Serenoa repens en el tratamiento de la alopecia androgenética. Revisión de la literatura

"Introducción. Serenoa repens es una planta cuyos frutos se han utilizado para tratar diferentes patologías, como la hiperplasia de próstata y otros problemas urológicos. Recientemente, se ha propuesto para el tratamiento de la alopecia androgenética. El objetivo es revisar la evidencia científica actual disponible sobre el tratamiento de la alopecia androgenética con extracto de S. repens. Material y método. Se realiza una revisión de la literatura científica sobre S. repens para el tratamiento de la alopecia androgenética, teniendo en cuenta el mecanismo de acción, eficacia, y posibles limitaciones de su empleo. Resultados. Existen pocos estudios de calidad sobre S. repens para el tratamiento de la alopecia androgenética y los que hay incluyen pocos pacientes. S. repens tiene diferentes mecanismos de acción, entre ellos es importante la inhibición de los andrógenos en el folículo piloso; aunque no se ha encontrado una estandarización de las dosis para el tratamiento de la alopecia con S. repens. Conclusión. La evidencia científica sugiere que S. repens es eficaz para el tratamiento de la alopecia androgenética, aunque su potencia es menor que finasterida. Se precisan nuevos estudios, bien diseñados, que permitan confirmar la utilidad de este producto."

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

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

Impact of the Treatment of Serenoa repens, Solanum lycopersicum, Lycopene and Bromelain in Combination with Alfuzosin for Benign Prostatic Hyperplasia. Results from a Match-Paired Comparison Analysis

Background: Phytotherapeutic agents aroused an increasing interest either as alternative or in addition to conventional therapy in the management of BPH. The aim of the article was to evaluate the clinical and functional changes after add-on treatment with Serenoa repens associated with Solanum lycopersicum, lycopene and bromelain in patients with BPH presenting with mild to moderate LUTS and previously treated only with Alfuzosin over a 6–12 months period. Materials and methods: Between January and July 2019, patients with symptomatic BPH already on treatment with Alfuzosin (Al) 10 mg for at least 6–12-month were enrolled at three academic referral centres, included in a prospective treatment group, and managed with a combination treatment of Al and 6-month daily oral single-tablet supplementation of Serenoa repens and Solanum lycopersicum + lycopene + bromelain (SeR + SL + Ly + Br). A retrospective control group with comparable baseline characteristics was obtained by performing a propensity score matching from a database of 434 patients managed with Alfuzosin 10 mg/day only over a 6–12 months period between March 2015 and December 2018. IPSS, QoL questionnaires, voiding diary assessment, postvoid residual volume (PVR), maximal (Qmax) and average (Qave) urinary flow rates were evaluated at baseline in the treatment group at the moment of patient accrual, in the control group after 6-month of treatment with alfuzosin, and thereafter at 3 and 6 months in both groups. Results: Overall, 250 patients entered the study (n = 125 treatment group; n = 125 control group). Total IPSS score significantly decreased at 6-month assessment from baseline in the treatment vs control group (17 [IQR: 12–20] vs 12 [IQR: 9–14], p = 0.02) with a significative storage symptoms improvement detected both at 3- (p = 0.03) and 6-month evaluation (p = 0.001). PVR significantly improved at each follow-up visit with the most relevant reduction at 6-month assessment (125 cc vs. 102 cc; p = 0.02). Moreover, a significative improvement in LUTS-related quality of life (QoL) was recorded at 3- and 6-month assessment with a median decrease of −1 and −2 (p = 0.05 and p = 0.001 respectively) from baseline. Conclusions: Combination treatment with AB and SeR + SL + Ly + Br led to meaningful improvements in LUTS severity compared to AB as monotherapy, after a 6-month treatment period in men with mild to moderate LUTS/BPH.

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

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

Serenoa Repens (Saw Palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part III

Parts I and II of this three-part series indicated how a global review of both English-language and non-English language papers, plus a focus on a lipidosterolic extract of Serenoa repens (LSESr) having a standardized fatty acid profile, have together engendered new insights about the biological activity of LSESr vs. LUTS. In this last part, data from the world literature is presented that confirms that LSESr efficacy is the predominant finding in clinical trials. Despite two placebo-controlled clinical trials performed in the U.S. that failed to confirm a benefit of LSESr vs. placebo in LUTS, the global body of the peer-reviewed literature attests not only to efficacy but also to safety. Results will be presented of important trials that compare LSESr to alpha-blockers such as tamsulosin (Flomax®) as well as to 5α-reductase inhibitors such as finasteride (Proscar®) that demonstrate consistent findings of near equivalency between LSESr and these pharmacologic agents. Studies relating data indicative of an additive effect or synergy between LSESr and tamsulosin will also be presented. The heightened effectiveness of LSESr in men with severe LUTS vs. moderate LUTS expands the importance of our scrutiny of the global literature concerning LSESr. Of great consequence are the contributions of non-English language peer-reviewed publications that have consistently provided evidence of LSESr efficacy in treating LUTS/BPH. These peer-reviewed articles have shown that the effect of LSESr is not that of a placebo. Finally, a comparison of the LSESr extraction products used in the treatment of LUTS, and a discussion of the milieu factors that affect the natural history of LUTS and influence the outcome of clinical trials, complete this detailed analysis of LSESr vs. LUTS.

Serenoa Repens (Saw Palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part II

Part I of this 3-part series provided the groundwork for understanding the role of a standardized lipidosterolic extract of Serenoa repens (LSESr) in the treatment of LUTS. It documented that a treatment having a high therapeutic index (i.e., a ratio of benefit to adverse reactions) is a critical need in the demographic context of a rapidly growing elder population. Part I described the clinical symptomatology of LUTS and how it is quantified. A critique of the reports from four authoritative bodies: the European Scientific Cooperative on Phytotherapy (ESCOP), Cochrane 2012, the European Medicines Agency (EMA), and the AUA (American Urological Association) was presented. The foundation above then fine-tuned our search to require (a) consistent evaluability criteria, (b) the quantification of clinical findings, (c) the need to focus on studies employing a standardized LSESr product meeting the fatty acid profile set forth by the European Medicines Agency (EMA) and the US Pharmacopeia and (d) a global assessment of scientific investigations published in all languages and not limited to only English. With the above four constraints, “new” findings about LSESr vs. LUTS are presented. How did the search strategy and selection criteria lead to new understandings about the role of LSESr vs. LUTS? How safe is LSESr in contrast to its counterpart prescription drugs? Of the proposed major mechanisms of action of LSESr (e.g., 5-alpha reductase inhibition and anti-inflammatory activity), what are the key points? After initiating treatment with LSESr, when is clinical improvement seen? How durable is LSESr in ameliorating LUTS? Can LSESr prevent the progression of BPH?

Serenoa repens (Saw palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part I

Lower urinary tract symptoms (LUTS) are classically characterized as being related to storage (e.g., frequency, urgency, and nocturia) or flow (e.g., weak stream, intermittency, straining, and incomplete emptying). Conventional prescription medications such as α1-blockers and 5α-reductase inhibitors are used to treat progressive LUTS in men. Due to the adverse events associated with these prescription drugs, many patients with mild-to-moderate LUTS may decide to initiate treatment with non-prescription medications and/or dietary supplements. The lipidosterolic extract of Serenoa repens (LSESr), at a recommended daily dose of 320 mg/day, has been the focus of numerous peer-reviewed studies and review articles concerning the treatment of LUTS, from the first publication in 1983 by Boccafoschi to the most recent publication in 2021 by Russo. Although it seems improbable that the beneficial effect of LSESr reflects a placebo effect given the consistent degree of efficacy comparing various studies published in different countries over a span of almost 40 years, this has been the prevailing impression stemming from essentially three publications in the Western medical literature. In addition, despite publications reporting findings of almost identical efficacy using LUTS endpoints such as the International Prostate Symptom Score (IPSS), the quality of life score (QoL), and the peak urinary flow (Qmax) in comparing LSESr with the α-blocker tamsulosin or the 5α-reductase inhibitor finasteride, and despite the recognized acceptance of the hexane lipidosterolic extract product (Permixon®) as an herbal medicine in Europe showing value in the treatment of LUTS, the use of LSESr remains controversial in the US. Contributing to such an opposing view in the US are the wide variability in quality, composition, and dosage of Serenoa products, the commercial prevalence of dried berry powder supplements, and the lack of awareness of a standardized Serenoa phytotherapy lipidosterolic profile. Can the controversy over the efficacy of LSESr in the context of LUTS be resolved? By understanding the main literature that has led to clinical practice guidelines for Serenoa repens for LUTS in Europe and the US, and by an in-depth analysis of the totality of the clinical literature concerning dose, extraction method, and quality of the Serenoa product used, it should be possible to answer this question. Given the extent of this global analysis, this report is presented in three sections. Part I introduces LUTS. What are the demographics of LUTS? What symptoms are assessed by LUTS, and how do we quantify LUTS? Why would a non-prescription item be a valuable consideration in LUTS treatment versus other treatment options? What is basic information about Serenoa repens, and what defines a standardized LSESr product? What are the published trials that have affected the acceptability of Serenoa repens in the treatment of LUTS? Finally, a major portion of Part I discusses the four major reviews of Serenoa repens versus LUTS that have influenced how it is accepted in the USA, in Europe, and in other parts of the world. Part I, therefore, lays the groundwork and is foundational for the important findings relating to LUTS and Serenoa repens that will be presented as Parts II and III in subsequent review articles.

Serenoa repens (Saw Palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part II

Part I of this 3-part series provided the groundwork for understanding the role of a standardized lipidosterolic extract of Serenoa repens (LSESr) in the treatment of LUTS. It documented that a treatment having a high therapeutic index (i.e., a ratio of benefit to adverse reactions) is a critical need in the demographic context of a rapidly growing elder population. Part I described the clinical symptomatology of LUTS and how it is quantified. A critique of the reports from four authoritative bodies: the European Scientific Cooperative on Phytotherapy (ESCOP), Cochrane 2012, the European Medicines Agency (EMA), and the AUA (American Urological Association) was presented. The foundation above then fine-tuned our search to require (a) consistent evaluability criteria, (b) the quantification of clinical findings, (c) the need to focus on studies employing a standardized LSESr product meeting the fatty acid profile set forth by the European Medicines Agency (EMA) and the US Pharmacopeia and (d) a global assessment of scientific investigations published in all languages and not limited to only English. Part II details the following &ldquo;new&rdquo; findings when LSESr vs. LUTS is examined with the above constraints.