'Tis the Season
Abstract & Commentary
By Barbara A. Phillips, MD, MSPH, Professor of Medicine, University of Kentucky; Director, Sleep Disorders Center, Samaritan Hospital, Lexington; Dr. Phillips reports no financial relationship to this field of study.
Synopsis: Neither antibiotics nor nasal steroids nor the combination of the two reduces the duration of acute sinusitis symptoms compared with placebo.
Source: Williamson IG, et al. Antibiotics and Topical Nasal Steroid for Treatment of Acute Maxillary Sinusitis. A Randomized Controlled Trial. JAMA. 2007;298(21):2487-2496.
This was a randomized, controlled study of 240 patients over a 4 year period. The patients were recruited from 58 family practices in England. Entry criteria included symptoms of less than 28 days duration, and were based on the Berg and Carenfelt criteria,1 which include: purulent nasal discharge with unilateral predominance, local pain with unilateral predominance, purulent nasal discharge bilaterally, and pus on inspection inside the nose. To be included, patients had to have at least 2 of these criteria. Exclusion criteria included significant comorbidities (eg, heart failure), allergy to penicillins or steroids, recent treatment with antibiotics or steroids, and chronic sinusitis (> 2 bouts of acute sinusitis in the previous year). The primary outcome was the proportion cured (eg, asymptomatic) vs still symptomatic at 10 days. Information about symptoms was collected in diaries. Symptoms were ranked on a Likert scale, and included nasal blockage and discharge, unpleasant smell or taste, pain in the face, either when still or when bending, restriction of daily activity, feeling of illness, and headache. At the end of 2 weeks or when all symptoms were rated 0 by the patient, symptoms diaries were collected for analysis. Those who were lost to follow-up were assumed to still be symptomatic at day 14. The investigators noted that many (54) patients refused to be randomized because they demanded antibiotics immediately. Others were not randomized (n=38) because the physician did not have time to recruit them. Still others (n= 24) reported allergies to penicillins. The final study sample was 75% female with a median age of 44 years. About 10% had asthma and 82% had had sinusitis before. The mean duration of symptoms prior to seeking treatment was 7 days. Patients were randomized to one of four possible treatment groups: active antibiotic (amoxicillin) and active nasal steroid (budesonide), inactive antibiotic, active nasal steroid, active antibiotic, inactive nasal steroid, or inactive antibiotic and inactive nasal steroid. Male patients and those with pus on examination were more likely to be lost to follow-up; 13.7% did not return diaries. There were 193 validated diaries used for the final analysis. The proportion of patients with symptoms lasting 10 or more days was about 30% for the entire group, and did not vary statistically for any of the four treatment groups. In looking at time to "cure" (resolution of symptoms), the authors did not find differences in time to resolution of symptoms; about 40% of patients in each group were cured at 1 week. The investigators did separate analyses for the "pain" and "unwell" symptoms, and found that nasal steroids may be beneficial for those patients with milder symptoms, but detrimental for those with more severe symptoms.
Commentary
It's the season for upper respiratory tract infections, including sinusitis. Acute sinusitis (or something like it) is an extremely common problem in primary care; it is estimated that 1-2 % of all patient visits to physicians in Europe relate to sinus problems.2 In the editorial that accompanies this paper,3 Dr Morten Lindack points out that the vast majority of patients who present with a chief complaint of sinusitis in the US receive antibiotics, despite lack of convincing evidence that antibiotics help. Indeed, international guidelines4 do not support the use of antibiotics for sinusitis that is clinically diagnosed. On the other hand, a recent Cochrane review5 suggested moderate effect sizes of penicillins in the treatment of sinusitis, based largely on studies of patients in secondary care settings in which x-ray confirmation of sinusitis was done. Since sinus films are rarely used to make the diagnosis of sinusitis in primary care, one of the aims of this study was to find out if antibiotics help patients with clinically-diagnosed sinusitis. The answer: apparently not.
The data about topical steroids (in this case, budesonide) are even more confusing. In the current study, nasal steroids may have helped symptoms in those with milder symptoms to begin with, but worsened them in those with more severe symptoms. Previous studies6,7 of steroids plus antibiotics for sinusitis have suggested that they may help to relieve symptoms, but these studies may have included patients with allergic rhinitis.
So, what to do? Many patients with sinus symptoms are convinced that they need antibiotics and will demand them (indeed, patients' demands for immediate antibiotics were a major reason for refusal to be enrolled in this study, where they might be randomized to placebo). On the other hand, our free hand with antibiotics has undoubtedly led to some of our current dilemmas with drug-resistant bacteria.8 Just saying no to patients with sinusitis symptoms, while offering reassurance and supportive care is difficult, but is the only approach that is well-supported by the evidence. Dr Lindbaek's editorial notes that some patients with sinusitis will still need antibiotic treatment, including those with "malaise, fever, and deteriorated general condition." Sorting out those patients who are likely to benefit from antibiotics from those who are not is part of the art of medicine.
References
1. Berg O, Carenfelt C. Analysis of symptoms and clinical signs in the maxillary sinus empyema. Acta Otolaryngol. 1988;105(3-4):343-349.
2. Lindbaek M. Acute sinusitis: a guide to selection of antibacterial therapy. Drugs. 2004;64:805-819.
3. Lindbaek M. Acute sinusitisto treat or not to treat? JAMA. 2007;298:2543-2544.
4. Ah-See K. Sinusitis (acute). Clin Evid. 2005;13:646-653.
5. Williams JW Jr, et al. Antibiotics for acute maxillary sinusitis. Cochrane Database Syst Rev. 2003(2):CD000243.
6. Dolor RJ, et al. Comparison of cefuroxime with or without intranasal fluticasone for the treatment of rhinosinusitis; the CAFFS trial: a randomized controlled trial. JAMA. 2001;286:3097-3105.
7. Meltzer EO, et al. Treating acute rhinosinusitis: comparing efficacy and safety of mometasone furoate nasal spray, amoxicillin, and placebo. J Allergy Clin Immunol. 2005;116:1289-1295.
8. Goossens H, et al. Outpatient antibiotic use in Europe and association with resistance: a cross-national database study. Lancet. 2005;365:579-587.
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