TY - JOUR T1 - Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: A randomized controlled trial AU - Williamson IG, Rumsby K, Benge S, et al Y1 - 2007/12/05 N1 - 10.1001/jama.298.21.2487 JO - JAMA SP - 2487 EP - 2496 VL - 298 IS - 21 N2 - Context  Acute sinusitis is a common clinical problem that usually results in a prescription for antibiotics but the role of antibiotics is debated. Anti-inflammatory drugs such as topical steroids may be beneficial but are underresearched.Objective  To determine the effectiveness of amoxicillin and topical budesonide in acute maxillary sinusitis.Design, Setting, and Patients  A double-blind, randomized, placebo-controlled factorial trial of 240 adults (aged ≥16 years) with acute nonrecurrent sinusitis (had ≥2 diagnostic criteria: purulent rhinorrhea with unilateral predominance, local pain with unilateral predominance, purulent rhinorrhea bilateral, presence of pus in the nasal cavity) at 58 family practices (74 family physicians) between November 2001 and November 2005. Patients were randomized to 1 of 4 treatment groups: antibiotic and nasal steroid; placebo antibiotic and nasal steroid; antibiotic and placebo nasal steroid; placebo antibiotic and placebo nasal steroid.Intervention  A dose of 500 mg of amoxicillin 3 times per day for 7 days and 200 μg of budesonide in each nostril once per day for 10 days.Main Outcome Measures  Proportion clinically cured at day 10 using patient symptom diaries and the duration and severity of symptoms.Results  The proportions of patients with symptoms lasting 10 or more days were 29 of 100 (29%) for amoxicillin vs 36 of 107 (33.6%) for no amoxicillin (adjusted odds ratio, 0.99; 95% confidence interval, 0.57-1.73). The proportions of patients with symptoms lasting 10 or more days were 32 of 102 (31.4%) for topical budesonide vs 33 of 105 (31.4%) for no budesonide (adjusted odds ratio, 0.93; 95% confidence interval, 0.54-1.62). Secondary analysis suggested that nasal steroids were significantly more effective in patients with less severe symptoms at baseline.Conclusion  Neither an antibiotic nor a topical steroid alone or in combination was effective as a treatment for acute sinusitis in the primary care setting.Trial Registration  isrctn.org Identifier: ISRCTN60825437 SN - 0098-7484 M3 - doi: 10.1001/jama.298.21.2487 UR - http://dx.doi.org/10.1001/jama.298.21.2487 ER -