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PubMed2000

Serenoa repens for benign prostatic hyperplasia.

OBJECTIVES: This systematic review aimed to assess the effects of Serenoa repens in the treatment of Benign Prostatic Hyperplasia (BPH). SEARCH STRATEGY: Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library, Phytodok), by checking bibliographies, and by contacting manufacturers and researchers. SELECTION CRITERIA: Trials were eligible if they (1) randomized men with BPH to receive preparations of Serenoa repens (alone or in combination) in comparison with placebo or other BPH medications, and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements. Eligibility was assessed by at least two independent observers. DATA COLLECTION AND ANALYSIS: Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of Serenoa repens with placebo or other BPH medications was the change in urologic symptom scale scores. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for side effects was the number of men reporting side effects. MAIN RESULTS: 2939 men from18 randomized trials lasting 4 to 48 weeks were assessed. 16 trials were double-blinded and treatment allocation concealment was adequate in 9 studies. Compared with placebo, Serenoa repens improved urinary symptom scores, symptoms, and urinary flow measures. The weighted mean difference (WMD) for the urinary symptom score was -1.41 points (scale range 0-19), (95%CI = -2.52, -0.30, n = 1 study) and the risk ratio (RR) for self rated improvement was 1.75 (95%CI = 1.21, 2.54, n = 6 studies). The WMD for nocturia was -0.76 times per evening (95%CI = -1.22, -0.32; n = 10 studies). The WMD for peak urine flow was 1.93 ml/sec (95%CI = 0.72, 3.14, n = 8 studies). Compared with finasteride, Serenoa repens produced similar improvements in urinary symptom scores (WMD = 0.37 IPSS points (scale range 0-35), 95%CI = -0.45, 1.19, n = 2 studies) and peak urine flow (WMD = -0.74 ml/sec, 95%CI = -1.66, 0.18, n = 2 studies). Adverse effects due to Serenoa repens were mild and infrequent. Withdrawal rates in men assigned to placebo, Serenoa repens or finasteride were 7%, 9%, and 11%, respectively. REVIEWER'S CONCLUSIONS: The evidence suggests that Serenoa repens improves urologic symptoms and flow measures compared with placebo. Serenoa repens produced similar improvement in urinary symptoms and flow compared to finasteride and is associated with fewer adverse treatment events. The long term effectiveness, safety and ability to prevent BPH complications are not known.

Androgen Antagonists↗
PubMed1996

Serenoa repens (Permixon). A review of its pharmacology and therapeutic efficacy in benign prostatic hyperplasia.

Serenoa repens (Permixon) has been available for several years for the treatment of men with benign prostatic hyperplasia (BPH). The drug is the n-hexane lipidosterolic extract of the dwarf American palm (also known as Serenoa repens) and is a complex mixture of various compounds. A number of pharmacodynamic effects have been demonstrated with the lipidosterolic extract of Serenoa repens (LSESR), suggesting multiple mechanisms of action including in vitro inhibition of both type 1 and type 2 isoenzymes of 5 alpha-reductase and interference with binding of dihydrotestosterone to cytosolic androgen receptors in prostate cells. In controlled clinical trials in men with BPH, oral administration of Serenoa repens 160 mg twice daily for 1 to 3 months was generally superior to placebo in improving subjective symptoms, such as dysuria, as well as objective parameters. The frequency of nocturia was reduced by 33 to 74%, while urinary frequency during the day decreased by 11 to 43% and peak urinary flow rate increased by 26 to 50% with Serenoa repens. Corresponding values for placebo were 13 to 39%, 1 to 29% and 2 to 35%. The only large comparative trial conducted to date, in which > 1000 men with moderate BPH were randomised to receive Serenoa repens 160 mg twice daily or finasteride 5 mg once daily for 6 months, demonstrated similar efficacy between the two drugs. No statistically significant difference was demonstrated between treatment groups for improvement in patient self-rated quality-of-life scores and the primary end-point of objective symptom score; International Prostate Symptom Score improved by 37% with Serenoa repens compared with 39% with finasteride. In much smaller comparative trials, few significant differences were demonstrated between Serenoa repens and alpha 1-receptor antagonists, and larger randomised trials of adequate duration are required to better compare the clinical efficacy of these drugs. The most frequently reported adverse events in clinical trials with Serenoa repens have been minor gastrointestinal problems (e.g. nausea and abdominal pain). In conclusion, Serenoa repens is well tolerated and has greater efficacy than placebo and similar efficacy to finasteride in improving symptoms in men with BPH. Although there is a need for further comparative studies, particularly with alpha 2-receptor antagonists, available data indicate that Serenoa repens is a useful alternative to alpha 1-receptor antagonists and finasteride in the treatment of men with BPH.

Androgen Antagonists↗
PubMedDate not supplied

Comparative effects of alfuzosin versus Serenoa repens in the treatment of symptomatic benign prostatic hyperplasia.

OBJECTIVES: Sixty-three patients suffering from benign prostatic hyperplasia (BPH) entered a double-blind, comparative, parallel-groups study lasting 3 weeks, carried out to compare the efficacy and safety of alfuzosin 2.5 mg tid (n = 32) vs serenoa repens 160 mg bid (n = 31) in BPH. METHODS: Efficacy was assessed both on clinical symptoms (Boyarsky's scale, visual analogue scale, clinical global impression), urinary flow rates (uroflowmetry) and residual urinary volume (transabdominal ultrasound). Events and reported signs were recorded throughout the entire study. RESULTS: Statistically significant and clinically relevant differences were found between the two treatments in favour of alfuzosin for Boyarsky's total score (decrease from 9.6 +/- 3.0 to 5.9 +/- 3.0, 38.8% for alfuzosin and from 9.3 +/- 2.5 to 6.8 +/- 2.8, 26.9% for serenoa repens) and obstructive score (decrease from 4.9 +/- 2.1 to 3.0 +/- 1.9, 37.8% for alfuzosin; from 4.4 +/- 1.7 to 3.4 +/- 1.8, 23.1% for Serenoa repens; p = 0.01 for both). Clinically relevant differences were found between the two treatments for visual analogue scale and overall clinical impression at the end of the study. Furthermore, the increase in quality of micturition was better with alfuzosin. The proportion of responders (increase on day 21 in peak flow rate of at least 25% relative to the baseline values) was in favour of alfuzosin (71.8% and 48.4% for alfuzosin and Serenoa repens, respectively; p = 0.057). Both treatments were well tolerated. No patient treated with alfuzosin complained of any adverse event at any time during the study. One patient in the Serenoa group complained of mild pruritus which cleared spontaneously. Systolic, diastolic blood pressure and heart rate did not show any clinically relevant change during treatment with alfuzosin. CONCLUSIONS: The findings confirm the efficacy and safety of alfuzosin in symptomatic BPH and indicate the superiority of alfuzosin over Serenoa repens in the treatment of urinary signs and symptoms of BPH.

Adrenergic alpha-Antagonists↗
PubMed2005

Serenoa repens (Permixon) inhibits the 5alpha-reductase activity of human prostate cancer cell lines without interfering with PSA expression.

The phytotherapeutic agent Serenoa repens is an effective dual inhibitor of 5alpha-reductase isoenzyme activity in the prostate. Unlike other 5alpha-reductase inhibitors, Serenoa repens induces its effects without interfering with the cellular capacity to secrete PSA. Here, we focussed on the possible pathways that might differentiate the action of Permixon from that of synthetic 5alpha-reductase inhibitors. We demonstrate that Serenoa repens, unlike other 5alpha-reductase inhibitors, does not inhibit binding between activated AR and the steroid receptor-binding consensus in the promoter region of the PSA gene. This was shown by a combination of techniques: assessment of the effect of Permixon on androgen action in the LNCaP prostate cancer cell line revealed no suppression of AR and maintenance of PSA protein expression at control levels. This was consistent with reporter gene experiments showing that Permixon failed to interfere with AR-mediated transcriptional activation of PSA and that both testosterone and DHT were equally effective at maintaining this activity. Our results demonstrate that despite Serenoa repens effective inhibition of 5alpha-reductase activity in the prostate, it did not suppress PSA secretion. Therefore, we confirm the therapeutic advantage of Serenoa repens over other 5alpha-reductase inhibitors as treatment with the phytotherapeutic agent will permit the continuous use of PSA measurements as a useful biomarker for prostate cancer screening and for evaluating tumour progression.

5-alpha Reductase Inhibitors↗
PubMed2004

Is there a scientific basis for the therapeutic effects of serenoa repens in benign prostatic hyperplasia? Mechanisms of action.

PURPOSE: The huge resurgence of interest in herbal remedies has spawned a global industry that now competes with conventional drugs as adjuncts and/or alternatives for various conditions. The medical treatment of benign prostatic hyperplasia (BPH) is no exception. Along with alpha-blockers and 5alpha-reductase inhibitors the extract of the American dwarf palm, Serenoa repens, is unquestionably the most widely used. Together with Pygeum africanum, an extract from the bark of the African plum tree, it is licensed in Germany, France and other European countries for symptomatic BPH. This review was done to analyze the large number of in vivo and in vitro laboratory studies that have been performed with extracts of Serenoa repens to elucidate mechanism(s) of action. MATERIALS AND METHODS: A literature search (MEDLINE) revealed more than 30 publications relating to laboratory studies with extracts of Serenoa repens, addressing the question of a mechanism of action. It would appear that the n-hexane lipidosterolic extract of Serenoa repens, namely Permixon (Pierre Fabre Medicament, Boulogne, France), is a product that has uniquely been subjected to more scientific investigation than any other such preparation. RESULTS: Placebo controlled and comparative clinical studies of Permixon indicate its efficacy for BPH/lower urinary tract symptoms. Numerous mechanisms of action have been proposed, including an antiandrogenic action, an anti-inflammatory effect and an antiproliferative influence through the inhibition of growth factors. CONCLUSIONS: Set against the background of our current knowledge of the pathophysiology of the aging prostate, the results of these studies suggest a wide spectrum of activity. However, precise mechanism(s) of action remain obscure. Balance and caution are needed when extrapolating the results of in vitro laboratory studies to the complex human situation.

Androgen Antagonists↗
PubMed2002

[Tamsulosin with or without Serenoa repens in benign prostatic hyperplasia: the OCOS trial].

OBJECTIVE: In the treatment of the symptoms of benign prostatic hyperplasia (BPH), a French guideline opposes the use of drugs in conjunction, in the absence of proven utility. The OCOS trial therefore compared one of the possible drug combinations (tamsulosin and Serenoa repens) with tamsulosin alone, to see if there was any difference in effectiveness and to evaluate the clinical tolerance of each in patients with symptoms of BPH. MATERIAL AND METHODS: In this double-blind, randomised trial, patients had to have an IPSS (International Prostate Symptom Score) > or = 13 and a Qmax between 7 and 15 mL/s. Tamsulosin (0.4 mg) was to be administered once a day for 52 weeks, with, twice daily, a placebo (TAM) or Serenoa repens 160 mg (TAM + SR). RESULTS: 352 patients were recruited by 47 centres; 329 (average age 65) were randomised: 161 into the TAM group and 168 into the TAM + SR group. No statistically significant difference was found between the two groups, neither for the major end-point [change in total IPSS between the baseline value and the final evaluation (TAM: -5.2; TAM + SR: -6.0; p = 0.286)], nor for the secondary end-points [changes in the voiding scores (p = 0.239) and in filling scores (p = 0.475) of the IPSS, Qmax (p = 0.564), percentage of respondents according to the IPSS (p = 0.361), improvement in quality of life (IPSS-QoL: p = 0.091; UROLIFE BPH QoL: p = 0.442), safety]. CONCLUSION: The addition of Serenoa repens to tamsulosin did not provide any significant benefit to the patients: the OCOS trial does not cast doubt on the guideline applicable to the treatment of BPH.

Adrenergic alpha-Antagonists↗
PubMed2004

[Efficacy of pretreatment with Serenoa repens on bleeding associated with transurethral resection of prostate].

AIM: Aim of the study is to evaluate the efficacy of a pretreatment with lipidic-sterolic extract of Serenoa repens (Permixon) to reduce bleeding during transurethral resection of prostate (TURP) in patients with benign prostatic hyperplasia. METHODS: This is a monocentric, randomised versus control group study. We enrolled 108 patients, randomised either in the experimental group or in the control one. Patients in the experimental group received a pretreatment with Serenoa repens (320 mg/die of Permixon) for at least 8 weeks before the TURP procedure. In the control group patients did not receive any medical treatment before the intervention. RESULTS: Out of 108 enrolled patients, 88 were evaluated per protocol. In the pretreated group the perioperative bleeding was significantly lower than in the control one (respectively 124 vs 287 ml) and the need of transfusion decreased remarkably. Moreover, in the pretreated group, the duration of postoperative catheterization (respectively 3 vs 5 days) and the evaluated hematological parameters (red cells 4.5 vs 4 million, hemoglobin 13.4 vs 11.9 g, hematocrit 40% vs 35%) were significantly lower than in the control group. CONCLUSION: The pretreatment with Serenoa repens, before TURP procedure, improves the efficacy of the procedure itself and reduces the risk of complications, in particular perioperative bleeding and duration of postoperative catheterization.

Aged↗
PubMedDate not supplied

The lipidosterolic extract of Serenoa repens in the treatment of benign prostatic hyperplasia: a comparison of two dosage regimens.

This 6-month double-blind, randomized, parallel-group study compared two dose regimens of Libeprosta, the lipidosterolic extract of Serenoa repens in 100 male outpatients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH). The patients received two 80-mg tablets twice daily or two 80-mg tablets three times daily. Baseline evaluations included maximum and mean urinary flow rates, postvoid residual urine volume, and International Prostate Symptom Score (I-PSS) total and quality-of-life scores. Both regimens significantly reduced the I-PSS mean total score from baseline values (P<.001); improvements achieved statistical significance after month 3 and were maintained for the duration of the study. Significant improvements from baseline also occurred in quality-of-life scores, maximum and mean urinary flow rates, and residual urine volume (P<.05). The decrease in residual urine with both regimens was highly significant (P<.001). No significant differences in efficacy were noted between the two dose groups, and no treatment-related complications or clinical adverse events occurred. In this clinical study, the lipidosterolic extract of Serenoa repens was a well-tolerated agent that may significantly improve lower urinary tract symptoms and flow measurements in men with BPH.

Androgen Antagonists↗
PubMed2000

A scientific basis for the therapeutic effects of Pygeum africanum and Serenoa repens.

In Europe, phytotherapeutic preparations have been prescribed for the treatment of symptomatic benign prostatic hyperplasia (BPH) for over 20 years [1-4]. In these countries, phytotherapeutic preparations represent approximately 1/3 of total sales of all therapeutic agents sold for the treatment of BPH. In France, and other countries, phytotherapeutic preparations are the most widely used drugs for the treatment of BPH. In Asia, Africa, and India, phytotherapy is considered a first-line treatment for BPH and has been utilized effectively for centuries. In the United States, the multimillion dollar sales of phytotherapeutic preparations for "the health of the prostate and bladder" attests to the widespread utilization of these agents [3, 4]. Two of the most popular phytotherapeutic agents that have undergone both clinical studies to determine their efficacy, and have been the subject of basic science studies to identify the mechanism(s) of action are Pygeum africanum (Tadenan), an extract from the bark of the African plum tree, and Serenoa repens (Permixon), a lipido-sterol extract of dwarf palm. Tadenan and Permixon are registered therapeutic agents of Debat Pharmaceuticals, and Pierre Fabre Medicament, respectively. Manufacture of both preparations are tightly controlled and subjected to strict quality control for stability of component composition. In regard to phytotherapeutic agents, each individual preparation (even from the same plant source) must be considered individually because of differences in the extraction techniques, preparation of products, composition, and biological activities. Thus, the clinical and biological activities of one preparation cannot be extrapolated to other preparations of the same plant source. Thus, studies described in this review which utilize the preparations that are manufactured by DEBAT (Pygeum africanum) or Pierre Fabre Medicament (Serenoa repens) are referred to by their trade names, Tadenan and Permixon, to differentiate them from other nonstandardized preparations of the same plants.

Androgen Antagonists↗
PubMed2005

Analysis of the inhibitory potential of Ginkgo biloba, Echinacea purpurea, and Serenoa repens on the metabolic activity of cytochrome P450 3A4, 2D6, and 2C9.

OBJECTIVE: To study the potential of three top-selling herbal products, Ginkgo biloba, Echinacea purpurea, and Serenoa repens to inhibit the in vitro enzymatic activity of three of the most important drug metabolizing enzymes, cytochrome P450 (CYP) 3A4, 2D6, and 2C9. METHODS: High throughput CYP inhibition screening was used to test the inhibitory capacity of extracts of commercially available herbal medications on the metabolism of CYP enzyme substrates. RESULTS: S. repens showed potent inhibition of the metabolic activity of all three CYPs tested. The effects of G. biloba and E. purpurea varied. E. purpurea demonstrated mild inhibition of CYP3A4 activity with 7- benzyloxy-4-trifluoromethylcoumarin (BFC) as the model substrate, but mild inducing effects in the presence of the model substrate resorufin benzyl ether (BzRes). Little effect on CYP2D6 and moderate inhibition of CYP2C9 was seen with both E. purpurea and G. biloba. G. biloba also showed mild-to-moderate inhibition of CYP3A4 depending on the model substrate. CONCLUSIONS: The inhibitory capacity of herbal products varies depending on the concentrations of the model substrate and the herbal extract, as well as the identity of the model substrate, as demonstrated by the varied effects of CYP3A4 enzymatic activity with different model substrates. The potential for strong adverse interactions exists for Serenoa repens, which was a potent inhibitor of all three CYPs examined. Physicians are encouraged to advise patients of the risks of combining herbal products with prescription medications.

Aryl Hydrocarbon Hydroxylases↗
PubMedDate not supplied

[Five-year experience in treating patients with prostatic hyperplasia patients with permixone (Serenoa repens "Pierre Fabre Medicament)].

Specialists of the urologic clinic of the I.M. Sechenov Moscow Medical Academy studied effectiveness of lipidosterol extract Serenoa repens (permixon) in 26 patients with prostatic hyperplasia (total prostate-specific antigen was under 4 ng/ml). The trial has been performed from November 1995 up to now. The drug was taken before meal with a small quantity of water in a total daily dose 320 mg twice a day. Initial IPSS values ranged from 8 to 18 scores (mean 11.65 +/- 0.59). Life quality index was 1 to 4 scores (mean 2.46 +/- 0.15). Initial size of the prostate varied from 26 to 63 cm3 (mean 36.23 +/- 1.57 cm3). Maximal urinary flow rate (Qmax) made up 8.7 to 14.6 ml/s (mean 11.83 +/- 0.31 ml/s). Residual urine was initially 0-60 ml (mean 10.58 +/- 2.91 ml). Permixon significantly reduced the disease symptoms and improved quality of life. 5 years of treatment decreased mean IPSS by 8.8 +/- 0.18 (75.5%). QOL--by 1.31 +/- 0.08 (53.3%), size of the prostate--by 10.81 +/- 0.55 cm3 (29.8%). Neither the symptoms nor quality of life became worse for these five years. The size of the prostate reduced in 16, unchanged in 9 and increased only in 1 patient. Qmax was initially under 15 ml/s and rose after the treatment by 4.13 +/- 0.51 ml/s (35%), on the average. Qmax rose above 15 ml/s in 16 patients. Residual urine increased during the treatment in one patient only. Permixon intolerance was not observed. Thus, continuous 5-year therapy with lipidosterol extract Serenoa repens (permixon) proved highly effective and safe in 26 patients with initial or moderate symptoms of prostatic hyperplasia.

Androgen Antagonists↗
PubMed1988

Lack of effects of a lyposterolic extract of Serenoa repens on plasma levels of testosterone, follicle-stimulating hormone, and luteinizing hormone.

Twenty men, aged 50 to 75 years (mean, 67 years), suffering from benign prostatic hypertrophy received 160 mg of a lyposterolic extract of Serenoa repens, twice daily for 30 days. Before and at the end of treatment, plasma levels of testosterone, follicle-stimulating hormone, and luteinizing hormone were determined. No changes in plasma hormone levels occurred as a result of treatment. It is concluded that Serenoa extract, which is useful in the treatment of benign prostatic hypertrophy, does not act via systemic changes of hormone levels.

Aged↗
PubMed1998

Effects of long-term treatment with Serenoa repens (Permixon) on the concentrations and regional distribution of androgens and epidermal growth factor in benign prostatic hyperplasia.

BACKGROUND: The n-hexane lipido-sterol extract of Serenoa repens (LSESr, Permixon, Pierre Fabre Medicament, Castres, France), a phytotherapeutic agent used in the treatment of benign prostatic hyperplasia (BPH), has a multisite mechanism of action including inhibition of types 1 and 2 5alpha-reductase and competitive binding to androgen receptors in prostatic cells. Here, the response of testosterone (T), dihydrotestosterone (DHT), and epidermal growth factor (EGF) in BPH tissue of patients treated with LSESr (320 mg/day for 3 months) is analyzed. METHODS: BPH samples were sectioned in periurethral, subcapsular, and intermediate regions: in each region T, DHT, and EGF were determined by radioimmunoassay after purification on celite columns or Sep-pak C18 cartridges. RESULTS: In the untreated group, T, DHT, and EGF presented the highest concentrations in the periurethral region (615 +/- 62 (SE) pg/g tissue, 7,317 +/- 551 pg/g tissue, and 20.9 +/- 3.3 ng/g tissue, respectively) with respect to the peripheral subcapsular region (425 +/- 45 pg/g tissue, 4,215 +/- 561 pg/g tissue, and 10.8 +/- 1.4 ng/g tissue, respectively). In the LSESr-treated group, a statistically significant reduction was observed, mainly in the periurethral region of DHT (2,363 +/- 553 pg/g tissue, P < 0.001) and EGF (6.98 +/- 2.48 ng/g tissue, P < 0.01), with increased T values (1,023 +/- 101 pg/g tissue, P < 0.001). CONCLUSIONS: The decrease of DHT and the rise of T in BPH tissue of patients treated with Permixon confirms the capacity of this drug to inhibit in vivo 5alpha-reductase in human pathological prostate. A marked decrease of EGF, associated with DHT reduction, was also observed. These biochemical effects, similar to those obtained with finasteride, are particularly evident in the periurethral region, whose enlargement is responsible for urinary obstruction, with respect to the subcapsular region. A possible speculation is that the preferential reduction of DHT and EGF content in the periurethral region is involved in the clinical improvement of the obstructive symptoms in BPH during LSESr therapy.

Aged↗
PubMed2000

Pharmacological effects of the lipidosterolic extract of Serenoa repens (Permixon) on rat prostate hyperplasia induced by hyperprolactinemia: comparison with finasteride.

BACKGROUND: The growth of the prostate gland is mainly dependent on androgens. Other hormones, like prolactin (PRL), also influence prostate development. Our purpose was to analyze and compare the effects of two drugs (5alpha-reductase inhibitor) used in the therapy of benign prostatic hyperplasia: lipidosterolic extract of Serenoa repens (LSESR), and finasteride in an in vivo model of rat prostate hyperplasia induced by hyperprolactinemia. METHODS: Hyperprolactinemia was induced by 30 daily injections of sulpiride. Wistar rats received daily gavages of LSESR or finasteride. We used the following groups: control, castrated, castrated with a substitute testosterone (T), or 5alpha-dihydrotestosterone (DHT) implant. RESULTS: Hyperprolactinemia increases the wet weight and induces hyperplasia in the lateral prostate (LP). Unlike finasteride, LSESR significantly reduced LP growth and hyperplasia in castrated, DHT-implanted, and sulpiride-treated rats. CONCLUSIONS: Finasteride was only capable of inhibiting the effect of androgens on rat prostate enlargement. LSESR inhibited not only the androgenic but also the trophic effect of PRL in rat LP hyperplasia.

Androgen Antagonists↗
PubMedDate not supplied

Effect of Serenoa repens extract (Permixon) on estradiol/testosterone-induced experimental prostate enlargement in the rat.

The effect of the lipidosterolic extract of Serenoa repens (LSESR) on experimental prostate enlargement was investigated in three groups of rats: shams treated with LSESR (sham rats), castrated animals treated with estradiol and testosterone (castrated rats), castrated animals treated with estradiol/testosterone and treated with LSESR (castrated and treated rats). Following three months of continuous hormonal treatment, the weight of prostates in estradiol/testosterone-treated castrated rats was significantly increased in comparison with sham-operated rats. Such an increase started rapidly, reached a maximum by 30 days and remained at a plateau or slightly declined thereafter. The increase of prostate total weight induced by the hormone treatment was inhibited by administration of LSESR. Indeed, the weight was significantly lower at day 60 and day 90 for the dorsal and lateral regions of the prostate. The weight of the ventral region of the prostate was significantly lower after 30 and 60 days treatment with LSESR. These results demonstrate that administering LSESR to hormone-treated castrated rats inhibits the increase in prostate wet weight. This effect of LSESR may explain the beneficial effect of this extract in human benign prostatic hypertrophy.

Androgen Antagonists↗
PubMedDate not supplied

Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic hyperplasia.

Permixon, the lipidosterolic extract of Serenoa repens, is widely used for the treatment of symptoms associated with benign prostatic hyperplasia (BPH). This open study assessed the efficacy and tolerability of Permixon 160 mg twice daily administered for 2 years. One hundred fifty-five men with clinically diagnosed BPH and complaints of prostatic symptoms were enrolled in the study. At 6, 12, 18, and 24 months, the International Prostate Symptom Score (I-PSS), quality of life, and sexual function score were recorded, and urodynamics and biologic values were measured. Adverse events were recorded every 3 months. I-PSS and quality of life improved significantly from baseline at each evaluation time point. At the end of the study and at each evaluation, maximum urinary flow also improved significantly. Prostate size decreased. Sexual function remained stable during the first year of treatment and significantly improved (P = .001) during the second year. Prostate-specific antigen was not affected, and no changes in plasma hormone levels were observed. Nine patients reported 10 adverse events, none related to treatment. Improvements in efficacy parameters began at 6 months and were maintained up to 24 months. These data demonstrate the long-term efficacy and tolerability of Permixon and support its use as a first-line medical therapy for uncomplicated symptomatic BPH.

Aged↗
PubMedDate not supplied

Distribution study of radioactivity in rats after oral administration of the lipido/sterolic extract of Serenoa repens (Permixon) supplemented with [1-14C]-lauric acid, [1-14C]-oleic acid or [4-14C]-beta-sitosterol.

The study carried out on rats given orally the n-hexane lipido/sterolic extract of Serenoa repens (LSESR), supplemented with [14C]-labelled oleic or lauric acids or beta-sitosterol, demonstrated that radioactivity uptake in prostatic tissues shows the highest level in the case of administration of LSESR supplemented with [14C]-labelled oleic acid. This was clearly demonstrated on a rat with an induced fibro-muscular hyperplasia of the prostate and by quantitative measurements of radioactivity. Ratios of radioactivity in tissues compared to plasma show an uptake of radioactivity greater in prostate as compared to other genital organs, i.e. the seminal vesicles or to other organs such as liver.

Administration, Oral↗
PubMed2002

In vivo effect of the lipido-sterolic extract of Serenoa repens (Permixon) on mast cell accumulation and glandular epithelium trophism in the rat prostate.

The Serenoa repens lipido-sterolic extract (SRLSE, Permixon, Pierre Fabre Medicament, Castres, France) is used to treat benign prostate hyperplasia. We studied the in vivo effect of SRLSE on mast cell accumulation and the histological characteristics of the rat ventral prostate. Adult Wistar rats received either tocopherol or SRLSE (50 and 100 mg/kg body weight, respectively) every second day for 90 days. Histological features were studied in hematoxylin-eosin stained tissue sections while mean mast cell numbers were determined in Giemsa-stained sections. The central region of the ventral prostate in treated animals showed significant changes with acinar epithelium becoming flat or low cuboidal. In the same region, mean mast cell number per optical field in the control, low-dose and high-dose groups were, respectively, 4.7+/-0.7, 3.4+/-1.0 and 2.4+/-0.6, showing a dose-dependent, statistically significant decrease. Administering SRLSE significantly reduces mast cell accumulation and provokes epithelium atrophy within the central area of the rat ventral prostate. These phenomena may participate in the clinical activity of the drug.

Androgen Antagonists↗