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

Uberos 2010.

Methods
  • Study design: parallel RCT

  • Power calculation: no

  • Intention‐to‐treat analysis: yes, and also survival analysis in which appearance of the event (UTI) was sufficient cause for ending the follow‐up period

Participants Inclusion criteria
  • Setting: paediatric nephrology and urology departments; single centre

  • Country: Spain

  • Children aged from 1 month to 13 years, with recurrent UTI (2 or more infections in 6 months), vesicoureteric reflux of any degree, pyelic ectasia or hydronephrosis or anatomical kidney disorder

  • Number: 198 randomised; 192 analysed

Interventions Treatment group
  • Cranberry syrup: 0.2 mL/kg (Urell, Pharmatoka)


Control group
  • TMP: 8 mg/kg

Outcomes
  • UTI

Notes
  • Published first as an abstract, more recently as a full report

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer and ID card
Allocation concealment (selection bias) Low risk Method stated
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk States double blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Possibly, uncertain who double blind refers to
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Losses to follow‐up/withdrawals: 3 in each group (six in total)
Selective reporting (reporting bias) Low risk Symptomatic UTI is most appropriate
Other bias Unclear risk Due to problems during the randomisation process, 75 patients were assigned to receive cranberry syrup and 117 to receive TMP. However, blinding to treatment was maintained.
Source of funding: Carlos III Institute of Health for Clinical Research, Madrid, Spain