Observational database serenoa repens (DOSSER): Overview analysis and results - A multicentric SIUrO (Italian Society of Oncological Urology) Project

Clinica Urologica, Policlinico Sant'Orsola-Malpighi, Università di Bologna, Italy.
Archivio italiano di urologia, andrologia: organo ufficiale [di] Società italiana di ecografia urologica e nefrologica / Associazione ricerche in urologia 09/2012; 84(3):117-22.
Source: PubMed


Men affected with Benign Prostate Hyperplasia (BPH) and Lower Urinary Tract Symptoms (LUTS) are demonstrating to require an increasing amount of attention from Urologists and Primary-care Physicians. Over the years, common urological medications were based on either alpha-blockers and/or 5alpha-reductase inhibitors. During the last decade the phytotherapeutic drugs are gaining a more often central role in the BPH and LUTS managements. In particular, clinical usage of the extract of the dried ripe fruit of serenoa repens with a dosage of 320 mg per day, has shown its clinical efficacy and its superiority. Purpose of this multicentric observational retrospective study was to evaluate all the urological aspects (clinical, biochemical, instrumental and pathological) of patients affected by BPH and LUTS, with a PSA < 10 ng/ml, a previous negative prostatic biopsy and in therapy with a daily dose of 320/640 mg of serenoa repens.
The study was conducted in 8 different centers throughout Italy from September 2010 to November 2011. Data and information of 298 men with an average of 63 years (mean PSA of 5.4 ng/ml and mean prostate gland volume of 57 cc), affected by non-acute urinary symptoms caused by BPH, a dosed PSA level inferior to 10 ng/ml, a previous negative prostate biopsy and in therapy with serenoa repens alone or associated to an alpha-blocker, were retrospectively inserted in an extensive on-line SIUrO Database. Comprehensive questionnaires were filled in for each patient at 3 and 6 months of follow-up. Each questionnaire contained various sections, each of them composed by several items: dosed PSA levels, uroflowmetry, International Prostate Symptoms Score (IPSS), International Index of Erectile Function (IIEF-5), trans-rectal ultrasound (TRUS) patterns, digital rectal examinations (DRE) aspects, previous prostate bioptical results (histology) and side effects.
PSA levels weren't subjected to an increase, revealing a stabilizing or downward trend. Percentage of patients with PSA below the level of 4 ng/mL was lower at the end of the study. The overall changes in the uroflowmetry were similar and parallel both in the group with only serenoa repens intake and in the group with serenoa repens plus alpha-blocker. The mean medium flow and the mean maximum flow had a slightly increase along the observation time. There was a substantial decreasing in the amount of patients presenting severe prostatic symptoms. Patients reported through the IIEF-5 score a sexual activity substantially unchanged after 6 months of follow-up. The serenoa repens intake resulted in an improvement of the "inflammatory-like reports", in terms of ultrasound patterns, DRE and bioptical features.
serenoa repens demonstrated its efficacy reducing dysuria with minimal side effects. Further prospective studies might confirm its stabilization or lowering role on PSA levels in this cohort of patients and its possible clinical anti-inflammatory action.

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    • "A meta-analysis of 18 controlled clinical studies conducted for periods ranging from 4 to 48 weeks, showed the therapeutic efficacy of Serenoa extracts to be significantly superior to placebo and identical to finasteride [153]. Favorable effects on IPSS, LUTS, urine flow, nocturia and dysuria, have been also reported [154]. However, other studies have not reached the same conclusion, pointing negative results on the improvement of urinary symptoms associated with BPH [134]. "
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    ABSTRACT: Benign prostatic hyperplasia (BPH) is one of the most common urological diseases in aging men. Because of its long latency, BPH is a good target for prevention. The aim of the study has been to review the various options of treatment, currently available, in the field of phytotherapy. Watchful waiting, pharmacological therapy, and surgery are also helpful, depending on the severity of the disease. Although drug therapy (alpha1-blockers, 5alpha-reductase inhibitors) and surgery (prostatectomy, transurethral resection, etc.) seem to be the most effective for patients with moderate-severe BPH, herbal medicines (i.e., Serenoa repens, Pygeum africanum, Urtica dioica) are also commonly used in patients with mild-moderate symptoms. On the basis of preclinical studies several mechanisms of action have been postulated, including 5alpha-reductase inhibition, alpha-adrenergic antagonism, dihydrotestoterone and estrogen receptors inhibition. Randomized clinical trials indicate significant efficacy in improving urinary symptoms and mild adverse effects for some of phytotherapeutic agents, while further clinical evidence is needed for others (e.g., Epilobium Spp., Secale cereale, Roystonea regia). Healthcare professionals should be constantly informed about BPH phytotherapy, taking into account the risks/benefits profile of the use of medicinal plants in the management of BPH. Copyright © 2015. Published by Elsevier Inc.
    Life Sciences 02/2015; 126. DOI:10.1016/j.lfs.2015.01.023 · 2.70 Impact Factor
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    • "An Iranian study showed that saw palmetto had equivalent effectiveness to tamsuloxin and in combination to nettle revealed similar effects to finasteride with less side effects (Azimi et al., 2012). Some studies have also documented the efficacy of saw palmetto in reducing dysuria in men affected with BPH (Bertaccini et al., 2012). And also three reviews assessed the efficacy and drawbacks of saw palmetto. "
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    ABSTRACT: Benign prostate hyperplasia (BPH) is a common condition affecting older men, with an incidence that is age-dependent. Histological BPH, which typically develops after the age of 40 years, ranges in prevalence from >50% at 60 years to as high as 90% by 85 years of age. Typical symptoms include increased frequency of urination, nocturia, urgency, hesitancy, and weak urine stream. Conventional medicines used for the treatment of BPH include alpha blockers and 5-alpha reductase inhibitors. This articles review the mode of action, the efficacy, and the safety, including herb-drug interactions of the most common botanicals (Serenoa repens, Pygeum africanum, Urtica dioica, and Cucurbita pepo) and nutraceuticals (isoflavones, lycopene, selenium, and β-Sitosterol) in controlling the lower urinary tract symptoms associated to BPH. Copyright © 2013 John Wiley & Sons, Ltd.
    Phytotherapy Research 07/2014; 28(7). DOI:10.1002/ptr.5084 · 2.66 Impact Factor
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    ABSTRACT: Introduction: Chronic prostatitis displays a variety of symptoms (mainly local pain exhibiting variability in origin and intensity). The purpose of this article is to briefly present the preliminary results of our study examining the role of phytotherapeutic agents in the treatment of chronic prostatitis patients. Material and Method. The study was designed as a prospective, randomized, single blind and included in total fifty-six patients who visited the outpatient department. Subjects were randomized in two groups. Subjects of the first group (29 patients) received prulifloxacin 600mg for 15 days, while subjects of the second group (27 patients) received prulifloxacin 600mg for 15 days and serenoa repens extract for 8 weeks. The response was tested with laboratory and clinical criteria. Results. We found statistically significant differences between the two groups regarding pain and discomfort in urination but no differences were found regarding erectile or sexual dysfunction. Conclusions. Serenoa repens extract for 8 weeks seems to improve pain and prostatitis related difficulty in urination. Further randomized placebo-controlled studies are needed to substantiate safer conclusions.