Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial.
BACKGROUND
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.


METHODS
A double-blind, randomized, placebo-controlled factorial trial of 240 adults (aged > or =16 years) with acute nonrecurrent sinusitis (had > or =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.


METHODS
A dose of 500 mg of amoxicillin 3 times per day for 7 days and 200 mug of budesonide in each nostril once per day for 10 days.


METHODS
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.


CONCLUSIONS
Neither an antibiotic nor a topical steroid alone or in combination was effective as a treatment for acute sinusitis in the primary care setting.


BACKGROUND
isrctn.org Identifier: ISRCTN60825437.
Department of Medicine, University of Southampton, Southampton, England. igw@soton.ac.uk
Ian G
IG
Williamson
Kate
K
Rumsby
Sarah
S
Benge
Michael
M
Moore
Peter W
PW
Smith
Martine
M
Cross
Paul
P
Little
D000208:Acute Disease; D000287:Administration, Topical; D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D015523:Maxillary Sinusitis / Q000188:drug therapy*; D008875:Middle Aged; D009296:Nasal Cavity
D000900:Anti-Bacterial Agents; D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D019819:Budesonide; D000658:Amoxicillin