A randomized, double‐blind, placebo‐controlled clinical trial to investigate the efficacy of cranberry fruit powder (Pacran®) in the prevention of recurrent urinary tract infection in women (639.4)

Abstract

Cranberry (Vaccinium macrocarpon) is being studied for use in the prevention of recurrent urinary tract infection (rUTI) where it affects the adhesion Escherichia coli to the uroepithelium. This 6 month, randomized, double‐blind, placebo‐controlled trial aimed to evaluate whether a daily dose of 500 mg Pacran® could prevent UTI occurrences in sexually active women with a medical history of at least 2 symptomatic UTI in the previous 12 months. Study participants were randomized to the Pacran® or the placebo group and were followed up for 6 months. The intent‐to‐treat analysis included 176 participants (n=93 in placebo and n=83 in Pacran® group). In the Pacran® group, the proportion of women experiencing at least one UTI was significantly lower than in the placebo group [10.8% versus 25.8%, respectively, p=0.04, with age adjusted 12‐month UTI history (p=0.01), age (p=0.73), and age‐squared (p=0.05) also included in the model]. There was a similar finding when risk of an E. coli UTI was assessed (p=0.03). When the Kaplan‐Meier survival curves were compared, women in the Pacran® group experienced a longer time to first UTI relative to the placebo group (p=0.04). The average number of UTIs per subject was significantly lower in the Pacran® group relative to placebo group (p=0.03). A daily dose of 500 mg Pacran®, proved effective in reducing the risk of symptomatic UTI in women with a history of rUTIs. Pacran® did not influence clinical chemistry, hematology or urinalysis parameters and was well‐tolerated, with no adverse effects reported.