Trial reportBMJ (Clinical research ed.)2000
Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years.
Trial report in BMJ (Clinical research ed.), 2000. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
46 citing papers in PubMed, 6 syntheses or guidelines pooled it, 239 citations in OpenAlex.
- Antibiotic treatment to prevent pediatric acute otitis media infectious complications: A meta-analysis.PloS one · 2024Pooled it
- Antibiotics for acute otitis media in children.The Cochrane database of systematic reviews · 2023Pooled it
- Antibiotics for acute otitis media in children.The Cochrane database of systematic reviews · 2015Pooled it
- Duration of symptoms of respiratory tract infections in children: systematic review.BMJ (Clinical research ed.) · 2013Pooled it
- Korean clinical practice guidelines: otitis media in children.Journal of Korean medical science · 2012Guideline
- Treatment of acute otitis media: are children entered into clinical trials representative?The British journal of general practice : the journal of the Royal College of General Practitioners · 2001Pooled it
- Improving pain management in childhood acute otitis media in general practice: a cluster randomised controlled trial of a GP-targeted educational intervention.The British journal of general practice : the journal of the Royal College of General Practitioners · 2020Trial
- Reduced-Concentration Clavulanate for Young Children with Acute Otitis Media.Antimicrobial agents and chemotherapy · 2017Trial
- Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2012Trial
- Recurrence up to 3.5 years after antibiotic treatment of acute otitis media in very young Dutch children: survey of trial participants.BMJ (Clinical research ed.) · 2009Trial
- 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 : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2005Trial
- Pragmatic randomised controlled trial of two prescribing strategies for childhood acute otitis media.BMJ (Clinical research ed.) · 2001Trial
- Antibiotic use and adherence to Finnish treatment guidelines in pediatric acute otitis media.European journal of pediatrics · 2026Article
- Interventions to Minimize Unnecessary Antibiotic Use for Acute Otitis Media: A Meta-Analysis.Children (Basel, Switzerland) · 2025Review
- Comparing Watchful Waiting Approach vs. Antibiotic Therapy in Children with Nonsevere Acute Otitis Media: A Randomized Clinical Trial.International journal of pediatrics · 2021Article
- Article
- Parental acceptability of the watchful waiting approach in pediatric acute otitis media.World journal of clinical pediatrics · 2016Article
- Role of a proprietary propolis-based product on the wait-and-see approach in acute otitis media and in preventing evolution to tracheitis, bronchitis, or rhinosinusitis from nonstreptococcal pharyngitis.International journal of general medicine · 2016Article
- Parent-reported symptoms of acute otitis media during the first year of life: what is beneath the surface?PloS one · 2015Article
- Acute otitis media--a structured approach.Deutsches Arzteblatt international · 2014Review
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine the effect of antibiotic treatment for acute otitis media in children between 6 months and 2 years of age.
designPractice based, double blind, randomised, placebo controlled trial.
setting53 general practices in the Netherlands. SUBJECTS: 240 children aged 6 months to 2 years with the diagnosis of acute otitis media.
interventionAmoxicillin 40 mg/kg/day in three doses.
main outcome measuresPersistent 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.
resultsPersistent 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.
conclusionsSeven 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.