Abstract
Background: Phytotherapeutic agents aroused an increasing interest either as alternative or in addition to conventional therapy in the management of BPH. The aim of the article was to evaluate the clinical and functional changes after add-on treatment with Serenoa repens associated with Solanum lycopersicum, lycopene and bromelain in patients with BPH presenting with mild to moderate LUTS and previously treated only with Alfuzosin over a 6–12 months period. Materials and methods: Between January and July 2019, patients with symptomatic BPH already on treatment with Alfuzosin (Al) 10 mg for at least 6–12-month were enrolled at three academic referral centres, included in a prospective treatment group, and managed with a combination treatment of Al and 6-month daily oral single-tablet supplementation of Serenoa repens and Solanum lycopersicum + lycopene + bromelain (SeR + SL + Ly + Br). A retrospective control group with comparable baseline characteristics was obtained by performing a propensity score matching from a database of 434 patients managed with Alfuzosin 10 mg/day only over a 6–12 months period between March 2015 and December 2018. IPSS, QoL questionnaires, voiding diary assessment, postvoid residual volume (PVR), maximal (Qmax) and average (Qave) urinary flow rates were evaluated at baseline in the treatment group at the moment of patient accrual, in the control group after 6-month of treatment with alfuzosin, and thereafter at 3 and 6 months in both groups. Results: Overall, 250 patients entered the study (n = 125 treatment group; n = 125 control group). Total IPSS score significantly decreased at 6-month assessment from baseline in the treatment vs control group (17 [IQR: 12–20] vs 12 [IQR: 9–14], p = 0.02) with a significative storage symptoms improvement detected both at 3- (p = 0.03) and 6-month evaluation (p = 0.001). PVR significantly improved at each follow-up visit with the most relevant reduction at 6-month assessment (125 cc vs. 102 cc; p = 0.02). Moreover, a significative improvement in LUTS-related quality of life (QoL) was recorded at 3- and 6-month assessment with a median decrease of −1 and −2 (p = 0.05 and p = 0.001 respectively) from baseline. Conclusions: Combination treatment with AB and SeR + SL + Ly + Br led to meaningful improvements in LUTS severity compared to AB as monotherapy, after a 6-month treatment period in men with mild to moderate LUTS/BPH.
Highlights
Benign prostatic hyperplasia (BPH) is one of the most common progressive disorders affecting nearly half of middle-age men and it is frequently associated with lower urinary tract symptoms (LUTS) and patients’ quality-of-life (QoL) impairment [1,2]. hormonal and vascular age-related changes seem to be involved in disease development, the exact pathophysiology of BPH is still yet to be identified [3]
Collected data were reported as number and percentages or median and interquartile range (IQR)
The outcome variables were tested as change from baseline to each visit
Summary
Benign prostatic hyperplasia (BPH) is one of the most common progressive disorders affecting nearly half of middle-age men and it is frequently associated with lower urinary tract symptoms (LUTS) and patients’ quality-of-life (QoL) impairment [1,2]. hormonal and vascular age-related changes seem to be involved in disease development, the exact pathophysiology of BPH is still yet to be identified [3]. In agreement with the current international guidelines, alpha1adrenoceptor blockers (AB), 5-alpha reductase inhibitors (5ARIs) and phosphodiesterase type 5 inhibitor (PDE5I) are extensively used as first-line treatment in BPH patients [5] These pharmacologic approaches are not devoid of adverse effects such as blood pressure modifications and sexuality disorders [6]. The aim of the article was to evaluate the clinical and functional changes after add-on treatment with Serenoa repens associated with Solanum lycopersicum, lycopene and bromelain in patients with BPH presenting with mild to moderate LUTS and previously treated only with Alfuzosin over a 6–12 months period.
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