akinohanayuki ブログ

学位を持っても、センスのない、感染制御専門薬剤師のブログ.  I have Ph.D. but less sense ID pharmacist.

Effect of Cranberry Capsules on Bacteriuria Plus Pyuria Among Older Women in Nursing Homes: A Randomized Clinical Trial.

Effect of Cranberry Capsules on Bacteriuria Plus Pyuria Among Older Women in Nursing Homes: A Randomized Clinical Trial.

2016年 JAMAに報告された、米国nursing home 21施設における高齢者細菌尿・膿尿に対するクランベリーカプセル vs プラセボを比較したRCT。

 

 


 

P : 

English-speaking women aged 65 years or older, with or without bacteriuria plus pyuria at baseline

E : 

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) 

C : placebo

O : 

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).

T : Double-blind, randomized, placebo-controlled efficacy trial

 

f:id:akinohanayuki:20170520060710j:plain

 

main outcomes

 

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).

 

Secondary outcomes

 

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).

limitations

 

First, since participants could not be catheterized to obtain bi-monthly urine specimens, only residents capable of providing a clean catch urine specimen were randomized. Exclusion of residents for complete incontinence limited the generalizability of these findings. For randomized participants, 20 became incontinent prior to the first outcome assessment and were unable to provide any urine samples. Others became incontinent or were transitioned to hospice care, so urine samples were not obtained. Nevertheless, 65% of planned urine specimens were collected.

Second, 78 nursing homes either did not respond or declined to participate and 7 that agreed to participate but subsequently declined.

Third, anti-adhesion of E.coli to uroepithelial cells in the urines of participants in the trial was not tested. Adhesion studies to date have been conducted on patients enrolled for relatively short observation periods. Since there were multiple assessment time points and it was not possible to ensure adherence to capsule ingestion on the day prior to obtaining a urine specimen for adhesion testing, thus anti-adhesion testing was not feasible.

Fourth, the baseline rate of bacteriuria plus pyuria and percentage of E.coli bacteriuria in this trial population was lower than in the pilot dosing study. 

Fifth, this study enrolled women with or without bacteriuria plus pyuria at baseline. 

 

感想

クランベリーカプセルの微妙な結果。

抗菌薬を使用しないアプローチ拡大に期待してこれからも注視。