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Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h6544 (Published 23 December 2015) Cite this as: BMJ 2015;351:h6544
  1. Ildikó Gágyor, senior researcher in primary care1,
  2. Jutta Bleidorn, senior researcher in primary care2,
  3. Michael M Kochen, senior investigator and emeritus professor of primary care3,
  4. Guido Schmiemann, senior researcher in primary care and epidemiology4,
  5. Karl Wegscheider, trial statistician and professor of medical biometry and epidemiology5,
  6. Eva Hummers-Pradier, senior investigator and professor of primary care1
  1. 1Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, 37073 Göttingen, Germany
  2. 2Institute of General Practice, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany
  3. 3Department of Medicine, Division of General Practice, University Medical Centre, Elsässerstrasse 2m, 79110 Freiburg, Germany
  4. 4Institute for Public Health and Nursing Research, Department for Health Services Research, University of Bremen, Grazer Strasse 4, 28359 Bremen, Germany
  5. 5Department of Medical Biometry and Epidemiology, University Medical Centre Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany
  1. Correspondence to: I Gágyor igagyor{at}gwdg.de
  • Accepted 29 October 2015

Abstract

Study question Can treatment of the symptoms of uncomplicated urinary tract infection (UTI) with ibuprofen reduce the rate of antibiotic prescriptions without a significant increase in symptoms, recurrences, or complications?

Methods Women aged 18-65 with typical symptoms of UTI and without risk factors or complications were recruited in 42 German general practices and randomly assigned to treatment with a single dose of fosfomycin 3 g (n=246; 243 analysed) or ibuprofen 3×400 mg (n=248; 241 analysed) for three days (and the respective placebo dummies in both groups). In both groups additional antibiotic treatment was subsequently prescribed as necessary for persistent, worsening, or recurrent symptoms. The primary endpoints were the number of all courses of antibiotic treatment on days 0-28 (for UTI or other conditions) and burden of symptoms on days 0-7. The symptom score included dysuria, frequency/urgency, and low abdominal pain.

Study answer and limitations The 248 women in the ibuprofen group received significantly fewer course of antibiotics, had a significantly higher total burden of symptoms, and more had pyelonephritis. Four serious adverse events occurred that lead to hospital referrals; one of these was potentially related to the trial drug. Results have to be interpreted carefully as they might apply to women with mild to moderate symptoms rather than to all those with an uncomplicated UTI.

What this paper adds Two thirds of women with uncomplicated UTI treated symptomatically with ibuprofen recovered without any antibiotics. Initial symptomatic treatment is a possible approach to be discussed with women willing to avoid immediate antibiotics and to accept a somewhat higher burden of symptoms.

Funding, competing interests, data sharing German Federal Ministry of Education and Research (BMBF) No 01KG1105. Patient level data are available from the corresponding author. Patient consent was not obtained but the data are anonymised and risk of identification is low.

Trial registration No ClinicalTrialGov Identifier NCT01488955.

Footnotes

  • We thank all participating women and all general practice investigators and their teams (Drs Albrecht, Annweiler, Baumgarten, Beverungen, Borchers, Böttcher, Brockstedt, Brucker, Buck, Coutelle, Dickow, Dockhorn, Egidi, Ertel, Falkenstein, Fleige, Gemen, Gerken, Glatzel, Gosewisch, Heiken, Hermann, Hiller, Hilgenberg, Holm, Keske, Kiwit-Putzer, Klinger-Bültemann, Knöpfel, Koch, Köhler, Löber, Lückerath, Meggers, Meier-Ahrens, Menke, Müller, Neidhardt, Preiskorn, Rötterink, Schaper, Schelp, Schmiemann, Schmitz, Seker, Stegemann, Wilde, Zedler, Zimny). We are grateful to our dedicated research nurses H Schneider-Rudt, C Tomala, J Westphal, and K Jürgensen-Muziol. We also thank Ludwig Balzer for support in the statistical analysis and Frank Sullivan for checking of some English language points.

    Data Safety and Monitoring Board: Norbert Donner-Banzhoff (Philipps-University Marburg, Department of General Practice, Preventive and Rehabilitation Medicine), Jürgen Brockmöller (University Medical Centre Göttingen, Clinical Pharmacology), Helmut Eiffert (University Medical Centre Göttingen, Institute for Medical Microbiology), Wilhelm Niebling (University Medical Centre Freiburg, Division of General Practice), Andreas Sönnichsen (Institute for General Practice and Family Medicine, Faculty of Health, Witten/Herdecke), Hans-Joachim Trampisch (Ruhr-University Bochum, Department of Medical Informatics and Epidemiology).

  • Contributors: IG and JB contributed equally to the manuscript and share first authorship. All authors conceived the concept and designed and supervised to study; acquired, analysed, and interpreted the data; and drafted and revised the manuscript. KW carried out the statistical analysis. EH-P obtained funding. The Institute for Clinical Research, Göttingen (IFS), pharmacy of the Charité (Berlin), medical laboratory AMEDES Holding AG (Göttingen) contributed administrative, material, and technical support. EH-P and IG are guarantors.

  • Funding: The trial was funded by the German Federal Ministry of Education and Research (BMBF) No 01KG1105. The funder had no role in trial design, data collection, analysis, or reporting.

  • Competing interests: All authors have completed the uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from the German Federal Ministry of Education and Research for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work. The University of Göttingen was responsible for the initiation, quality control and financial management the clinical study but did not participate in the collection, clinical project management, analysis, and interpretation of data.

  • Ethical approval: This study was approved by the ethics committee of Hannover Medical School (No 5986M). All participants provided written informed consent.

  • Transparency: The guarantors affirm that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies are disclosed.

  • Data sharing: Patient level data are available on reasonable request from the corresponding author. Patient consent was not obtained but the presented data are anonymised and risk of identification is low.

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