Clinical Efficacy of Serenoa repens Versus Placebo Versus Alpha-blockers for the Treatment of Lower Urinary Tract Symptoms/Benign Prostatic Enlargement: A Systematic Review and Network Meta-analysis of Randomized Placebo-controlled Clinical Trials.

CONTEXT: International guidelines do not make any specific recommendations on Serenoa repens (SeR) for the treatment of male lower urinary tract symptoms (LUTS) secondary to benign prostatic enlargement (BPE), due to product heterogeneity and methodological limitations of the published trials and meta-analyses. OBJECTIVE: We aimed to compare the clinical efficacy of hexanic extract of SeR (HESr) versus non-HESr (nHESr) versus placebo versus alpha-blockers (ABs) in patients affected by LUTS secondary to BPE through a network meta-analysis method. EVIDENCE ACQUISITION: The search was conducted until December 31, 2018 using Medline, Scopus, and Web of Science databases without restriction. We included randomized controlled trials (RCTs) with at least one comparison between SeR, ABs, or placebo for the treatment of LUTS/BPE. Outcomes of the study were the mean change in the International Prostate Symptom Score (IPSS) and peak flow (PF). This systematic review has been registered on PROSPERO (CRD42018084360). EVIDENCE SYNTHESIS: In total, 2115 articles were identified. After the global assessment, 22 RCTs matched with the inclusion criteria, including 8564 patients. For IPSS, the mean efficacies against placebo were +0.48 and -1.69 for HESr and nHESr, respectively, at 3 mo; 0.59 for nHESr at 6 mo; and -1.31 and -3.30 for nHESr and HESr, respectively, at 12 mo. For PF, the mean efficacies against placebo were +0.53 and +2.82 for HESr and nHESr, respectively, at 3 mo; +1.85 for nHESr at 6 mo; and +4.05 and +5.52 for HESr and nHESr, respectively, at 12 mo. Based on the surface under the cumulative ranking curve rankograms, terazosin showed the highest score (99.6%), while alfuzosin, tamsulosin, silodosin, HESr, and nHESr showed scores of 53.7%, 42.3%, 68.5%, 36.7%, and 47.3%, respectively. CONCLUSIONS: In this network meta-analysis, we demonstrated that SeR did not show clinically meaningful improvement in LUTS and PF. PATIENT SUMMARY: In the present study, we found no clinically meaningful improvement of Serenoa repens for the treatment of lower urinary tract symptoms/benign prostatic enlargement. The analysis showed that the benefit over placebo was minimal and may not justify its clinical use before higher level of evidence will be available.

Holmium laser for RIRS. Watts are we doing? / Laser holmium para ureteroscopia flexible retrograda. ¿Qué estamos haciendo?

OBJECTIVE: To review recent and relevant information regarding the use of high-power (HPL) and low-power (LPL) Holmium:YAG lasers (Ho:YAG) in retrograde intrarenal surgery (RIRS) for lithotripsy. METHODS: A PubMed/Embase search was conducted and recent and relevant papers on Ho:YAG for RIRS were reviewed. RESULTS: Settings for Ho:YAG are pulse energy (PE), pulse frequency (PF), and pulse width. Currently, the majority of LPL can also adjust pulse-width but cannot reach PF as high as HPL, however, the higher energy outputs reached by HPL are rarely useful in lithotripsy. Higher PE might enhance ablation but generates larger fragments and higher retropulsion. Pulse width does not affect energy output but delivers energy for a longer time-length. Dusting and basketing are complementary techniques. Dusting seeks to pulverize stones into particles ≤250 µm avoiding the use of instruments for stone retrieval, whereas in fragmenting, the stones are break into smaller pieces which are then retrieved. Dusting can prevent the use of supplies such as access sheaths and baskets and also prevent the complications related to their use. However, is not always feasible in clinical practice to fully ablate a stone into dust, then the use of this supplies and popcorn technique are helpful for rendering a patient stonefree. The energy gap between HPL and LPL is wide and leaves room for a mid-power laser classification, which can overcome the main drawback of LPL, the expenses of HPL, and still holding its versatility for other procedures beyond stones. CONCLUSIONS: HPL and LPL have similar effectiveness, but long-term cost-effectiveness comparisons are underexplored. Newer HPL would need to be compared to emerging technologies as the thulium fiber, and prove superiority to mid-power laser to determine how powerful is enough for Ho:YAG in the years to come.

OBJETIVO: El láser Holmio:YAG (Ho:YAG) es el de elección para litotricia en cirugía retrógrada intrarenal (RIRS). Los equipos láser de alto poder (HPL) y bajo poder (LPL) tienen diferentes características, por lo tanto, pueden tener diferente desempeño. En el presente trabajo tuvimos el objetivo de revisar evidencia sobre el uso de HPL y LPL en RIRS. MATERIAL Y MÉTODOS: Se realizó una búsqueda en PubMed/Embase y la información reciente y relevante sobre HPL y/o LPL en RIRS fue evaluada para una revisión monográfica. RESULTADOS: Los HPL y algunos LPL más recientes permiten al cirujano ajustar la duración del pulso, por lo tanto, al configurar un pulso largo, alta frecuencia y baja energía, se puede lograr una verdadera pulverización. Los LPL no pueden alcanzar la misma emisión de energía que los HPL. La retropulsión aumenta si la energía de pulso es mayor, entonces, se previene la retropulsión al incrementar la emisión total de energía mediante el incremento de la frecuencia. El costo de adquisión de los HPL es considerablemente mayor que el de los LPL, sin embargo, el costo a largo plazo pudiera ser similar pues los procedimientos pueden abaratarse al disminuir el uso de insumos para recuperar los litos, preservar la punta de las fibras reutilizables y disminuir el tiempo quirúrgico. CONCLUSIONES: La evidencia no favorece la efectividad de los HPL o LPL de modo abrumador. Ambos dispositivos son efectivos y seguros. No cabe duda de que los HPL alcanzan mayor emisión de energía que los LPL, pero los dispositivos de 50-80 Watts, tienen emisiones de energía que rara vez se alcanzan para litotricia y por lo tanto pudiera considerarse demasiada energía. A medida que nuevas tecnologías han surgido, la brecha entre LPL y HPL se amplía, dejando espacio para una clasificación de poder intermedio (36-55 Watts) y la comparación entre estos dispositivos sería más justa. Asimismo, los HPL aún necesitan ser contrastados en el escenario clínico, con las nuevas tecnologías disponibles, tal como la fibra de laser tulio.

Pharmacotherapeutic management of lower urinary tract symptoms in Multiple Sclerosis patients.

INTRODUCTION: Multiple Sclerosis (MS) manifests with a plethora of signs and symptoms affecting brain structures and spinal pathways. The multitude of lesions in MS patients makes difficult to establish the relative role of each of them to lower urinary tract symptoms (LUTS). Generally, the subcortical white-matter lesions result in detrusor overactivity, whilst lesions of the spinal cord result in the combined occurrence of detrusor overactivity and detrusor-sphincter dyssynergia (DSD). It has been estimated that 80-90% of patients with MS will suffer from some form of LUTS over the course of the disease. Among LUTS, the most reported is detrusor overactivity which includes urinary urgency, frequent urination, nocturia, and urge urinary incontinence. AREAS COVERED: The authors review the management of lower urinary tract symptoms in MS patients providing their expert opinions on the subject matter. EXPERT OPINION: LUTS affect the quality of life substantially and are associated with a significantly increased mortality. The adequate management is an important challenge for both patients and caregivers with a multidisciplinary approach likely necessary.

Association between dietary flavonoids intake and prostate cancer risk: A case-control study in Sicily.

OBJECTIVES: The aim of this study is to test the association between dietary flavonoids intake and prostate cancer (PCa) in a sample of southern Italian individuals. DESIGN: A population-based case-control study on the association between PCa and dietary factors was conducted from January 2015 to December 2016, in a single institution. SETTING: Patients with elevated PSA (Prostate Specific Antigen) and/or suspicion of PCa underwent transperineal prostate biopsy (≥12 cores). A total of 118 histopathological-verified PCa cases were collected and matched with controls, which were selected from a sample of 2044 individuals randomly recruited among the same reference population. Finally, a total of 222 controls were selected. MAIN OUTCOME MEASURES: Prevalence of PCa. RESULTS: Consumption of certain groups of flavonoids significantly differed between controls and cases, in particular: flavonols (63.36 vs 37.14 mg/d, P < 0.001), flavanols (107.61 vs. 74.24 mg/d, P = .016), flavanones (40.92 vs. 81.32 mg/d, P < 0.001), catechins (63.36 vs. 36.18 mg/d, P = .006). In the multivariate model, flavanols and flavones were associated with reduced risk of PCa, despite not in the highest quartile of intake. Higher flavonol and catechin intake was consistently associated with reduced risk of PCa (Odds Ratio (OR) = 0.19, 95% CI: 0.06-0.56 and OR = 0.12, 95% CI: 0.04-0.36). In contrast, the highest intake of flavanones was positively associated with PCa. CONCLUSION: Flavonols and catechins have proved to be the most promising molecules for a potential protective role against PCa. Nevertheless, further research on flavanones is needed to better establish whether they are associated with PCa.

Association between dietary phytoestrogens intakes and prostate cancer risk in Sicily.

OBJECTIVE: In this study we aimed to investigate the association between dietary phytoestrogen consumption and prostate cancer in a sample of southern Italian individuals. METHODS: A population-based case-control study on the association between prostate cancer and dietary factors was conducted from January 2015 to December 2016 in a single institution of the municipality of Catania, southern Italy (Registration number: 41/2015). A total of 118 histopathological-verified prostate cancer (PCa) cases and a total of 222 controls were collected. Dietary data was collected by using two food frequency questionnaires. RESULTS: Patients with PCa consumed significantly higher levels of phytoestrogens. Multivariate logistic regression showed that lignans (Q[quartile]4 vs. Q1, OR [odds ratio] = 4.72; p < .05) and specifically, lariciresinol (Q4 vs. Q1, OR = 4.60; p < .05), pinoresinol (Q4 vs. Q1, OR = 5.62; p < .05), matairesinol (Q4 vs. Q1, OR = 3.63; p < .05), secoisolariciresinol (Q4 vs. Q1, OR = 4.10; p < .05) were associated with increased risk of PCa. Furthermore, we found that isoflavones (Q3 vs. Q1, OR = 0.28; p < .05) and specifically, genistein (Q4 vs. Q1, OR = 0.40; p < .05) were associated with reduced risk of PCa. CONCLUSION: We found of an inverse association between dietary isoflavone intake and PCa, while a positive association was found with lignans intake.

A phase II, randomized, single-blinded, placebo-controlled clinical trial on the efficacy of Curcumina and Calendula suppositories for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome type III.

OBJECTIVE: The management of chronic prostatitis/ chronic pelvic pain syndrome type III (CP/CPPS) has been always considered complex due to several biopsychological factors underling the disease. In this clinical study, we aimed to evaluate the efficacy of the treatment with Curcumin and Calendula extract in patients with CP/CPPS III. MATERIAL AND METHODS: From June 2015 to January 2016 we enrolled 60 consecutive patients affected by CP/CPPS III in our institution. Patients between 20 and 50 year of age with symptoms of pelvic pain for 3 months or more before study, a total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score ≥ 15 point and diagnosed with NIH category III. Patients were then allocated to receive placebo (Group A) or treatment (Group B). Treatment consisted of rectal suppositories of Curcumin extract 350 mg (95%) and Calendula extract 80 mg (1 suppository/die for 1 month). Patients of Group B received 1 suppository/die for 1 month of placebo. The primary endpoint of the study was the reduction of NIH-CPSI. The secondary outcomes were the change of peak flow, IIEF-5, VAS score and of premature ejaculation diagnostic tool (PEDT). RESULTS: A total of 48 patients concluded the study protocol. The median age of the all cohort was 32.0 years, the median NIH-CPSI was 20.5, the median IIEF-5 was 18.5, the median PEDT was 11.0, the median VAS score was 7.5 and the median peak flow was 14.0. After 3 months of therapy in group A we observed a significant improvement of NIH-CPSI (-5.5; p < 0.01), IIEF-5 (+ 3.5; p < 0.01), PEDT (-6.5; p < 0.01), peak flow (+2.8; p < 0.01) and VAS (-6.5; p < 0.01) with significant differences over placebo group (all p-value significant). CONCLUSIONS: In this phase II clinical trial we showed the clinical efficacy of the treatment with Curcumin and Calendula in patients with CP/CPPS III. The benefits of this treatment could be related to the reduction of inflammatory cytokines and of inflammatory cells. These results should be confirmed in further studies with greater sample size.

Survivin and NAIP in Human Benign Prostatic Hyperplasia: Protective Role of the Association of Serenoa repens, Lycopene and Selenium from the Randomized Clinical Study.

Benign prostatic hyperplasia (BPH) treatment includes the apoptosis machinery modulation through the direct inhibition of caspase cascade. We previously demonstrated that Serenoa repens (Ser) with lycopene (Ly) and selenium (Se) reawakened apoptosis by reducing survivin and neuronal apoptosis inhibitory protein (NAIP) levels in rats. The aim of this study was to evaluate the effectiveness of Ser-Se-Ly association on survivin and NAIP expression in BPH patients. Ninety patients with lower urinary tract symptoms (LUTS) due to clinical BPH were included in this randomized, double-blind, placebo-controlled trial. Participants were randomly assigned to receive placebo (Group BPH + placebo, n = 45) or Ser-Se-Ly association (Group BPH + Ser-Se-Ly; n = 45) for 3 months. At time 0, all patients underwent prostatic biopsies. After 3 months of treatment, they underwent prostatic re-biopsy and specimens were collected for molecular, morphological, and immunohistochemical analysis. After 3 months, survivin and NAIP were significantly decreased, while caspase-3 was significantly increased in BPH patients treated with Ser-Se-Ly when compared with the other group. In BPH patients treated with Ser-Se-Ly for 3 months, the glandular epithelium was formed by a single layer of cuboidal cells. PSA showed high immunoexpression in all BPH patients and a focal positivity in Ser-Se-Ly treated patients after 3 months. Evident prostate specific membrane antigen (PSMA) immunoexpression was shown in all BPH patients, while no positivity was present after Ser-Se-Ly administration. Ser-Se-Ly proved to be effective in promoting apoptosis in BPH patients.

Alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide improve erectile function, sexual quality of life, and ejaculation function in patients with moderate mild-moderate erectile dysfunction: a prospective, randomized, placebo-controlled, single-blinded study.

We aimed to evaluate the efficacy of oral therapy with alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide (Tradamix TX1000) in patients with erectile dysfunction (ED) at 3 months of follow-up. From January 2013 to September 2013, 177 patients diagnosed with mild-moderate ED (IIEF-EF < 26) were enrolled in this multicenter, single-blinded, placebo-controlled study and randomized in Group A (Tradamix, n = 87) and Group B (placebo, n = 90). Penile color Doppler ultrasound measures, IIEF-15 questionnaire, male sexual health questionnaire-ejaculation disorder (MSHQ-EjD), and sexual quality of life (SQoL-M) were collected. We observed significant changes of the IIEF-15 in Group A (mean difference: 11.54; P < 0.05) at 3 months versus Group B (P < 0.05). PSV (P < 0.05), IIEF-intercourse satisfaction (P < 0.05), IIEF-orgasmic function (mean P < 0.05), IIEF-sexual desire (P < 0.05), IIEF-overall satisfaction (P < 0.05), MSHQ-EjD (mean difference: 1.21; P < 0.05), and SQoL-M (mean difference: 10.2; P < 0.05) were significantly changed in Group A versus baseline and Group B. Patients with moderate arterial dysfunction showed significant increase of PSV (P < 0.05), IIEF-EF (P < 0.05), MSHQ-EjD (P < 0.05), and SQoL-M (P < 0.05) in Group A. Therapy with Tradamix improves erectile and ejaculation function and sexual quality of life in patients with mild-moderate ED and in particular for those with moderate arterial dysfunction.

Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial).

BACKGROUND: Phytotherapy has been used to treat patients with lower urinary tract symptoms (LUTS). We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens (SeR), Lycopene (Ly), and Selenium (Se) + tamsulosin versus single therapies. METHODS: PROCOMB trial (ISRCTN78639965) was a randomized double-blinded, double-dummy multicenter study of 225 patients between 55 and 80 years old, PSA ≤ 4 ng/ml, IPSS ≥12, prostate volume ≤60 cc, Qmax ≤15 ml/sec, postvoid residual urine (PVR) <150 ml. Participants were randomized group A (SeR-Se-Ly), group B (tamsulosin 0.4 mg), group C (SeR-Se-Ly + tamsulosin 0.4 mg). The primary endpoints of the study were the reduction of IPSS, PVR, and increase of Qmax in group C versus monotherapy groups. RESULTS: The decrease for combination therapy was significantly greater versus group A (P < 0.05) and group B (P < 0.01) for IPSS and versus group A (P < 0.01) for PVR from baseline to 6 months. A greater decrease in IPSS was observed for Group C versus group A (P < 0.01) and increase in Qmax versus group B (P < 0.01), from 6 months to 12 months. At one year, the changes of IPSS and Qmax were greater for Group C versus monotherapies (each comparison <0.05). The proportions of men with a decrease of at least three points (each comparison P < 0.05) and decrease of 25% for IPSS (each comparison P < 0.01) were greater for Group C. CONCLUSION: SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS.

Correlation between lipid profile and heme oxygenase system in patients with benign prostatic hyperplasia.

OBJECTIVE: To investigate the role of heme oxygenase (HO) system in moderate to severe benign prostatic hyperplasia and lower urinary tract symptom patients and the influence of metabolic syndrome (MetS) components on HO-1 or HO-2 prostatic levels. METHODS: One hundred thirty-two consecutive patients who underwent transurethral resection of the prostate were prospectively enrolled. MetS was defined by the International Diabetes Federation. Patients were divided in 2 groups: group A (high-density lipoprotein-cholesterol [HDL-C]≥40 mg/dL and triglycerides<150 mg/dL) and group B (HDL-C<40 mg/dL and triglycerides≥150 mg/dL). Surgical specimens were collected for HO level determination. HO-1 levels were determined by enzyme-linked immunosorbent assay and HO-1 levels by Western blotting. RESULTS: Patients with MetS showed lower levels of HO-1 (5.29 vs 6.28 ng/mL; P=.04), HO-2 (1.01 vs 1.83 ng/mL; P=.04), phosphorylated activated protein kinase (pAMPK; 0.62 vs 1.11 AUI; P<.01), and HO-activity (61.43 vs 70.22 AUI; P<.01) with respect to normal. The Pearson correlation analysis showed that HO-1, HO-2, and HO activity were negatively associated with waist circumference (P<.05), body mass index (P<.05), triglycerides (P<.05) and positively with HDL-C (P<.05). Group B showed lower levels of HO-1 (4.7 vs 6.6 ng/mL; P<.05), HO-2 (1.4 vs 0.4 ng/mL; P=.03), HO-activity (69.63 vs 58.42 AUI; P=.04), and higher International Prostate Symptoms Score (21.4 vs 25.0; P<.05) with respect to group A. The enzyme-linked immunosorbent assay showed that HO-1 and HO activity levels were significantly lower in group B compared with group A. Reduced HDL-C and elevated triglyceride levels decreased HO-1 expression in the prostate tissue. Western blot analysis of tissue samples showed significant differences in basal protein expression levels of HO-2 and pAMPK in group B compared with group A. CONCLUSION: Alteration of serum triglycerides and HDL-C significantly impairs HO-1 and HO-2 levels in benign prostatic hyperplasia patients.

Inhibitors of apoptosis proteins in experimental benign prostatic hyperplasia: effects of serenoa repens, selenium and lycopene.

BACKGROUND: The apoptosis machinery is a promising target against benign prostatic hyperplasia (BPH). Inhibitors of apoptosis proteins (IAPs) modulate apoptosis by direct inhibition of caspases. Serenoa Repens (SeR) may be combined with other natural compounds such as Lycopene (Ly) and Selenium (Se) to maximize its therapeutic activity in BPH. We investigated the effects of SeR, Se and Ly, alone or in association, on the expression of four IAPs, cIAP-1, cIAP-2, NAIP and survivin in rats with experimental testosterone-dependent BPH. Moreover, caspase-3, interleukin-6 (IL-6) and prostate specific membrane antigen (PSMA) have been evaluated.Rats were administered, daily, with testosterone propionate (3 mg/kg/sc) or its vehicle for 14 days. Testosterone injected animals (BPH) were randomized to receive vehicle, SeR (25 mg/kg/sc), Se (3 mg/kg/sc), Ly (1 mg/kg/sc) or the SeR-Se-Ly association for 14 days. Animals were sacrificed and prostate removed for analysis. RESULTS: BPH animals treated with vehicle showed unchanged expression of cIAP-1 and cIAP-2 and increased expression of NAIP, survivin, caspase-3, IL-6 and PSMA levels when compared with sham animals. Immunofluorescence studies confirmed the enhanced expression of NAIP and survivin with a characteristic pattern of cellular localization. SeR-Se-Ly association showed the highest efficacy in reawakening apoptosis; additionally, this therapeutic cocktail significantly reduced IL-6 and PSMA levels. The administration of SeR, Se and Ly significantly blunted prostate overweight and growth; moreover, the SeR-Se-Ly association was most effective in reducing prostate enlargement and growth by 43.3% in treated animals. CONCLUSIONS: The results indicate that IAPs may represent interesting targets for drug therapy of BPH.

Effects of Serenoa repens, selenium and lycopene (Profluss®) on chronic inflammation associated with benign prostatic hyperplasia: results of "FLOG" (Flogosis and Profluss in Prostatic and Genital Disease), a multicentre Italian study.

OBJECTIVE: To evaluate the efficacy of Profluss® on prostatic chronic inflammation (PCI). MATERIALS AND METHODS: We prospectively enrolled 168 subjects affected by LUTS due to bladder outlet obstruction submitted to 12 cores prostatic biopsy for suspected prostate cancer + 2 cores collected for PCI valuation. First group consisted of 108 subjects, with histological diagnosis of PCI associated with BPH and high grade PIN and/or ASAP, randomly assigned to 1:1 ratio to daily Profluss® (group I) for 6 months or to control group (group Ic). Second group consisted of 60 subjects, with histological diagnosis of BPH, randomly assigned to 1:1 ratio to daily Profluss® + a-blockers treatment (group II) for 3 months or to control group (group IIc). After 6 months first group underwent 24 cores prostatic re-biopsy + 2 cores for PCI while after 3 months second group underwent two-cores prostatic for PCI. Specimens were evaluated for changes in inflammation parameters and for density of T-cells (CD3, CD8), B-cells (CD20) and macrophages (CD68). RESULTS: At follow-up there were statistical significant reductions of extension and grading of flogosis, mean values of CD20, CD3, CD68 and mean PSA value in group I compared to Ic, while extension and grading of flogosis in group II were inferior to IIc but not statistical significant. A statistically significant reduction in the density of CD20, CD3, CD68, CD8 was demonstrated in group II in respect to control IIc. CONCLUSIONS: Serenoa repens+Selenium+Lycopene may have an anti-inflammatory activity that could be of interest in the treatment of PCI in BPH and/or PIN/ASAP patients.

Potential efficacy of some african plants in benign prostatic hyperplasia and prostate cancer.

Traditional medicine is very popular in Africa and it is considered as an alternative form of health care. Plants and vegetables used in folk and traditional medicine have gained wide acceptance as one of the main sources of prophylactic and chemopreventive drug discovery and this is due to the evidence of particular biological and biochemical characteristics of each plants extracts. The role of these compounds in urological field may be explained by the antiinflammatory effect through interference with prostaglandin metabolism, alteration of lipid peroxidation, direct inhibition of prostate growth and moreover through an antiandrogenic or antiestrogenic effect and a decrease of the availability of sex hormone-binding globulin. Since Benign Prostatic Hyperplasia and Prostate Cancer are two of the most diffuse diseases of aging male and considering that standard medical therapy is accompanied with different side effects, the emerging use of African plants may be justified. This review takes a look at some African plants extracts properties and their relative urological application. Different biomolecular mechanisms of action are promising, suggesting a real application in reducing prostate cells proliferation.

Effects of Serenoa Repens, Selenium and Lycopene (Profluss®) on chronic inflammation associated with Benign Prostatic Hyperplasia: results of “FLOG” (Flogosis and Profluss in Prostatic and Genital Disease), a multicentre Italian study

Objective To evaluate the efficacy of Profluss® on prostatic chronic inflammation (PCI). Materials and Methods We prospectively enrolled 168 subjects affected by LUTS due to bladder outlet obstruction submitted to 12 cores prostatic biopsy for suspected prostate cancer + 2 cores collected for PCI valuation. First group consisted of 108 subjects, with histological diagnosis of PCI associated with BPH and high grade PIN and/or ASAP, randomly assigned to 1:1 ratio to daily Profluss® (group I) for 6 months or to control group (group Ic). Second group consisted of 60 subjects, with histological diagnosis of BPH, randomly assigned to 1:1 ratio to daily Profluss® + α-blockers treatment (group II) for 3 months or to control group (group IIc). After 6 months first group underwent 24 cores prostatic re-biopsy + 2 cores for PCI while after 3 months second group underwent two-cores prostatic for PCI. Specimens were evaluated for changes in inflammation parameters and for density of T-cells (CD3, CD8), B-cells (CD20) and macrophages (CD68). Results At follow-up there were statistical significant reductions of extension and grading of flogosis, mean values of CD20, CD3, CD68 and mean PSA value in group I compared to Ic, while extension and grading of flogosis in group II were inferior to IIc but not statistical significant. A statistically significant reduction in the density of CD20, CD3, CD68, CD8 was demonstrated in group II in respect to control IIc. Conclusions Serenoa repens+Selenium+Lycopene may have an anti-inflammatory activity that could be of interest in the treatment of PCI in BPH and/or PIN/ASAP patients. .

Polyphenols: key issues involved in chemoprevention of prostate cancer.

Prostate cancer is is the most common solid neoplasm and it is now recognized as one of the most important medical problems facing the male population. Due to its long latency and its identifiable preneoplastic lesions, prostate cancer is an ideal target tumor for chemoprevention. Different compounds are available and certainly polyphenols represent those with efficacy against prostate cancer. This review take a look at activity and properties of major polyphenolic substances, such as epigallocatechin-3-gallate, curcumin, resveratrol and the flavonoids quercetin and genistein. Although the current studies are limited, mechanisms of action of polyphenols added with the lack of side effects show a a start for future strategies in prostate chemoprevention.