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

Barbosa‐Cesnik 2011.

Methods
  • Study design: parallel RCT

  • Power calculation: yes

  • Intention‐to‐treat analysis: no

Participants Inclusion criteria
  • Setting: Women presenting to a health service with symptoms of UTI

  • Country: USA

  • Women 18‐40 years, with UTI symptoms, residing in Ann Arbor next 6 months

  • Number: 419 randomised; 319 analysed

  • Average age: 21 years

  • Previous UTIs: 3‐4 previously; 1 in previous year


Exclusion criteria
  • Antibiotics in past 48 hours; hospitalisation or catheterisation within past 2 weeks; kidney stones; diabetes; pregnancy; cranberry allergy; negative urine culture

Interventions Treatment group
  • Low calorie cranberry cocktail: 240 mL (8 oz) twice a day

  • Mean PAC: 112 mg/240 mL


Control group
  • Placebo drink: same volume matched for flavour and colour


Treatment duration: 6 months
Outcomes
  • Primary outcome: UTI (≥ 10³ cfu/L of known pathogen)

  • Secondary outcome: urinary symptoms and vaginal symptoms at day 3, 1‐2 weeks, and ≥ 1 month

Notes
  • Compliance measured by direct questioning

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated
Allocation concealment (selection bias) Low risk External, web based allocation
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Placebo drink matched, participants and clinicians blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk NS
Incomplete outcome data (attrition bias) 
 All outcomes High risk 100 participants randomised but no outcomes reported for them, they were actually not eligible to be randomised since they were culture negative
Selective reporting (reporting bias) Low risk UTI is most appropriate outcome
Other bias High risk Selection bias, representative nature of consenters is questionable
Source of funding: National centre for alternative medicine at NIH