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. 2015 Dec 23;2015(12):CD008772. doi: 10.1002/14651858.CD008772.pub2

Reid 1992.

Methods
  • Study design: parallel RCT

  • Study duration: recruitment date not reported, patients were followed for 6 months (final follow up date unknown)

Participants
  • Setting: outpatient

  • Country: Canada

  • Premenopausal women with signs and symptoms of an acute lower UTI with dysuria, frequency, urgency, or nocturia, but no flank pain or fever and positive screening results for bacteriuria using a leukocyte esterase strip

  • Number: treatment group (19); control group (21)

  • Mean age ± SD: 23 ± 4.4 years

  • Exclusion criteria: pregnancy; diabetes; known allergy to fluoroquinolones or TMP/SMX; history of urinary cancer or other urinary tract abnormalities; use of medications other than the study medications

Interventions Treatment group
  • Lactobacillus casei var rhamnosus GR‐1 and Lactobacillus fermentum B‐54 vaginal suppository

    • 1.6 x 109 organisms/capsule, intravaginally, twice a week for 2 weeks then at the end of each of the next 2 months


Control group
  • Sterilised skim milk placebo vaginal suppository

    • intravaginally, twice a week for 2 weeks then at the end of each of the next 2 months

Outcomes
  • UTI recurrence

    • defined as both asymptomatic and symptomatic bacteriuria with urine cultures performed routinely during follow up visits

  • Adverse effects

    • determined by questioning the patients about signs of rash, vomiting, diarrhoea, nausea, irritation, or discharge

Notes
  • Funding was provided by grants from Merck‐Frosst, Canada and University Research Incentive Fund of Ontario, Canada

  • The authors were contacted 7 May 2012 with the following questions:

    • Did the patients enrolled in this trial have a history of recurrent UTI?

    • How was the random number sequence generated?

    • Which of the groups involved in the trial were blinded?

    • No response received

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "...each patient randomly received one capsule..." Page 12 ‐ Study design
Allocation concealment (selection bias) Low risk Allocation was blinded randomly by hospital pharmacists
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk “Six patients decided not to take suppositories...” Page 13 ‐ Results
“...31 of the original 41 patients complied well...” Page 13 ‐ Results
“...nine did not return for long‐term follow up so could not be included in recurrent UTI analysis” Table Page 13
Selective reporting (reporting bias) Unclear risk All outcomes appear to be reported in full. No published protocol cited or available.
Other bias High risk Sponsored by Merck Frosst
Used skim milk placebo – unknown effect on promotion or inhibition of UTI or lactobacillus growth/colonisation