Suspected adverse reactions to medications and food supplements containing Serenoa repens: A worldwide analysis of pharmacovigilance and phytovigilance spontaneous reports.

The safety of Serenoa repens (SR)-containing products was evaluated conducting a retrospective worldwide analysis of pharmaco- and phytovigilance report forms of suspected adverse reactions (SARs) collected up to 31 January 2022. Multivariate logistic regression was performed to estimate the odds ratios (ORs) of serious SAR. A total of 1810 report forms were analysed; 92% of subjects were males, with a median age of 69 years; 44% of cases were defined as serious. Subjects exposed to dietary supplements had a higher risk of developing serious SARs (OR: 1.60 [95% CI: 1.20-2.15]), as subjects exposed to 2-5 (OR: 1. 83 [95% CI: 1.30-2.58]) or more than 5 (OR: 3.45 [95% CI: 2.36-5.06]) suspect/interacting products. The probability of experiencing serious SAR was higher for subjects exposed to concomitant products (OR: 1.55 [95% CI: 1.15-2.08]), to more than four active compounds (OR: 4.38 [95% CI: 3.21-5.99]) and to SR for more than 14 days (OR: 1.89 [95% CI: 1.10-3, 22]), and lower for subjects exposed to higher doses of SR (OR: of 0.34 [95% CI: 0.20-0.58]). This evidence improves awareness on safety of SR containing products, suggesting the need of a further update of periodic reviews by national and international regulatory agencies.

Serenoa repens for the treatment of lower urinary tract symptoms due to benign prostatic enlargement.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a non-malignant enlargement of the prostate, which can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH. OBJECTIVES: To assess the effects of Serenoa repens in the treatment of men with LUTS consistent with BPH. SEARCH METHODS: We performed a comprehensive search of multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Web of Science, and LILACS), trials registries, other sources of grey literature, and conference proceedings published up to 16 September 2022, with no restrictions on language or publication status. SELECTION CRITERIA: We included randomized controlled trials of participants with BPH who were treated with Serenoa repens or placebo/no treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion at each stage and undertook data extraction and risk of bias assessment and GRADE assessment of the certainty of the evidence. We considered review outcomes measured up to 12 months after randomization as short term, and beyond 12 months as long term. Our main outcomes included urologic symptom scores, quality of life, and adverse events. MAIN RESULTS: For this update, we narrowed the review question to only comparisons with placebo. We included 27 studies (of which 9 were new) involving a total of 4656 participants, 19 studies comparing Serenoa repens with placebo, and 8 studies comparing Serenoa repens in combination with other phytotherapeutic agents versus placebo. Most studies included men aged > 50 (mean age range 52 to 68) with moderate urologic symptoms (International Prostate Symptom Score [IPSS] range 8 to 19). Ten studies were funded by the pharmaceutical industry; two studies were funded by government agencies; and the remaining studies did not specify funding sources. Serenoa repens versus placebo or no intervention Results for this comparison are based on predefined sensitivity analyses limited to studies at low risk of bias. Serenoa repens results in little to no difference in urologic symptoms at short-term follow-up (3 to 6 months; IPSS score range 0 to 35, higher scores indicate worse symptoms; mean difference (MD) -0.90, 95% confidence interval (CI) -1.74 to -0.07; I2 = 68%; 9 studies, 1681 participants; high-certainty evidence). Serenoa repens results in little to no difference in the quality of life at short-term follow-up (3 to 6 months; IPSS quality of life domain range 0 to 6, higher scores indicate worse quality of life; MD -0.20, 95% CI -0.40 to -0.00; I2 = 39%; 5 studies, 1001 participants; high-certainty evidence). Serenoa repens probably results in little to no difference in adverse events (1 to 17 months; risk ratio (RR) 1.01, 95% CI 0.77 to 1.31; I2 = 18%; 12 studies, 2399 participants; moderate-certainty evidence). Based on 164 cases per 1000 men in the placebo group, this corresponds to 2 more (38 fewer to 51 more) per 1000 men in the Serenoa repens group. Serenoa repens results in little to no difference in urologic symptoms at long-term follow-up (12 to 17 months, IPSS score, MD 0.07, 95% CI -0.75 to 0.88; I2 = 34%; 3 studies, 898 participants; high-certainty evidence). Serenoa repens results in little to no difference in quality of life at long-term follow-up (12 to 17 months, IPSS quality of life, MD -0.11, 95% CI -0.41 to 0.19; I2 = 65%; 3 studies, 882 participants; high-certainty evidence). There were no data on long-term adverse events for this comparison. Serenoa repens in combination with other phytotherapy versus placebo or no intervention Different phytotherapeutic agents that include Serenoa repens may result in little to no difference in urologic symptoms compared to placebo at short-term follow-up (12 to 24 weeks, IPSS score, MD -2.41, 95% CI -4.54 to -0.29; I2 = 67%; 4 studies, 460 participants; low-certainty evidence). We are very uncertain about the effects of these agents on quality of life (very low-certainty evidence). These agents may result in little to no difference in the occurrence of adverse events; however, the CIs included substantial benefits and harms (12 to 48 weeks, RR 0.91, 95% CI 0.58 to 1.41; I2 = 0%; 4 studies, 481 participants; low-certainty evidence). Based on 132 cases per 1000 men in the placebo group, this corresponds to 12 fewer (55 fewer to 54 more) per 1000 men in the combined phytotherapeutic agents with Serenoa repens group. AUTHORS' CONCLUSIONS: Serenoa repens alone provides little to no benefits for men with lower urinary tract symptoms due to benign prostatic enlargement. There is more uncertainty about the role of Serenoa repens in combination with other phytotherapeutic agents.

Permixon®, hexane-extracted Serenoa repens, inhibits human prostate and bladder smooth muscle contraction and exerts growth-related functions in human prostate stromal cells.

AIMS: Recently, the European Association of Urology recommended hexane-extracted fruit of Serenoa repens (HESr) in their guidelines on management of non-neurogenic male lower urinary tracts symptoms (LUTS). Despite previously lacking recommendations, Permixon® is the most investigated HESr in clinical trials, where it proved effective for male LUTS. In contrast, underlying mechanisms were rarely addressed and are only marginally understood. We therefore investigated effects of Permixon® on human prostate and detrusor smooth muscle contraction and on growth-related functions in prostate stromal cells. MAIN METHODS: Permixon® capsules were dissolved using n-hexane. Contractions of human prostate and detrusor tissues were induced in organ bath. Proliferation (EdU assay), growth (colony formation), apoptosis and cell death (flow cytometry), viability (CCK-8) and actin organization (phalloidin staining) were studied in cultured human prostate stromal cells (WPMY-1). KEY FINDINGS: Permixon® inhibited α1-adrenergic and thromboxane-induced contractions in prostate tissues, and methacholine-and thromboxane-induced contractions in detrusor tissues. Endothelin-1-induced contractions were not inhibited. Neurogenic contractions were inhibited in both tissues in a concentration-dependent manner. In WPMY-1 cells, Permixon® caused concentration-dependent breakdown of actin polymerization, inhibited colony formation, reduced cell viability, and proliferation, without showing cytotoxic or pro-apoptotic effects. SIGNIFICANCE: Our results provide a novel basis that allows, for the first time, to fully explain the ubiquitous beneficial effects of HESr in clinical trials. HESr may inhibit at least neurogenic, α1-adrenergic and thromboxane-induced smooth muscle contraction in the prostate and detrusor, and in parallel, prostate stromal cell growth. Together, this may explain symptom improvements by Permixon® in previous clinical trials.

Development and optimization of a tamsulosin nanostructured lipid carrier loaded with saw palmetto oil and pumpkin seed oil for treatment of benign prostatic hyperplasia.

Benign prostatic hyperplasia (BPH) is a nonmalignant growth of the prostate tissue and causes urinary tract symptoms. To provide effective treatment, tamsulosin (TM), saw palmetto oil (SP), and pumpkin seed oil (PSO) were combined and fabricated a nanostructured lipid carrier (NLC) as TM-S/P-NLC using experimental design. The purpose was to enhance the permeation and therapeutic activity of TM; combining TM with SP and PSO in an NLC generates a synergistic activity. An optimized TM-S/P-NLC was obtained after statistical analysis, and it had a particle size, percentage of entrapment efficiency, and steady-state flux of 102 nm, 65%, and 4.5 µg/cm2.min, respectively. Additionally, the optimized TM-S/P-NLC had spherical particles with a more or less uniform size and a stability score of 95%, indicating a high level of stability. The in vitro release studies exhibited the optimized TM-S/P-NLC had the maximum release profile for TM (81 ± 4%) as compared to the TM-NLCs prepared without the addition of S/P oil (59 ± 3%) or the TM aqueous suspension (30 ± 5%). The plasma TM concentration-time profile for the TM-S/P-NLC and the marketed TM tablets indicated that when TM was supplied in a TM-S/P-NLC, the pharmacokinetic profile of the drug was improved. Simultaneously, in vivo therapeutic efficacy studies also showed favorable results for the TM-S/P-NLC in terms of the prostate weight and prostate index following treatment of BPH. Based on the findings of present study, we suggest that in the future, the TM-S/P-NLC could be a novel drug delivery system for treating BPH.

Anti-androgenic potential of the fruit extracts of certain Egyptian Sabal species and their genetic variability studies: a metabolomic-molecular modeling approach.

This work aimed to evaluate the anti-androgenic activity of S. blackburniana Glazebrook, S. causiarum (O. F. Cook) Becc, and S. palmetto (Walter) Lodd. Ex Schult fruit extracts in rats using Hershberger assay. Furthermore, to annotate secondary metabolites using LC-HRMS technique, to investigate underlying mechanisms responsible for 5-α-reductase inhibitory activity in silico and to compare cytotoxic effects in vitro against human prostatic stromal myofibroblast (WPMY-1) and human benign prostatic hyperplasia (BPH-1) cell lines using MTT, 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (spectrophotometrically). The results showed significant anti-androgenic implications with varying degrees, markedly decreased sex organ weights, reduction in testosterone and increase in LH and FSH serum levels. Genetic diversity study ensured the correct genotype and revealed outperformance of SCoT compared with CBDP markers to interpret polymorphism among selected species. S. blackburniana exhibited selective cytotoxic activity against BPH-1 compared to finasteride. Molecular docking of 59 dereplicated metabolites belonging to various chemical classes revealed that helasaoussazine, pinoresinol and tetra-O-caffeoylquinic acid are the top inhibitors of 5-α-reductase-2. Our study provides an insight into the anti-androgenic activity of selected species of Egyptian Sabal supported by docking study for the first time, demonstrates safety toward liver and kidney and highlights a new potential therapeutic candidate for anti-androgenic related disease such as benign prostatic hyperplasia.

[Our experience of using hexane extract of Serenoa Repens fruit (Permixone) in the treatment of LUTS in clinical practice].

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.

Wires with Continuous Sabal Leaf-Patterned Micropores Constructed by Freeze Printing for a Wearable Sensor Responsible to Multiple Deformations.

The design of porous structure in wearable sensors is very important for the detection of mechanical signals. However, it remains challenging to construct a porous structure capable of detecting all kinds of mechanical signals. Here, round wire with long-range orientated micropores (RW-LOM) is fabricated by a newly established freeze printing technique and constructed into a wearable sensor by the incorporation of carbon nanotubes and polydimethylsiloxane. The Sabal leaf-like lamellar structure in RW-LOM is realized and can be tuned by the proper coordination of slurry concentration and the printing parameters. The fine structures in RW-LOM allow the wearable sensor to detect compression, stretching, twisting, and bending with a high sensitivity, stability, and broad detecting range. This work not only provides a wearable sensor with high stability and high sensitivity but also establishes a technique to construct porous wires that could find applications in the fields like intelligent industry and healthcare.

Phytotherapy for male luts: What happens then? 10-year research.

INTRODUCTION AND OBJECTIVES: Our objective is to assess the long-term results of phytotherapy, focusing on the interval between phytotherapy and pharmacological treatment and the predisposing risk factors to such switch on a 10-year follow-up. MATERIAL AND METHODS: The data of patients taking phytotherapy for mild to moderate male lower urinary tract symptoms (LUTS) from January to December 2010 were retrospectively reviewed from a prospectively maintained database. Patients were followed for 10 years through medical visits and telephone consultations. RESULTS: 102 patients underwent at least one cycle of phytotherapy for LUTS. Twenty (19.6%) patients resolved their symptoms after one phytotherapy cycle and stopped any treatment, 27 (26.4%) continued phytotherapy, and 52 (51%) switched to alpha-blockers and/or 5a-reductase inhibitors after a median interval of 24 months. The reasons for treatment switch were symptoms (n = 45) or clinical progression (increased residual volume n = 15; urinary retention, n = 5). Patients switching to synthetic drugs had median higher age (60 vs 49), prostate volume (40 vs 26 cc), prostate specific antigen (PSA) (1.9 vs 0.9 ng/ml), residual volume (40 vs 0 cc), and a lower maximum flow rate (Qmax) (12 vs 15 ml/s) at presentation. CONCLUSIONS: 46% patients with mild to moderate LUTS undergoing phytotherapy will be either free of treatment or still on phytotherapy at 10 years from disease presentation. Older patients with larger prostates, increased residual volume and PSA, should be informed regarding their higher risk of symptomatic or clinical progression: the risk of a treatment switch to alpha-blockers or 5a-reductase inhibitors becomes an actual fact after an average span of 2 years.

Beneficial Effects of Saw Palmetto Fruit Extract on Urinary Symptoms in Japanese Female Subjects by a Multicenter, Randomized, Double-Blind, Placebo-Controlled Study.

Saw palmetto berry extract (SPE) is the most commonly consumed supplement by men with benign prostatic hyperplasia (BPH). The oral administration of SPE was previously shown to significantly attenuate urodynamic symptoms in the hyperactive bladders of female rats by increasing bladder capacity and prolonging the micturition interval. The amelioration of urodynamic symptoms by SPE may be partly attributed to its binding to muscarinic receptors in the urinary bladder and its inhibition of vanilloid receptors on afferent nerves. Therefore, SPE may be pharmacologically effective at mitigating lower urinary tract symptoms (LUTS) in women. The efficacy and safety of a 12-week treatment with SPE in adult women with urinary symptoms were examined herein. The daytime frequency score in the core lower urinary symptom score (CLSS) questionnaire was significantly lower in women with LUTS treated with SPE for 12 weeks than in the placebo group. A subgroup analysis revealed that SPE alleviated the symptoms of daytime frequency (CLSS Q1) and nocturia (CLSS Q2) in a subset of subjects with a CLSS Q5 score of 1 or higher. The daytime frequency of urination in overactive bladder symptom score (OABSS) Q1 was also significantly improved by the SPE treatment. In conclusion, the present study is the first to demonstrate the potential of SPE to mitigate LUTS in adult women.

Hexanic Extract of Serenoa repens (Permixon®): A Review in Symptomatic Benign Prostatic Hyperplasia.

The hexanic extract (HE) of Serenoa repens (Permixon®) is indicated for the symptomatic treatment of benign prostatic hyperplasia (BPH). The drug is the n-hexane lipidosterolic extract of the American dwarf palm tree (also known as saw palmetto). The anti-inflammatory activity of HE S. repens has been demonstrated in vitro, in vivo and in men with prostatic inflammation. In randomized clinical trials, the efficacy of HE S. repens was similar to that of an α-blocker in terms of improving voiding and storage symptoms, increasing urinary flow rate and reducing prostate volume in men with BPH. HE S. repens was also as effective as 5α-reductase inhibitors and/or α-blockers at improving lower urinary tract symptoms (LUTS) and quality of life (QOL) in real-world observational studies. HE S. repens was generally well tolerated, with a lesser impact on male sexual function compared with other available therapies. Thus, HE S. repens is a useful option for the treatment of symptomatic BPH.

BPH (enlargement of the prostate gland) compresses the urethra, leading to uncomfortable LUTS such as difficulty starting a urine stream, weak flow, incomplete bladder emptying, frequent urination, urgency, and waking at night to urinate. To avoid side effects often associated with other available treatments such as 5α-reductase inhibitors and α-blockers, plant extracts like HE Serenoa repens (Permixon^®) are commonly used to treat the symptoms of BPH. HE S. repens is derived from a small palm tree native to America and has been shown to have anti-inflammatory effects in prostate inflammation. In clinical studies, HE S. repens was as effective as an α-blocker at improving urinary symptoms, increasing urinary flow rate and reducing prostate volume in men with BPH. In real-world studies, HE S. repens was as effective as 5α-reductase inhibitors and/or α-blockers at improving LUTS and QOL. European guidelines recommend HE S. repens as a treatment option for men with LUTS who want to avoid any potential side effects, especially those related to sexual function. HE S. repens was generally well tolerated, and is a useful option for the treatment of symptomatic BPH.

Effects of saw palmetto extract on the vanilloid receptor TRPV1.

OBJECTIVE: 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). METHODS: 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. RESULTS: 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 ± 7.6 nM. 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 ± 1.4 µg/mL. CONCLUSIONS: 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.

Cytotoxic potential of three Sabal species grown in Egypt: a metabolomic and docking-based study.

The phytochemical profiles of leaves and pollen grains' extracts of S. causiarum, S. palmetto and S. yapa were investigated and characterised by LC-HR-MS-based metabolomic analysis. Further, biomarker metabolites were determined using multivariate and clustering analysis. S. causiarum leaves extract along with both S. palmetto and S. yapa pollen grains extracts showed interesting in vitro cytotoxic activity using MTT assay against PC-3 cell lines. While, both S. yapa leaves and pollen grains-derived extracts and S. causiarum pollen grains-derived extracts were active against A-172 cell line. OPLS-DA models was generated, to putatively determine the most active cytotoxic metabolites, these models suggested that alkaloids, flavonoids and phenolic acids are the most important metabolites in the active extracts. In silico analysis (neural-networking-based activity prediction and docking studies) of these top-scoring metabolites further supported OPLS-DA models predictability. This study could be considered as primary step in the in-depth exploration of bioactive natural products from Sabal.

Inhibition of polymicrobial biofilm formation by saw palmetto oil, lauric acid and myristic acid.

Biofilms are communities of bacteria, fungi or yeasts that form on diverse biotic or abiotic surfaces, and play important roles in pathogenesis and drug resistance. A generic saw palmetto oil inhibited biofilm formation by Staphylococcus aureus, Escherichia coli O157:H7 and fungal Candida albicans without affecting their planktonic cell growth. Two main components of the oil, lauric acid and myristic acid, are responsible for this antibiofilm activity. Their antibiofilm activities were observed in dual-species biofilms as well as three-species biofilms of S. aureus, E. coli O157:H7 and C. albicans. Transcriptomic analysis showed that lauric acid and myristic acid repressed the expressions of haemolysin genes (hla and hld) in S. aureus, several biofilm-related genes (csgAB, fimH and flhD) in E. coli and hypha cell wall gene HWP1 in C. albicans, which supported biofilm inhibition. Also, saw palmetto oil, lauric acid and myristic acid reduced virulence of three microbes in a nematode infection model and exhibited minimal cytotoxicity. Furthermore, combinatorial treatment of fatty acids and antibiotics showed synergistic antibacterial efficacy against S. aureus and E. coli O157:H7. These results demonstrate that saw palmetto oil and its main fatty acids might be useful for controlling bacterial infections as well as multispecies biofilms.

Serenoa repens and its effects on male sexual function. A systematic review and meta-analysis of clinical trials.

BACKGROUND: Serenoa repens (SR) is a plant used to treat benign prostatic hyperplasia and prostatitis. We know that SR act as a 5α-reductase inhibitor, moreover, several studies have proved that SR has anti-inflammatory and antioxidant properties. There is some belief among patients that SR may negatively impact male sexual function. Such belief is circulating in non-medical social networks and is perhaps maintained by patients as a result of incorrect web surfing. However, it is also possible that SR may exert a "nocebo" effect thus negatively impacting on the general well-being of patients. OBJECTIVE: The aim of this study is to investigate whether SR is causing negative effects on male sexual function. METHODS: To ascertain the effect of SR on male sexual function, we conducted a systematic review and meta-analysis, by performing an electronic database search in accordance with the PRISMA guidelines. RESULTS: Out of 20 included papers, 8 papers reported comparisons of SR with placebo, and 7 studies reported comparisons of SR with tamsulosin. The standardized mean difference of changes from baseline scores of sexual function was not significantly different between SR and placebo (SMD: 0.43, 95% CI: 0.18 to 1.05; I^2 = 95%). Similarly, no significant mean differences in the Male Sexual Function-4 (MSF-4) test scores were found between SR and tamsulosin (SMD: -0.31, 95% CI: -0.82 to 0.19; I^2 = 90%). CONCLUSIONS: We found no statistically significant differences between negative effects on sexual function in patients treated with SR compared to patients who received placebo. The results of our meta-analysis are similar to those of other systematic reviews. Studies are warranted to ascertain whether any such effects might occur as a result of a nocebo effect.

Treatment of Benign Prostatic Hyperplasia by Natural Drugs.

Benign prostatic hyperplasia (BPH) is one of the most common urinary diseases affecting men, generally after the age of 50. The prevalence of this multifactorial disease increases with age. With aging, the plasma level of testosterone decreases, as well as the testosterone/estrogen ratio, resulting in increased estrogen activity, which may facilitate the hyperplasia of the prostate cells. Another theory focuses on dihydrotestosterone (DHT) and the activity of the enzyme 5α-reductase, which converts testosterone to DHT. In older men, the activity of this enzyme increases, leading to a decreased testosterone/DHT ratio. DHT may promote prostate cell growth, resulting in hyperplasia. Some medicinal plants and their compounds act by modulating this enzyme, and have the above-mentioned targets. This review focuses on herbal drugs that are most widely used in the treatment of BPH, including pumpkin seed, willow herb, tomato, maritime pine bark, Pygeum africanum bark, rye pollen, saw palmetto fruit, and nettle root, highlighting the latest results of preclinical and clinical studies, as well as safety issues. In addition, the pharmaceutical care and other therapeutic options of BPH, including pharmacotherapy and surgical options, are discussed, summarizing and comparing the advantages and disadvantages of each therapy.

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.

Serenoa repens for the treatment of lower urinary tract symptoms due to benign prostatic enlargement: A systematic review and meta-analysis.

PURPOSE: To assess the effects of Serenoa repens alone or in combination with other phytotherapy compared to placebo in men with LUTS due to benign prostatic enlargement. MATERIALS AND METHODS: Following a registered protocol (CRD42021226655), we searched (December 2020) MEDLINE, CENTRAL, Embase, ClinicalTrials.gov, WHO-ICTRP trials platform and other sources with no restrictions on language, publication date or status. We included randomized controlled trials, and we critically appraised them using the Cochrane Tool for Risk of Bias Assessment (RoB 2). We conducted random-effects meta-analysis when appropriate. The primary outcomes included urinary symptoms score, quality of life, and adverse events. The certainty of the evidence was rated using GRADE. RESULTS: We included 27 trials with 4,853 participants. S. repens results in little to no difference in urinary symptoms, quality of life, and adverse events at short- and long-term follow-up. S. repens combined with other phytotherapy may slightly reduce urinary symptoms at short-term follow-up, but the results are uncertain. The results on quality of life and adverse events are also very uncertain. CONCLUSIONS: S. repens alone may result in no clinical benefits for men with LUTS. There is greater uncertainty in the effects of S. repens in combination with other phytotherapy.