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Do cranberry capsules with sufficient proanthocyanidin content affect the presence of bacteriuria plus pyuria in older women living in nursing homes?
In this randomized clinical trial of 185 women nursing home residents, after adjusting for missing data and covariates, there was no statistically significant difference in presence of bacteriuria plus pyuria between the treatment (29.1%) and control (29.0%) groups over 1 year.
Among older women living in nursing homes, cranberry capsules, compared with placebo, did not have a significant effect on the presence of bacteriuria plus pyuria over 1 year.
Bacteriuria plus pyuria is highly prevalent among older women living in nursing homes. Cranberry capsules are an understudied, nonantimicrobial prevention strategy used in this population.
To test the effect of 2 oral cranberry capsules once a day on presence of bacteriuria plus pyuria among women residing in nursing homes.
Design, Setting, and Participants
Double-blind, randomized, placebo-controlled efficacy trial with stratification by nursing home and involving 185 English-speaking women aged 65 years or older, with or without bacteriuria plus pyuria at baseline, residing in 21 nursing homes located within 50 miles (80 km) of New Haven, Connecticut (August 24, 2012-October 26, 2015).
Two oral cranberry capsules, each capsule containing 36 mg of the active ingredient proanthocyanidin (ie, 72 mg total, equivalent to 20 ounces of cranberry juice) vs placebo administered once a day in 92 treatment and 93 control group participants.
Main Outcomes and Measures
Presence of bacteriuria (ie, at least 105 colony-forming units [CFUs] per milliliter of 1 or 2 microorganisms in urine culture) plus pyuria (ie, any number of white blood cells on urinalysis) assessed every 2 months over the 1-year study surveillance; any positive finding was considered to meet the primary outcome. Secondary outcomes were symptomatic urinary tract infection (UTI), all-cause death, all-cause hospitalization, all multidrug antibiotic–resistant organisms, antibiotics administered for suspected UTI, and total antimicrobial administration.
Of the 185 randomized study participants (mean age, 86.4 years [SD, 8.2], 90.3% white, 31.4% with bacteriuria plus pyuria at baseline), 147 completed the study. Overall adherence was 80.1%. Unadjusted results showed the presence of bacteriuria plus pyuria in 25.5% (95% CI, 18.6%-33.9%) of the treatment group and in 29.5% (95% CI, 22.2%-37.9%) of the control group. The adjusted generalized estimating equations model that accounted for missing data and covariates showed no significant difference in the presence of bacteriuria plus pyuria between the treatment group vs the control group (29.1% vs 29.0%; OR, 1.01; 95% CI, 0.61-1.66; P = .98). There were no significant differences in number of symptomatic UTIs (10 episodes in the treatment group vs 12 in the control group), rates of death (17 vs 16 deaths; 20.4 vs 19.1 deaths/100 person-years; rate ratio [RR], 1.07; 95% CI, 0.54-2.12), hospitalization (33 vs 50 admissions; 39.7 vs 59.6 hospitalizations/100 person-years; RR, 0.67; 95% CI, 0.32-1.40), bacteriuria associated with multidrug-resistant gram-negative bacilli (9 vs 24 episodes; 10.8 vs 28.6 episodes/100 person-years; RR, 0.38; 95% CI, 0.10-1.46), antibiotics administered for suspected UTIs (692 vs 909 antibiotic days; 8.3 vs 10.8 antibiotic days/person-year; RR, 0.77; 95% CI, 0.44-1.33), or total antimicrobial utilization (1415 vs 1883 antimicrobial days; 17.0 vs 22.4 antimicrobial days/person-year; RR, 0.76; 95% CI, 0.46-1.25).
Conclusions and Relevance
Among older women residing in nursing homes, administration of cranberry capsules vs placebo resulted in no significant difference in presence of bacteriuria plus pyuria over 1 year.
clinicaltrials.gov Identifier: NCT01691430
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Corresponding Author: Manisha Juthani-Mehta, MD, Section of Infectious Diseases, Department of Internal Medicine, Yale University School of Medicine, PO Box 208022, New Haven, CT 06520 (firstname.lastname@example.org).
Published Online: October 27, 2016. doi:10.1001/jama.2016.16141
Author Contributions: Drs Juthani-Mehta and Van Ness had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Juthani-Mehta, Argraves, Acampora, Quagliarello, Peduzzi.
Acquisition, analysis, or interpretation of data: Juthani-Mehta, Van Ness, Bianco, Rink, Rubeck, Ginter, Argraves, Charpentier, Trentalange, Quagliarello, Peduzzi.
Drafting of the manuscript: Juthani-Mehta, Van Ness, Argraves, Acampora, Quagliarello.
Critical revision of the manuscript for important intellectual content: Van Ness, Bianco, Rink, Rubeck, Ginter, Argraves, Charpentier, Acampora, Trentalange, Quagliarello, Peduzzi.
Statistical analysis: Van Ness, Argraves, Trentalange, Peduzzi.
Administrative, technical, or material support: Bianco, Rink, Rubeck, Ginter, Argraves, Charpentier, Acampora.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: This study was supported by grants P30 AG021342 Claude D. Pepper Older Americans Independence Center, R01 AG041153, and K07 AG030093 all from the National Institute on Aging, National Institutes of Health. Cranberry and placebo capsules used in this study were manufactured and donated by Pharmatoka.
Role of Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Pharmatoka had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank Leo M. Cooney Jr, MD, Humana Foundation Professor of Medicine (Geriatrics), Yale School of Medicine, for serving as the independent safety monitor for this study. Dr Cooney did not receive compensation for serving in this role.
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