Am Fam Physician. 2002 Jun 1;65(11):2341-2332.
A combination treatment of antibiotics and inhaled intranasal steroids is often used for the treatment of chronic persistent sinusitis. However, this treatment regimen has not been well studied. Dolor and colleagues studied this question for the Ceftin and Flonase for Sinusitis study. Cefuroxime has been shown to be effective in the treatment of acute bacterial sinusitis. The authors examined whether adding fluticasone to this regimen could affect the speed and rate of recovery in patients with rhinosinusitis.
Adult patients with acute sinus symptoms and a history of chronic or recurrent sinusitis were included. Symptom criteria for sinusitis included two of the following: headache, facial pain, facial pressure, thick discharge, or olfactory disturbance. Plain film radiographs (showing air-fluid levels, mucosal thickening, or opacification of the maxillary sinus) and nasal endoscopy (showing purulent drainage) were the methods used to confirm the presence of sinusitis. Patients who had used antibiotics or intranasal steroids recently were excluded.
All patients received 250 mg of cefuroxime axetil (Ceftin) twice a day for 10 days and two puffs of xylometazoline (Otrivin) in each nostril twice a day for three days (before using the trial nasal spray). Patients were randomized to receive placebo nasal spray or two puffs of fluticasone nasal spray (Flonase). Medical history and information about the current symptoms were collected. Physical examination included sinus palpation and evaluation for nasal edema, erythema, or discharge. Each patient recorded information such as symptoms, work attendance and performance, and completed a sinusitis-related quality-of-life questionnaire. Telephone follow-up occurred three times during the 56-day follow-up period; patients were asked to rate their sinus symptoms on a six-point scale from cured to much worse. Adverse effects and recurrences were reviewed.
There were 47 patients who received fluticasone and 48 who received placebo. Overall, 94 percent of the patients completed all study medications and 71 percent produced completed diaries. Blinding was successful, in that 36 percent of those receiving the treatment spray thought they had received placebo, and 52 percent of those who received placebo thought they had received active medication. The median time to clinical improvement was shorter in those receiving fluticasone than those receiving placebo (6.0 versus 9.5 days). There was also a 1.7-times higher chance of cure in the fluticasone group than in the placebo group. Subjective levels of work performance were higher by day 21 in those who received active treatment than in those who received placebo.
The authors conclude that the addition of intranasal inhaled steroids to a standard antibiotic regimen in patients with acute paranasal sinusitis is beneficial. Optimal length of time for treatment is still to be determined.
Dolor RJ, et al. for the Ceftin and Flonase for Sinusitis (CAFFS) Investigators. Comparison of cefuroxime with or without intranasal fluticasone for the treatment of rhinosinusitis. The CAFFS trial: a randomized controlled trial. JAMA. December 26, 2001;286:3097–105.
Copyright © 2002 by the American Academy of Family Physicians.
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