Researchers believe these results indicate that steroid nasal sprays should be part of a recommended treatment regimen for patients with recurrent episodes of acute rhinosinusitis or chronic sinusitis. The study is in the Dec. 26, 2001, issue of the Journal of the American Medical Association.
In the United States, patients make 25 million visits annually for sinusitis symptoms. Nasal sprays containing corticosteriods such as fluticasone propionate are used primarily to control symptoms of allergies and post-nasal drip by reducing inflammation and swelling in the sinuses. The Duke researchers, led by Dr. Rowena Dolor, believed that these same nasal sprays, called intranasal corticosteriods, when combined with antibiotics, might speed the recovery time in patients with acute sinus infections.
"Because recurrent and chronic sinus disease is more difficult to treat, our goal was to examine the benefits of adding an intranasal corticosteroid to standard antibiotic therapy," Dolor said.
For the study, 95 adults with a history of recurrent or chronic sinusitis and evidence of an acute infection were recruited from October 1998 through April 2000 at 12 primary care and 10 otolaryngology community-based clinics nationwide. The study was a double-blind, randomized, placebo-controlled trial.
Participants were confirmed to have sinusitis by X-ray or endoscopic examination. Forty-seven patients were given two puffs of fluticasone in each nostril for 21 days, and 48 were given two puffs of a placebo nasal spray for the same period of time. All participants were given two puffs of the decongestant xylometazoline hydrochloride twice daily for three days and the antibiotic cefuroxime axetil twice daily for 10 days. Patients recorded in a diary their daily symptom status and were contacted by telephone at 10, 21 and 56 days to record any adverse effects or treatment failures.
A total of 88 patients completed the three-week treatment and follow-up. Ninety-three percent of patients receiving fluticasone reported a cure or significant improvement of sinus problems, compared to only 74 percent receiving placebo. Patients on fluticasone also had their symptoms improve an average of three days faster than patients receiving placebo. Dolor believes that the more rapid improvement is key because it is associated with greater productivity in working populations.
There were no serious adverse effects reported; however, there was a trend toward more mild adverse events in the fluticasone group. One limitation of the study was that providers based the diagnosis of sinusitis on clinical symptoms and either sinus radiograph or endoscopy, but did not collect samples to analyze whether the infection was bacterial or viral. Dolor said this mirrors diagnostic approaches in usual clinical practice.
Dolor believes this research is compelling enough to recommend that expert panels developing evidence-based treatment guidelines for acute rhinosinusitis include intranasal corticosteriods as part of the therapeutic regimen for patients presenting with recurrent or chronic symptoms.
GlaxoSmithKline, maker of fluticasone (Flonase®) and cefuroxime (Ceftin®), funded and supplied the medication for the study.
Journal
JAMA