A randomized, placebo-controlled trial of antimicrobial treatment for children with clinically diagnosed acute sinusitis.
OBJECTIVE
Although antimicrobial treatment for children with acute sinusitis is used commonly, it is unclear whether it offers significant clinical benefit. The purpose of this study was to evaluate the effectiveness of antimicrobial treatments for acute sinusitis as they are used in community pediatric practice.


METHODS
We conducted a randomized, placebo-controlled trial in 3 community pediatric practices in St Louis, Missouri. A total of 188 patients who were between the ages of 1 and 18 years and who had had 10 to 28 days of persistent sinus symptoms and a clinical diagnosis of acute sinusitis were randomized to receive 14 days of amoxicillin (40 mg/kg/d in 3 daily doses), amoxicillin-clavulanate (amoxicillin 45 mg/kg/d in 2 daily doses), or placebo. Change in sinus symptoms was assessed both by a quantitative symptom score (the S5 score) and subjectively by the parent. Secondary outcomes included adverse effects of treatment and recurrence or relapse of sinus symptoms. Outcomes were assessed by telephone interviews over a 2-month period.


RESULTS
Of the 161 patients who were included in the analysis, 58 received amoxicillin, 48 received amoxicillin-clavulanate, and 55 received placebo. Day 14 improvement rates were 79%, 81%, and 79%, respectively. There were no differences in the 14-day change in S5 score among treatment groups. The rates of adverse events (amoxicillin, 19%; amoxicillin-clavulanate, 11%; placebo, 10%), relapse (amoxicillin, 12%; amoxicillin-clavulanate, 13%; placebo, 13%), and recurrence (amoxicillin, 9%; amoxicillin-clavulanate, 13%; placebo, 13%) of sinus symptoms were similar among treatment groups.


CONCLUSIONS
Neither amoxicillin nor amoxicillin-clavulanate offered any clinical benefit compared with placebo for children with clinically diagnosed acute sinusitis.
Garbutt
J M
JM
Division of General Medical Sciences, Washington University School of Medicine, St Louis, Missouri, USA. jgarbutt@im.wustl.edu
Goldstein
M
M
Gellman
E
E
Shannon
W
W
Littenberg
B
B
D000208:Acute Disease; D000293:Adolescent; D000658:Amoxicillin / Q000627:therapeutic use*; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D006801:Humans; D007223:Infant; D010919:Placebos; D012852:Sinusitis / Q000188:drug therapy*; D016896:Treatment Outcome
D010919:Placebos; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin