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New meta-analyses, RCTs and systematic reviews that we monitor daily in PubMed. Independently indexed, not editorially curated.
Nutrients · 2025
Background: Knee osteoarthritis (KOA) is a prevalent degenerative joint disease that can greatly affect quality of life in middle-aged and elderly individuals. Nutritional supplements are increasingly used for KOA due to their low risk, but direct comparative evidence on their efficacy and safety remains scarce. This study aimed to systematically compare the effectiveness and safety of seven common nutritional supplements for KOA. Methods: A systematic review and network meta-analysis were conducted following PRISMA guidelines. Embase, PubMed, and the Cochrane Library were searched through December 2024 for randomized controlled trials (RCTs) evaluating use of eggshell membrane, vitamin D, Boswellia, curcumin, ginger, krill oil, or collagen, versus placebo, in adults with KOA. Primary outcomes included changes in scores for WOMAC pain, stiffness and function, and pain visual analog scale (VAS). Adverse events were also assessed. Bayesian network meta-analyses estimated ranking probabilities for each intervention. Results: In total, 39 RCTs (42 studies; 4599 patients) were included. Compared with placebo, Boswellia showed significant improvements in WOMAC pain (mean difference [MD] = 10.58, 95% CI: 6.45 to 14.78, p < 0.05), stiffness (MD = 9.47, 95% CI: 6.39 254 to 12.74, p < 0.05), function (MD = 14.00, 95% CI: 7.74 to 20.21, p < 0.05), and VAS pain (MD = 17.26, 95% CI: 8.06 to 26.52, p < 0.05). Curcumin, collagen, ginger, and krill oil also demonstrated benefits in some outcomes. No supplement was associated with increased adverse events compared to placebo. Bayesian rankings indicated Boswellia had the highest probability of being most effective for pain and stiffness, with krill oil and curcumin showing potential for function improvement. Conclusions: Nutritional supplements, particularly Boswellia, appear to be effective and well-tolerated for improving KOA symptoms and function. These results suggest that certain supplements may be useful as part of non-pharmacological KOA management. However, further large-scale, well-designed randomized controlled trials (RCTs) are needed to confirm these findings, particularly those that include more standardized dosages and formulations, as well as to evaluate their long-term efficacy.
Complementary therapies in medicine · 2026
Herbal interventions such as Curcuma longa (CL) and Boswellia serrata (BS) have demonstrated efficacy and safety in managing knee osteoarthritis (KOA); however, the effects of their combined formulation, including both direct and indirect outcomes, remain insufficiently explored. We performed systematic review and network meta-analysis for clinical effects of CL, BS, and their mixed formulation in alleviating KOA symptoms. The CENTRAL, PubMed, EMBASE, and EBSCO Open Dissertations, databases and also from Snowballing and citation searching were searched through March 2025. The randomized controlled trials (RCTs) that studied effectiveness of CL or BS in KOA participants using Visual Analog Scale (VAS) and KOA severity by the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and adverse events as the main outcomes, were eligibly included. The Cochrane Risk of Bias a random-effects model, standardized mean differences (SMDs) along with 95 % confidence intervals (CIs) were employed. In total, 20 RCTs comprising 1633 participants were included. The modified formulations of CL showed a significant reduction in VAS compared to placebo (SMD: -2.82; 95 %CI: -5.30 to -0.33), while the modified formulations of BS demonstrated significant improvement in WOMAC pain, stiffness, and knee function compared to other intervention groups. No significant differences in adverse events were observed among all comparisons. BS extract, particularly in modified formulations, improves joint function in patients with mild to moderate KOA, while only the modified formulation of CL demonstrates notable pain-reducing efficacy. The potential benefits of combined CL and BS preparations warrant further investigation.
Journal of ethnopharmacology · 2026
Glycyrrhiza glabra L. (Fabaceae), commonly known as liquorice, has been valued for millennia in Ayurveda, Traditional Chinese Medicine (TCM), Persian medicine, and European folk practice. Across these cultures, liquorice root decoctions and formulations are employed to reduce joint pain, curb inflammation, restore systemic balance, and serve as a harmonising "guide herb" in polyherbal prescriptions. To provide an integrated review of G. glabra in rheumatoid arthritis (RA) management, linking its traditional therapeutic roles with modern pharmacological evidence and exploring its synergistic potential with other agents. A systematic literature review was conducted using PubMed, Scopus, Springer, ScienceDirect, and Google Scholar. Ethnobotanical, phytochemical, in vitro, in vivo, in silico, and integrative medicine studies were included. Traditional preparations such as roasted, honey-fried, crude root decoctions are reflected in modern bioassays confirming anti-inflammatory, antioxidant, immunomodulatory and cartilage-protective activities. Bioactives, including glycyrrhizin, glycyrrhetinic acid, isoliquiritigenin, liquiritin, and licochalcone A, modulate NF-κB, MAPK, COX/LOX, JAK/STAT and angiogenic pathways, restore Th17/Treg balance, and regulate gut microbiota. Synergistic effects are reported with methotrexate, triptolide, mangiferin, Boswellia serrata extract, and platelet-rich plasma. The convergence of ancient ethnomedical use and robust modern pharmacology positions G. glabra as a promising adjunctive therapeutic for RA. Future directions should focus on community-based clinical trials, sustainable cultivation, benefit-sharing with knowledge holders, and the development of standardised extracts.
Urologiia (Moscow, Russia : 1999) · 2019
Benign prostatic hyperplasia (BPH) is the most common proliferative disease of the prostate gland in the elderly. The results of an open, randomized comparative study of the effectiveness of Serenoa repens in the combination with Urtica dioiccus (Prostagut-forte) are presented in the article. All patients were divided into two groups, depending on the therapy. In group I (n=51) Serenoa repens in combination with Urtica dioiccus 160/120 mg twice daily for 3 months was given, while in Group II (n=51) patients were prescribed to Serenoa repens 320 mg once a day, for 3 months. According to the results, herbal preparations, like Serenoa repens, are effective for the medical treatment of BPH, which is confirmed by a decrease in LUTS severity, an increase in Qmax, a decrease in postvoid residual urine volume and an intensity of the inflammatory process in the prostatic tissue. However, in patients with BPH associated with chronic inflammation, it is preferable to use Serenoa repens in combination with Urtica dioiccus.
Clinical nutrition ESPEN · 2019
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. Systematic review was performed within the MEDLINE database and Cochrane Library Central Search using a combination of Medical Subject Headings (MeSH) and keywords. 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. Lifestyle changes, diet modification and certain nutritional supplements can favorably influence BPH symptoms.
Urologia internationalis · 2019
To evaluate the efficacy of Bifiprost® + Serenoa Repens 320 mg versus Serenoa Repens 320 mg alone for the prevention of chronic bacterial prostatitis (CBP) due to enterobacteriaceae. Between September 2016 and September 2018, 120 patients with CBP at the National Institutes of Health (NIH type II) with recurrent infections due to enterobacteriaceae (Escherichia Coli and Enterococcus faecalis) were enrolled and randomized into 2 groups each to receive Bifiprost® + Serenoa Repens 320 mg (Group A) or Serenoa Repens 320 mg alone (Group B) daily for 24 weeks (after receiving a proper antibiotic treatment with subsequent culture negativization). The primary endpoint was the reduction in the episodes of prostatitis. The secondary endpoint evaluated was the score of the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI). Evaluation was performed at baseline and at 12, 24, and 36 weeks. The patients of the Group A experienced a significantly larger reduction in the prostatitis episodes than the Group B at 24 and 36 weeks, but they did not experience a significantly larger reduction at 12 weeks. After 12 weeks of treatment, the mean NIH-CPSI score was reduced in both groups compared with baselines, but no significant differences were seen between the Group A and Group B. On the contrary, we observed a significant difference in the mean NIH-CPSI score between the 2 groups at 24 and 36 weeks. The association of Bifiprost® and Serenoa Repens 320 mg improves the prevention of the episodes of CBP due to enterobacteriaceae and ameliorates prostatitis-related symptoms after 6 months of therapy. The long-term impact on the entero-urinary route was also seen 3 months after the end of the treatment.
European urology focus · 2021
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. 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. 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). 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. In this network meta-analysis, we demonstrated that SeR did not show clinically meaningful improvement in LUTS and PF. In the present study, we found no clinically meaningful improvement of Serenoa repens for the treatment of lower urinary tract symptoms/benign prostatic enlargement. The analysis showed that the benefit over placebo was minimal and may not justify its clinical use before higher level of evidence will be available.
Zhonghua nan ke xue = National journal of andrology · 2019
To evaluate the effect and safety of Serenoa repens extract (SR) combined with α-receptor blocker (αRB) in the treatment of BPH. We included 7 published randomized controlled trials (RCT) studying the effect and safety of SR+αRB versus αRB monotherapy in the treatment of 1 009 BPH patients, and performed a meta-analysis on the data obtained using the RevMan 5.1.3 software. The baseline data from the RCTs were all comparable. Compared with the patients treated by αRB monotherapy, those of the SR+αRB group showed significant decreases in the total IPSS, sub-IPSS in the storage and voiding stages, quality of life score (QOL) and PSA level (all P < 0.05), an increase in the maximum urinary flow rate (Qmax) (P = 0.04), but no statistically significant differences in the prostate volume and postvoid residual urine volume (P > 0.05). Serenoa repens extract combined with α-receptor blocker is safe and effective, and even better than α-receptor blocker monotherapy, in the treatment of BPH.
American journal of men's health · 2020
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.
BMC urology · 2020
The present clinical trial was conducted to evaluate the efficacy and tolerability of a standardized saw palmetto oil containing 3% β-sitosterol in the treatment of benign prostate hyperplasia (BPH) and androgen deficiency. Subjects aged 40-65 years with symptomatic BPH were randomized to 12-week double-blind treatment with 500 mg doses of β-sitosterol enriched saw palmetto oil, conventional saw palmetto oil and placebo orally in the form of capsules (n = 33 in each group). BPH severity was determined using the International Prostate Symptom Score (IPSS), uroflowmetry, serum measurement of prostate specific antigen (PSA), testosterone and 5α-reductase. During the trial, the androgen deficiency was evaluated using Aging Male Symptoms (AMS) scale, the Androgen Deficiency in the Aging Male (ADAM) questionnaire, serum levels of free testosterone. Subjects treated with β-sitosterol enriched saw palmetto oil showed significant decrease in IPSS, AMS and ADAM scores along with reduced postvoiding residual volume (p < 0.001), PSA (p < 0.01) and 5α-reductase from baseline to end of 12-week treatment as compared to placebo. There was also a significant increment in the maximum and average urine flow rate (p < 0.001), and serum free testosterone level of subjects treated with enriched saw palmetto oil as compared to placebo. This study demonstrates the efficacy of β-sitosterol enriched saw palmetto oil superior to conventional oil thus extending the scope of effective BPH and androgen deficiency treatment with improved quality of life through the intake of functional ingredients. CTRI/2018/12/016724 dated 19/12/2018 prospectively registered. URL: http://ctri.nic.in/Clinicaltrials/advsearch.php.
World journal of urology · 2021
To perform a placebo-controlled trial to evaluate the efficacy and safety of Serenoa repens extract (SRE) for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). We conducted a double-blind, randomized, placebo-controlled, multicenter, clinical phase 4 study of 221 patients with CP/CPPS across 11 centers. Participants were randomly assigned in a 2:1 ratio to receive SRE or placebo for 12 weeks. The primary efficacy endpoint was the change in total score on the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). Secondary efficacy endpoints included improvements within each domain of NIH-CPSI, clinical response rate, and International Index of Erectile Function 5 items (IIEF-5). In total, 226 patients were enrolled and randomized between January 2017 and June 2018. Of these 221 patients were included in the intent-to-treat analysis: 148 in the SRE group and 73 patients in the placebo group. Compared to the placebo, SRE led to statistically significant improvements in the NIH-CPSI total score and sub-scores. The significant improvements of NIH-CPSI scores were established after 2 weeks from the first dose, and continued to the end of the treatment. Furthermore, a significantly higher rate of patients achieved a clinical response in the SRE group compared with that in the placebo group (73.0% vs 32.9%, P < 0.0001). Only minor adverse events were observed across the entire study population. SRE was effective, safe, and clinically superior to placebo for the treatment of CP/CPPS. ChiCTR-IPR-16010196, December 21, 2016 retrospectively registered.
Investigative and clinical urology · 2021
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. 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. 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. 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.
Archivio italiano di urologia, andrologia : organo ufficiale [di] Societa italiana di ecografia urologica e nefrologica · 2021
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. The aim of this study is to investigate whether SR is causing negative effects on male sexual function. 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. 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%). 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.
Asian journal of surgery · 2022
Nutrients · 2022
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.
Nutrition and health · 2025
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).
Investigative and clinical urology · 2024
This study evaluated the effectiveness of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) treatments using multiple pharmaceutical agents that could simultaneously preserve or enhance fertility capability. This was a single-center-based, randomized controlled study, whereas the final analysis evaluated a total 350 CP/CPPS patients (age range, 28-40 years) and 50 patients were randomly allocated to each therapeutic group, with a 1:1 ratio. The therapeutic groups consist of tadalafil (group 1, 5 mg daily), L-carnitine (group 2, 2 g daily), Serenoa repens extract (group 3, 320 mg daily), group 4 (tadalafil+L-carnitine), group 5 (tadalafil+S. repens), group 6 (L-carnitine+S. repens), and group 7 (tadalafil+L-carnitine+S. repens). The treatment outcomes at 3 months post-therapy were analyzed. At 3 months post-therapy, the mean total sperm motility was significantly improved in all groups. A normal morphology improvement was observed in L-carnitine receiving groups. The mean total score on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) and the mean International Prostate Symptom Score (IPSS) showed the greatest reduction in intensity in group 7. Logistic regression analyses showed that group 5 and group 7 were significantly associated with improvements in total IPSS and total NIH-CPSI scores at 3 months post-therapy. Group 7 was a significant predictor for improving total sperm motility, leukocytospermia and normal form of sperm. Tadalafil, carnitine, and S. repens combination therapy could be considered a feasible treatment option for CP/CPPS males with subfertility.
Naunyn-Schmiedeberg's archives of pharmacology · 2025
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.
Journal of cosmetic dermatology · 2025
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. 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. 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. The results indicated that oral supplementation significantly increased the clinical efficacy of pharmacological treatments for mild-to-severe AGA/FAGA compared to drug treatment alone (great improvement: Group A 36.5% vs. Group B 25%; p = 0.04). Oral supplementation of AGA-P significantly increases the clinical efficacy of pharmacological treatments for mild-to-severe AGA/FAGA (Study Registration: ISRCTN-19671217).
The Prostate · 2026
Chronic inflammation is commonly observed in benign prostatic hyperplasia (BPH) tissue and may contribute to lower urinary tract symptoms (LUTS) as well as disease progression. This study evaluated the efficacy of combining a standardized extract of Serenoa repens (Sr) with alfuzosin versus alfuzosin monotherapy in men with LUTS due to BPH. In this prospective Phase III, randomized, multicenter, real-world study, 300 treatment-naïve men with moderate-to-severe LUTS (IPSS > 7) and prostate volume > 30 cc were enrolled. Patients received either alfuzosin 10 mg/day or alfuzosin 10 mg plus HESr 320 mg/day for 12 months. Primary endpoints included changes in IPSS and uroflowmetry (Qmax). Secondary endpoints included quality of life (IPSS-Q8), storage symptoms (IPSS-Q2 and Q4), nocturia (IPSS-Q7), erectile function (IIEF-5), and ejaculatory function (MSHQ-Ej). Outcomes were analyzed using mixed-model ANOVA with post hoc Tukey's tests. Statistical analysis was performed using JMP Pro 14 (SAS Institute Inc.). The protocol was approved by our Ethical Committee Lazio Area 1, Protocol 0949/2023, Rif 7385 on December 12, 2023. Both treatments significantly improved total IPSS over time (p < 0.0001). Across all time points, combination therapy was associated with consistently lower IPSS scores, demonstrating a significant time-by-treatment interaction (p = 0.007). Nocturia improved significantly over time (p < 0.0001); the combination group showed greater benefit from Month 3 onward (p = 0.006), though the main treatment effect was not statistically significant (p = 0.076). Qmax improved in both groups (p < 0.0001), with a significant time-treatment interaction (p = 0.006), but no significant main effect of treatment type (p = 0.113). A mild but significant decline in IIEF-5 was observed in both groups over time. Treatment adherence exceeded 86% in both arms. The combination of HESr and alfuzosin was significantly more effective than alfuzosin monotherapy in relieving LUTS, with greater benefits from Month 3 onward. Qmax and nocturia also showed greater, although mild, improvements with combination therapy. Sexual function outcomes were comparable between groups. High adherence and real-world applicability support the clinical value of this combination in managing BPH-related LUTS.