Is mometasone furoate aqueous nasal spray (MFNS) effective in reducing symptoms in acute recurrent sinusitis?

BACKGROUND: Published guidelines recommend using intranasal corticosteroids as an adjunctive measure to reduce inflammation in the treatment of sinusitis,¹ yet insufficient data exist to support these recommendations.

POPULATION STUDIED: The authors of this study included 407 patients aged older than 12 years with symptoms that characterized acute sinusitis and who had at least a 2-year history of acute recurrent sinusitis (at least 2 sinus infections requiring antibiotic treatment per year separated by symptom-free periods). Patients were included if they met a minimum symptom score based on a severity rating of 6 symptoms (purulent rhinorrhea, congestion, postnasal drip, headache, facial pain, cough). Sinusitis was confirmed by computed tomography. Patients were excluded if they used nasal steroids in the previous 2 weeks or oral steroids in the previous 4 weeks or had anatomic abnormalities (nasal polyps, sinus surgery), cystic fibrosis, or steroid-related conditions, such as cataracts. Patients were also excluded if they had active seasonal allergic rhinitis and viral upper respiratory infections. Both groups were similar in age (40 years), men to women ratio, smoking history (40%), history of allergic rhinitis (40%), and sinusitis symptom scores

STUDY DESIGN AND VALIDITY: Patients were randomized to receive 21 days of treatment with amoxacillin clavulanate potassium (ACP) 875 mg twice daily combined with either MFNS 400 (g twice daily (divided between both nostrils) or matching placebo. Patients kept symptom diaries and rated the severity of the 6 symptoms twice daily. On day 21 the investigators evaluated patient symptoms using the same severity scale, and each patient evaluated their overall therapeutic response to treatment. Data were analyzed using an intention-to-treat approach. This was a well-done study that was multicentered and double blinded. Although allocation concealment is unclear, the design of this study minimizes systematic bias. It focused on patients with recurrent acute sinusitis, so the results may not be as positive in patients with a first episode of acute sinusitis.

OUTCOMES MEASURED: The outcomes measured were the presence of purulent rhinorrhea, congestion, postnasal drip, headache, facial pain, and cough. The patients evaluated overall response to treatment on a 5-point scale.

RESULTS: At the end of 2 weeks mean total symptom scores decreased more in the steroid group compared with the placebo-treated patients (50.5% vs 44%; P=.01). For days 16 through 21 mean total symptom scores decreased 68% and 56.5%, respectively (P <.01). Inflammatory symptoms (congestion, facial pain, headache) showed significant improvement in patients using a nasal steroid (P≤.05), while secretory symptoms (purulent rhinorrhea, postnasal drip, cough) were not significantly improved. There were no differences in symptom response between smokers and nonsmokers or between those with or without atopy. Physician evaluations at the end of treatment showed a 68% reduction in total symptoms in the nasal steroid group and a 61% reduction in the placebo group (P <.01). At the conclusion of 21 days of treatment, 62% of the patients treated with MFNS and an antibiotic reported complete or marked relief compared with the 49% treated with antibiotic alone (P <.05; number needed to treat=8). Only 12% of the treatment group reported no or slight improvement of symptoms (treatment failure) compared with 23% in the placebo group. Adverse events were relatively uncommon, with 12% of the treatment group and 12% of the placebo group reporting such adverse events as headaches, nasal irritation, epistaxis, and diarrhea. Dropout rates were 4% in the nasal steroid group and 3% in the placebo group.