Dolor RJ, Witsell DL, Hellkamp AS, Williams JW, Califf RM, Simel DL. JAMA. 2001;286:3097–3105
Purpose of the Study.
It is not known whether intranasal corticosteroids are beneficial to treat acute rhinosinusitis in patients with a history of chronic or recurrent sinus symptoms. This study specifically seeks to determine if the addition of an intranasal corticosteroid to antibiotic therapy affects the speed and rate of recovery of patients with acute rhinosinusitis.
Patients 18 years or older presenting with acute sinonasal symptoms and a history of previously diagnosed recurrent or chronic sinusitis that necessitated antibiotic therapy were eligible for enrollment. All patients were required to have evidence of sinus infection on either plain film sinus radiograph (Waters view) or nasal endoscopy. Patients were screened using the major symptom criteria for acute rhinosinusitis developed by the Task Force on Rhinosinusitis of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). These criteria included the following: headache; facial pain and pressure; nasal congestion; thick, colored nasal discharge; and olfactory disturbance. Patients with 2 or more of these 5 symptoms were eligible for enrollment. Excluded were patients with nasal polyposis, previous sinus surgery, chronic bacterial sinusitis with failure of antimicrobial therapy, intranasal steroids within the past 14 days, or antimicrobial treatment in the past 7 days.
This double-blind, randomized, placebo-controlled multicenter trial randomly assigned patients to 2 puffs (total dose: 200 μg) of either fluticasone propionate (Flonase, GlaxoSmithKline) or placebo nasal spray taken once a day in each nostril for 21 days. All patients received cefuroxime axetil (Ceftin, GlaxoSmithKline) 250 mg twice daily for 10 days, as well as 2 puffs of xylometazoline hydrochloride per nostril twice daily for 3 days, 10 minutes before using study nasal spray. Oral antihistamines, oral decongestants, and mucolytics were not allowed. The primary outcome was the proportion of patients in each treatment group who experienced clinical success (patient reported cure or much improved) at 10, 21, or 56 days, based on telephone follow-up. Secondary outcomes included differences over time in the sinusitis and general health quality of life scores via survey.
A total of 88 (93%) patients completed follow-up. Patients recorded their symptoms, work assessment, and compliance during the 3-week treatment phase. Patients receiving fluticasone achieved a significantly higher rate of clinical success than patients receiving placebo (93.5% vs 73.9%; P = .009). Patients treated with fluticasone improved significantly more rapidly (median of 6.0 days to clinical success) versus patients in the placebo group (median of 9.5 days; P = .01). An absolute benefit increase of 19.6% (95% confidence interval [CI]: 5.3%–33.9%) was noted; hence, the number needed to treat with fluticasone to gain 1 additional cure was 6 patients (95% CI: 3–19). Sinusitis-related quality of life, as determined via survey, improved equally over time for both treatment groups. Patients treated with fluticasone had a higher subjective level of work performance that was statistically significant on day 21 (P = .009).
Patients with acute paranasal sinusitis were more likely to achieve clinical improvement when treated with fluticasone and cefuroxime than with cefuroxime alone. For every 6 patients treated with fluticasone, cefuroxime, and xylometazoline, 1 additional patient is cured compared with patients treated with cefuroxime and xylometazoline alone.
More studies are needed to assess the impact of intranasal corticosteroids on patients with acute sinusitis, as well as those who present with signs and symptoms of sinusitis but negative radiographs or endoscopic findings. Evaluation of subjects with chronic bacterial sinusitis as well as nasal polyposis is needed as well. Nevertheless, sinusitis treatment guidelines should be amended to include intranasal corticosteroids as adjunctive therapy to antibiotics for acute sinusitis to enhance recovery.