title: Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  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.
authors.affiliation: Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, 37073 Göttingen, Germany igagyor@gwdg.de.
authors.forename: Ildikó
authors.initials: I
authors.lastname: Gágyor
authors.affiliation: Institute of General Practice, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany.
authors.forename: Jutta
authors.initials: J
authors.lastname: Bleidorn
authors.affiliation: Department of Medicine, Division of General Practice, University Medical Centre, Elsässerstrasse 2m, 79110 Freiburg, Germany.
authors.forename: Michael M
authors.initials: MM
authors.lastname: Kochen
authors.affiliation: Institute for Public Health and Nursing Research, Department for Health Services Research, University of Bremen, Grazer Strasse 4, 28359 Bremen, Germany.
authors.forename: Guido
authors.initials: G
authors.lastname: Schmiemann
authors.affiliation: Department of Medical Biometry and Epidemiology, University Medical Centre Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
authors.forename: Karl
authors.initials: K
authors.lastname: Wegscheider
authors.affiliation: Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, 37073 Göttingen, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Hummers-Pradier
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D005260:Female; D005578:Fosfomycin / Q000008:administration & dosage*; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage*; D008875:Middle Aged; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D005578:Fosfomycin; D007052:Ibuprofen