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A Randomized Controlled Trial

Ian G. Williamson, MD; Kate Rumsby, BA; Sarah Benge, PhD; Michael Moore, FRCGP; Peter W. Smith, PhD; Martine Cross, BA; Paul Little, MD

JAMA. 2007;298(21):2487-2496.

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

Author Affiliations: Department of Medicine, University of Southampton, Southampton, England (Drs Williamson, Benge, Moore, and Little and Ms Rumsby); Southampton Statistical Sciences Research Institute, Southampton, England (Dr Smith); and NightingaleSurgery, Romsey, England (Ms Cross).

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