Clinical Question: Are intranasal steroids alone effective in the treatment of acute uncomplicated rhinosinusitis?

Setting: Outpatient (specialty)

Study Design: Randomized controlled trial (double-blinded)

Allocation: Concealed

Synopsis: Intranasal steroids used with antibiotics are more effective in the treatment of recurrent sinus infections than antibiotics alone. The benefit of intranasal steroids alone for uncomplicated sinusitis is uncertain. The investigators randomized (concealed allocation assignment) 981 participants with acute uncomplicated sinusitis to one of four treatment groups: mometasone furoate nasal spray (Nasonex) 200 mcg once daily; mometasone furoate nasal spray 200 mcg twice daily; amoxicillin 500 mg three times daily; or placebo. Exclusion criteria included fever higher than 101 °F (38.3 °C), severe unilateral facial or tooth pain, facial swelling, dental involvement, or a worsening of symptoms after initial improvement. These criteria likely excluded participants with a significant bacterial infection.

Fourteen-day follow-up occurred for 90 percent of participants. Patients, blinded to treatment group assignment, self-reported outcomes. Using intention-to-treat analysis, the major symptom score (sum of scores for rhinorrhea, postnasal drip, nasal congestion, headache, and facial pain or pressure) was significantly reduced for patients receiving mometasone furoate nasal spray twice daily compared with those receiving amoxicillin or placebo. Amoxicillin and mometasone furoate nasal spray once daily were similarly more effective than placebo. At the two-week follow-up, however, patients in all four treatment groups reported more than a 50 percent reduction in their major symptom score. Patients receiving mometasone furoate nasal spray twice daily were less likely to meet criteria for treatment failure or to discontinue treatment early because of failure to improve.

Bottom Line: The majority of patients with acute uncomplicated rhinosinusitis improve in two to four weeks without any specific treatment. Treatment with mometasone furoate nasal spray 200 mcg twice daily significantly reduces the time to resolution compared with amoxicillin alone or placebo. Some patients may still find it easier and cheaper to try other modalities such as nasal saline. (Level of Evidence: 1b)