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QUESTION: In patients with acute rhinosinusitis and a history of chronic or recurrent sinus symptoms, is the addition of intranasal fluticasone to cefuroxime more effective than the addition of placebo for prompting recovery?
Design
Randomised {allocation concealed*}†, blinded (clinicians, patients, data collectors and {outcome assessors}†),* placebo controlled trial with 8 weeks of follow up.
Setting
12 primary care and 10 otolaryngology sites in the USA.
Patients
95 patients who were ≥ 18 years of age (median age 38 to 41 y, 68% women) with recurrent or chronic sinusitis requiring antibiotic treatment. All patients were required to have evidence of sinus infection on either plain film radiography or nasal endoscopy. Exclusion criteria were previous sinus surgery, sinus lavage in the previous 7 days, nasal polyposis, recurrent moderate epistaxis, chronic bacterial sinusitis with antimicrobial treatment failure, intranasal corticosteroid use in the previous 14 days, long term corticosteroid or immunosuppressive agent use, immunocompromised state, allergy to cephalosporins or penicillins, antibiotic use in the previous 7 days, or potential for pregnancy. 92 patients (97%) were included in the analysis.
Intervention
All patients received cefuroxime axetil, 250 mg twice daily for 10 days, and 2 puffs of xylometazoline hydrochloride per nostril twice daily for 3 days, after which they were allocated to fluticasone propionate, 2 puffs of 200 μg (n=47), or placebo (n=48) for 21 days.
Main outcome measures
Clinical success. Patients reported by telephone interview whether they were cured or much improved using a 6 point scale (cured, much improved, somewhat improved, no change, somewhat worse, and much worse). Secondary outcomes were health status and quality of life changes measured by the Sinonasal Outcome Test-20 (SNOT-20) and the Short Form-12 (SF-12).
Main results
Analysis was by intention to treat. More patients who received fluticasone than placebo achieved clinical success (p=0.009) (table) and reached it in fewer days (median 6.0 v 9.5 d, p=0.01). The fluticasone and placebo groups did not differ for changes on the SNOT-20 (change from baseline to 56 days –1.0 v –1.0, p=0.54) or changes on the SF-12 survey (change from baseline to day 21 physical component score 7.8 v 4.6, p=0.39, and mental component score 2.4 v 1.4, p=0.21).
Conclusion
In patients with acute rhinosinusitis and a history of chronic or recurrent sinus symptoms, the addition of intranasal fluticasone to cefuroxime was more effective than the addition of placebo in achieving cure or improvement.
Commentary
In the USA, an estimated 3 million patients per year are treated for symptoms suggestive of acute rhinosinusitis.1 Currently, physicians are advised to diagnose the condition by clinical criteria1 and to use amoxicillin or trimethoprim-sulfamethoxazole as first-line treatment agents.2 Such adjunctive agents as topical decongestants and corticosteroids have been considered by many to be useful but have been less thoroughly investigated than have antibiotics.2
The patients in the study by Dolor et al were not previously healthy people with an isolated episode of acute sinusitis. A third to a half had a known diagnosis of allergic illness in addition to recurrent or chronic sinusitis. About a quarter showed only mucosal thickening on radiography (Dolor RJ, personal communication): a finding that is non-specific and often seen in allergic or viral illness.3
This study does not prove that fluticasone speeds resolution of acute bacterial sinusitis unrelated to atopy. However, these conditions frequently coexist, and differentiating between them may be difficult. The addition of fluticasone (and perhaps 3 days of xylometazoline) to first-line antibiotics in clinically diagnosed sinusitis is now a better validated option, especially if a history of recurrent episodes or underlying allergy exists.
Fluticasone v placebo added to cefuroxime for acute rhinosinusitis at 8 weeks‡
QUESTION: In patients with acute rhinosinusitis and a history of chronic or recurrent sinus symptoms, is the addition of intranasal fluticasone to cefuroxime more effective than the addition of placebo for prompting recovery?
Footnotes
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Source of funding: GlaxoSmithKline.
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For correspondence: Dr R J Dolor, Duke Clinical Research Institute, Durham, North Carolina, USA. dolor001{at}mc.duke.edu.
↵† Information provided by author.