Double blinded, randomized, placebo-controlled trial: Chewable cranberry tablets for the prevention of recurrent urinary tract infections in children
Blake Palmer, MD1, Valerie Cathey, ARNP2, Kristy Reyes, B.S.1, Andrew Sprouse, BS2, Elizabeth Jackson, M.D.3, Marion Schulte, MHSA, BSN, RN3, Dominic Frimberger, MD2, Brad Kropp, MD1.
1Cook Children's Hospital, Fort Worth, TX, USA, 2University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA, 3Cincinnati Children's Hospital, Cincinnati, OH, USA.
BACKGROUND: Approximately 7-8% of girls and 2% of boys will be diagnosed with a UTI before the age of 8, with up to 30% having a recurrence within six months. Limited evidence suggests that proanthocyanidins (PACs) in cranberries may be effective in preventing recurrence of UTIs in children. Prior studies have been poorly designed and had poor adherence to protocol with mixed results. There has been limited ability to draw conclusions on the effectiveness of PAC in cranberry as a therapy for the prevention of UTIs in Children. Recent studies in adults have shown a decrease in UTIs when used daily. The Hypothesis was daily use of chewable cranberry tablets will decrease the incidence of UTI compared to placebo in the 6 months after enrollment. METHODS: Females between the age of 2 and 16 who could chew tablets and had a culture-documented UTI in the prior 6 months without a urinary tract abnormality or significant comorbidity were eligible for the study. Patients were randomized 1:1 to a dysfunctional elimination program + placebo OR dysfunctional elimination program + chewable cranberry tablets. Patients were followed for 6 months with a primary outcome assessed of culture-documented urinary tract infection. Secondary measures included vitals, uroflow, post void residuals, Bristol diaries, urinalysis, cultures, tablet consumption adherence and DVSS and Kidscreen27 questionnaires. RESULTS: 120 females were randomized with an average age of 7.2. Caucasians represented 57.5% of the population. In the 6 months prior to randomization the patients had a total of 270 culture documented UTIs with an average of 2.25 per enrollee. In the total cohort 40.8% (49/120) had a documented UTI in the 6 months of follow up with 103 total UTIs documented for an average of 0.86 UTIs per enrollee. The full 6 months of the study was completed by 50.8% (61/120). 9.2% (11/120) withdrew due to taste, whereas 35% (42/120) were lost to follow up. The placebo group consisted of 66 patients with 152 UTIs (mean 2.3) and the treatment group was 54 patients with 118 UTIs (mean 2.2) in the 6 months prior to enrollment. The study was completed by 56.1% (37/66) of placebo and 44.4% (24/54) of the treatment group. In the placebo group 45.6% (30/66) had at least one UTI with a total of 66 UTIs (average 1.00) and in the treatment group 35.2% (19/54) had at least one UTI with a total of 37 UTIs (average 0.69) in the 6 months of follow up. CONCLUSIONS: The total cohort had a decrease in the number of UTIs in the 6 months following intervention with a dysfunctional elimination program and placebo or chewable cranberry tablets. The treatment group had a lower incidence of UTIs and a lower average number of UTIs during the 6 months after randomization, but our study was underpowered to determine statistical significance. Only a small number of patients were dropped from the study due to taste or stomach ache. A majority of the high dropout rate were secondary to inability to complete follow up protocol.
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