Saw Palmetto

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    Saw Palmetto


    studies concerning its main uses, that is, as cheap protection against damage to, and treatment for the prostate (as well as a few concerning prostate cancer cell growth, androgenetic alopecia, etc). *as can be seen, there is a whopping amount of evidence supporting its use {and these are only the main studies... SP's effectiveness is mentioned in numerous other studies as well}... point is... *IT WORKS*... yes, we know that but many people (on other boards, ssshh )don't, and since this is the central locale for this kind of ****... well, here you have it.

    after an hour and a half or so of compilation, I thought it would probably be best to give all 21 titles/citations here, and string them out accordingly below... this thread (along with the others: Cr, HMB, etc) is primarily for reference purposes, nobody likes sifting through pages and pages of studies on indexed databases with tons of other **** when they can have immediate results here at AnaMinds... so yeah, if somebody gives you **** (probably at a different board, our bros are so damn smart ), just refer them to this thread, and tell them to shut their stupid monkey faces!!


    1."Saw palmetto for prostate disorders."
    Am Fam Physician 2003 Mar 15;67(6):1281-3

    2."Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic hyperplasia."
    Adv Ther 2002 Nov-Dec;19(6):297-306

    3."The lipidosterolic extract of Serenoa repens in the treatment of benign prostatic hyperplasia: a comparison of two dosage regimens."
    Adv Ther 2002 Nov-Dec;19(6):285-96

    4."Saw palmetto alters nuclear measurements reflecting DNA content in men with symptomatic BPH: evidence for a possible molecular mechanism."
    Urology 2002 Oct;60(4):617-22

    5."Herbs for benign prostatic hyperplasia."
    Ann Pharmacother 2002 Sep;36(9):1443-52

    6."Serenoa repens for benign prostatic hyperplasia."
    Cochrane Database Syst Rev 2002;(3):CD001423

    7."Randomized trial of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) on symptoms of benign prostatic hyperplasia (BPH)."
    Int Urol Nephrol 2001;33(2):217-25

    8."A randomized, double-blind, placebo-controlled trial to determine the effectiveness of botanically derived inhibitors of 5-alpha-reductase in the treatment of androgenetic alopecia."
    J Altern Complement Med 2002 Apr;8(2):143-52

    9."Saw palmetto berry extract inhibits cell growth and Cox-2 expression in prostatic cancer cells."
    Cell Biol Int 2001;25(11):1117-24

    10."Randomized, double-blind, placebo-controlled trial of saw palmetto in men with lower urinary tract symptoms."
    Urology 2001 Dec;58(6):960-4; discussion 964-5

    11."The Lipidosterolic Extract fromSerenoa repens Interferes with Prolactin Receptor Signal Transduction."
    J Biomed Sci 1995 Oct;2(4):357-365

    12."Tissue effects of saw palmetto and finasteride: use of biopsy cores for in situ quantification of prostatic androgens."
    Urology 2001 May;57(5):999-1005

    13."Phytotherapy for benign prostatic hyperplasia."
    Public Health Nutr 2000 Dec;3(4A):459-72

    14."Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia."
    J Urol 2000 May;163(5):1451-6

    15."Saw palmetto for the treatment of men with lower urinary tract symptoms."
    J Urol 2000 May;163(5):1408-12

    16."Role of herbal compounds (PC-SPES) in hormone-refractory prostate cancer: two case reports."
    J Altern Complement Med 2000 Oct;6(5):449-51

    17."Botanical derivatives for the prostate."
    Fitoterapia 2000 Aug;71 Suppl 1:S21-8

    18."Is there a rational therapy for symptomatic treatment of benign prostatic hyperplasia with phytogenic drugs? Illustrated with the example of the prostate agent from Serenoa repens (Sabal fructus)"
    Wien Med Wochenschr 1999;149(8-10):236-40

    19."Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review."
    JAMA 1998 Nov 11;280(18):1604-9

    20."Saw palmetto (Serenoa repens) in men with lower urinary tract symptoms: effects on urodynamic parameters and voiding symptoms."
    Urology 1998 Jun;51(6):1003-7

    21."Phytotherapy of benign prostatic hyperplasia"
    Urologe A 1997 Jan;36(1):10-7

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    1.Saw palmetto for prostate disorders.

    Am Fam Physician 2003 Mar 15;67(6):1281-3


    Gordon AE, Shaughnessy AF.

    Harrisburg Family Practice Residency Harrisburg, Pennsylvania 17110-2098, USA. agordon@pinnacle.health.org

    Saw palmetto is an herbal product used in the treatment of symptoms related to benign prostatic hyperplasia. The active component is found in the fruit of the American dwarf palm tree. Studies have demonstrated the effectiveness of saw palmetto in reducing symptoms associated with benign prostatic hyperplasia. Saw palmetto appears to have efficacy similar to that of medications like finasteride, but it is better tolerated and less expensive. There are no known drug interactions with saw palmetto, and reported side effects are minor and rare. No data on its long-term usage are available. The herbal product also has been used to treat chronic prostatitis, but currently there is no evidence of its efficacy.
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    2.Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic hyperplasia.

    Adv Ther 2002 Nov-Dec;19(6):297-306


    Pytel YA, Vinarov A, Lopatkin N, Sivkov A, Gorilovsky L, Raynaud JP.

    Scientific Research Institute of Urology, Moscow, Russia.

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

    Adv Ther 2002 Nov-Dec;19(6):285-96


    Giannakopoulos X, Baltogiannis D, Giannakis D, Tasos A, Sofikitis N, Charalabopoulos K, Evangelou A.

    Department of Urology, Ioannina University School of Medicine, Ioannina, Greece.

    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.
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    4.Saw palmetto alters nuclear measurements reflecting DNA content in men with symptomatic BPH: evidence for a possible molecular mechanism.

    Urology 2002 Oct;60(4):617-22


    Veltri RW, Marks LS, Miller MC, Bales WD, Fan J, Macairan ML, Epstein JI, Partin AW.

    Department of Urology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.

    OBJECTIVES: To examine the nuclear chromatin characteristics of epithelial cells, looking for an SPHB-mediated effect on nuclear DNA structure and organization. Saw palmetto herbal blend (SPHB) causes contraction of prostate epithelial cells and suppression of tissue dihydrotestosterone levels in men with symptomatic benign prostatic hyperplasia, but a fundamental mechanism remains unknown. METHODS: A 6-month randomized trial, comparing prostatic tissue of men treated with SPHB (n = 20) or placebo (n = 20), was performed. At baseline, the two groups were similar in age (65 versus 64 years), symptoms (International Prostate Symptom Score 18 versus 17), uroflow (maximal urinary flow rate 10 versus 11 mL/s), prostate volume (59 versus 58 cm(3)), prostate-specific antigen (4.2 versus 2.7 ng/mL), and percentage of epithelium (17% versus 16%). Prostatic tissue was obtained by sextant biopsy before and after treatment. Five-micron sections were Feulgen stained and quantitatively analyzed using the AutoCyte QUIC-DNA imaging system. Images were captured from 200 randomly selected epithelial cell nuclei, and 60 nuclear morphometric descriptors (NMDs) (eg, size, shape, DNA content, and textural features) were determined for each nucleus. Logistic regression analysis was used to assess the differences in the variances of the NMDs between the treated and untreated prostate epithelial cells. RESULTS: At baseline, the SPHB and placebo groups had similar NMD values. After 6 months of placebo, no significant change from baseline was found in the NMDs. However, after 6 months of SPHB, 25 of the 60 NMDs were significantly different compared with baseline, and a multivariate model for predicting treatment effect using 4 of the 25 was created (P <0.001). The multivariate model had an area under the receiver operating characteristic curve of 94% and an accuracy of 85%. CONCLUSIONS: Six months of SPHB treatment appears to alter the DNA chromatin structure and organization in prostate epithelial cells. Thus, a possible molecular basis for tissue changes and therapeutic effect of the compound is suggested.
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    5.Herbs for benign prostatic hyperplasia.

    Ann Pharmacother 2002 Sep;36(9):1443-52


    Dvorkin L, Song KY.

    Center for Integrative Therapies in Pharmaceutical Care, Massachusetts College of Pharmacy and Health Sciences, Boston, MA 02115-5896, USA. Ldvorkin@mcp.edu

    OBJECTIVE: To review and evaluate the literature relative to the use of herbal therapies in the treatment of benign prostatic hyperplasia. DATA SOURCES: Literature was identified by MEDLINE, Embase, International Pharmaceutical Abstracts, and the International Bibliographic Information on Dietary Supplements searches and through cross-referencing of selected articles. STUDY SELECTION/DATA EXTRACTION: All articles identified from the data sources were evaluated and all information deemed relevant was included in this review. DATA SYNTHESIS: A large percentage of men >50 years old begin to experience signs and symptoms of benign prostatic hyperplasia (BPH). Herbs hold promise in the treatment of BPH. Serenoa repens, Pygeum africanum, Urtica dioica radix, and Cucurbita peponis semen are some of the botanical therapies used in the treatment of BPH. CONCLUSIONS: There are many European studies examining efficacy, dose, and adverse effects of these plants in the treatment of BPH. However, numerous questions remain. These include issues concerning long-term beneficial and adverse effects of herbal therapy, prevention of complications, standardization of extracts, and concomitant use with "mainstream" medications. Based on the information available today, these botanical therapies can be used for treatment of a number of objective and subjective symptoms in patients with BPH, stages I and II.
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    6.Serenoa repens for benign prostatic hyperplasia.

    Cochrane Database Syst Rev 2002;(3):CD001423

    Wilt T, Ishani A, Mac Donald R.

    General Internal Medicine (111-0), Minneapolis VA/VISN 13 Center for Chronic Disease Outcomes Research, One Veterans Drive, Minneapolis, Minnesota 55417, USA. Tim.Wilt@med.va.gov

    BACKGROUND: Benign prostatic hyperplasia (BPH), nonmalignant enlargement of the prostate, 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 has been growing steadily. The extract of the American saw palmetto or dwarf palm plant, Serenoa repens (also known by its botanical name of Sabal serrulatum), is one of the several phytotherapeutic agents available for the treatment of BPH. OBJECTIVES: This systematic review aimed to assess the effects of Serenoa repens in the treatment of LUTS consistent with 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: In this update, 3 new trials involving 230 additional men (7.8%) have been included. 3139 men from 21 randomized trials lasting 4 to 48 weeks were assessed. 18 trials were double-blinded and treatment allocation concealment was adequate in 11 studies. Compared with placebo, Serenoa repens improved urinary symptom scores, symptoms, and 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 1.76 (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 1.86 ml/sec (95%CI = 0.60, 3.12, n = 9 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 provides mild to moderate improvement in urinary symptoms and flow measures. 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. The results of this update are in agreement with our initial review.
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    7.Randomized trial of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) on symptoms of benign prostatic hyperplasia (BPH).

    Int Urol Nephrol 2001;33(2):217-25


    Preuss HG, Marcusen C, Regan J, Klimberg IW, Welebir TA, Jones WA.

    Department of Physiology and Biophysics, Georgetown University Medical Center, Washington, DC 20007, USA. preusshg@georgetown.edu

    Because benign prostatic hyperplasia (BPH) is relatively common, it is important to discover safe and effective means to treat this often debilitating perturbation. Accordingly, we examined the effectiveness of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) in treating symptoms of BPH. We undertook a randomized, placebo-controlled, double-blind study. Patients were enrolled from 3 urological practices in the USA. 144 subjects were randomized for study. 17 subjects eventually withdrew, leaving 70 patients in the test group and 57 in the placebo group to complete the study. Inclusion criteria consisted of a diagnosis of BPH, no evidence of cancer, and a maximal urinary flow rate between 5 and 15 ml/second. Patients received either placebo or the combined natural products for 3 months. Evaluations were performed via the American Urological Association (AUA) Symptom Index score, urinary flow rate, PSA measurement, and residual bladder volume. Nocturia showed a markedly significant decrease in severity in patients receiving the combined natural products compared to those taking placebo (p < 0.001). Daytime frequency was also lessened significantly (p < 0.04). When the average individual total AUA Symptom Index score in the test group was compared to that in the placebo group at the end of the study, the difference proved highly significant (p < 0.014). PSA measurements, maximal and average urinary flow rates, and residual volumes showed no statistically significant differences. When taken for 3 months, a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) compared to placebo can significantly lessen nocturia and frequency and diminish overall symptomatology of BPH as indicated by an improvement in the total AUA Symptom Index score. The combination of natural products caused no significant adverse side effects.
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    8.A randomized, double-blind, placebo-controlled trial to determine the effectiveness of botanically derived inhibitors of 5-alpha-reductase in the treatment of androgenetic alopecia.

    J Altern Complement Med 2002 Apr;8(2):143-52


    Prager N, Bickett K, French N, Marcovici G.

    Clinical Research and Development Network, Aurora, CO, USA.

    BACKGROUND: Androgenetic alopecia (AGA) is characterized by the structural miniaturization of androgen-sensitive hair follicles in susceptible individuals and is anatomically defined within a given pattern of the scalp. Biochemically, one contributing factor of this disorder is the conversion of testosterone (T) to dihydrotestosterone (DHT) via the enzyme 5-alpha reductase (5AR). This metabolism is also key to the onset and progression of benign prostatic hyperplasia (BPH). Furthermore, AGA has also been shown to be responsive to drugs and agents used to treat BPH. Of note, certain botanical compounds have previously demonstrated efficacy against BPH. Here, we report the first example of a placebo-controlled, double-blind study undertaken in order to examine the benefit of these botanical substances in the treatment of AGA. OBJECTIVES: The goal of this study was to test botanically derived 5AR inhibitors, specifically the liposterolic extract of Serenoa repens (LSESr) and beta-sitosterol, in the treatment of AGA. Subjects: Included in this study were males between the ages of 23 and 64 years of age, in good health, with mild to moderate AGA. RESULTS: The results of this pilot study showed a highly positive response to treatment. The blinded investigative staff assessment report showed that 60% of (6/10) study subjects dosed with the active study formulation were rated as improved at the final visit. CONCLUSIONS: This study establishes the effectiveness of naturally occurring 5AR inhibitors against AGA for the first time, and justifies the expansion to larger trials.
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    9.Saw palmetto berry extract inhibits cell growth and Cox-2 expression in prostatic cancer cells.

    Cell Biol Int 2001;25(11):1117-24


    Goldmann WH, Sharma AL, Currier SJ, Johnston PD, Rana A, Sharma CP.

    Boston BioProducts Inc., Ashland, MA 01721, USA.

    The cytotoxicity of a commonly used material to alleviate the symptoms of benign prostatic hyperplasia (BPH), Saw Palmetto Berry Extract (SPBE), was examined as neat oil using a set of prostatic cell lines; 267B-1, BRFF-41T and LNCaP. Proliferation of these prostatic derived cell lines is inhibited to different degrees when dosed for 3 days with SPBE. The amount of SPBE required to inhibit 50% growth (IC50) of these cell lines was 20-30 nl equivalents of SPBE per ml of medium for cell lines 267B-1 and BRFF-41T and approximately 10-fold more for the LNCaP cell line. The effect of SPBE dosing on these cell lines is not irreversible, since a 30 min treatment with SPBE at an IC50 concentration does not inhibit their growth. Normal prostate cells were inhibited by 20-25% when grown in the presence of 200 nl SPBE equivalent per ml media. Growth of other non-prostatic cancer cell lines, i.e. Jurkat and HT-29, was affected by approx. 50% and 40%, respectively. When LNCaP cells were grown in the presence of dihydrotestosterone and SPBE, the IC50 concentration decreased significantly compared to LNCaP cells grown in the presence of serum and SPBE. Reduced cellular growth after SPBE treatment of these cell lines may relate to decreased expression of Cox-2 and may be due to changes observed in the expression of Bcl-2. Expression of Cox-1 under similar conditions is not affected because of its constitutive expression. Since increased Cox-2 expression is associated with an increased incidence of prostate cancer, and decrease in its expression by SPBE would provide a basis for further investigation of its use against BPH and in prostatic cancer chemoprevention.
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    10.Randomized, double-blind, placebo-controlled trial of saw palmetto in men with lower urinary tract symptoms.

    Urology 2001 Dec;58(6):960-4; discussion 964-5


    Gerber GS, Kuznetsov D, Johnson BC, Burstein JD.

    Section of Urology, Department of Surgery, University of Chicago Pritzker School of Medicine, Chicago, Illinois, USA

    OBJECTIVES: To assess the effects of saw palmetto on urinary symptoms, sexual function, and urinary flow rate in men with lower urinary tract symptoms using a double-blind, randomized, placebo-controlled trial. METHODS: The eligible patients were 45 years of age or older and had an International Prostate Symptom Score of 8 or greater. After a 1-month placebo run-in period, 85 men were randomized to receive saw palmetto or placebo for 6 months. Patients were evaluated using the International Prostate Symptom Score, a sexual function questionnaire, and by measurement of the urinary flow rate. RESULTS: The mean symptom score decreased from 16.7 to 12.3 in the saw palmetto group compared with 15.8 to 13.6 in the placebo group (P = 0.038). The quality-of-life score improved to a greater degree in the saw palmetto group, but this difference was not statistically significant. No change occurred in the sexual function questionnaire results in either group. The peak flow rate increased by 1.0 mL/s and 1.4 mL/s in the saw palmetto and placebo groups, respectively (P = 0.73). CONCLUSIONS: Saw palmetto led to a statistically significant improvement in urinary symptoms in men with lower urinary tract symptoms compared with placebo. Saw palmetto had no measurable effect on the urinary flow rates. The mechanism by which saw palmetto improves urinary symptoms remains unknown.
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    11.The Lipidosterolic Extract fromSerenoa repens Interferes with Prolactin Receptor Signal Transduction.

    J Biomed Sci 1995 Oct;2(4):357-365


    Vacher P, Prevarskaya N, Skryma R, Audy MC, Vacher AM, Odessa MF, Dufy B.

    Laboratory of Neurophysiology, University of Bordeaux II, CNRS URA 1200, Bordeaux, France.

    The lipidosterolic extract from the saw palmetto Serenoa repens (LSESr) is commonly used for medical treatment of benign prostatic hypertrophia due to its ability to inhibit 5alpha-reductase which permits the conversion of testosterone to dihydrotestosterone, the active androgen on prostate cell proliferation. However, the complete action mechanism of LSESr is still unknown. Several lines of evidence suggest that, in addition to inhibition of 5alpha-reductase, it may interfere with the action of prolactin (PRL). We therefore investigated a possible interference of this plant extract with another hormone that controls prostate gland growth, PRL. As the action mechanism of PRL is now fully documented in Chinese hamster ovary cells expressing the PRL receptor, we have conducted our experiments on these cells. In this study, using electrophysiological (whole-cell recording and single-channel recording), microspectrofluorimetric and biochemical techniques, we show that LSESr (1-30 &mgr;g/ml) reduced the basal activity of a K(+) channel and of protein kinase C (PKC) in CHO cells. In addition, pretreatment of the cells with 1-10 &mgr;g/ml LSESr for 6-36 h abolished the effects of PRL on [Ca(2+)](i), K(+) conductance and PKC. LSESr may block PRL-induced prostate growth by inhibiting several steps of PRL receptor signal transduction. LSESr may also be useful for diseases implicating PRL. Copyright 1995 S. Karger AG, Basel
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    12.Tissue effects of saw palmetto and finasteride: use of biopsy cores for in situ quantification of prostatic androgens.

    Urology 2001 May;57(5):999-1005


    Marks LS, Hess DL, Dorey FJ, Luz Macairan M, Cruz Santos PB, Tyler VE.

    Urological Sciences Research Foundation, Culver City, California, USA.

    OBJECTIVES: To determine the effects of a saw palmetto herbal blend (SPHB) compared with finasteride on prostatic tissue androgen levels and to evaluate needle biopsies as a source of tissue for such determinations. METHODS: Prostate levels of testosterone and dihydrotestosterone (DHT) were measured on 5 to 10-mg biopsy specimens (18-gauge needle cores) in three groups of men with symptomatic benign prostatic hyperplasia: 15 men receiving chronic finasteride therapy versus 7 untreated controls; 4 men undergoing prostate adenomectomy to determine sampling variability (10 specimens each); and 40 men participating in a 6-month randomized trial of SPHB versus placebo, before and after treatment. RESULTS: Prostatic tissue DHT levels were found to be several times higher than the levels of testosterone (5.01 versus 1.51 ng/g), that ratio becoming reversed (1.05 versus 3.63 ng/g) with chronic finasteride therapy. The finasteride effect was statistically significant for both androgens (P <0.01), and little overlap of individual values between finasteride-treated and control patients was seen. In the randomized trial, tissue DHT levels were reduced by 32% from 6.49 to 4.40 ng/g in the SPHB group (P <0.005), with no significant change in the placebo group. CONCLUSIONS: For control versus finasteride-treated men, the tissue androgen values obtained with needle biopsy specimens were similar-both for absolute values and the percentage of change-to those previously reported using surgically excised volumes of prostatic tissue. The quantification of prostatic androgens by assay of needle biopsies is thus feasible and offers the possibility of serial studies in individual patients. The SPHB-induced suppression of prostatic DHT levels, modest but significant in a randomized trial, lends an element of support to the hypothesis that inhibition of the enzyme 5-alpha reductase is a mechanism of action of this substance.
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    13.Phytotherapy for benign prostatic hyperplasia.

    Public Health Nutr 2000 Dec;3(4A):459-72


    Wilt TJ, Ishani A, Rutks I, MacDonald R.

    Minneapolis VA Center for Chronic Diseases Outcomes Research, MN 55417, USA. wilt.timothy@minneapolis.va.go v

    OBJECTIVE: To systematically review the existing evidence regarding the efficacy and safety of phytotherapeutic compounds used to treat men with symptomatic benign prostatic hyperplasia (BPH). DESIGN: Randomized trials were identified searching MEDLINE (1966--1997), EMBASE, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with relevant authors and drug companies. The studies were included if men had symptomatic benign prostatic hyperplasia, the intervention was a phytotherapeutic preparation alone or combined, a control group received placebo or other pharmacologic therapies for BPH, and the treatment duration was at least 30 days. Key data were extracted independently by two investigators. RESULTS: A total of 44 studies of six phytotherapeutic agents (Serenoa repens, Hypoxis rooperi, Secale cereale, Pygeum africanum, Urtica dioica, Curcubita pepo) met inclusion criteria and were reviewed. Many studies did not report results in a method allowing meta-analysis. Serenoa repens, extracted from the saw palmetto, is the most widely used phytotherapeutic agent for BPH. A total of 18 trials involving 2939 men were reviewed. Compared with men receiving placebo, men taking Serenoa repens reported greater improvement of urinary tract symptoms and flow measures. Serenoa repens decreased nocturia (weighted mean difference (WMD) = -0.76 times per evening; 95% CI = -1.22 to -0.32; n = 10 studies) and improved peak urine flow (WMD = 1.93 ml s(-1); 95% CI = 0.72 to 3.14, n = 8 studies). Men treated with Serenoa repens rated greater improvement of their urinary tract symptoms versus men taking placebo (risk ratio of improvement = 1.72; 95% CI = 1.21 to 2.44, n = 8 studies). Improvement in symptoms of BPH was comparable to men receiving the finasteride. Hypoxis rooperi (n = 4 studies, 519 men) was also demonstrated to be effective in improving symptom scores and flow measures compared with placebo. For the two studies reporting the International Prostate Symptom Score, the WMD was -4.9 IPSS points (95% CI = -6.3 to -3.5, n = 2 studies) and the WMD for peak urine flow was 3.91 ml s(-1) (95% CI = 0.91 to 6.90, n = 4 studies). Secale cereale (n = 4 studies, 444 men) was found to modestly improve overall urological symptoms. Pygeum africanum (n = 17 studies, 900 men) may be a useful treatment option for BPH. However, review of the literature has found inadequate reporting of outcomes which currently limit the ability to estimate its safety and efficacy. The studies involving Urtica dioica and Curcubita pepo are limited although these agents may be effective combined with other plant extracts such as Serenoa and Pygeum. Adverse events due to phytotherapies were reported to be generally mild and infrequent. CONCLUSIONS: Randomized studies of Serenoa repens, alone or in combination with other plant extracts, have provided the strongest evidence for efficacy and tolerability in treatment of BPH in comparison with other phytotherapies. Serenoa repens appears to be a useful option for improving lower urinary tract symptoms and flow measures. Hypoxis rooperi and Secale cereale also appear to improve BPH symptoms although the evidence is less strong for these products. Pygeum africanum has been studied extensively but inadequate reporting of outcomes limits the ability to conclusively recommend it. There is no convincing evidence supporting the use of Urtica dioica or Curcubita pepo alone for treatment of BPH. Overall, phytotherapies are less costly, well tolerated and adverse events are generally mild and infrequent. Future randomized controlled trials using standardized preparations of phytotherapeutic agents with longer study durations are needed to determine their long-term effectiveness in the treatment of BPH.
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    14.Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia.

    J Urol 2000 May;163(5):1451-6


    Marks LS, Partin AW, Epstein JI, Tyler VE, Simon I, Macairan ML, Chan TL, Dorey FJ, Garris JB, Veltri RW, Santos PB, Stonebrook KA, deKernion JB.

    Department of Urology, University of California Los Angeles School of Medicine, Los Angeles, CA, USA.

    PURPOSE: We tested the effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia (BPH) via a randomized, placebo controlled trial. MATERIALS AND METHODS: We randomized 44 men 45 to 80 years old with symptomatic BPH into a trial of a saw palmetto herbal blend versus placebo. End points included routine clinical measures (symptom score, uroflowmetry and post-void residual urine volume), blood chemistry studies (prostate specific antigen, sex hormones and multiphasic analysis), prostate volumetrics by magnetic resonance imaging, and prostate biopsy for zonal tissue morphometry and semiquantitative histology studies. RESULTS: Saw palmetto herbal blend and placebo groups had improved clinical parameters with a slight advantage in the saw palmetto group (not statistically significant). Neither prostate specific antigen nor prostate volume changed from baseline. Prostate epithelial contraction was noted, especially in the transition zone, where percent epithelium decreased from 17.8% at baseline to 10.7% after 6 months of saw palmetto herbal blend (p <0.01). Histological studies showed that the percent of atrophic glands increased from 25. 2% to 40.9% after treatment with saw palmetto herbal blend (p <0.01). The mechanism of action appeared to be nonhormonal but it was not identified by tissue studies of apoptosis, cellular proliferation, angiogenesis, growth factors or androgen receptor expression. We noted no adverse effects of saw palmetto herbal blend. When the study was no longer blinded, 41 men elected to continue therapy in an open label extension. CONCLUSIONS: Saw palmetto herbal blend appears to be a safe, highly desirable option for men with moderately symptomatic BPH. The secondary outcome measures of clinical effect in our study were only slightly better for saw palmetto herbal blend than placebo (not statistically significant). However, saw palmetto herbal blend therapy was associated with epithelial contraction, especially in the transition zone (p <0.01), indicating a possible mechanism of action underlying the clinical significance detected in other studies.
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    15.Saw palmetto for the treatment of men with lower urinary tract symptoms.

    J Urol 2000 May;163(5):1408-12


    Gerber GS.

    Section of Urology, Department of Surgery, University of Chicago Pritzker School of Medicine, Chicago, Illinois, USA.

    PURPOSE: A comprehensive review of the literature on the use of saw palmetto in men with lower urinary tract symptoms is provided. MATERIALS AND METHODS: A literature search of studies that have assessed the mechanism of action and clinical results of saw palmetto in men with benign prostatic hyperplasia was performed. RESULTS: A variety of potential mechanisms of action of saw palmetto have been demonstrated through in vitro studies, including 5-alpha reductase inhibition, adrenergic receptor antagonism and intraprostatic androgen receptor blockade. Clinical evidence of the relevance of these effects is largely unavailable. The use of saw palmetto in men with benign prostatic hyperplasia is safe with no recognized adverse effects. No effect on serum prostate specific antigen has been noted. Placebo controlled trials and meta-analyses have suggested that saw palmetto leads to subjective and objective improvement in men with lower urinary tract symptoms. However, most studies are significantly limited by methodological flaws, small patient numbers and brief treatment intervals. CONCLUSIONS: Evidence suggests that saw palmetto may have a significant effect on urinary flow rates and symptom scores compared to placebo in men with lower urinary tract symptoms. However, large scale, placebo controlled trials are needed to assess the efficacy of saw palmetto.
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    16.Role of herbal compounds (PC-SPES) in hormone-refractory prostate cancer: two case reports.

    J Altern Complement Med 2000 Oct;6(5):449-51


    de la Taille A, Hayek OR, Burchardt M, Burchardt T, Katz AE.

    The Squier Urological Clinic, Columbia University College of Physicians and Surgeons, Department of Urology, Columbia-Presbyterian Medical Center, New York, USA.

    PURPOSE: Herbal therapies are unconventional treatments that have been used for several different diseases. PC-SPES is an herbal mixture, composed of eight different herbs (chrysanthemum, isatis, licorice, Ganoderma lucidum, Panax pseudo-ginseng, Rabdosia rubescens, saw palmetto, and scutellaria), which has been used as an alternative in the treatment of prostate cancer. We report two cases of hormone-refractory prostate cancer patients, who showed a favorable response to therapy with this herbal combination, controlling the progression of the disease. METHODS: We report two cases of biopsy proven prostate cancer patients with metastatic disease, treated with total androgen blockade, progressing to an androgen-independent status. These patients were offered traditional therapies for hormone-resistant prostate cancer, and they chose to take PC-SPES. The follow-up as well as their evolution are described. RESULTS: PC-SPES extract decreased the prostate-specific antigen (PSA) value for both patients from an initial value of 100 and 386 ng/mL to 24 and 114 ng/mL after 1 year and 4 months, respectively, remaining stable until now. No gynecomastia or hot flashes were observed in these patients and the treatment was well tolerated. CONCLUSION: PC-SPES has shown a strong estrogenic in vitro and in vivo activity as an alternative tool in the management of prostate cancer patients. These cases suggest that PC-SPES might have some potential activity against hormone-independent prostate cancers.
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    17.Botanical derivatives for the prostate.

    Fitoterapia 2000 Aug;71 Suppl 1:S21-8


    Cristoni A, Di Pierro F, Bombardelli E.

    Scientific Department, Indena S.p.A., Viale Ortles 12, 20139, Milan, Italy. indenami@tin.it

    The prostate, after the age of 45 years, may undergo benign hyperplasia (BPH). Its etiology has not yet been completely explained, but different factors play a major role in its occurrence, among them, the sexual hormones (with a fundamental role of 5 alpha reductase). The 5-alpha reductase activity and inflammatory aspects in the prostate tissue can be effectively controlled with the use of highly standardized plant extracts (Pygeum africanum, Serenoa repens, etc.), which yield excellent results in the prophylaxis and treatment of the symptoms linked to prostate hypertrophy. The prostate tissue is not affected only by benign diseases but may also be subject to neoplastic transformation. From an epidemiological point of view, a vegetable derivative, lycopene, was linked with a lower occurrence of prostate carcinoma. A recent clinical study demonstrated that lycopene might not only prevent prostate cancer but also have therapeutic effects.
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    18.[Is there a rational therapy for symptomatic treatment of benign prostatic hyperplasia with phytogenic drugs? Illustrated with the example of the prostate agent from Serenoa repens (Sabal fructus)]

    [Article in German]

    Wien Med Wochenschr 1999;149(8-10):236-40


    Schilcher H.

    Freien Universitat Berlin, Deutschland.

    In summary, even when the scientific findings are subjected to a stringently critical evaluation, it must be concluded that the denigration of herbal prostate drugs to mere placebos, as occasionally occurs, is not scientifically tenable. This is especially true of the lipophilic extract of Saw Palmetto (Serenoa repens fruits) in a daily dose of 320 mg extract. All in all, far more experimental and clinical studies have been conducted with herbal prostate drugs than with "fashionable" drugs, such as alpha 1-receptor antagonists and finasteride, since with the latter only studies of recent design are available. A dogmatic evaluation of one drug group or another is certainly not in the patients' best interest. As the overview shows, both groups of substances are useful for individualized treatment of benign prostatic hyperplasia (BPH), provided that conservative pharmacological treatment of BPH is basically accepted and that the patients' quality of life is also considered. Phytomedicines have less side effects and lower costs.
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    19.Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review.

    JAMA 1998 Nov 11;280(18):1604-9


    Wilt TJ, Ishani A, Stark G, MacDonald R, Lau J, Mulrow C.

    Department of Veterans Affairs Coordinating Center of the Cochrane Collaborative Review Group in Prostatic Diseases and Urologic Malignancies, Minneapolis Veterans Affairs Medical Center, Minn 55417, USA. wilt.timothy@minneapolis.va.go v

    OBJECTIVE: To conduct a systematic review and, where possible, quantitative meta-analysis of the existing evidence regarding the therapeutic efficacy and safety of the saw palmetto plant extract, Serenoa repens, in men with symptomatic benign prostatic hyperplasia (BPH). DATA SOURCES: Studies were identified through the search of MEDLINE (1966-1997), EMBASE, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with relevant authors and drug companies. STUDY SELECTION: Randomized trials were included if participants had symptomatic BPH, the intervention was a preparation of S repens alone or in combination with other phytotherapeutic agents, a control group received placebo or other pharmacological therapies for BPH, and the treatment duration was at least 30 days. DATA EXTRACTION: Two investigators for each article (T.J.W., A.I., G.S., and R.M.) independently extracted key data on design features, subject characteristics, therapy allocation, and outcomes of the studies. DATA SYNTHESIS: A total of 18 randomized controlled trials involving 2939 men met inclusion criteria and were analyzed. Many studies did not report results in a method that permitted meta-analysis. Treatment allocation concealment was adequate in 9 studies; 16 were double-blinded. The mean study duration was 9 weeks (range, 4-48 weeks). As compared with men receiving placebo, men treated with S repens had decreased urinary tract symptom scores (weighted mean difference [WMD], -1.41 points [scale range, 0-19] [95% confidence interval (CI), -2.52 to -0.30] [n = 1 study]), nocturia (WMD, -0.76 times per evening [95% CI, -1.22 to -0.32] [n = 10 studies]), and improvement in self-rating of urinary tract symptoms; risk ratio for improvement (1.72 [95% CI, 1.21-2.44] [n = 6 studies]), and peak urine flow (WMD, 1.93 mL/s [95% CI, 0.72-3.14] [n = 8 studies]). Compared with men receiving finasteride, men treated with S repens had similar improvements in urinary tract symptom scores (WMD, 0.37 International Prostate Symptom Score points [scale range, 0-35] [95% CI, -0.45 to 1.19] [n = 2 studies]) and peak urine flow (WMD, -0.74 mL/s [95% CI, -1.66 to 0.18] [n = 2 studies]). Adverse effects due to S repens were mild and infrequent; erectile dysfunction was more frequent with finasteride (4.9%) than with S repens (1.1%; P<.001). Withdrawal rates in men assigned to placebo, S repens, or finasteride were 7%, 9%, and 11%, respectively. CONCLUSIONS: The existing literature on S repens for treatment of BPH is limited in terms of the short duration of studies and variability in study design, use of phytotherapeutic preparations, and reports of outcomes. However, the evidence suggests that S repens improves urologic symptoms and flow measures. Compared with finasteride, S repens produces similar improvement in urinary tract symptoms and urinary flow and was associated with fewer adverse treatment events. Further research is needed using standardized preparations of S repens to determine its long-term effectiveness and ability to prevent BPH complications.
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    20.Saw palmetto (Serenoa repens) in men with lower urinary tract symptoms: effects on urodynamic parameters and voiding symptoms.

    Urology 1998 Jun;51(6):1003-7


    Gerber GS, Zagaja GP, Bales GT, Chodak GW, Contreras BA.

    Department of Surgery, University of Chicago Pritzker School of Medicine, Illinois, USA.

    OBJECTIVES: To assess the effects of saw palmetto on voiding symptoms and urodynamic parameters in men with lower urinary tract symptoms (LUTS) presumed secondary to benign prostatic hyperplasia (BPH). METHODS: Fifty men with previously untreated LUTS and a minimum International Prostate Symptom Score (IPSS) of 10 or greater were treated with a commercially available form of saw palmetto (160 mg twice per day) for 6 months. The initial evaluation included measurement of peak urinary flow rate, postvoid residual urine volume, pressure-flow study, and serum prostate-specific antigen (PSA) level. Patients completed an IPSS, serum PSA was determined, and flow rate was measured every 2 months during the course of the study. A urodynamic evaluation was repeated at the completion of the 6-month trial. RESULTS: The mean IPSS (+/-SD) improved from 19.5+/-5.5 to 12.5+/-7.0 (P <0.001) among the 46 men who completed the study. Significant improvement in the symptom score was noted after treatment with saw palmetto for 2 months. An improvement in symptom score of 50% or greater after treatment with saw palmetto for 2, 4, and 6 months was noted in 21% (10 of 48), 30% (14 of 47), and 46% (21 of 46) of patients, respectively. There was no significant change in peak urinary flow rate, postvoid residual urine volume, or detrusor pressure at peak flow among patients completing the study. No significant change in mean serum PSA level was noted. CONCLUSIONS: Saw palmetto is a well-tolerated agent that may significantly improve lower urinary tract symptoms in men with BPH. However, we were unable to demonstrate any significant improvement in objective measures of bladder outlet obstruction. Placebo-controlled trials of saw palmetto are needed to evaluate the true effectiveness of this compound.
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    21.[Phytotherapy of benign prostatic hyperplasia]

    Urologe A 1997 Jan;36(1):10-7


    [Article in German]

    Bracher F.

    Institut fur Pharmazeutische Chemie, Technische Universitat Braunschweig.

    Phytopharmaceutical agents have been used for a long time in the treatment of symptomatic benign prostatic hyperplasia (BPH). However, until recently, it has been questioned whether phytotherapy is superior to a placebo treatment. In this article, the most widely used phytopharmaceutical agents, such as saw palmetto berry extracts, Radix urticae extracts, pumpkin seeds, pollen extracts and different phytosterols, are described. In addition, both in vitro and in vivo studies are discussed in an attempt to explain a possible mechanism of action. There are several new clinical studies which demonstrate a significant benefit compared with placebo treatment. Based on these results, the use of phytopharmaceutical agents for the treatment of mild to moderate symptomatic BPH seems to be well justified. So far, no significant inhibition of further prostate growth has been demonstrated. For this, a careful follow-up of the patients is necessary so as not to miss a deterioration and perhaps the need for an operation.
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    Thanks Biggin'. Good stuff.
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