Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years

doi:10.1136/bmj.320.7231.350

BMJ 2000;320:350-354 ( 5 February )

General Practice

Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years

Roger A M J Damoiseaux, general practitioner, ^a Frank A M van Balen, general practitioner, ^a Arno W Hoes, professor of clinical epidemiology, ^b Theo J M Verheij, professor of general practice, ^a Ruut A de Melker, professor of general practice. ^a

^a Department of General Practice, University Medical Centre, Universiteitsweg 100, 3584 CG Utrecht, Netherlands, ^b Department of General Practice and Julius Centre for Patient Oriented Research, University Medical Centre

Correspondence to: R A M J Damoiseaux R.A.M.J.Damoiseaux{at}med.uu.nl

Objective: To determine the effect of antibiotic treatmentfor acute otitis media in children between 6 months and 2 yearsofage.
Design: Practice based, double blind, randomised,placebo controlledtrial.
Setting: 53 general practices in theNetherlands.
Subjects: 240 children aged 6 months to 2 years withthe diagnosis of acute otitismedia.
Intervention: Amoxicillin 40 mg/kg/day in threedoses.
Main outcome measures: Persistent symptoms at day four and durationof fever and pain or crying, or both. Otoscopy at days four and11, tympanometry at six weeks, and use ofanalgesic.
Results: Persistent symptoms at day four were lesscommon in the amoxicillin group (risk difference 13%; 95% confidenceinterval 1% to 25%). The median duration of fever was two daysin the amoxicillin group versus three in the placebo group (P=0.004).No significant difference was observed in duration of pain orcrying, but analgesic consumption was higher in the placebo groupduring the first 10 days (4.1 v 2.3 doses, P=0.004). In addition,no otoscopic differences were observed at days four and 11, andtympanometric findings at six weeks were similar in bothgroups.
Conclusions: Seven to eight children aged 6 to 24 monthswith acute otitis media needed to be treated with antibioticsto improve symptomatic outcome at day four in one child. Thismodest effect does not justify prescription of antibiotics atthe first visit, provided close surveillance can beguaranteed.

© BMJ 2000

CiteULike

Complore

Connotea

Del.icio.us Add to Digg

Digg

StumbleUpon Add to Technorati

Technorati What's this?

Relevant Articles

Recurrence up to 3.5 years after antibiotic treatment of acute otitis media in very young Dutch children: survey of trial participants: Natália Bezáková, Roger A M J Damoiseaux, Arno W Hoes, Anne G M Schilder, and Maroeska M Rovers
BMJ 2009 338: b2525. [Abstract] [Full Text] [PDF]

Amoxicillin for otitis media in general practice: Andrew Thornett, Erdem I Cantekin, Elizabeth King, R J Lilford, David Braunholtz, G Sandhu, H A Saleh, T Wright, R A M J Damoiseaux, F A M van Balen, A W Hoes, T J M Verheij, and R A de Melker
BMJ 2000 321: 765. [Extract] [Full Text]

Even infants with otitis media do not need antibiotics
BMJ 2000 320: 0. [Full Text]

This article has been cited by other articles:

Vouloumanou, E. K., Karageorgopoulos, D. E., Kazantzi, M. S., Kapaskelis, A. M., Falagas, M. E. (2009). Antibiotics versus placebo or watchful waiting for acute otitis media: a meta-analysis of randomized controlled trials. J Antimicrob Chemother 64: 16-24 [Abstract] [Full text]
Bezakova, N., Damoiseaux, R. A M J, Hoes, A. W, Schilder, A. G M, Rovers, M. M (2009). Recurrence up to 3.5 years after antibiotic treatment of acute otitis media in very young Dutch children: survey of trial participants. BMJ 338: b2525-b2525 [Abstract] [Full text]
Meropol, S. B., Glick, H. A., Asch, D. A. (2008). Age Inconsistency in the American Academy of Pediatrics Guidelines for Acute Otitis Media. Pediatrics 121: 657-668 [Abstract] [Full text]
Koopman, L., Hoes, A. W., Glasziou, P. P., Appelman, C. L., Burke, P., McCormick, D. P., Damoiseaux, R. A., Le Saux, N., Rovers, M. M. (2008). Antibiotic Therapy to Prevent the Development of Asymptomatic Middle Ear Effusion in Children With Acute Otitis Media: A Meta-analysis of Individual Patient Data. Arch Otolaryngol Head Neck Surg 134: 128-132 [Abstract] [Full text]
McWilliams, D. B., Jacobson, R. M., Van Houten, H. K., Naessens, J. M., Ytterberg, K. L. (2008). A Program of Anticipatory Guidance for the Prevention of Emergency Department Visits for Ear Pain. Arch Pediatr Adolesc Med 162: 151-156 [Abstract] [Full text]
Chandler, S. M., Garcia, S. M. S., McCormick, D. P. (2007). Consistency of Diagnostic Criteria for Acute Otitis Media: A Review of the Recent Literature. CLIN PEDIATR 46: 99-108 [Abstract]
Rovers, M. M., Glasziou, P., Appelman, C. L., Burke, P., McCormick, D. P., Damoiseaux, R. A., Little, P., Le Saux, N., Hoes, A. W. (2007). Predictors of Pain and/or Fever at 3 to 7 Days for Children With Acute Otitis Media Not Treated Initially With Antibiotics: A Meta-analysis of Individual Patient Data. Pediatrics 119: 579-585 [Abstract] [Full text]
Coco, A. S. (2007). Cost-Effectiveness Analysis of Treatment Options for Acute Otitis Media. Ann Fam Med 5: 29-38 [Abstract] [Full text]
Block, S L (2006). Searching for the Holy Grail of acute otitis media.. Arch. Dis. Child. 91: 959-961 [Full text]
Spiro, D. M., Tay, K.-Y., Arnold, D. H., Dziura, J. D., Baker, M. D., Shapiro, E. D. (2006). Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial.. JAMA 296: 1235-1241 [Abstract] [Full text]
Siegel, R. M., Bien, J., Lichtenstein, P., Davis, J., Khoury, J. C., Knight, J. E., Kiely, M., Bernier, J. (2006). A Safety-Net Antibiotic Prescription for Otitis Media: The Effects of a PBRN Study on Patients and Practitioners. CLIN PEDIATR 45: 518-524 [Abstract]
Damoiseaux, R. A., Rovers, M. M, Van Balen, F. A., Hoes, A. W, de Melker, R. A (2006). Long-term prognosis of acute otitis media in infancy: determinants of recurrent acute otitis media and persistent middle ear effusion. Fam Pract 23: 40-45 [Abstract] [Full text]
Cober, M. P., Johnson, C. E (2005). Otitis Media: Review of the 2004 Treatment Guidelines. The Annals of Pharmacotherapy 39: 1879-1887 [Abstract] [Full text]
Finkelstein, J. A., Stille, C. J., Rifas-Shiman, S. L., Goldmann, D. (2005). Watchful Waiting for Acute Otitis Media: Are Parents and Physicians Ready?. Pediatrics 115: 1466-1473 [Abstract] [Full text]
Lieberthal, A. S., Ganiats, T. G. (2005). Thoughts on the American Academy of Pediatrics/American Academy of Family Physicians Clinical Practice Guideline on Acute Otitis Media: A Different Perspective: In Reply. Pediatrics 115: 1444-1445 [Full text]
Wald, E. R. (2005). To Treat or Not to Treat. Pediatrics 115: 1087-1089 [Full text]
Damoiseaux, R.A.M.J. (2005). Antibiotic treatment for acute otitis media: time to think again. CMAJ 172: 657-658 [Full text]
Le Saux, N., Gaboury, I., Baird, M., Klassen, T. P., MacCormick, J., Blanchard, C., Pitters, C., Sampson, M., Moher, D. (2005). A randomized, double-blind, placebo-controlled noninferiority trial of amoxicillin for clinically diagnosed acute otitis media in children 6 months to 5 years of age. CMAJ 172: 335-341 [Abstract] [Full text]
Stille, C. J., Andrade, S. E., Huang, S. S., Nordin, J., Raebel, M. A., Go, A. S., Chan, K. A., Finkelstein, J. A. (2004). Increased Use of Second-Generation Macrolide Antibiotics for Children in Nine Health Plans in the United States. Pediatrics 114: 1206-1211 [Abstract] [Full text]
Rosenfeld, R. M. (2004). Otitis, Antibiotics, and the Greater Good. Pediatrics 114: 1333-1335 [Full text]
Green, L. A., Fryer, G. E. Jr, Froom, P., Culpepper, L., Froom, J. (2004). Opportunities, Challenges, and Lessons of International Research in Practice-Based Research Networks: The Case of an International Study of Acute Otitis Media. Ann Fam Med 2: 429-433 [Abstract] [Full text]
Siegel, R. M., Bien, J. P. (2004). Acute Otitis Media in Children: A Continuing Story. Pediatr. Rev. 25: 187-193 [Full text]
Subcommittee on Management of Acute Otitis Media, (2004). Diagnosis and Management of Acute Otitis Media. Pediatrics 113: 1451-1465 [Abstract] [Full text]
Zintzaras, E., Ioannidis, J. P. A. (2003). Modelling of escalating outpatient antibiotic expenditures. J Antimicrob Chemother 52: 1001-1004 [Abstract] [Full text]
Siegel, R. M., Kiely, M., Bien, J. P., Joseph, E. C., Davis, J. B., Mendel, S. G., Pestian, J. P., DeWitt, T. G. (2003). Treatment of Otitis Media With Observation and a Safety-Net Antibiotic Prescription. Pediatrics 112: 527-531 [Abstract] [Full text]
Ruohola, A., Heikkinen, T., Meurman, O., Puhakka, T., Lindblad, N., Ruuskanen, O. (2003). Antibiotic Treatment of Acute Otorrhea Through Tympanostomy Tube: Randomized Double-Blind Placebo-Controlled Study With Daily Follow-up. Pediatrics 111: 1061-1067 [Abstract] [Full text]
Jackson, A. B., Kadota, R., Gordon, J. (2003). Recurrent Otitis Media in Children. JAMA 289: 1382-1383 [Full text]
Paradise, J. L. (2002). A 15-Month-Old Child With Recurrent Otitis Media. JAMA 288: 2589-2598 [Full text]
Hendley, J. O. (2002). Otitis Media. NEJM 347: 1169-1174 [Full text]
West, J V (2002). Acute upper airway infections: Childhood respiratory infections. Br Med Bull 61: 215-230 [Abstract] [Full text]
Schoem, S. R., Choi, S. S. (2002). AOM: Implications of the AHRQ Evidence Report. AAP Grand Rounds 7: 14-15 [Full text]
Ioannidis, J. P.A., Contopoulos-Ioannidis, D. G., Chew, P., Lau, J. (2001). Meta-analysis of randomized controlled trials on the comparative efficacy and safety of azithromycin against other antibiotics for upper respiratory tract infections. J Antimicrob Chemother 48: 677-689 [Abstract] [Full text]
Melhus, A. (2001). Effects of amoxicillin on the expression of cytokines during experimental acute otitis media caused by non-typeable Haemophilus influenzae. J Antimicrob Chemother 48: 397-402 [Abstract] [Full text]
Takata, G. S., Chan, L. S., Shekelle, P., Morton, S. C., Mason, W., Marcy, S. M. (2001). Evidence Assessment of Management of Acute Otitis Media: I. The Role of Antibiotics in Treatment of Uncomplicated Acute Otitis Media. Pediatrics 108: 239-247 [Abstract] [Full text]
Lavin, A., Ofran, Y., Ofran, A., Damoiseaux, R. A.M.J., Cantekin, E. I., Sauder, K. L., Kilpi, T., Eskola, J., Makela, P. H., the Finnish Otitis Media Study Group, (2001). A Pneumococcal Conjugate Vaccine and Acute Otitis Media. NEJM 344: 1719-1720 [Full text]
Little, P., Gould, C., Williamson, I., Moore, M., Warner, G., Dunleavey, J. (2001). Pragmatic randomised controlled trial of two prescribing strategies for childhood acute otitis media. BMJ 322: 336-342 [Abstract] [Full text]
BAUCHNER, H (2001). Ear, ears, and more ears!. Arch. Dis. Child. 84: 185-186 [Full text]
Thornett, A., Cantekin, E. I, King, E., Lilford, R J, Braunholtz, D., Sandhu, G, Saleh, H A, Wright, T, Damoiseaux, R A M J, van Balen, F A M, Hoes, A W, Verheij, T J M, de Melker, R A (2000). Amoxicillin for otitis media in general practice. BMJ 321: 765-765 [Full text]
Mar, C. B D. (2000). Amoxicillin resolved otitis media symptoms in young children better than did placebo at day 4 but not at day 11. Evid. Based Med. 5: 149-149 [Full text]
Kemp, C. (2000). . AAP News 16: 2-3 [Full text]
(2000). Do Kids Under 2 with Otitis Need Antibiotics?. JWatch Emergency Med. 2000: 11-11 [Full text]
(2000). Should All Children with Acute Otitis Media Receive Antibiotics?. JWatch General 2000: 1-1 [Full text]

Rapid Responses:

Read all Rapid Responses

Meeting parental expectations: Andrew Thornett
bmj.com, 5 Feb 2000 [Full text]
physicians must know it: Oslim Malina
bmj.com, 6 Feb 2000 [Full text]
A grandparent's view: Elizabeth King
bmj.com, 9 Feb 2000 [Full text]
A parental view: Louise Locock
bmj.com, 11 Feb 2000 [Full text]
Time to Stop the Antibiotic Misuse for Otitis Media: Erdem I Cantekin
bmj.com, 12 Feb 2000 [Full text]
The results do not justify the conclusions: R J Lilford, et al.
bmj.com, 22 Feb 2000 [Full text]
Concern re risk of meningitis: Paul Scott
bmj.com, 24 Feb 2000 [Full text]
Concerns about study: T Wright
bmj.com, 17 Mar 2000 [Full text]
Acute Otitis Media In Children: A P Coatesworth
bmj.com, 21 Mar 2000 [Full text]
Reanalysis of breastfed children: David S Ziska
bmj.com, 31 Mar 2000 [Full text]
Acute otitis media in young children-withholding antibiotics not justified: Pradeep Morar
bmj.com, 7 Apr 2000 [Full text]
Methodological concerns: A O Owa
bmj.com, 8 May 2000 [Full text]
Antibiotic Prescribing for acute otitis media in children: A R Crawfurd
bmj.com, 12 Oct 2000 [Full text]
Re: Time to Stop the Antibiotic Misuse for Otitis Media: Michael J O'Halloran
bmj.com, 19 Aug 2001 [Full text]