This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow P3Rs: Submit a response
Right arrow P3Rs: View responses
Right arrow Alert me when this article is cited
Right arrow Alert me when P3Rs are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow E-mail this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My File Cabinet
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via CrossRef
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Garbutt, J. M.
Right arrow Articles by Littenberg, B.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Garbutt, J. M.
Right arrow Articles by Littenberg, B.
Related Collections
Right arrow Infectious Disease & Immunity

PEDIATRICS Vol. 107 No. 4 April 2001, pp. 619-625

A Randomized, Placebo-Controlled Trial of Antimicrobial Treatment for Children With Clinically Diagnosed Acute Sinusitis

Received May 10, 2000; accepted Sep 7, 2000.

Jane M. Garbutt*, Marion Goldstein*, Elliot GellmanDagger , William Shannon*, and Benjamin Littenberg§

From the * Division of General Medical Sciences, and Dagger  Department of Pediatrics, Washington University School of Medicine, St Louis, Missouri; and the § Department of Medicine, University of Vermont, Burlington, Vermont.

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.

Conclusion.  Neither amoxicillin nor amoxicillin-clavulanate offered any clinical benefit compared with placebo for children with clinically diagnosed acute sinusitis.  Key words:  acute sinusitis, antimicrobial treatment, randomized controlled trial, pediatric.




This article has been cited by other articles:


Home page
 AAP Grand RoundsHome page
M. W. Weinberger
Additional Evidence Antibiotics Are Not Helpful for Sinusitis
AAP Grand Rounds, April 1, 2008; 19(4): 37 - 38.
[Full Text] [PDF]

Home page
 PediatricsHome page
J. A. Finkelstein, C. Stille, J. Nordin, R. Davis, M. A. Raebel, D. Roblin, A. S. Go, D. Smith, C. C. Johnson, K. Kleinman, et al.
Reduction in Antibiotic Use Among US Children, 1996-2000
Pediatrics, September 1, 2003; 112(3): 620 - 627.
[Abstract] [Full Text] [PDF]

Home page
 PediatricsHome page
H. Bauchner and R. E. Besser
Promoting the Appropriate Use of Oral Antibiotics: There Is Some Very Good News
Pediatrics, March 1, 2003; 111(3): 668 - 670.
[Full Text] [PDF]

Home page
 PediatricsHome page
J. Kahn, J. G. Frohna, and E. R. Wald
'Sinusitis'?
Pediatrics, July 1, 2002; 110(1): 192 - 193.
[Full Text] [PDF]

Home page
 JAMAHome page
J. F. Piccirillo, D. E. Mager, M. E. Frisse, R. H. Brophy, and A. Goggin
Impact of First-Line vs Second-Line Antibiotics for the Treatment of Acute Uncomplicated Sinusitis
JAMA, October 17, 2001; 286(15): 1849 - 1856.
[Abstract] [Full Text] [PDF]

Home page
 Evid. Based Nurs.Home page
Other Articles Noted
Evid. Based Nurs., October 1, 2001; 4(4): E1 - 11.
[Full Text] [PDF]

Home page
 AAP Grand RoundsHome page
D. R. Neuspiel
Short-Course, High-Dose Amoxicillin: Effect on Pneumococcal Carriage
AAP Grand Rounds, October 1, 2001; 6(4): 43 - 44.
[Full Text] [PDF]

Home page
 AAP NewsHome page
L. O'Keefe
AAP guideline: Note history before prescribing antibiotics for sinusitis
AAP News, September 1, 2001; 19(3): 115 - 115.
[Full Text] [PDF]

Home page
 Arch Otolaryngol Head Neck SurgHome page
F. M. Baroody
Pediatric Sinusitis
Arch Otolaryngol Head Neck Surg, September 1, 2001; 127(9): 1099 - 1101.
[Full Text] [PDF]

Home page
 PediatricsHome page
Subcommittee on Management of Sinusitis and Commit
Clinical Practice Guideline: Management of Sinusitis
Pediatrics, September 1, 2001; 108(3): 798 - 808.
[Abstract] [Full Text] [PDF]

Home page
 Pediatr. Rev.Home page
D. Nash
Point-Counterpoint: Sinusitis
Pediatr. Rev., September 1, 2001; 22(9): 291 - 292.
[Full Text] [PDF]

Home page
 AAP Grand RoundsHome page
M. H. Rathore
Are Antimicrobials Useful in the Treatment of Acute, Uncomplicated Sinusitis in Children?
AAP Grand Rounds, July 1, 2001; 6(1): 2 - 3.
[Full Text] [PDF]

Home page
 JWatch GeneralHome page
Antibiotics for Children with Acute Sinusitis?
Journal Watch (General), April 17, 2001; 2001(417): 2 - 2.
[Full Text]

P3Rs:

Read all P3Rs

A parent's view of treatments for sinusitis
Freya J Schultz
Pediatrics Online, 2 Apr 2001 [Full text]
response to letter
jane garbutt
Pediatrics Online, 4 Apr 2001 [Full text]
Sterilizing abscesses used to be considered bad form. Why are we studying it as a treatment option?
Mary Fay
Pediatrics Online, 9 Apr 2001 [Full text]
14 days of symptoms: better place to start?
Marc Habert
Pediatrics Online, 13 Apr 2001 [Full text]
response to Dr Fay's letter
jane garbutt
Pediatrics Online, 14 Apr 2001 [Full text]
Re: 14 days of symptoms: better place to start?
Michael Buebel
Pediatrics Online, 7 May 2001 [Full text]
Response to Dr Habert and Dr Buebel
jane garbutt
Pediatrics Online, 12 May 2001 [Full text]