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. 2012 Oct 17;2012(10):CD001321. doi: 10.1002/14651858.CD001321.pub5

Kontiokari 2001.

Methods
  • Study design: parallel 3‐arm RCT

  • Power calculation: yes, but recruitment stopped before appropriate number recruited

  • Intention‐to‐treat analysis: yes

Participants Inclusion criteria
  • Setting: Finnish student health service; single centre

  • Country: Finland

  • Women who had a UTI caused by E. coli (105 cfu/mL in clean voided MSU) and were not taking antimicrobial prophylaxis.

  • Number: 150 randomised/analysed

  • Mean age: 29‐32 years


Exclusion criteria: NS
Interventions Treatment group 1
  • Cranberry‐lingonberry juice concentrate (Maija, Marli, Finland): 50 mL/d

    • Cranberry concentrate: 7.5 g

    • Lingonberry concentrate: 1.7 g

    • Water: 50 mL with no added sugars


Treatment group 2
  • Lactobacillus GG drink (Gefilus, Valio, Finland): 100 mL for five days a week


Control group
  • No intervention


Duration of treatment: 6 months cranberry‐lingonberry concentrate; 12 months lactobacillus
Outcomes
  • First recurrence of symptomatic UTI

Notes
  • Method of obtaining urine sample: clean voided MSU specimen

  • Definition of bacteriuria

    • Bacterial growth 105 cfu/mL

  • Recruitment had to be stopped prematurely because the cranberry juice supplier stopped producing the juice. A total of 150 women gave their informed consent and were randomly allocated into three groups, 50 in each. One subject in the lactobacillus group who was taking post coital antimicrobials was excluded from the analysis.

  • Exclusions post randomisation: none

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Tables of random numbers and block technique with block size of 6
Allocation concealment (selection bias) Low risk Sealed opaque envelopes (additional information provided by authors)
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and physicians not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Lab staff blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Losses to follow‐up/withdrawals: 13. Analysed drop outs and withdrawals
Selective reporting (reporting bias) Low risk Appropriate outcomes
Other bias Unclear risk Uncertain about selection bias, few details
Source of funding: Emil Aaltonen, Juho Vainio, and Alma and K A Snellman Foundations