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The effect of amoxicillin in lower respiratory tract infection (LRTI): A placebo controlled RCT in 16 primary care GRACE networks from 12 countries in Europe

Paul Little, Beth Stuart, Theo Verheij, Chris Butler, Michael Moore, Samuel Coenen, Maciek Godycki-Cwirko, Artur Mierzecki, Slawomir Shlabicz, Antoni Torres, Jordi Almirall, Peter Edwards, Tom Schaberg, Sigvard Mölstad, Francesco Blasi, An De Sutter, Janko Kersnik, Helena Hupkova, Pia Touboul, Mark Mullee, Herman Goossens
European Respiratory Journal 2011 38: 4509; DOI:
Paul Little
1Primary Care Medical Group, University of Southampton Medical School, Southampton, United Kingdom
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Beth Stuart
1Primary Care Medical Group, University of Southampton Medical School, Southampton, United Kingdom
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Theo Verheij
3Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands
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Chris Butler
4Department of General Practice, Cardiff University, Cardiff, United Kingdom
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Michael Moore
1Primary Care Medical Group, University of Southampton Medical School, Southampton, United Kingdom
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Samuel Coenen
5Department of General Practice, University of Antwerp, Antwerp, Belgium
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Maciek Godycki-Cwirko
6Department of Family and Community Medicine, Medical University of Lodz, Lodz, Poland
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Artur Mierzecki
7Independent Laboratory of Family Physician Education, Pomeranian Medical University, Szczecin, Poland
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Slawomir Shlabicz
8Department of Family Medicine and Community Nursing, Medical University of Bialystok, Bialystok, Poland
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Antoni Torres
9Servei de Pneumologia, Institut Clinic del Torax, Barcelona, Spain
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Jordi Almirall
10Intensive Care Unit, Hospital de Mataro, Mataro, Spain
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Peter Edwards
11Ely Bridge Surgery, Ely Bridge Surgery, Cardiff, United Kingdom
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Tom Schaberg
12Zentrum für Pheumologie, Diakoniekrankenhaus Rotenburg, Rotenburg, Germany
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Sigvard Mölstad
13Unit of Research and Development in Primary Health Care, Jonkoping, Jonkoping, Sweden
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Francesco Blasi
14Istituto Malattie Respiratorie, University of Milan, Milan, Italy
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An De Sutter
15Ghent University, University Hospital, Ghent, Belgium
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Janko Kersnik
16Zdravstveni dom Jesenice, Zdravstveni dom Jesenice, Jesenice, Slovenia
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Helena Hupkova
17Faculty of Pharmacy, Comenius University Bratislava, Bratislava, Slovakia (Slovak Republic)
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Pia Touboul
18Département de Santé Publique, Hôpital de l' Archet 1, Nice, France
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Mark Mullee
1Primary Care Medical Group, University of Southampton Medical School, Southampton, United Kingdom
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Herman Goossens
2Laboratory of Medical Microbiology, University of Antwerp, Antwerp, Belgium
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Abstract

Introduction: LRTI is the commonest acute presentation managed in primary care and still a major driver of antibiotic prescribing. Systematic reviews of placebo controlled studies are small (<1000).

Aim: To determine the effectiveness of amoxicillin for lower respiratory tract infection.

Methods: 2054 patients presenting with uncomplicated acute cough (<4 weeks) as the main symptom were randomised to amoxicillin 1g three times a day or placebo for 7 days. Patients completed validated symptom diaries for symptom severity (7 point scale) and duration. Notes were reviewed for repeat consultations

Results: 593 of trial population (28%) were aged 60+, and symptom severity documented and duration were documented in 87% of patients. There was no significant difference in symptoms severity in the first 4 days after seeing the doctor (placebo mean 1.69, antibiotic 1.62; difference -0.07 (-0.18 to 0.06)), and no significant difference in the proportion with moderately bad or worse symptoms at 7 days (47% vs 40% respectively, p=0.07 NNT 14). Among the subgroup of patients aged 60 or over there was no evidence of selective benefit. 5% more patients in the antibiotic group compared with the placebo group developed nausea, rash or diarrhoea (NNH 20).

Conclusion: Antibiotics are very unlikely to provide meaningful symptomatic benefit in LRTI for most patients, and any benefit is likely to be similar to the magnitude of harm.

  • © 2011 ERS
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The effect of amoxicillin in lower respiratory tract infection (LRTI): A placebo controlled RCT in 16 primary care GRACE networks from 12 countries in Europe
Paul Little, Beth Stuart, Theo Verheij, Chris Butler, Michael Moore, Samuel Coenen, Maciek Godycki-Cwirko, Artur Mierzecki, Slawomir Shlabicz, Antoni Torres, Jordi Almirall, Peter Edwards, Tom Schaberg, Sigvard Mölstad, Francesco Blasi, An De Sutter, Janko Kersnik, Helena Hupkova, Pia Touboul, Mark Mullee, Herman Goossens
European Respiratory Journal Sep 2011, 38 (Suppl 55) 4509;

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The effect of amoxicillin in lower respiratory tract infection (LRTI): A placebo controlled RCT in 16 primary care GRACE networks from 12 countries in Europe
Paul Little, Beth Stuart, Theo Verheij, Chris Butler, Michael Moore, Samuel Coenen, Maciek Godycki-Cwirko, Artur Mierzecki, Slawomir Shlabicz, Antoni Torres, Jordi Almirall, Peter Edwards, Tom Schaberg, Sigvard Mölstad, Francesco Blasi, An De Sutter, Janko Kersnik, Helena Hupkova, Pia Touboul, Mark Mullee, Herman Goossens
European Respiratory Journal Sep 2011, 38 (Suppl 55) 4509;
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More in this TOC Section

  • Lower respiratory tract infections in the European GRACE primary care network: Bacterial causes or do viruses also matter?
  • Detecting pneumonia in patients with acute cough in primary: Results from the European GRACE study
  • GRACE Network of Excellence: Genetic susceptibility to lower respiratory tract infections in Europe
Show more 462. Appropriate use of antibiotics in respiratory infections in Europe (the GRACE project)

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