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1: BMJ. 2000 Feb 5;320(7231):350-4.Click here to read Click here to read Links
Comment in:
ACP J Club. 2000 Sep-Oct;133(2):62.
BMJ. 2000 Sep 23;321(7263):765-6.
BMJ. 2000 Sep 23;321(7263):765; author reply 766.
BMJ. 2000 Sep 23;321(7263):765; author reply 766.
BMJ. 2000 Sep 23;321(7263):766.
BMJ. 2000 Sep 23;321(7263):766.

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

Damoiseaux RA, van Balen FA, Hoes AW, Verheij TJ, de Melker RA.

Department of General Practice, University Medical Centre, Universiteitsweg 100, 3584 CG Utrecht, Netherlands. Damoiseaux@med.uu.nl

OBJECTIVE: To determine the effect of antibiotic treatment for acute otitis media in children between 6 months and 2 years of age. DESIGN: Practice based, double blind, randomised, placebo controlled trial. SETTING: 53 general practices in the Netherlands. SUBJECTS: 240 children aged 6 months to 2 years with the diagnosis of acute otitis media. INTERVENTION: Amoxicillin 40 mg/kg/day in three doses. MAIN OUTCOME MEASURES: Persistent symptoms at day four and duration of fever and pain or crying, or both. Otoscopy at days four and 11, tympanometry at six weeks, and use of analgesic. RESULTS: Persistent symptoms at day four were less common in the amoxicillin group (risk difference 13%; 95% confidence interval 1% to 25%). The median duration of fever was two days in the amoxicillin group versus three in the placebo group (P=0.004). No significant difference was observed in duration of pain or crying, but analgesic consumption was higher in the placebo group during 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, and tympanometric findings at six weeks were similar in both groups. CONCLUSIONS: Seven to eight children aged 6 to 24 months with acute otitis media needed to be treated with antibiotics to improve symptomatic outcome at day four in one child. This modest effect does not justify prescription of antibiotics at the first visit, provided close surveillance can be guaranteed.

PMID: 10657332 [PubMed - indexed for MEDLINE]

PMCID: PMC27282

Patient Drug Information

  • Penicillin G Potassium or Sodium Injection (Pfizerpen® )

    Your doctor has ordered penicillin, an antibiotic, to help treat your infection. The drug will be either injected into a large muscle (such as your buttock or hip) or added to an intravenous fluid that will drip through ...

  • Amoxicillin (Amoxil® , Amoxil® Pediatric Drops, Trimox® , ...)

    Amoxicillin is used to treat certain infections caused by bacteria, such as pneumonia; bronchitis; gonorrhea; and infections of the ears, nose, throat, urinary tract, and skin. It is also used in combination with other m...

  • Source: AHFS Consumer Medication Information