Saw Palmetto Extract Research Articles

Beneficial effects of saw palmetto (Serenoa repens) fruit extract on the urinary symptoms of healthy Japanese adults with possible lower urinary tract symptoms: A randomized, double-blind, placebo-controlled study.

Saw palmetto extract (SPE) is the most commonly used supplement for the treatment of lower urinary tract symptoms (LUTS), but most evidence is for those with LUTS, and little data is verifying its effectiveness for those who do not have the disease but are troubled by symptoms. The purpose of this study was to examine the effect of SPE on the improvement of urinary frequency problems that present stress due to urinary urgency in daily life, among healthy Japanese adults aged ≥50 years who are not diagnosed with benign prostatic hyperplasia or overactive bladder. They were randomly assigned to the SPE group or placebo group (34 participants per group) using a computerized random number generator. Each participant was instructed to take one capsule containing SPE (320 mg) or placebo every day for 12 weeks. Subjective symptoms were assessed using the overactive bladder questionnaire, and the score of symptom bother by frequent urination during the daytime hours was set as the primary outcome. The other outcomes were subjective urinary symptoms and urinary frequencies. The final efficacy analysis dataset was per protocol set, and 33 participants in each group were analyzed. After SPE intervention for 12 weeks, the score of symptom bother by frequent urination during the daytime hours was significantly improved and the daytime frequency of urination assessed using the urinary log was significantly decreased. The consumption of SPE improved urinary frequency-related quality of life such as bother of urinary symptoms in healthy Japanese adults (UMIN000045334).

Clinical effect of phytosterol-enriched saw palmetto extract on urinary function in healthy middle-aged and older males: a double-blind, placebo-controlled randomized comparative study

Background: Saw palmetto extract (SPE) is one of the most widely used supplements for benign prostatic hyperplasia (BPH) due to its pharmacological effects. β-sitosterol-enriched saw palmetto oil (VISPO™) contains more than 3% β-sitosterol and 85% total fatty acids and has been shown to improve symptoms in patients with BPH. Lower urinary tract symptoms (LUTS) require primary preventive measures in countries with accelerated population aging, including Japan. VISPO™ is expected to be effective against the early symptoms of LUTS. However, the effect of VISPO™ on urinary function in healthy individuals has not been elucidated. Objective: This clinical study evaluated the efficacy and tolerability of VISPO™ in the management of urinary complaints among healthy middle-aged and older men who did not require treatment. Methods: We conducted a randomized, double-blind, placebo-controlled trial that included 54 male participants who were assigned to consume VISPO™ or placebo (olive oil) capsules for 12 weeks. Biometric data, uroflowmetry results, and salivary hormone levels were assessed at weeks 1 and 12. Urinary function and quality of life were assessed at weeks 1, 4, 8, and 12 using the International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), Core Lower Urinary Tract Symptom Score (CLSS), and WHOQOL-26. Results: Two-way analysis of variance revealed that IPSS and OABSS were significantly lower in the VISPO™ group that in the placebo group. However, there were no significant differences in urine volume, urinary flow rate, or salivary hormone levels. In addition, no participants reported adverse effects (diarrhea, abdominal pain, etc.). Conclusion: The results of the present study, which is the first randomized controlled trial of VISPO™ conducted among healthy participants, demonstrate the effectiveness of VISPO™ in the management of lower urinary tract complaints that do not require treatment. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN000046386). Keywords: saw palmetto, VISPO™, β-sitosterol, fatty acids, healthy subjects, primary preventive, IPSS, OABSS, lower urinary tract symptoms (LUTS)

Multi-pharmacological treatment for young subfertile males with chronic prostatitis/chronic pelvic pain syndrome.

This study evaluated the effectiveness of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) treatments using multiple pharmaceutical agents that could simultaneously preserve or enhance fertility capability. This was a single-center-based, randomized controlled study, whereas the final analysis evaluated a total 350 CP/CPPS patients (age range, 28-40 years) and 50 patients were randomly allocated to each therapeutic group, with a 1:1 ratio. The therapeutic groups consist of tadalafil (group 1, 5 mg daily), L-carnitine (group 2, 2 g daily), Serenoa repens extract (group 3, 320 mg daily), group 4 (tadalafil+L-carnitine), group 5 (tadalafil+S. repens), group 6 (L-carnitine+S. repens), and group 7 (tadalafil+L-carnitine+S. repens). The treatment outcomes at 3 months post-therapy were analyzed. At 3 months post-therapy, the mean total sperm motility was significantly improved in all groups. A normal morphology improvement was observed in L-carnitine receiving groups. The mean total score on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) and the mean International Prostate Symptom Score (IPSS) showed the greatest reduction in intensity in group 7. Logistic regression analyses showed that group 5 and group 7 were significantly associated with improvements in total IPSS and total NIH-CPSI scores at 3 months post-therapy. Group 7 was a significant predictor for improving total sperm motility, leukocytospermia and normal form of sperm. Tadalafil, carnitine, and S. repens combination therapy could be considered a feasible treatment option for CP/CPPS males with subfertility.

Variability of Commercial Saw Palmetto–Based Supplements for the Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms

ABSTRACT Purpose: Some men with mild-to-moderate benign prostatic hyperplasia/lower urinary tract symptoms use saw palmetto supplements to proactively manage their symptoms as an alternative to watchful waiting and/or to avoid prescription medication side effects. This study assessed the potency and authenticity of commercially available saw palmetto–based supplements in the United States. Materials and Methods: Twenty-eight saw palmetto berry powders, powdered extracts, berry blends, lipid extracts, and multiactive products (lycopene, pumpkin oil, etc) were purchased from major online retailers and retail stores. Total fatty acid content (% weight/weight) and individual fatty acid profile of each product were determined using validated gas chromatography-fatty acid methyl ester methodology and compared with the US Pharmacopeia monograph standards for lipidosterolic extracts of Serenoa repens. Results: Total fatty acid content ranged from 0.796% for a berry powder product to 89.923% for a lipid extract product. None of the berry powders or powdered extracts, 6 of 9 lipid extracts, and 1 multiactive product met criteria for ≥80% total fatty acid content. Only 1 of the 28 products met the US Pharmacopeia criteria for a standardized lipidosterolic extract, defined as total fatty acid content ≥80% and a fatty acid profile indicative of authentic S. repens based on the ratios of the lauric acid concentration to 9 other individual fatty acid concentrations. Conclusions: There is substantial heterogeneity in fatty acid content and profile in saw palmetto supplements. Lipidosterolic extracts of saw palmetto berries standardized to ≥80% fatty acids are most likely to meet established criteria for quality and identity.

Lipid Profile and 5α-Reductase Inhibition Activity of Proprietary Ultrahigh-Pressure Supercritical Carbon Dioxide and Hexane Saw Palmetto Extracts

Inhibition of 5α-reductase (5αR), which blocks the conversion of testosterone to its active metabolite, dihydrotestosterone, has been shown to impact further prostate enlargement (benign prostatic hyperplasia, or BPH). Clinical trials of standardized lipidosterolic extracts of Serenoa repens (LSESr), also known as standardized extracts of saw palmetto, have demonstrated improvement in lower urinary tract symptoms (LUTS) and delayed progression of BPH. The aim of this preclinical study was to compare two standardized LSESr, a proprietary ultrahigh-pressure supercritical carbon dioxide extract of S. repens (UHP-sCESr) and the well-established hexanic extract of S. repens (HESr), for both 5αR inhibition activity and lipid profiles. UHP-sCESr and HESr had nearly identical inhibition curves and comparable IC50 values for 5αR-1 (9.25 ± 0.87 and 9.86 ± 0.11 μg/mL, respectively; p = 0.43) and 5αR-2 (7.47 ± 0.07 and 7.72 ± 0.05 μg/mL, respectively; p = 0.0544). UHP-sCESr and HESr also had comparable lipid profiles based on similar total fatty acid levels (87.7% and 91.5%, respectively), weight/weight comparisons of individual fatty acids, and individual fatty acid ratios to lauric acid. In addition, UHP-sCESr meets the standard set by the United States Pharmacopeia (USP) monograph for authenticity and purity for a supercritical carbon dioxide (SCCO2) extract of saw palmetto, whereas HESr meets the standard set by the European Medicines Agency (EMA) for a well-established medicinal product. In conclusion, based on enzyme inhibition curves and IC50 values, a standardized lipid profile is important to achieve comparable mechanisms of action for lipidosterolic extracts of saw palmetto. UHP-sCESr offers a comparable, standardized LSESr for men with LUTS/BPH in regions where the proprietary HESr is not available.

The Role of Combination Therapy with α-Blockers and Hexanic Extract of Serenoa repens in the Treatment of LUTS/BPH.

The hexanic extract of Serenoa repens (HESr) has been in use for decades as an effective, safe and well-tolerated therapy for relieving bothersome lower urinary tract symptoms (LUTS) associated with benign prostate hyperplasia (BPH). This manuscript gives an overview of HESr as monotherapy for LUTS/BPH treatment and focuses on the currently available literature investigating the possible clinical benefits of HESr combination therapy with α-blockers. Combination therapy of HESr with α-blockers has been gaining significant interest in recent years, as an increasing body of evidence shows the beneficial pharmacological effects that HESr treatment can add to standard first-line treatment with α-blockers. By reducing persistent Prostatic Inflammatory Status (PIS), commonly present in LUTS/BPH patients, HESr complements the relaxation of prostate smooth muscle induced by α-blockers, thus providing additional symptom relief. Data suggest that patients harbouring PIS and having a specific clinical profile might especially benefit from the combination therapy. Future therapeutic efforts may take advantage of more personalised strategies for LUTS/BPH management.

Rationale for the Use of Serenoa Repens Extract for Inflammatory Processes in the Prostate

Phytotherapy remains one of the most popular methods of treating the initial stages of benign prostatic hyperplasia (BPH). One of the main mechanisms of action of herbal remedies is antiproliferative and anti-inflammatory effects of biologically active substances, which occur in the form of reducing the percentage of inflammatory infiltrates in intraoperative samples of prostate tissue. The main direction of treatment of the initial stages of BPH is the appointment of plant inhibitors of 5α-reductase, the most famous of which is the extract of Serenoa repens (SESr). This plant extract has become widespread in the world and has one of the most reliable evidence bases based on many years of research. In modern meta-analyzes of SESr, the mechanisms of action and evidence of its high clinical efficacy are quite clear. Scientific studies have shown that Serenoa repens can have selective antiandrogenic, anti-inflammatory, anti-edematous, prolactin-modulating and antiproliferative effects, the implementation of which in total can affect both the reduction of nodular hyperproliferation and prostate volume. The mechanisms of realization of the effects of Serenoa repens extract in people with BPH are multifactorial, and some of them are not defined at all. In addition to the recognized antiphlogenic effects of inhibition of cyclooxygenase-2 and 5-lipoxygenases, modern studies have established the phenomenon of exposure at the level of apoptosis regulators in prostate cells. The histological aspect of the combination of foci of benign hyperplasia with foci of chronic inflammation in prostate tissues is a factor of mutual burden, which causes rapid progression of BPH stages and the risk of prostate cancer (PC). The role of inflammation in the development of PC may be due to the presence of long-term elevated local levels of its mediators, which contribute to the formation of both genetic and metabolic conditions of acute apoptosis regulation. This is consistent with the assumption that changes in genes involved in inflammatory cascades can promote carcinogenesis, so the strategy of attempts to correct genetic polymorphism under BPH should contain a strong antiphlogenic component. The pharmacological effects of Serenoa repens fully correspond to the pathogenetic essence of the prevention of the main prostate diseases of inflammatory and hyperplastic origin, as they are aimed at reducing the severity of two key processes: hyperproliferation and chronic inflammatory response, which successfully demonstrates the clinical use of Serenoa repens extract in long-term hypertensive therapy.

Наш опыт применения гексанового экстракта плодов Serenoa Repens (Пермиксон) при лечении СНМП в клинической практике

Benign prostatic hyperplasia (BPH) and chronic prostatitis (CP) are among the most common causes of LUTS in men. LUTS occur on average in 62.5% of males, with irritative symptoms occurring in 51%, obstructive symptoms in 26%, and postmicturic symptoms in 17% of cases. According to the literature, moderate and severe LUTS were observed in 13% of men under the age of 50 and in 28% after 70 years. It should be noted that LUTS are not BPH-specific, since may be caused by prostate inflammation. According to publications, 57% of patients examined for CP have BPH, and 39% of patients with BPH have CP. The first line of drug therapy in patients with BPH is currently considered to be alpha-blockers and inhibitors of 5-a-reductase. In addition, it is possible to use herbal preparations made from fruits, roots, seeds, pollen and plant bark. Preparations based on Serenoa repens extract are among the most studied and are widely used both in our country and worldwide for the treatment of patients with BPH and LUTS. Only lipidosterol hexane extract of Serenoa repens is recognized as a drug, the use of which has a good evidence base. The clinical examples illustrating the pharmacological properties and results of the use of the preparation of lipidosterol hexane extract Serenoa repens are presented in the article. CONCLUSION: The presented clinical cases demonstrate the efficiency of the hexane extract of Serenoa repens fruit for the treatment of LUTS associated with BPH and CP. At the same time, the drug can be effectively used both as monotherapy and in combination with alphablockers. Therefore, it is reasonable to use the hexane extract of Serenoa repens fruit in clinical practice for the treatment of LUTS associated with BPH.

The Therapeutic Potential of Saw Palmetto Extract in Urological Disorders

Saw palmetto extract (SPE) has been widely used as a therapeutic remedy for urinary dysfunction in western countries. Furthermore, as an herb drug, it can be used as an alternative therapy for benign prostatic hyperplasia (BPH) due to its safety and minimum adverse effects. Reportedly, SPE improves the urinary symptoms, which mainly depend on anti-androgenic effects and effects on autonomic receptors in the lower urinary tract. However, the mechanisms of action responsible for the therapeutic roles of SPE have not been fully elucidated. Relevant studies indicate that SPE has some positive effects on the treatment of urological diseases in animals, and clinical trials are ongoing. In this review, we summarize the pharmacological properties and discuss the possible therapeutic mechanisms of SPE in urological diseases, including anti-androgenic effects, effects on autonomic receptors in the lower urinary tract, anti-inflammatory activity, anti-proliferative and pro-apoptotic effects, and highlight a potential therapeutic approach in the clinical treatment of patients with BPH, prostate cancer, chronic prostatitis (CP) and erectile dysfunction (ED).

Effects of saw palmetto extract on the vanilloid receptor TRPV1.

Transient receptor potential vanilloid subtype 1 (TRPV1) may play a significant role in the pathophysiology of the bladder. The present study investigated the effects of the herbal product, saw palmetto extract (SPE) on TRPV1-mediated Ca2+ influx and specific [3 H]resiniferatoxin ([3 H]RTX) binding to TRPV1 in HEK293 cells expressing TRPV1 (HEK293VR11 cells). Ca2+ influx induced by and the direct binding activity of TRPV1 were measured using a method with Fura 2-AM, a cytoplasmic calcium indicator, and a radioligand binding assay using a [3 H]RTX, respectively. SPE did not markedly affect Ca2+ influx in HEK293VR11 cells; however, it significantly inhibited capsaicin-induced increases in Ca2+ influx in these cells. The specific binding of [3 H]RTX in HEK293VR11 cells was saturable with Kd value of 120 ± 7 pM and Bmax of 1.07 ± 0.10 fmol/mg protein, and was inhibited by low concentrations of non-labeled RTX with Ki of 60.1 ± 7.6nM. These results confirmed the pharmacological specificity of specific binding sites of [3 H]RTX to TRPV1 in HEK293VR11 cells. SPE inhibited the specific binding of [3 H]RTX in a concentration-dependent manner, with Ki of 24.2 ± 1.4μg/mL. The present study demonstrated for the first time, that SPE inhibited capsaicin-induced Ca2+ influx with binding to TRPV1 in HEL293VR11 cells. These results will contribute to a more detailed understanding of the pharmacological effects of SPE on urinary dysfunction.

Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients

In a subset analysis of data from a 6-month, multicenter, non-interventional study, we compared change in symptoms and quality of life (QoL), and treatment tolerability, in men with moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving tamsulosin (TAM, 0.4 mg/day) or the hexanic extract of Serenoa repens (HESr, 320 mg/day) as monotherapy. Symptoms and QoL were assessed using the IPSS and BII questionnaires, respectively. Patients in the treatment groups were matched using two statistical approaches (iterative and propensity score matching). Within the iterative matching approach, data was available from a total of 737 patients (353 TAM, 384 HESr). After 6 months, IPSS scores improved by a mean (SD) of 5.0 (4.3) points in the TAM group and 4.5 (4.7) points in the HESr group (p = 0.117, not significant). Improvements in QoL were equivalent in the two groups. TAM patients reported significantly more adverse effects than HESr patients (14.7% vs 2.1%; p < 0.001), particularly ejaculation dysfunction and orthostatic hypotension. These results show that HESr is a valid treatment option for men with moderate/severe LUTS/BPH; improvements in urinary symptoms and QoL were similar to those observed for tamsulosin, but with considerably fewer adverse effects.

Inhibition of U87 Glioblastoma in BALB/c Nude Mice by Serenoa Repens Extract

Inhibition of U87 Glioblastoma in BALB/c Nude Mice by Serenoa Repens Extract

Дискуссия о применении гексанового экстракта Serenoa repens в комбинированной терапии больных СНМП/ДГПЖ

Based on literature data, feasibility of combined therapy with Serenoa repens extracts (including Permixon) and 1-adrenoblocators in patients with LUTS/BPH based on the pathogenesis of these drugs and clinical results was analyzed. The composition and biological activity of various SRE is influenced by the extraction method, as well as the production technology used by the manufacturer, which can lead to different results of experimental and clinical studies. The mechanism of action of SRE, including hexane extract Permixon, is multicomponent, which combines an antiandrogenic effect, influence on neurogenic regulation of urinary tract function (-adrenoreceptors, M-holinoreceptors, vanilloid receptors), anti-inflammatory and anti-edematous actions. At the same time, the effect of these preparations is not limited to the influence on the prostate gland, but can directly affect the bladder, helping to reduce functional disorders. A wider range of mechanisms of action and a possible direct effect of SRE on the bladder provides the same clinical effect as other traditionally used drugs (-blockers, 5-reductase inhibitors) with a significantly lower frequency of side effects of therapy. A number of publications demonstrate the feasibility of combined therapy with 1-adrenoblockers and SRE in patients with LUTS/BPH, especially with a high degree of urination dysfunction. Futher investigations are needed. The role of Serenoa repens extracts in the combination therapy of LUTS/BPH is still under discussion. Serenoa repens extracts monotherapy demonstrates similar effectiveness in patients with LUTS as 1-adrenoblockers and 5-reductase inhibitors. Recent studies indicate the advantages of combining Serenoa repens extracts with 1-adrenoblockers, especially in patients with moderate or severe symptoms. These advantages are associated with the multicomponent action of Serenoa repens extracts, which complements the blockade of 1-adrenergic receptors with other mechanisms of action (in particular, anti-inflammatory). The combination of drugs with different mechanisms of action, in particular, Serenoa repens extracts (Permixon) and 1-adrenoblockers has certain pathophysiologically based advantages, which allows to increase the efficiency of therapy. In addition, combination therapy is not associated with an increased rate of side effects.

The efficacy and safety of Serenoa repens extract for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, randomized, double-blind, placebo-controlled trial

PurposeTo perform a placebo-controlled trial to evaluate the efficacy and safety of Serenoa repens extract (SRE) for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).MethodsWe conducted a double-blind, randomized, placebo-controlled, multicenter, clinical phase 4 study of 221 patients with CP/CPPS across 11 centers. Participants were randomly assigned in a 2:1 ratio to receive SRE or placebo for 12 weeks. The primary efficacy endpoint was the change in total score on the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). Secondary efficacy endpoints included improvements within each domain of NIH-CPSI, clinical response rate, and International Index of Erectile Function 5 items (IIEF-5).ResultsIn total, 226 patients were enrolled and randomized between January 2017 and June 2018. Of these 221 patients were included in the intent-to-treat analysis: 148 in the SRE group and 73 patients in the placebo group. Compared to the placebo, SRE led to statistically significant improvements in the NIH-CPSI total score and sub-scores. The significant improvements of NIH-CPSI scores were established after 2 weeks from the first dose, and continued to the end of the treatment. Furthermore, a significantly higher rate of patients achieved a clinical response in the SRE group compared with that in the placebo group (73.0% vs 32.9%, P < 0.0001). Only minor adverse events were observed across the entire study population.ConclusionsSRE was effective, safe, and clinically superior to placebo for the treatment of CP/CPPS. ChiCTR-IPR-16010196, December 21, 2016 retrospectively registered

Экстракты Serenoa repens в лечении расстройств мочеиспускания у больных ДГПЖ: дискуссия об эффективности и комплексном механизме действия

Introduction. The review analyzes the clinical efficacy and mechanism of action of lipidsterol extracts of the American dwarf palm fruit Serenoa repens (SRE), including the drug Permixon (Pierre Fabre), used for the treatment of urination disorders in men with benign prostatic hyperplasia (BPH). Material and methods. When writing the review, data from the PubMed database was used (https://www.ncbi.nlm.nih.gov/pubmed/) and scientific electronic library Elibrary.ru (https://elibrary.ru/). Search keywords for articles on the review topic were «BPH», «therapy of urinary dysfunction», «Serenoa repens», «Permixon», «mechanism of action», «bladder receptors». As a result, 48 publications were selected in peerreviewed foreign and domestic journals. Results. It is noted that the composition of extracts from different manufacturers and for different types of extraction (supercritical fluid extraction with carbon dioxide under high pressure, extraction with hexane, ethanol or diethyl ether) differs significantly, which may affect the effectiveness of therapy. At the same time, according to the authors, the greatest effect is observed when using preparations with hexane extraction of SRE components, which include Permixon. The main ingredients that provide antiandrogenic, adreno- and cholinolytic and antiinflammatory effects of SRE drugs were determined. Analysis of the effectiveness of the Permixon in the form of monotherapy, in comparison with the traditionally used α-blockers and in combination with them, showed a significant improvement in the quality of urination in patients with BPH during treatment with this drug, comparable to the effect of α-blockers. Data are discussed indicating that the mechanism of action of SRE can be associated not only with the effect on the prostate gland, but also on the bladder, improving the contractile function of detrusor due to α-adrenolytic, M-cholinolytic and antiinflammatory actions, which helps to reduce the dysfunction of urine accumulation in the spectrum of lower urinary tract symptoms. Conclusion. The mechanisms of action of SRE in LUTS/BPH should be considered more broadly and comprehensively, including the possible effect of drugs not only on the prostate, but also on the obstructive bladder. However, there are few objective data on this issue, which requires new special studies.

Clinical Benefit of Tamsulosin and the Hexanic Extract of Serenoa Repens, in Combination or as Monotherapy, in Patients with Moderate/Severe LUTS-BPH: A Subset Analysis of the QUALIPROST Study

To investigate whether tamsulosin (TAM) and the hexanic extract of Serenoa repens (HESr) are more effective in combination than as monotherapy in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Subset analysis of data from a 6-month, multicenter observational study. Patients received either tamsulosin (0.4 mg/day) or HESr (320 mg/day) alone or in combination. Primary endpoints were change in symptoms and quality of life. Tolerability was also assessed. Seven hundred and nine patients were available for intention to treat (ITT) analysis, 263 treated with tamsulosin, 262 with HESr, and 184 with TAM + HESr. After 6 months, International Prostate Symptom Score (IPSS) scores improved by a mean (standard deviation) of 7.2 (5.0) points in the TAM + HESr group compared to 5.7 (4.3) points with TAM alone and 5.4 (4.6) points with HESr (p < 0.001). Quality of life showed greatest improvement with combination therapy (p < 0.02). Adverse effects were reported by 1.9% of patients receiving HESr, 13.3% receiving TAM, and 12.0% receiving TAM + HESr (p < 0.001). In men with moderate/severe LUTS/BPH, combination treatment with TAM + HESr produced more effective symptom relief and greater improvement in quality of life than with either treatment alone, with acceptable tolerability.

Re: 15 Years' Survey of Safety and Efficacy of Serenoa Repens Extract in Benign Prostatic Hyperplasia Patients with Risk of Progression.

Re: 15 Years' Survey of Safety and Efficacy of Serenoa Repens Extract in Benign Prostatic Hyperplasia Patients with Risk of Progression.

HP-4-1 Improvement of Sexual Functions in Men With Benign Prostatic Hyperplasia With Long-Term Use of the Serenoa Repens Extract

To evaluate the effectiveness of Serenoa repens (SR) extract in the treatment of erectile and ejaculatory function disorders in individuals with BPH. The study included 34 patients with BPH and various sexual dysfunctions who received SR extract in monotherapy 320 mg per day for 12 months. In all patients who received SR extract, after 12 months there was a significant increase in all integrative scores of the IIEF. The average score “erectile function” increased from 14.28±0.98 to 24.86±0.23 (p< 0.01), “satisfaction with sexual intercourse” - from 7.24±0.31 to 13.52±0.58 (p< 0.05), “orgasm” - from 4.92±0.14 to 9.31±0.38 (p< 0.05), “total satisfaction” - from 4.01±0 , 29 to 8.13±0.32 (p< 0.01), which in percentage terms indicated an increase in scores by an average of 2 times. Enhancement of libido, increase in sexual desire in dynamics, according to IIEF, averaged 58.2%. The effectiveness of SR monotherapy in the restoration of erectile function score averaged 83.3%. The effect of SR was studied separately in 23 men with secondary PEj due to BPH (disease duration on average 5.4±0.4 years). Patients were divided into groups depending on the duration of sexual intercourse before treatment: ejaculation before insertion of the penis into the vagina in 2 (8.7%) patients (group 1); up to 30 seconds - in 10 (43.5%) (group 2); up to 60 seconds - in 8 (34.8%) patients (group 3); up to 120 seconds - in 3 (13.0%) (group 4).

P-02-18 Estimation of Combined Treatment Efficiency of Sexual Dysfunctions in Patients after Surgery for Benign Prostatic Hyperplasia

The purpose of the study was to evaluate the effectiveness of the combined treatment of sexual dysfunctions (SD) in patients with benign prostatic hyperplasia. 160 men who underwent surgery for BPH and had manifestations of SD were examined, they were divided into two groups: group A 77 patients (48.1%), operated byTURP and having SD up to surgery; group B included 83 (51.9%) patients in whom SD occurred after TURP. The period between surgery and inclusion in the study was ≥3 months. After surgery, patients received combination therapy: tamsulosin 0.4 mg OD and Serenoa repens (SR) extract 320 mg OD for 12 months. Evaluated on 1, 3, 6 and 12 months. After 12 months of observation, a strong linear relationship (r=0.96) was revealed between the severity of LUTS and the degree of ED, which accounted for 91.5% in the structure of SD. SD appeared in 85.0% of cases with orgasmic dysfunction, retrograde ejaculation mainly in the operated patients (90.6% versus 73.3%; p< 0.05) and a decrease in their libido (69.4% versus 30.7% among others ; p< 0.05). Characteristic was a decrease in the quality of life on the scales of the physical (with the existence of SD before surgery) and the mental components (the occurrence of SD after surgery). In 89% of cases, subclinical personal and situational anxiety was detected in all groups. The inclusion of individual rational psychotherapy in treatment, depending on the prevalence of depression form, was used in 70.0%, in 61.0% in the presence of SD before TUR and in 74.7% of SD development after surgery.

The Clinical Impact of Hexanic Extract of Serenoa repens in Men with Prostatic Inflammation: A Post Hoc Analysis of a Randomized Biopsy Study.

A randomized biopsy study showed that hexanic Serenoa repens (HESr) treatment resulted in prostatic inflammation reduction. This post-hoc analysis evaluated the clinical impact of HESr and investigated correlations between baseline parameters and treatment response. Patients were randomized to receive HESr 320mg/day for six months or no therapy. Assessment included International Prostate Symptoms Score (IPSS), prostate volume (PV), and maximum flow rate (Qmax). Baseline characteristics were recorded, including body mass index (BMI) and metabolic syndrome (MetS) components. In patients under α1-adrenoceptor antagonists (α1-blockers), the addition of HESr resulted in statistically significant IPSS improvement after 6 months (p = 0.006). IPSS remained stable in patients under a1-blockers only (p = 0.346). Patients treated only with HESr reported a significant IPSS amelioration (p = 0.001). In the control group of naïve patients, no significant IPSS change was detected (p = 0.298). Baseline PV showed fair correlation (r = −0.20) with inflammation reduction in the HESr patients. BMI (r = 0.40), diabetes mellitus (r = 0.40), and PV (r = 0.23) showed fair correlation with Qmax increase but without reaching statistical significance. MetS (p = 0.06) was an influent biomarker for Qmax improvement. Treatment with HESr (as monotherapy or add-on therapy to a-blockers) may improve urinary symptoms in terms of IPSS in patients with prostatic inflammation.