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Rodolfo T. Rafael,MD.


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Intranasal steroids alone effective for acute uncomplicated sinusitis


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

Bottom Line:
The vast majority of patients with acute uncomplicated rhinosinusitis improve in 2 to 4 weeks without any specific treatment. Treatment with mometasone furoate nasal spray (Nasonex) 200 ug twice daily significantly reduces the time to resolution compared with amoxicillin alone or placebo. Patients who "must do something" may still find it easier and cheaper to try other modalities such as nasal saline.

Reference:
Meltzer EO, Bachert C, Staudinger H. Treating acute rhinosinusitis: Comparing efficacy and safety of mometasone furoate nasal spray, amoxicillin, and placebo. J Allergy Clin Immunol 2005;116:1289-95.

Study Design:
Randomized controlled trial (double-blinded)

Synopsis:
Intranasal corticosteroids used with antibiotics are known to improve rhinosinusitis symptoms compared with antibiotic therapy alone. However, the efficacy of intranasal corticosteroid monotherapy for acute, uncomplicated rhinosinusitis is not established. To evaluate efficacy and safety of mometasone furoate nasal spray (MFNS) versus amoxicillin and placebo in patients with acute, uncomplicated rhinosinusitis. In this double-blind, double-dummy trial, subjects (> or =12 years; N = 981) were randomized to MFNS 200 microg once daily or twice daily for 15 days, amoxicillin 500 mg 3 times daily for 10 days, or respective placebo. Follow-up was 14 days. The primary efficacy endpoint was mean am/pm major symptom score over the treatment phase. Secondary efficacy endpoints included total symptom score. Safety assessments included disease recurrence during follow-up and adverse event monitoring. Mometasone furoate nasal spray 200 microg twice daily was significantly superior to placebo (P < .001) and amoxicillin (P = .002) at improving major symptom score. Starting on day 2, MFNS 200 microg twice daily improved total symptom score throughout treatment versus amoxicillin (P = .012) and placebo (P < .001). Global response to treatment was significantly greater with MFNS 200 microg twice daily versus amoxicillin (P = .013) and placebo (P = .001). Although significantly superior to placebo, MFNS 200 microg once daily was not superior to amoxicillin for the primary or secondary efficacy endpoints. All treatments were well tolerated with a similar incidence of adverse events.

 

 

   

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