title: Oral vaccine (OM-89) in the recurrent urinary tract infection prophylaxis: a realistic systematic review with meta-analysis.
abstract: OBJECTIVE
  To evaluate the efficacy of Escherichia Coli extract (OM-89) in the prophylaxis of recurrent uncomplicated urinary tract infection (UTI) through a contemporary systematic review and meta-analysis.
  
  
  METHODS
  Inclusion criteria were double-blind randomized trials using orally administrated OM-89, 6mg daily, during three months with a minimum of three months of monitoring. Outcomes were the frequency of bacteriuria in 3 and 6 months, dysuria in 6 months and UTI in 6 months.
  
  
  METHODS
  PubMed, MEDLINE, Cochrane Collaboration and their key references. After analysis by three independent reviewers, 15 double-blind randomized trials were identified, 10 papers excluded due to methods flaws and 5 used for data analysis due to double blinding and reporting drop-outs.
  
  
  RESULTS
  Among 5 selected studies the date of publication ranged from 1985 to 2005, totalizing 396 patients in the OM-89 group and 392 in the control group. Overall, there were 61 dropouts in the control group and 76 in the OM-89 group. As a major limitation there was no appropriate description of their methodologies and none of the studies described conflict of interest or commitment to the pharmaceutical industry. All studies were multi-centric, except for two, which showed no clarity on allocation concealment. All studies show benefit in favor of vaccine.
  
  
  CONCLUSIONS
  Current literature on prospective randomized controlled trials evaluating the use of oral OM-89 vaccine in the recurrent UTI prophylaxis is of low quality, limited to the first six months only and with variable definition of bacteriuria and UTI. Although all studies show benefit in favor of vaccine, no robust trial was identified, resulting in a high heterogeneity in the data analyzed. Also, publication bias could not be excluded and future higher quality studies are warranted adding intermediate (>12 months) and long-term follow-up.
authors.affiliation: Faculty of Medicine, Center of Life Sciences, Pontifical Catholic University of Campinas, PUC-Campinas, Campinas, São Paulo, Brasil.
authors.forename: K A
authors.initials: KA
authors.lastname: Taha Neto
authors.affiliation: Radium Institute, Campinas, São Paulo, Brasil.
authors.forename: L
authors.initials: L
authors.lastname: Nogueira Castilho
authors.affiliation: Faculty of Medicine, Center of Life Sciences, Pontifical Catholic University of Campinas, PUC-Campinas, Campinas, São Paulo, Brasil. Electronic address: reisleo.l@gmail.com.
authors.forename: L O
authors.initials: LO
authors.lastname: Reis
mesh_terms: D000284:Administration, Oral; D001428:Bacterial Vaccines / Q000008:administration & dosage*; D004311:Double-Blind Method; D004926:Escherichia coli / Q000276:immunology*; D004927:Escherichia coli Infections / Q000517:prevention & control*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D014552:Urinary Tract Infections / Q000517:prevention & control*
chemical_list: D001428:Bacterial Vaccines
keywords: Active immunization; Bacterial vaccines; Cistitis; Cystitis; Disuria; Dysuria; Escherichia coli; Infección del tracto urinario; Inmunización activa; Urinary tract infection; Vacunas bacterianas