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| Date: 12-31-2015 | HC# 071524-535 |
Vidlar A, Student V Jr, Vostalova J, et al. Cranberry fruit powder (Flowens™) improves lower urinary tract symptoms in men: a double-blind, randomized, placebo-controlled study. World J Urol. June 7, 2015; [epub ahead of print]. doi: 10.1007/s00345-015-1611-7.
Lower urinary tract symptoms (LUTS) become increasingly problematic and their incidence rises as men age. The occurrence of LUTS may be associated with benign prostatic hyperplasia (BPH) or bladder detrusor dysfunction. Regardless of the cause, LUTS can significantly diminish quality of life (QoL). The fruit of cranberry (Vaccinium macrocarpon, Ericaceae) has been used traditionally by Native Americans to treat kidney and urinary tract disorders. Cranberries have high concentrations of antioxidants, including phenols and anthocyanins, which have antibacterial properties and can reduce the inflammation associated with LUTS. The goal of this double-blind, placebo-controlled, randomized study was to evaluate the effect of cranberry powder on LUTS in men with moderate to severe symptoms.
The study was conducted between October 2012 and July 2013 at the Department of Urology, University Hospital Olomouc in Olomouc, Czech Republic. Men with moderate to severe LUTS were recruited. The included patients had an International Prostate Symptom Score (IPSS) of ≥ 8 and a prostate-specific antigen (PSA) concentration of < 2.5 ng/mL. Patients were excluded if they were allergic to components of the treatment or placebo; had prostatitis or prior surgery for BPH; were taking α-blockers, 5α-reductase inhibitors, or phytotherapy; or had any systemic or chronic illness. Patients were randomly divided into 3 groups.
The placebo group (n = 41) took a placebo capsule that contained maltodextrin, canola (Brassica spp., Brassicaceae) oil, red and blue dyes, and sodium aluminum silicate. The low-dosage treatment group (n = 43) took capsules that contained 250 mg FlowensTM (dried cranberry powder supplied by Naturex-DBS LLC; Sagamore, Massachusetts) and 250 mg of the placebo mixture. The high-dosage treatment group (n = 40) took capsules that contained 500 mg of Flowens. The concentration of the cranberry powder and its chemical profile were not reported. Treatment and placebo groups ingested 1 capsule per day for 6 months. The bottles containing treatment and placebo capsules were collected at 3 and 6 months to estimate patient compliance.
The primary endpoint was IPSS, which was measured at baseline, 3 months, and 6 months. Secondary endpoints were QoL, bladder voided volume (Vol), maximum urinary flow rate (Qmax), average urinary flow rate (Qave), post-void residual urine volume (PVR), PSA, interleukin-6 (IL-6), and C-reactive protein (CRP), which were measured at baseline and 6 months.
Two patients in the high-dosage treatment group were lost to follow-up. Compliance was 100%. Baseline averages and standard deviations for all parameters except IL-6 and CRP were reported, but statistical comparisons among the groups were not provided. Based on visual inspection of the data, PVR was higher in the high-dosage treatment group and Vol was higher in the placebo group at baseline; however, it is impossible to discern if these differences are important in terms of the study findings.
Compared to baseline, IPSS decreased significantly in the high-dosage treatment group (P < 0.001) over the course of the study. The voiding/obstructive symptoms score and the storage and irritation score were significantly reduced in the high-dosage treatment group (P < 0.001 and P = 0.018, respectively). Vol, Qmax, and Qave increased significantly (P = 0.014, P = 0.018, and P = 0.04, respectively), while PVR decreased significantly (P = 0.027) in the high-dosage group over the course of the study.
The decrease in IPSS was significant and dose-dependent in the 250-mg and 500-mg groups (P = 0.05 and P < 0.001, respectively) versus the placebo group, while no side effects were observed. The decrease in IPSS from baseline was > 3 for both doses, which is clinically meaningful according to the American Urological Association guidelines. In the 500-mg group, voiding symptoms were significantly reduced at 3 and 6 months versus placebo, and storage symptoms were significantly reduced versus placebo at 6 months (P values not reported). Clinical biomarkers remained within normal parameters over the course of the study.
The authors conclude that "250 or 500 mg of Flowens™ taken once daily showed significant, clinically meaningful and dose-dependent reduction in LUTS, as demonstrated by a reduction in IPSS score of >3 after a 6-month period. Larger, multi-centric clinical studies with a longer follow-up period and side effects reporting may be warranted to confirm these data … ." The study was limited by the failure to describe the type of extraction, concentration, and chemical profile/standardization of the Flowens cranberry powder.
Financial support for the study was provided by Naturex-DBS. One author (E. Fromentin) is employed by Naturex-DBS, and another (M. Roller) by Naturex SA (Avignon, France).
—Cheryl McCutchan, PhD
