Background: Lower urinary tract symptoms (LUTS) are prevalent among aging men and negatively affect quality of life. Salvia miltiorrhiza extract (SAGX), which exhibits anti-inflammatory and antioxidant properties, has been developed as a functional ingredient to improve LUTS. However, comparative clinical data against established standards, such as saw palmetto, are currently lacking. Objectives: To compare the efficacy and safety of SAGX with saw palmetto extract in men with LUTS. Methods: In this randomized, parallel-group pilot study, 30 men with LUTS were assigned to receive either 400 mg of SAGX or 320 mg of saw palmetto extract once daily for 12 weeks. The primary outcome was the change in the International Prostate Symptom Score (IPSS) and the LUTS-related quality-of-life (QoL) score. Secondary outcomes included changes in the erectile function assessed using the International Index of Erectile Function (IIEF). Safety was evaluated by monitoring adverse events. Results: SAGX supplementation resulted in a significantly greater reduction in total IPSS compared with the saw palmetto group (p = 0.031), with notable improvements in storage symptoms (p = 0.003) and QoL (p = 0.035). Erectile function also improved significantly in the SAGX group (p = 0.005). All adverse events were mild and transient, with treatment-related events occurring less frequently in the SAGX group. Conclusions: Although this study was a pilot study with a limited cohort, these findings provide preliminary evidence for the use of SAGX as a functional ingredient for supporting urinary health in men with LUTS.

This systematic review assessed the potential effectiveness and safety of Serenoa repens (saw palmetto) for benign prostatic disorders, mainly benign prostatic hyperplasia and associated lower urinary tract symptoms. Following PRISMA guidance (PROSPERO: CRD420251032255), we searched PubMed, Cochrane and ScienceDirect for human studies from January 2020 to May 2025. Sixteen studies (>3000 participants) met criteria, including randomized trials, observational cohorts, a post hoc analysis, an open-label comparative study and a pharmacovigilance analysis. Overall, S. repens was associated with improvements in symptom severity (International Prostate Symptom Score) in several trials, with variable effects on urinary flow, post-void residual volume, and patient-reported quality of life. Signals of benefit appeared more consistently with hexanic lipidosterolic extracts and β-sitosterol-enriched preparations, and some real-world and head-to-head comparisons suggested outcomes comparable to alpha-blockers with fewer adverse events. Combination therapy, especially with the addition of alpha-blockers, showed larger symptom reductions in select populations, particularly with more pronounced baseline symptoms or prostatic inflammation. However, heterogeneity in extract formulations, dosing, study design, and outcome reporting limited cross-study comparability. Safety findings were generally favourable, with mostly mild gastrointestinal events and fewer sexual adverse effects than reported for conventional pharmacotherapies. Taken together, recent evidence supports S. repens as a potentially useful, well-tolerated option for benign prostatic hyperplasia-related symptoms - especially in certain formulations and as part of combination strategies - whilst underscoring the need for standardized, adequately powered trials to clarify which patients benefit most, optimal dosing, and durability of effects.

Aim of this review is to evaluate the pharmacological efficacy and safety of Serenoa repens extracts in managing lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH). Using PubMed, Web of Science, and the Cochrane database, we identified studies published until November 2023 reporting effect of Serenoa repens extracts on LUTS and BPH. All studies were included in the literature search. The most relevant studies were selected to identify the effects of different extracts of serenoa repens in terms of pharmacology, efficacy and safety. Hexanic extract of Serenoa repens (HESr), presents important anti-inflammatory, antiproliferative, and antiandrogenic activities proven through various in vitro, in vivo, and clinical trials. The current phytotherapeutic landscape is very heterogeneous and limited by the lack of a regulatory framework for herbal substances. There is a clear disparity in the qualitative and quantitative composition of extracts due to varied extractive processes, affecting the therapeutic efficacy. Several studies (prospective randomized clinical trials) demonstrated the clinical efficacy of HESr compared to placebo and other pharmacological treatments. Particularly, HESr improves nocturia and Qmax. Other extraction techniques, such as alcoholic and CO<inf>2</inf> need further RCT to better define their efficacy. The review identifies the critical role of Serenoa repens extract in managing LUTS in patients with BPH. Particularly the evidence suggests significant in vitro and in vivo differences in terms of inflammation reduction, symptoms relief and flow improvement depending on the extraction technique.

Background: Benign prostatic hyperplasia (BPH) is a prevalent condition affecting over 50% of men aged 60 and above, often leading to lower urinary tract symptoms that significantly impact quality of life. Current pharmacological treatments, including α-adrenergic receptor antagonists and 5α-reductase inhibitors, are associated with adverse effects, prompting the exploration of alternative therapies. This study investigates the potential role of a novel multi-component phytocomplex (PhytoBPH-Mix) comprising Serenoa repens, Pygeum africanum, Urtica dioica, Epilobium angustifolium L., Protium heptaphyllum, lycopene, Vitamin E, zinc, and selenium. Methods: The anti-androgenic, anti-inflammatory, and antimicrobial properties of the mixture were evaluated in vitro. Results: The formulation significantly inhibited 5α-reductase activity, reduced the release of pro-inflammatory cytokines (IL-6 and TNF-α), and exhibited antibacterial effects against E. coli compared to individual extracts. Conclusions: These findings suggest that this specific mixture offers a promising natural alternative or an adjuvant for managing BPH by targeting multiple pathological mechanisms with minimal side effects and could also serve as an effective adjuvant in conventional therapy.

Serenoa repens (Saw palmetto) contain 85–90% fatty acids and other constituents include sterols rich in components as carotenoids, lipases, tannin and sugars. The purpose of this study is to investigate the therapeutic potential of Saw palmetto fruit extract against Alzheimer’s disease in a mice model. Phytochemical analysis was performed by HPLC analysis after preparation of plant extract by microwave assisted extraction technique.AD induced in mice by D-galactose and aluminum chloride 100 mg/kg of each (orally), and treated with saw palmetto fruit extract 250 mg/kg, 500 mg/kg, and 800 mg/kg were administered orally for 21 days. Neurobehavioral observations were performed to determine the pharmacological manipulation on cognitive and behavioral functions. Mice were sacrificed after behavioral studies to perform biochemical, neurochemical and gene expression analysis. Neuro-active compounds detected in HPLC analysis like chlorogenic acid, p-coumaric acid, gallic acid, HB acid and salicylic acid were screened by the molecular docking and interaction analysis. SP extract treatment showed dose-dependent neuroprotective effects as manifested by neurobehavioral, histopathological analysis which showed that with 250 mg/kg moderately enhance the synaptic density and neuronal survival. Notable neurodegenerative effects were observed at 800 mg/kg, accompanied by reduced neurodegenerative histopathology at 500 mg/kg. Phytochemicals in SP extract showed most stable conformation within the active site of target protein AChE. ADMET results sustained the computational experiments by presenting significant results, further molecular dynamic analysis also confirms the perfect interaction of the target AChE protein with Quercetin, Chlorogenic acid. These five phytochemicals could be recommended for clinical testing for management of Alzheimer’s disease.

Serenoa repens is widely used for benign prostatic hyperplasia and androgenetic alopecia due to its 5alpha-reductase inhibitory activity. However, emerging reports describe sexual, psychiatric and somatic adverse effects resembling a post-finasteride syndrome. Cases were identified from self-reports submitted to an Italian online forum dedicated to post-finasteride syndrome. All individuals underwent structured clinical evaluation at the CERFIT centre, including medical and psychiatric history, symptom assessment and available laboratory data. Reports were documented using the official Italian pharmacovigilance forms (www.vigierbe.it), and causality was independently assessed by two clinicians using the Naranjo Scale. Reported doses ranged from 120-900 mg/day, with adverse effects emerging within 1 month in 61% of cases. Symptoms were severe and persistent (mean duration 4.7 years), with complete remission in only three patients. According to the Naranjo Scale, causality was deemed 'probable' in 54% of reports; combined therapies (e.g., S. repens plus finasteride) were associated with increased severity and persistence. A possible post-Serenoa syndrome marked by persistent sexual and neuropsychiatric symptoms may represent an underestimated issue. Misbelief in the absolute safety of S. repens likely hinders reporting. Given its widespread, unsupervised use, further pharmacovigilance and clinical studies are warranted.

Menopause is a natural physiological transition affecting over one billion women globally. It often brings distressing symptoms, including hair loss, which impacts up to 52% of postmenopausal women due to estrogen decline, increased androgen sensitivity, and oxidative stress. Conventional treatments like minoxidil provide limited efficacy and may cause side effects, underscoring the need for accessible, culturally attuned alternatives. This mini-review explores ethnopharmacological approaches that empower women through traditional remedies targeting multi-mechanistic pathways, supported by emerging clinical data. We conducted a systematic literature search across databases (PubMed, Scopus, Web of Science), focusing on studies from 2015 to 2025 involving botanical interventions. We prioritized randomized controlled trials in vitro studies, and animal models. Key remedies include saw palmetto (Serenoa repens), which inhibits 5α-reductase to reduce dihydrotestosterone by approximately 30%-40%; rosemary oil (Salvia rosmarinus Spenn.), which promotes scalp microcirculation similar to minoxidil; and ginseng (Panax ginseng C.A.Mey.), which enhances follicle proliferation via ginsenosides. Emerging evidence from 2024 to 2025 reviews highlights multi-target mechanisms in plant extracts, including phytoestrogenic and anti-inflammatory effects. Nutraceuticals have demonstrated improved hair density in menopausal cohorts. These low-cost, community-rooted therapies foster women's autonomy and cultural resilience. This mini-review is not comprehensive; it highlights key challenges in current research, such as limited menopausal-specific evidence and standardization gaps. It advocates for future priorities like interdisciplinary trials integrating ethnobotany with modern pharmacology to bridge global health disparities. This aligns with the special issue's vision of empowering women through sustainable, nature-based solutions.