-126.

19. Linder JA, Singer DE, Ancker M, Atlas SJ. Measures of health-related quality of life for adults with acute sinusitis. A systematic review. J Gen Intern Med 2003;18:390-401.

20. Theis J, Oubichon T. Are antibiotics helpful for acute maxillary sinusitis? J Fam Pract 2003;52:490-492;discussion 491.-

21. de Ferranti SD, Ioannidis JP, Lau J, Anninger WV, Barza M. Are amoxycillin and folate inhibitors as effective as other antibiotics for acute sinusitis? A meta-analysis. BMJ 1998;317:632-637.

22. Scott J, Orzano AJ. Evaluation and treatment of the patient with acute undifferentiated respiratory tract infection. J Fam Pract 2001;50:1070-1077.

Practice recommendations

If the goal of treating sinusitis with antibiotics is to cure purulent nasal discharge, we are likely over-treating; as our study showed, after 2 weeks most patients in the treatment and placebo groups still had nasal symptoms (A).
Persons with higher scores on the clinical prediction rule for sinusitis are no more likely to improve with antibiotic treatment than are those with lower scores (A).
Among those who did improve on antibiotics, a subgroup that could not be clinically characterized improved at a much quicker rate than the others. Until further clinical trials can describe this favorable clinical profile, routine prescribing of antibiotics for sinusitis should be avoided (A).

Abstract

Background: Sinusitis is the fifth most common reason for patients to visit primary care physicians, yet clinical outcomes relevant to patients are seldom studied.

Objective To determine whether patients with purulent rhinitis, “sinusitis-type symptoms,” improved with antibiotics. Second, to examine a clinical prediction rule to provide preliminary validation data.

Methods: Prospective clinical trial, with double-blinded placebo controlled randomization. The setting was a suburb of Washington, DC, from Oct 1, 2001, to March 31, 2003. All participants were 18 years or older, presenting to a family practice clinic with a complaint of sinusitis and with pus in the nasal cavity, facial pressure, or nasal discharge lasting longer than 7 days. The main outcome measures were resolution of symptoms within a 14-day follow-up period and the time to improvement (days).

Results: After exclusion criteria, 135 patients were randomized to either placebo (n=68) or amoxicillin (n=67) for 10 days. Intention-to-treat analyses showed that 32 (48%) of the amoxicillin group vs 25 (37%) of the placebo group (P=.26) showed complete improvement by the end of the 2-week follow-up period (relative risk=1.3; 95% confidence interval [CI], 0.87–1.94]). Although the rates of improvement were not statistically significantly different at the end of 2 weeks, the amoxicillin group improved significantly earlier, in the course of treatment, a median of 8 vs 12 days, than did the placebo group (P=.039).

Conclusion: For most patients with sinusitis-type complaints, no improvement was seen with antibiotics over placebo. For those who did improve, data suggested there is a subgroup of patients who may benefit from antibiotics.

It is estimated that adults have 2 to 3 colds a year, of which just 0.5% to 2% are complicated by bacterial sinusitis. However, primary care physicians treat over half of these colds with antibiotics.¹ Sinusitis is the fifth most common diagnosis for which antibiotics are prescribed in the outpatient setting, with more than $6 billion spent annually in the United States on prescription and over-the-counter medications.^1-3 Can we know with greater certainty when antibiotics are indicated for sinusitis?

A meta-analysis of randomized controlled studies has shown that the likelihood of bacterial sinusitis is increased (sensitivity 76%, specificity 79%) and antibiotics are helpful when a patient exhibits at least 3 of 4 cardinal clinical features: 1) purulent nasal discharge predominating on one side; 2) local facial pain predominating on one side; 3) purulent nasal discharge on both sides; and 4) pus in the nasal cavity.² Although use of these criteria is encouraged, they are based on studies that recruited patients from subspecialty clinics and measured disease-oriented outcomes such as findings on sinus radiographs, CT scans, and sinus puncture with culture.^4-12 Most cases of sinusitis, however, are treated in primary care settings where measuring such outcomes is impractical.

Given the lack of epidemiologic evidence as to which patients would benefit from treatment of sinusitis, primary care physicians face the dilemma of deciding during office encounters which patients should receive antibiotics and which have a viral infection for which symptomatic treatment is indicated.¹³

Our goal was to study the type of patient for whom this dilemma arises and to use clinical improvement as our primary outcome. We randomly assigned patients presenting with sinusitis complaints to receive amoxicillin or placebo, and compared the rates of improvement, time to improvement, and patient’s self-rating of sickness at the end of 2 weeks. We also tested the clinical prediction rule to see if participants with 3 or 4 signs and symptoms had different clinical outcomes than the others.

Methods

Setting

We conducted a randomized double-blind clinical trial of amoxicillin vs placebo. All patients were recruited from a suburban primary care office. Two physicians and one nurse practitioner enrolled and treated all patients over an 18-month period (Oct 1, 2001 to March 31, 2003). The clinicians involved in the study were trained to identify purulent discharge in the nasal cavity. Institutional Review Board approval was obtained from Georgetown University prior to the study. Written informed consent was obtained from all participating patients.