Dolor RJ. Witsell DL, Hellkamp AS, et al. Comparison of cefuroxime with or without intranasal fluticasone for the treatment of rhinosinusitis. The CAFFS trial: a randomized controlled trial. JAMA 2001; 286:3097-105.
* BACKGROUND The combination of antibiotics and inhaled intranasal corticosteroids for the treatment of chronic persistent sinusitis is a common clinical practice. Theoretically, nasally inhaled steroids should decrease mucosal inflammation and hasten recovery from an acute sinusitis. Previous small studies show a trend toward improvement with this regimen. This study measures the benefit of the addition of fluticasone to cefuroxime in patients with confirmed acute sinusitis and a documented history of chronic or recurrent sinusitis.
* POPULATION STUDIED Patients presenting with acute sinonasal symptoms and a history of previously diagnosed recurrent or chronic sinusitis requiring antibiotic treatment were enrolled from 22 sites (12 primary care and 10 otolaryngology clinics). Patients were aged 30 to 55 years; 68% were female and 880 were Caucasian. All patients were required to have evidence of sinus infection on either plain films (Waters view) or nasal endoscopy. Subjects were screened for major sinus ,symptoms with an instrument developed by the American Academy of Otolaryngology--Head and Neck Surgery. Exclusion criteria included previous sinus surgery, nasal polyposis, intranasal corticosteroid use within the previous 2 weeks, and prior antibiotic use within 7 days of enrollment in the study.
* STUDY DESIGN AND VALIDITY Ninety-five patients were randomly assigned in a double-blind fashion (concealed allocation assignment) to receive 2 puffs (200 [micro]g/day) of fluticasone propionate (Flonase) or identical plat,elm nasal spray in each nostril once daily for 21 days. All patients also received 250 mg cefuroxime (Ceftin) twice daily for 10 days and 2 puffs of xylometazoline hydrochloride in each nostril twice daily for 3 days. Follow-up was complete in 93% of patients at 10, 21, and 56 days via telephone interview. Interviewers were blind to treatment group assignment.
* OUTCOMES MEASURED The primary outcome was the proportion of patients in each treatment arm who experienced clinical success at 10, 21, or 56 days. Clinical success was defined as a patient report of "cured" or "much improved." Secondary outcomes included differences over time in the scores for sinusitis and general health quality of life as measured by the Sinonasal Outcome Test-20 (SNOT-20) and Short Form-12 (SF-12). All measures were taken during telephone interviews at 10, 21, and 56 days post enrollment.
* RESULTS Using intention-to-treat analysis, a higher proportion of patients in the fluticasone group achieved clinical success (93.5% vs 73.9%; P = .009; number needed to treat [NNT] = 6). No significant differences in treatment success rates were found between patients enrolled from otolaryngology vs primary care sites (P = .21). Patients in the fluticasone group also improved more rapidly (median of 6.0 days vs 9.5 days, P = .01). Differences in symptom scores between treatment groups were not significant, however, as measured by SNOT-20 (day 10, P = .8; day 21, P = .88; day 56, P = .54) and SF-12 (PCS-12, P = .39; MCS-12, P = .21). Reports of adverse effects were not significantly different between the groups (P = .07).
RECOMMENDATIONS FOR CLINICAL PRACTICE
Intranasal corticosteroids increase patient-reported clinical success when used in addition to antibiotics for the treatment of acute sinusitis in patients with a history of recurrent sinusitis (NNT = 6). Although the primary outcome of patient-reported clinical success was improved in the treatment group, the symptom scores also reported by the patients were not significantly different between groups. The current study did not adequately define "recurrent," but a previous study found a similar benefit of intranasal steroids plus antibiotics for patients reporting at least 2 sinus infections requiring antibiotic treatment per year for at least the previous 2 years. (1) There is no evidence that steroids provide additional benefit to the treatment of simple acute sinusitis. In addition, children who are given intranasal steroids for upper respiratory infections are more likely to develop ear infections. (2)
(1.) Meltzer EO, Charous BL, Busse WW, Zinreich SJ, Lorber RR, Danzig MR. Added relief in the treatment of acute recurrent sinusitis with adjunctive mometasone furoate nasal spray. J Allergy Clin Immunol 2000; 106:630-7.
(2.) Ruohola A, Heikkinen T, Waris M, Puhakka T, Ruuskanen O. Intranasal fluticasone propionate does not prevent acute otitis media during viral upper respiratory infection in children J Allergy Clin Immunol 2000, 106:467-71.
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