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1. J Cosmet Dermatol. 2026 Feb;25(2):e70717. doi: 10.1111/jocd.70717. The Safety and Efficacy of a Novel Saw Palmetto (Serenoa repens) Extract for Promoting Hair Growth in Adults With Self-Perceived Thinning Hair: 180-Day Results. Ablon G(1). Author information: (1)Medical, Surgical, and Cosmet

BACKGROUND: Hair loss is a global concern for both men and women. AIMS: This study assessed the efficacy and safety of a proprietary extract of bioactive fatty acids from saw palmetto for treating self-perceived thinning hair in healthy adult male and female subjects. METHODS: In this 6-month, randomized, double-blind, placebo-controlled study, subjects were randomized to receive active treatment (n = 40) or placebo (n = 20). Half of the enrolled subjects were female. Subjects took one oral dose of their assigned treatment daily. Assessments were performed at baseline, Day 56 and Day 90. Preliminary 90-day results are presented here. PATIENTS/METHODS: The active group showed significant improvement in terminal hair count from baseline in anterior (p < 0.0007) and posterior (p < 0.0005) areas. Compared to placebo, the improvement was also significant in the anterior (p < 0.05) and posterior (p < 0.03) areas. Anterior vellus hair count improved significantly versus baseline (p < 0.0005) and placebo (p < 0.01). Posterior vellus hair count showed significant within-group growth (p < 0.05). Total hair count was significantly greater than baseline for anterior (p < 0.001) and posterior (p < 0.0005) and significantly greater for anterior (p < 0.005) and posterior (p < 0.05) compared to placebo. Total terminal hair counts improved 7-fold, and total hair count improved 12-fold compared to placebo. A significant reduction in hair shedding was observed in the active group versus baseline (p < 0.05). No meaningful improvements were observed in the placebo group, and no adverse events were reported. CONCLUSION: These preliminary results indicate the daily administration of a proprietary saw palmetto (Serenoa repens) extract safely and effectively promotes hair growth in men and women with self-perceived thinning hair. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT06920758. © 2025 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: Tadalafil, carnitine, and S. repens combination therapy could be considered a feasible treatment option for CP/CPPS males with subfertility. © The Korean Urological Association.

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).

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.

Carboxylesterase 1 (CES1) is an abundant hepatic drug metabolizing enzyme whose substrates include endogenous compounds and medications from a variety of therapeutic classes. CES1 is a serine hydrolase that catalyzes the cleavage of amides, esters, and thioesters. Concerns have been raised over botanical-drug interactions (BDIs) and their potential to impair enzymatic function resulting in therapeutic failures or adverse effects. BDIs have been extensively investigated with the cytochrome P450 family of enzymes; however, CES1 BDIs have remained largely uninvestigated. This study assessed the CES1 in vitro inhibitory effects of 18 commonly used botanical extracts and their major constituents using an established probe assay and liquid chromatography-tandem mass spectrometry analysis. The following plant extracts demonstrated significant reversible inhibition of CES1 metabolism: ashwagandha, cannabis, saw palmetto, St. John's wort, turmeric, and yohimbe. The following phytochemical constituents demonstrated significant reversible inhibition of CES1: cannabigerol, curcumin, lauric acid, linoleic acid, hypericin, hyperforin, kaempferol, and tetrahydrocannabinolic acid. Tetrahydrocannabinolic acid was the most potent inhibitor of CES1 and displayed a complete mixed competitive-noncompetitive type inhibition. Cannabis, St. John's wort, and turmeric all displayed inhibition potencies (inhibition constants; Kis) of <1 μM relative to their most abundant constituent. Using available pharmacokinetic data, it is anticipated that most extracts and constituents may impact the area under the curve of CES1 substrate medications. However, further in vitro and clinical studies must be conducted to fully elucidate BDI risk through CES1 impairment. SIGNIFICANCE STATEMENT: Carboxylesterase 1, an abundant drug metabolizing enzyme in the liver, metabolizes many drugs, but studies regarding its botanical interaction potential are limited. An in vitro assessment determined the interaction liability between carboxylesterase 1 and botanical products and found some botanicals may pose a concern.

Selected phenotypes of dried maca (Lepidium peruvianum) hypocotyls and supercritical CO2 extract (USPlus®) of saw palmetto (Serenoa repens) were used to determine their targeted, cytotoxic action in prostate cancer cells. Fingerprinting by HPLC-MS and PCA analysis showed compositional differences in glucosinolates, amides, macamides, and other alkaloids, which varied based on the color and the size of hypocotyls. These phytochemical differences translated into a higher antioxidant potential of red maca than black maca samples. The greatest COX-2 inhibition was demonstrated with a combination of red maca: saw palmetto (67%:33%) and red maca: saw palmetto: black maca (25%:50%:25%). The LNCaP androgen-dependent prostate cancer cell line was the most sensitive to the three-component mixture of black, red maca, and saw palmetto treatment. This combination provided the most abundant set of high-activity metabolites, and is worthy of consideration in further clinical applications and future in-depth study.

Commercial formulations of 29 commonly used herbal supplements (HSs) and grapefruit juice were evaluated for drug interaction potential via quantification of their CYP3A inhibitory potential in two in vitro experimental models of human small intestine, cryopreserved human intestinal mucosa (CHIM), and cryopreserved human enterocytes (CHEs). Two CYP3A substrates were used-in the studies with CHIM, CYP3A activity was quantified via liquid chromatography tandem mass spectrometry quantification of midazolam 1'-hydroxylation, whereas in CHE, luciferin-IPA metabolism to luciferin was quantified by luminescence. Upon treatment of CHIM with the estimated lumen concentration of the HS upon each oral administration (manufacturers' recommended dosage dissolved in 200 ml of culture medium), >80% CYP3A inhibition was observed for green tea extract, St. John's wort, valerian root, horehound, and grapefruit juice. Less than 50% inhibition was observed for fenugreek, aloe vera, guarana, soy isoflavone, maca, echinacea, spirulina, evening primrose, milk thistle, cranberry, red yeast rice, rhodiola, ginkgo biloba, turmeric, curcumin, white kidney bean, garlic, cinnamon, saw palmetto berries, panax ginseng, black elderberry, wheat grass juice, flaxseed oil, black cohosh, and ginger root. The results were confirmed in a a dose-response study with HSs obtained from three suppliers for the four inhibitory HSs (green tea extract, horehound, St. John's wort, valerian root) and three representative noninhibitory HSs (black cohosh, black elderberry, echinacea). Similar results were obtained with the inhibitory HSs in CHE. The results illustrate that CHIM and CHE represent physiologically relevant in vitro experimental models for the evaluation of drug interaction potential of herbal supplements. Based on the results, green tea extract, horehound, St. John's wort, and valerian root may cause drug interactions with orally administered drugs that are CYP3A substrates, as was observed for grapefruit juice. SIGNIFICANCE STATEMENT: In vitro evaluation of 29 popular herbal supplements in cryopreserved human intestinal mucosa identified green tea extract, horehound, St. John's wort, and valerian

BACKGROUND: The use of herbal medicinal products (HMPs) is common among older adults; however, little is known about concurrent use with prescription drugs, as well as potential interactions associated with such combinations. OBJECTIVE: The aim of this systematic review was to identify and evaluate the literature on concurrent prescription and HMP use among older adults to assess prevalence, patterns, potential interactions and factors associated with this use. METHODS: Systematic searches were conducted in the MEDLINE, PsycINFO, EMBASE, CINAHL, AMED, Web of Science and Cochrane databases from inception to May 2017 for studies reporting concurrent use of prescription medicines with HMPs in adults ≥ 65 years of age. Quality was assessed using the Joanna Briggs Institute checklists. And the Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre) three-stage approach to mixed method research was used to synthesise data. RESULTS: Twenty-two studies were included. A definition of HMPs or what was considered an HMP was frequently missing. Prevalence of concurrent use by older adults varied widely between 5.3 and 88.3%. Prescription medicines most combined with HMPs were antihypertensive drugs, β-blockers, diuretics, antihyperlipidemic agents, anticoagulants, analgesics, antihistamines, antidiabetics, antidepressants and statins. The HMPs most frequently used were Ginkgo biloba, garlic, ginseng, St John's wort, Echinacea, saw palmetto, evening primrose oil and ginger. Potential risks of bleeding due to the use of Ginkgo biloba, garlic or ginseng with aspirin or warfarin was the most reported herb-drug interaction. Some data suggest being female, and having a lower household income and less than a high-school education were associated with concurrent use. CONCLUSION: The prevalence of concurrent prescription drugs and HMP use among older adults is substantial and potential interactions have been reported. Knowledge of the extent and manner in which older adults combine prescription drugs will aid healthcare professionals in appropriately identifying and managing patients at risk. Systematic Review Registration Number: PROSPERO 2014:CRD4201400

Nearly 25% of U.S. adults report concurrently taking a prescription medication with a dietary supplement. Some supplements, such as St. John's wort and goldenseal, are known to cause clinically important drug interactions and should be avoided by most patients receiving any pharmacologic therapy. However, many other supplements are predicted to cause interactions based only on in vitro studies that have not been confirmed or have been refuted in human clinical trials. Some supplements may cause interactions with a few medications but are likely to be safe with other medications (e.g., curcumin, echinacea, garlic, Asian ginseng, green tea extract, kava kava). Some supplements have a low likelihood of drug interactions and, with certain caveats, can safely be taken with most medications (e.g., black cohosh, cranberry, ginkgo, milk thistle, American ginseng, saw palmetto, valerian). Clinicians should consult reliable dietary supplement resources, or clinical pharmacists or pharmacologists, to help assess the safety of specific herbal supplement-drug combinations. Because most patients do not disclose supplement use to clinicians, the most important strategy for detecting herb-drug interactions is to develop a trusting relationship that encourages patients to discuss their dietary supplement use.

Herbal products are commonly used to treat clinical conditions and are often purchased online without the supervision of a healthcare provider. The use of herbals remains controversial because of widespread exaggerated claims of clinical efficacy and safety. We conducted an online search of 13 common herbals (including black cohosh, echinacea, garlic, ginkgo, ginseng, green tea, kava, saw palmetto, and St John's wort) and reviewed the top 50 Web sites for each using a Google search. We analyzed clinical claims, warnings, and other safety information. A total of 1179 Web sites were examined. Less than 8% of retail sites provided information regarding potential adverse effects, drug interactions, and other safety information; only 10.5% recommended consultation with a healthcare professional. Less than 3% cited scientific literature to accompany their claims. Key safety information is still lacking from many online sources of herbal information. Certain nonretail site types may be more reliable, but physicians and other healthcare professionals should be aware of the variable quality of these sites to help patients make more informed decisions. Published by Elsevier Inc.

In recent years, the issue of herbal medicine-drug interactions has generated significant concern. Such interactions can increase the risk for an individual patient, especially with regard to drugs with a narrow therapeutic index (e.g. warfarin, ciclosporin and digoxin). The present article summarizes herbal medicine-drug interactions involving mainly inhibition or induction of cytochrome P450 enzymes and/or drug transporters. An increasing number of in vitro and animal studies, case reports and clinical trials evaluating such interactions have been reported, and the majority of the interactions may be difficult to predict. Potential pharmacodynamic and/or pharmacokinetic interactions of commonly used herbal medicines (black cohosh, garlic, Ginkgo, goldenseal, kava, milk thistle, Panax ginseng, Panax quinquefolius, saw palmetto and St John's wort) with conventional drugs are presented, and sometimes the results are contradictory. Clinical implications of herbal medicine-drug interactions depend on a variety of factors, such as the co-administered drugs, the patient characteristics, the origin of the herbal medicines, the composition of their constituents and the applied dosage regimens. To optimize the use of herbal medicines, further controlled studies are urgently needed to explore their potential for interactions with conventional drugs and to delineate the underlying mechanisms.

This article provides an overview of the clinical evidence of interactions between herbal and conventional medicines. Herbs involved in drug interactions--or that have been evaluated in pharmacokinetic trials--are discussed in this review. While many of the interactions reported are of limited clinical significance and many herbal products (e.g. black cohosh, saw palmetto, echinacea, hawthorn and valerian) seem to expose patients to minor risk under conventional pharmacotherapy, a few herbs, notably St. John's wort, may provoke adverse events sufficiently serious to endanger the patients' health. Healthcare professionals should remain vigilant for potential interactions between herbal medicines and prescribed drugs, especially when drugs with a narrow therapeutic index are used.

As the uses of herbal medicines from traditional natural products are increased, the need for pharmacokinetic studies and relevant data are also increased for safe pharmacotherapy. The market entry for the traditional herbal medicine is easier compared with that for synthetic drugs because of a lower regulatory barrier. Thus, the exact mechanisms for the absorption, distribution, metabolism and excretion of active components in herbal medicines and the potential herb-drug interactions are not always fully understood. Recently, there has been an increasing interest in pharmacokinetic studies of herbal remedies and relevant data of commonly used herbal remedies are accumulating in this field. In this review, the effects of nine botanicals (ginkgo, green tea, grapes, licorice, saw palmetto, garlic milk thistle, ginseng and St. John's wort) on metabolic enzymes and transporters affecting absorption and disposition of herbal products are summarized. The source of samples (extracts and individual components), the species (human and animal) and in vivo and in vitro systems were separately reviewed for a better understanding of herb-drug interactions.

The aim of this study was to investigate the effect of commonly used botanicals on UDP-glucuronosyltransferase (UGT) 1A4, UGT1A6, and UGT1A9 activities in human liver microsomes. The extracts screened were black cohosh, cranberry, echinacea, garlic, ginkgo, ginseng, milk thistle, saw palmetto, and valerian in addition to the green tea catechin epigallocatechin gallate (EGCG). Formation of trifluoperazine glucuronide, serotonin glucuronide, and mycophenolic acid phenolic glucuronide was used as an index reaction for UGT1A4, UGT1A6, and UGT1A9 activities, respectively, in human liver microsomes. Inhibition potency was expressed as the concentration of the inhibitor at 50% activity (IC(50)) and the volume in which the dose could be diluted to generate an IC(50)-equivalent concentration [volume/dose index (VDI)]. Potential inhibitors were EGCG for UGT1A4, milk thistle for both UGT1A6 and UGT1A9, saw palmetto for UGT1A6, and cranberry for UGT1A9. EGCG inhibited UGT1A4 with an IC(50) value of (mean ± S.E.) 33.8 ± 3.1 μg/ml. Milk thistle inhibited both UGT1A6 and UGT1A9 with IC(50) values of 59.5 ± 3.6 and 33.6 ± 3.1 μg/ml, respectively. Saw palmetto and cranberry weakly inhibited UGT1A6 and UGT1A9, respectively, with IC(50) values >100 μg/ml. For each inhibition, VDI was calculated to determine the potential of achieving IC(50)-equivalent concentrations in vivo. VDI values for inhibitors indicate a potential for inhibition of first-pass glucuronidation of UGT1A4, UGT1A6, and UGT1A9 substrates. These results highlight the possibility of herb-drug interactions through modulation of UGT enzyme activities. Further clinical studies are warranted to investigate the in vivo extent of the observed interactions.

BACKGROUND: Herbal medicines are used by a considerable number of surgical patients. An increased risk of bleeding, substantiated by anecdotal reports, has been attributed to the use of certain herbs, and numerous in vitro experiments have identified some herbal extracts as platelet inhibitors. The purpose of this investigation was to determine whether standard commercial preparations of commonly used herbal medicines have an effect on platelet function in vivo and, by extension, to provide clinical scientific evidence of the safety of their use in the perioperative period. METHODS: Five commercially available herbal agents were investigated, including Ginkgo biloba, garlic, Asian ginseng, St. John's wort, and saw palmetto. In a blinded fashion, one of the agents was administered to 10 adult volunteers at the manufacturer's recommended dose for 2 weeks. At the end of the 2-week period, in vivo platelet function was quantified using the PFA-100 assay. After a 2-week "washout" period, the protocol was repeated using a different agent. This 4-week cycle was repeated for each of the five herbal agents, as well as the control agent aspirin. RESULTS: In vivo platelet function was not affected by the administration of any herbal agent and was markedly inhibited with the administration of aspirin. CONCLUSIONS: The herbal medicines investigated in this study do not affect platelet function in vivo. Neither this experiment nor a review of the literature supports the concern of perioperative bleeding in users of these herbal medicines.

Unsafe and potentially safe herbal therapies are discussed. The use of herbal therapies is on the rise in the United States, but most pharmacists are not adequately prepared educationally to meet patients' requests for information on herbal products. Pharmacists must also cope with an environment in which there is relatively little regulation of herbal therapies by FDA. Many herbs have been identified as unsafe, including borage, calamus, coltsfoot, comfrey, life root, sassafras, chaparral, germander, licorice, and ma huang. Potentially safe herbs include feverfew, garlic, ginkgo, Asian ginseng, saw palmetto, St. John's wort, and valerian. Clinical trials have been used to evaluate feverfew for migraine prevention and rheumatoid arthritis; garlic for hypertension, hyperlipidemia, and infections; ginkgo for circulatory disturbances and dementia; ginseng for fatigue and cancer prevention; and saw palmetto for benign prostatic hyperplasia. Also studied in formal trials have been St. John's wort for depression and valerian for insomnia. The clinical trial results are suggestive of efficacy of some herbal therapies for some conditions. German Commission E, a regulatory body that evaluates the safety and efficacy of herbs on the basis of clinical trials, cases, and other scientific literature, has established indications and dosage recommendations for many herbal therapies. Pharmacists have a responsibility to educate themselves about herbal therapies in order to help patients discern the facts from the fiction, avoid harm, and gain what benefits may be available.

Hair loss is a distressing problem that affects the self-image and quality of life of many people. The increasing demand for alternative treatments has led to growing interest in using herbal medicine for hair loss management. This literature review is divided into two main parts: a narrative overview and a systematic synthesis, evaluating the efficacy of herbal remedies, gathering findings from recent clinical studies, and traditional practices. The narrative section explores the pathophysiology of hair loss, contributing factors, and conventional pharmacological treatments, including their limitations and adverse effects. The second part presents a systematic review of sixteen randomized controlled trials evaluating the clinical efficacy and safety of herbal remedies for hair loss. Natural products such as rosemary, green tea, ginseng, Aloe vera, olive, and saw palmetto have shown promising efficacy in promoting hair growth, improving hair density, reducing hair shedding, and enhancing patient satisfaction through mechanisms involving anti-inflammatory, hormonal, and enhanced scalp circulation. However, study design limitations and outcome variability necessitate further rigorous, standardized research. This review aims to offer an integrative, evidence-informed perspective on the therapeutic potential of herbal medicine for hair loss in clinical evidence. © 2025. The Author(s).

Comment in Am J Mens Health. 2020 May-Jun;14(3):1557988320936897. doi: 10.1177/1557988320936897. Studies reported that Serenoa repens was effective in relieving lower urinary tract symptoms (LUTS). This article carried out a systematic review and meta-analysis to compare Serenoa repens with tamsulosin in the treatment of benign prostatic hyperplasia (BPH) after at least 6-month treatment cycle. Four studies involving 1,080 patients (543 in the Serenoa repens group and 537 in the tamsulosin group) were included in the meta-analysis. The results were as follows: compared with tamsulosin, Serenoa repens had a same effect in treating BPH in terms of International Prostate Symptom Score (IPSS) (mean difference [MD] 0.63, 95% confidence interval [CI] [-0.33, 1.59], p = 0.20), quality of life (QoL) (MD 1.51, 95% CI [-1.51, 4.52], p = 0.33), maximum flow rate (Qmax) (MD 0.27, 95% CI [-0.15, 0.68], p = 0.21), postvoid residual volume (PVR) (MD -4.23, 95% CI [-22.97, 14.44], p = 0.65), prostate-specific antigen (PSA) (MD 0.46, 95% CI [-0.06, 0.97], p = 0.08) with the exception of prostate volume (PV) (MD -0.29, 95% CI [-0.41, -0.17], p < 0.00001). For side effects, Serenoa repens was well tolerated compared with tamsulosin especially in ejaculation disorders (odds ratio [OR] = 12.56, 95% CI [3.83, 41.18], p < 0.0001) and decreased libido (OR = 5.40; 95% CI [1.17, 24.87]; p = 0.03). This study indicated that Serenoa repens had the same effect in treating BPH compared with tamsulosin in terms of IPSS, QoL, and PVR after at least 6-month treatment cycle, however, the latter had a greater improvement in PV compared with the former. And Serenoa repens did not increase the risk of adverse events especially with respect to ejaculation disorders and libido decrease.

Comment in Eur Urol Focus. 2021 May;7(3):662-663. doi: 10.1016/j.euf.2020.04.010. Eur Urol Focus. 2021 Jul;7(4):894-896. doi: 10.1016/j.euf.2020.03.011. 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 repen

BACKGROUND: and aims: Benign Prostatic hyperplasia (BPH) is an important public health problem. Roughly half of all men will suffer from BPH related symptoms later in life. The prostate gland, a hormone dependent part of the male reproductive system, is susceptible to internal and external disruptions of regulatory systems. We attempt in this paper to collect available evidence on influence of lifestyle modifications, and naturally occurring substances, plants, micronutrients and supplements on BPH symptoms. METHODS: Systematic review was performed within the MEDLINE database and Cochrane Library Central Search using a combination of Medical Subject Headings (MeSH) and keywords. RESULTS: Moderate exercise and the type and amount of protein intake have a considerable influence on BPH symptoms. The intake of zinc and vitamin D also positively influence BPH symptoms, and so do certain supplements, such as saw palmetto, cemilton and pygeum extracts. CONCLUSIONS: Lifestyle changes, diet modification and certain nutritional supplements can favorably influence BPH symptoms.

OBJECTIVES: To comprehensively evaluate the efficacy and safety of the hexanic extract of Serenoa repens (HESr, Permixon® ; Pierre Fabre Médicament, Castres, France), at a dose of 320 mg daily, as monotherapy for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). MATERIALS AND METHODS: We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) and prospective observational studies in patients with LUTS/BPH identified through searches in Medline, Web of Knowledge (Institute for Scientific Information), Scopus, the Cochrane Library, and bibliographic references up to March 2017. Articles studying S. repens extracts other than Permixon were excluded. Data were collected on International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax ), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions (ADRs). Data obtained from RCTs and observational studies were analysed jointly and separately using a random effects model. A sub-group analysis was performed of studies that included patients on longer-term treatment (≥1 year). RESULTS: Data from 27 studies (15 RCTs and 12 observational studies) were included for meta-analysis (total N = 5 800). Compared with placebo, the HESr was associated with 0.64 (95% confidence interval [CI] -0.98 to -0.31) fewer voids/night (P < 0.001) and an additional mean increase in Qmax of 2.75 mL/s (95% CI 0.57 to 4.93; P = 0.01). When compared with α-blockers, the HESr showed similar improvements on IPSS (weighted mean difference [WMD] 0.57, 95% CI -0.27 to 1.42; P = 0.18) and a comparable increase in Qmax to tamsulosin (WMD -0.02, 95% CI -0.71 to 0.66; P = 0.95). Efficacy assessed using the IPSS was similar after 6 months of treatment between the HESr and 5α-reductase inhibitors (5ARIs). Analysis of all available published data for the HESr showed a mean improvement in IPSS from baseline of -5.73 points (95% CI -6.91 to -4.54; P < 0.001). HESr did not negatively affect sexual function and no clinically relevant effect was observed on prostate-specific antigen. Prostate volume decreased slightly. Similar efficacy resu

BACKGROUND: Benign prostatic hyperplasia (BPH) is a nonmalignant 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: This systematic review aimed to assess the effects and harms of Serenoa repens in the treatment of men with LUTS consistent with BPH. SEARCH METHODS: We searched for trials in general and in specialized databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE®, EMBASE, CINAHL®, Web of Science, SCOPUS, BIOSIS Previews®, LILACS, ClinicalTrials.gov, Controlled-Trials.com, World Health Organization (WHO), and Google Scholar. We also handsearched systematic reviews, references, and clinical practice guidelines. There were no language restrictions. SELECTION CRITERIA: Trials were eligible if they randomized men with symptomatic BPH to receive preparations of SR (alone or in combination) for at least four weeks in comparison with placebo or other interventions, and included clinical outcomes, such as urologic symptom scales, symptoms, and urodynamic measurements. Eligibility was assessed by at least two independent observers (JT, RM). DATA COLLECTION AND ANALYSIS: One review author (JT) extracted Information on patients, interventions, and outcomes which was then checked by another review author (RM). The main outcome measure for comparing the effectiveness of SR with active or inert controls was change in urologic symptom-scale scores, with validated scores taking precedence over non validated ones. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for harms was the number of men reporting side effects. MAIN RESULTS: In a meta-analysis of two high quality long-term trials (n = 582), Serenoa repens therapy was not superior to placebo in reducing LUTS based on

INTRODUCTION: Lower urinary tract symptoms related to benign prostatic hyperplasia (BPH) and bladder outlet obstruction may affect up to 30% of men in their early 70s. Symptoms can improve without treatment, but the usual course is a slow progression of symptoms, with acute urinary retention occurring in 1% to 2% of men with BPH per year. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of medical, herbal, and surgical treatments? We searched: Medline, Embase, The Cochrane Library, and other important databases up to July 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found 63 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: 5 alpha-reductase inhibitors, alpha-blockers, beta-sitosterol plant extract, Pygeum africanum, rye grass pollen extract, saw palmetto plant extracts, transurethral electrovaporisation, transurethral Holmium laser enucleation of the prostate, transurethral microwave thermotherapy, transurethral needle ablation, and transurethral resection (including transurethral resection versus transurethral incision, and transurethral resection versus visual laser ablation/laser vaporisation).

The concomitant use of herbal medicines and pharmacotherapy is wide spread. We have reviewed the literature to determine the possible interactions between seven popular herbal medicines (ginkgo, St John's wort, ginseng, garlic, echinacea, saw palmetto and kava) and conventional drugs. Literature searches were performed using MEDLINE, Cochrane Library and EMBASE and we identified 128 case reports or case series, and 80 clinical trials. Clinical trials indicate that St John's wort (Hypericum perforatum), via cytochrome P450 (CYP) and/or P-glycoprotein induction, reduces the plasma concentrations (and/or increases the clearance) of alprazolam, amitriptyline, atorvastatin, chlorzoxazone, ciclosporin, debrisoquine, digoxin, erythromycin, fexofenadine, gliclazide, imatinib, indinavir, irinotecan, ivabradine, mephenytoin, methadone, midazolam, nifedipine, omeprazole, oral contraceptives, quazepam, simvastatin, tacrolimus, talinolol, verapamil, voriconazole and warfarin. Case reports or case series suggest interactions of St John's wort with adrenergic vasopressors, anaesthetics, bupropion, buspirone, ciclosporin, eletriptan, loperamide, nefazodone, nevirapine, oral contraceptives, paroxetine, phenprocoumon, prednisone, sertraline, tacrolimus, theophylline, tibolone, tryptophan, venlafaxine and warfarin. Ginkgo (Ginkgo biloba) decreases the plasma concentrations of omeprazole, ritonavir and tolbutamide. Clinical cases indicate interactions of ginkgo with antiepileptics, aspirin (acetylsalicylic acid), diuretics, ibuprofen, risperidone, rofecoxib, trazodone and warfarin. Ginseng (Panax ginseng) may interact with phenelzine and warfarin. Kava (Piper methysticum) increases the clearance of chlorzoxazone (a CYP2E1 substrate) and may interact with alprazolam, levodopa and paroxetine. Garlic (Allium sativum) interacts with chlorpropamide, fluindione, ritonavir and warfarin; it also reduces plasma concentrations of chlorzoxazone (a CYP2E1 probe). Echinacea might affect the clearance of caffeine (a CYP1A2 probe) and midazolam (a CYP3A4 probe). No interactions have been reported for saw palmetto (Serenoa repens). Numerous interactions between herbal medicines and conventional dr

Serenoa repens (W. Bartram) Small, also known as saw palmetto, is one of the most widely used herbal preparations for the treatment of lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH). Although a number of randomized controlled trials (RCTs) and systematic reviews of the efficacy of S. repens for the treatment of LUTS and BPH have been published, no systematic review on its drug interactions or adverse events currently exists. This review assesses all available human safety data of S. repens monopreparations. Systematic literature searches were conducted from date of inception to February 2008 in five electronic databases; reference lists and our departmental files were checked for further relevant publications. Information was requested from spontaneous reporting schemes of the WHO and national safety bodies. Twenty-four manufacturers/distributors of S. repens preparations and four herbalist organizations were contacted for additional information. No language restrictions were imposed. Only reports of adverse events in humans from monopreparations of S. repens were included. Data from all articles, regardless of study design, reporting adverse events or interactions were independently extracted by the first author and validated by the second. Forty articles (26 randomized controlled trials, 4 non-randomized controlled trials, 6 uncontrolled trials and 4 case reports/series) were included. They suggest that adverse events associated with the use of S. repens are mild and similar to those with placebo. The most frequently reported adverse events are abdominal pain, diarrhoea, nausea, fatigue, headache, decreased libido and rhinitis. More serious adverse events such as death and cerebral haemorrhage are reported in isolated case reports and data from spontaneous reporting schemes, but causality is questionable. No drug interactions were reported. Currently available data suggest that S. repens is well tolerated by most users and is not associated with serious adverse events. The majority of adverse events are mild, infrequent and reversible, and include abdominal pain, diarrhoea, nausea and fatigue, headache, decreased libido and rhinitis

INTRODUCTION: Serenoa repens extract has been widely used as a phytotherapeutic option for benign prostatic hyperplasia (BPH), potentially offering a milder alternative to pharmaceutical treatments such as 5-alpha reductase inhibitors or alpha-blockers. However, its effects on sexual function remain inconsistent across randomized trials. This study aimed to evaluate the effects of S. repens extract on sexual function and quality of life in men withBPH. METHODS: Five electronic databases were searched from inception to January 21, 2026, for randomized controlled trials comparing S. repens extract with placebo in men with BPH. The primary outcome was sexual function, with analyses restricted to studies using the International Index of Erectile Function (IIEF) where possible to improve comparability. Quality of life was evaluated as a secondary outcome. Random-effects meta-analyses were performed using standardized mean differences with Hartung-Knapp-Sidik-Jonkman adjustment and restricted maximum likelihood estimation. RESULTS: Six randomized controlled trials were included. The pooled analysis showed no statistically significant effect of S. repens extract on sexual function compared with placebo (Hedges' g = -0.08, 95% CI -0.93 to 0.77; I 2 = 96.16%). The corresponding 95% prediction interval ranged from -2.448 to 2.286, indicating considerable between-study variability and suggesting that future studies could plausibly demonstrate effects favoring either S. repens or placebo. In the subgroup analysis restricted to studies using the IIEF, heterogeneity was substantially reduced (Hedges' g = -0.206, 95% CI -0.540 to 0.128; I 2 = 28.76%), although the treatment effect remained statistically

Background: There is limited evidence on comparative effectiveness of off-label therapies approved by the United States Food and Drug Administration (FDA) for androgenetic alopecia (AGA) and the unregulated ones. Objective: To evaluate and compare the molecular mechanisms, clinical efficacy, and safety of off-label therapies for male AGA through a network meta-analysis (NMA). Methods: A systematic literature search in PubMed, Scopus, Web of Science, and ClinicalTrials.gov was conducted on 23 January 2026. We examined studies that assessed mean 6-month change in total hair density of off-label monotherapies, including topical minoxidil (2%, 5%) for male AGA. Sensitivity analyses were conducted. Results: Our search identified 23 studies (15 off-label and 8 topical minoxidil). We found topical minoxidil 5% to be ranked most effective. Other effective therapies included melatonin (topical), diaminopyrimidine oxide 1% (topical), procyanidin 1% (topical), saw palmetto (topical), exosome-based formulation containing plant-derived extracts (subcutaneous), cetirizine 1% (topical) and finasteride (topical). Conclusions: Our results substantiate topical minoxidil 5% being the most effective option; our findings also suggest that other off-label therapies demonstrate potential clinical benefit, warranting further high-quality comparative trials.

INTRODUCTION: Androgenic alopecia (AGA) is the most common type of hair loss that occurs due to androgens, specially, dihydrotestosterone (DHT), and the 5-alpha reductase is the key enzyme to control AGA, as it is responsible for the conversion of testosterone to DHT, the more potent form of testosterone involved in the pathogenesis of AGA. Blockers of this enzyme suppress the conversion of androgens to DHT. Dutasteride is one of the 5-alpha reductase inhibitors and is frequently used as an anti-hair loss treatment. Gamma-oryzanol (GO) is an anti-oxidant and anti-5-alpha reductase, which has been i

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 -

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.

BACKGROUND: In recent years, androgenetic alopecia (AGA) has emerged as a significant public health concern due to its high prevalence and progressive nature. In addition to progressive scalp thinning and hair loss, patients often experience psychological distress and diminished quality of life. While standard treatments such as finasteride and minoxidil are effective, their side effects and adherence issues limit long-term use, making the exploration of safe and accessible intervention strategies essential. Dietary supplements, claimed to promote hair growth by inhibiting androgen pathways and improving the follicular microenvironment, have become an attractive adjunct for both clinicians and patients due to their low cost and ease of use. However, existing studies have limitations, including the diversity of supplements, small sample sizes, and the lack of direct comparisons among different supplements, making it unclear how they compare in terms of efficacy and safety. This study aims to use a network meta-analysis (NMA) to compare the effectiveness and safety of various dietary supplements based on outcomes such as hair density and terminal hair density, providing evidence-based support for clinical decision-making. METHODS: A systematic search was conducted in English-language databases such as PubMed, Cochrane Library, Embase, and Web of Science for randomized controlled trials (RCTs) investigating the use of dietary supplements for treating AGA. Stata 16.0 software was used for network meta-analysis, and Revman 5.4 software was utilized for evaluating study quality and bias risk; additionally, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework was applied to rate the certainty (quali

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

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 evidenc

OBJECTIVE: The male lower urinary tract symptoms (LUTS) panel of the French Urological Association (AFU) aimed to update the 2012 French guidelines for pharmacological treatment of LUTS secondary to benign prostatic hyperplasia (BPH). METHODS: A systematic review of articles published between 2012 and 2024 was conducted in PubMed® to update the previous guidelines. The methodology included a predefined search strategy, critical appraisal of the literature with assignment of evidence levels, and the development of evidence-based conclusions and recommendations. RESULTS/RECOMMENDATIONS: Monitoring may be offered to patients with mild to moderate LUTS who are not bothered by their symptoms. Men with LUTS should be offered lifestyle and dietary advice before or when initiating treatment. Alpha-blockers may be offered to patients with moderate to severe LUTS as first-line therapy. 5-alpha-reduc

While androgenetic alopecia (AGA) is primarily driven by excessive 5-α reductase (5-αR) activity, further mechanisms also contribute to the development of AGA and other hair loss disorders. Here, we explored the properties of the proprietary lipidosterolic extracts of the plant Serenoa repens (LSESr), also known as Saw Palmetto, focusing on USPlus® DERM Bioactive Fatty Acids (USPlus® DERM). USPlus® DERM contains concentrated levels of bioactive free fatty acids (FFAs) that are integral lipids found in the hair shaft and modulate pathways relevant to hair follicle (HF) function. Therefore, USPlus® DERM promises to have both 5-αR-dependent and also -independent hair growth-promoting effects. Here, we initially confirmed the 5-αR inhibitor activity of USPlus® DERM in primary human hair follicle dermal papilla cells. USPlus® DERM exhibited a more potent 5-αR inhibition than a standard, commercially available saw palmetto extract and a standardized LSESr meeting the US Pharmacopoeia monograph, with IC50 values of 0.39, 29.1 and 9.1 μg/mL respectively. To explore potential 5-αR-independent responses, USPlus® DERM was administered at two different concentrations, 0.4 and 10 μg/mL, to androgen-independent, 'clinically healthy' full-length HFs ex vivo obtained from the occipital scalp of male donors, in the absence of testosterone. Interestingly, USPlus® DERM at 0.4 μg/mL significantly reduced the number of melanin clumps, regarded as

BACKGROUND: Standard medical treatments for patients with uncomplicated LUTS include alpha-blockers, 5-alpha-reductase inhibitors (5ARIs), phosphodiesterase type 5 inhibitors, antimuscarinics, and beta-3 agonists. The lipido-sterolic extract of Serenoa repens (Sr) is also recommended as a therapeutic option. Our study prospectively evaluated the impact of a 6-month assumption of lipido-sterolic extract of Sr alone or in combination with Phenolmicin P3 and Bosexil medical devices suppositories on symptoms and on PSA levels in patients affected by BPO related-LUTS. METHODS: We prospectively enrolled 509 patients: 194 (group 1) were prescribed only a 6-month assumption of Sr extract, while 315 (group 2) were also prescribed a 20-day therapy with Phenolmicin P3 and Bosexil medical devices suppositories. RESULTS: After 6 months, 371 patients' data were registered and analyzed. Furthermore, patients' withdrawal and motivations were also considered. CONCLUSIONS: In our clinical study, the patients treated with Sr extract (320 mg daily) showed a significant relief regarding LUTS, and the association of a 6-month assumption of Sr extract with a 20-day prescription of Phenolmicin P3 and Bosexil medical device in suppository form seems to significantly improve both efficacy on LUTS and decrease of PSA levels.

12. Int J Dermatol. 2026 Mar;65(3):614-616. doi: 10.1111/ijd.17987. Epub 2025 Aug 4. The Over-The-Counter Finasteride Alternative: A Critical Review of Saw Palmetto's Efficacy, Safety, and Regulatory Concerns. Nguyen KT(1), Verma KK(1), Matthew E(2), Friedmann DP(3), Tarbox MB(2). Author information: (1)Texas Tech University Health Sciences Center, School of Medicine, Lubbock, Texas, USA. (2)Department of Dermatology, Texas Tech University Health Sciences Center, Lubbock, Texas, USA. (3)Westlake Dermatology Clinical Research Center, Westlake Dermatology & Cosmetic Surgery, Austin, Texas, USA. DOI: 10.1111/ijd.17987 PMID: 40928144

BACKGROUND: Minoxidil and finasteride are currently the only FDA-approved pharmacological treatments for androgenic alopecia (AGA) and female androgenic alopecia (FAGA). However, substantial improvement is observed in no more than 20% of patients in the medium term. To enhance clinical responses, nonpharmacological dietary supplementation is often utilized. AIMS: This study evaluated the efficacy of a novel dietary supplement, AGA-P, which contains Serenoa repens extract, Cucurbita pepo extract, L-Cystine, and Vitamin C, in a multicenter, randomized, assessor-blinded, real-life trial alongside pharmacological treatments. The objective was to determine whether dietary supplementation could improve the clinical efficacy of minoxidil and finasteride. PATIENTS AND METHODS: A total of 225 subjects with AGA or FAGA (165 men, mean age 40 ± 14 years, range 18-74) were enrolled after obtaining informed consent. Inclusion criteria included male subjects over 18 years and postmenopausal women with mild to moderate AGA/FAGA, eligible for dietary and/or pharmacological treatment. Of these participants, 106 (24 women and 82 men) were assigned to receive pharmacological treatment plus dietary supplementation (one capsule daily; Group A), while 119 (36 women and 83 men) received drug treatment only (Group B). The pharmacological treatments consisted of topical minoxidil and oral finasteride in most cases. Treatment duration was 6 months. RESULTS: The results indicated that oral supplementation significantly increased the clinical efficacy of pharmacological treatments for mild-to-severe AGA/FAGA compare