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| EVIDENCE FOR EFFICACY (HUMAN DATA) |
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Clinical Trials
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[Extracts Serenoa repens in the treatment of prostatic adenoma and chronic abacterial prostatitis: results of short-term (3-month courses) therapy] [Article in Russian].
[No authors listed] 2007
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Administration of Serenoa repens (SR) 320 mg / day or Tamsulosin (TAM) 0.4 mg / day or SR + TAM in cases of benign prostatic hyper-plasia revealed that SR & TAM seem to be effective alone & none was superior to other & additionally, SR + TAM therapy does not provide extra benefits.
Hizli 2007
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The efficacy of drugs for the treatment of LUTS/BPH, with Tamsulosin or Finasteride or Serenoa repens or Pygeum africanum revealed that improvements were seen in 43% of patients on phytotherapy with Serenoa repens or Pygeum africanum compared to 57% of those on finasteride & 68% on alpha-blockers.
Hutchison 2007
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137 patients with chronic bacterial prostatitis subjected to combination therapy with antimicrobials (ciprofloxacin /azithromycin), alpha-blockers (alfuzosin) & Serenoa repens extracts. 20% of patients who were refractory to 6-week combination therapy, could be 'rescued' by a 2nd cycle.
Magri 2007
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A review found saw palmetto may exert physiologic effects consistent with a beneficial clinical effect on the mechanisms of benign prostatic hyperplasia although most clinical studies tend to suggest a modest efficacy benefit of saw palmetto.
Avins 2006
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A double-blind trial in which 225 men over 49 years who had moderate-to-severe symptoms of benign prostatic hyperplasia (BSP) were given one year treatment with saw palmetto extract (160 mg twice a day) or placebo, showed saw palmetto did not improve symptoms or objective measures of BSP.
Bent 2006
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Efficacy & safety of a combination of sabal & urtica extract in urinary tract symptoms were studied in a randomized, double-blind, multicenter clinical trial which showed that non-inferiority of PRO 160/120 in comparison to tamsulosin in treatment of LUTS caused by BPH.
Engelmann 2006
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A clinical trial with 257 patients was performed to study efficacy & tolerance of PRO 160/120 (Combined extract of Sabal palm & nettle) in elderly men with lower urinary tract symptoms due to benign prostatic hyperplasia which showed that PRO 160/120 was superior to placebo. [Article in Russian]
Lopatkin 2006
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Enough data on randomised clinical trials of single-herb interventions are available on 3 herbs Ginkgo biloba, St John's wort and saw palmetto for meta-analyses. Strategies for investigating the full holistic approach of phytotherapy and its main elements are discussed.
Walker 2006
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N-of-1 study embedded within a placebo-controlled trial of saw palmetto for a participant who considered withdrawing because he believed the study medication caused an increase in his blood pressure.
In this case, the N-of-1 study not only reassured the patient, who decided to remain in the study.
Avins 2005
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A meta-analysis of all available published trials of Permixon (extract from the fruit of American dwarf palm tree, Serenoa repens ) for treating men with BPH showed a significant improvement in peak flow rate and reduction in nocturia above placebo, and a 5-point reduction in the IPSS.
Boyle 2005
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Serenoa repens(SR) extract is comparable with 5-alpha reductase & alpha-1 antagonist in treatment of benign prostatic hyperplasia in terms of symptom score & peak urinary flow rate but has a lower incidence of associated sexual dysfunction. Usage for 36 months of SR decreases progression rate.
Fong 2005
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Serenoa repens is an effective dual inhibitor of 5alpha-reductase activity in human prostate cancer(PC) cell lines. It induces its effects without interfering with secretion of PSA hence permits continuous PSA measurements as an useful biomarker for PC screening & for evaluating tumour progression.
Habib 2005
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A placebo-controlled, double-blind, trial to evaluate efficacy and safety of a combination of sabal and urtica extract for lower urinary tract symptoms (LUTS) revealed that PRO 160/120 was superior to placebo for the amelioration of LUTS and tolerability of herbal extract was excellent.
Lopatkin 2005
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In a placebo-controlled double-blind study, combined Sabal-urtica preparation (PRO 160/120) when administered for 24 weeks, ameliorated symptoms of urinary urgency and frequency in cases of benign prostatic hyperplasia. [Article in German]
Popa 2005
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Permixon (lipidosterolic Serenoa extract) increased molecular markers involved in apoptotic process ie. Bax-to-Bcl-2 expression ratio & caspase-3 activity in men with benign prostatic hyperplasia. This could have clinical relevance due to improvement in symptoms produced by treatment with this drug.
Vela-Navarrete 2005
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Treatment of Chronic nonbacterial prostatitis / chronic pelvic pain syndrome by antibiotics, alpha-blockade, anti-inflammatory agents, including Saw palmetto and finasteride and cognitive behavioral interventions such as biofeedback and psychotherapy etc. reviewed.
Yang 2005
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Evaluation of male sexual function in patients with Lower Urinary Tract Symptoms associated with Benign Prostatic Hyperplasia treated with Permixon (a lipidosterolic extract of Serenoa repens) Tamsulosin or Finasteride revealed that Permixon therapy has no negative impact on male sexual function.
Zlotta 2005
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Placebo controlled and comparative clinical studies of Permixon indicate its efficacy for BPH/lower urinary tract symptoms. Mechanisms proposed include antiandrogenic action, anti-inflammatory effect and antiproliferative influence through the inhibition of growth factors.
Buck 2004
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In Benign prostatic hypertrophy, lipidic liposterolic extracts of Serenoa repens were effective as inhibitors of 5alpha-reductase or alpha1-adrenergic blockers in relieving urinary symptoms. Serenoa also exerts anti-inflammatory & complementary cellular actions & it does not suppress serum PSA.
Comhaire 2004
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Evaluation in severe benign prostatic hyperplasia patients-PERMAL study subset analysis revealed that Permixon (lipido-sterolic extract of Serenoa repens) 320 mg/day was slightly superior to tamsulosin 0.4 mg/day in reducing low urinary tract symptoms after 3 months and up to 12 months.
Debruyne 2004
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A review has shown that S. repens extract significantly reduces the symptoms of benign prostatic hyperplasia, increases urinary flow, improves the quality of life and is well tolerated. Hence S. repens may be considered a viable first-line therapy for treating lower urinary tract symptoms.
Gerber 2004
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A review has shown that use of Saw palmetto leads to improvements in urinary function for those suffering from benign prostatic hyperplasia in comparison with tamsulosin.
Gong 2004
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A Chronic trial with 155 cases of benign prostatic hyperplasia & lower UT-symptoms treated with permixon 160mg twice a day for 2 yrs reduced IPSS & quality of life, increased maximal urine flow speed but had no effect on level of prostate-specific antigen & plasma hormones.[Article in Russian].
Pytel' IuA 2004
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A study on effects of prostadyn sabale capsules on 125 chronic prostatitis cases showed general cure rate of 19.2%, alleviation rate of 63.5% and the total effectivity rate of 82.7%. No side effects
were observed. [Article in Chinese].
Wu 2004
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The potential harmful side effects as well as adverse interactions of commonly used herbal medications Ginkgo Biloba, St. John's Wort, Ginseng, Echinacea, Saw Palmetto, Garlic, Kava and Ephedra in dental patients have been reviewd. [Article in Hebrew].
Zlotogorski 2004
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[Long-term efficacy and safety of PRO 160/120 (a combination of sabal and urtica extract) in patients with lower urinary tract symptoms (LUTS).]
Bondarenko 2003
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A study on fast control of bothersome symptoms and improvement in the patient's quality of life(QOL) in the treatment of lower urinary tract symptoms(LUTS) revealed that alpha(1)-adrenoceptor antagonist such as Tamsulosin has a more rapid onset of action than the plant extract Serenoa repens.
Djavan 2003
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A review on Saw palmetto for prostate disorders revealed that Saw palmetto appears to have efficacy similar to that of finasteride, but it is better tolerated & less expensive with no known drug interactions & reported side effects are minor & rare. No data on its long-term usage are available.
Gordon 2003
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A prospective, 1-year trial using saw palmetto (325 mg daily) versus finasteride (5 mg once daily) in the treatment of category III prostatitis/chronic pelvic pain syndrome revealed that saw palmetto had no appreciable long-term improvement but, finasteride treatment showed good improvement.
Kaplan 2003
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A study on whether a characterized saw palmetto product affects the activity of cytochrome P450, revealed that multiple doses of saw palmetto (Serenoa repens) did not alter cytochrome P450 2D6 and 3A4 activity in normal volunteers.
Markowitz 2003
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A multicenter open pilot study on BPH patients treated with oral Permixon (P) 160 mg bid for three months showed that number of lymphocytes in P treated to be (58.2+/-53.7) with lower biological markers TNF alpha and IL-1beta.
Vela Navarrete 2003
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A randomized controlled 12-week trial on Serenoa repens extract for benign prostate hyperplasia in 100 men with symptoms of BPH revealed that all participants had some improvement in their symptoms of BPH but there was no significant beneficial effect of this S. repens extract over placebo.
Willetts 2003
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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. [Article in Russian]
Aliaev 2002
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Up to 12 months of therapy showed that Permiwon and tamsulosin were equivalent in the medical treatment of lower urinary tract symptoms in men with BPH. [Article in French]
Debruyne 2002
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A 6-month double-blind, randomized, study which compared two dose regimens 160-mg tablets twice or thrice daily of Libeprosta, the lipidosterolic extract of Serenoa repens in 100 male patients of benign prostatic hyperplasia showed well-tolerability & improvement of lower urinary tract symptoms.
Giannakopoulos 2002
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The addition of Serenoa repens to tamsulosin did not provide any significant benefit to patients. [Article in French]
Glemain 2002
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This study establishes the effectiveness of naturally occurring 5-alpha-reductase inhibitors against androgenetic alopecia.
Prager 2002
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The urodynamics and biologic values on administration of Lipidosterolic extract of Serenoa repens (Permixon ) 160 mg twice daily for 2 years in 155 men with clinically diagnosed BPH and complaints of prostatic symptoms demonstrated the long-term efficacy and tolerability of Permixon.
Pytel 2002
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The study found ingestion of androstenedione combined with herbal products increased serum free testosterone concentrations in older men. These herbal products did not prevent the conversion of ingested androstenedione to estradiol and dihydrotestosterone.
Brown 2001
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The study found that ingestion of androstenediol combined with herbal products did not prevent the formation of estradiol and dihydrotestosterone.
Brown 2001
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Saw palmetto led to a statistically significant improvement in urinary symptoms in men with lower urinary tract symptoms compared with placebo. No effects found on urinary flow rates.
Gerber 2001
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Despite their alpha1-adrenoceptor antagonist effects in vitro, therapeutically used doses of saw palmetto extracts do not cause alpha1-adrenoceptor antagonism in man in vivo.
Goepel 2001
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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 with no significant adverse side effects.
Preuss 2001
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In patients with mild/moderate BPH, Permixon(R) treatment reduced infravesical obstruction and produced a rapid improvement in urodynamic parameters and symptoms.
Al-Shukri 2000
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This meta-analysis of all available published trials of Permixon in the treatment of men with benign prostatic hyperplasia revealed a significant improvement in peak flow rate and reduction in nocturia greater than with placebo.
Boyle 2000
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The study provides evidence that the addition of these herbal extracts to androstenedione does not result in increased serum testosterone concentrations, reduce the estrogenic effect of androstenedione, and does not augment the adaptations to resistance training.
Brown 2000
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Review of clinical trials and studies of mechanisms of action suggests saw palmetto may have a significant effect on urinary flow rates and symptom scores compared to placebo in men with lower urinary tract symptoms. More research needed.
Gerber 2000
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Saw palmetto herbal blend appears to be a safe, highly desirable option for men with moderately symptomatic BPH. The saw palmetto herbal blend therapy was associated with epithelial contraction, pointing to a possible mechanism of action.
Marks 2000
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The analysis showed that the efficacy of both saw palmetto fruit (Serenoa repens) and nettle root (Urtica dioica) (PRO 160/120)PR and the synthetic 5alpha-reductase inhibitor finasteride was equivalent. PRO 160/120 had better tolerability than finasteride.
Sokeland 2000
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Permixon is an effective inhibitor of 5-alpha-reductase isoenzyme activities in the prostate. Unlike other 5-alpha-reductase inhibitors, Permixon induces this effect without interfering with the secretion of PSA, thus permitting the continued use of PSA measurements for prostate cancer screening.
Bayne 1999
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This article provides an overview of systematic reviews of herbal treatments for conditions common in elderly individuals. Serenoa repens (saw palmetto) is effective in improving the symptoms of benign prostatic hyperplasia.
Ernst 1999
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The lipophilic extract of Saw Palmetto in a daily dose of 320 mg extract is 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.
Schilcher 1999
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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.
Di Silverio 1998
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50 men taking Serenoa extract 160 mg twice a day for 6 months had reduced urinary symptoms and IPSS improved from 19 to 12 but no change in peak flow or PSA.
Gerber 1998
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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
Wilt 1998
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Review concludes that plant based therapies for BPH are well justified
Bracher 1997
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Comparable results in urine flow increase and symptom decrease seen in 48 week double blind study of 543 patients of Sabal+Urtica vs. finasteride
Sokeland 1997
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Study of 1,098 BPH patients in 6 month double blind comparison of Serenoa extract (160 mg twice daily) compared with Proscar (5 mg per day) found similar urinary benefit although prostate size was reduced 18% by Proscar and 6% by Serenoa
Carraro 1996
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Review of the literature in 1996 found that 160 mg twice daily of Serenoa extract improves subjective urinary symptoms compared with placebo and benefit is comparable to 5 mg finasteride (Proscar)
Plosker 1996
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Peak flow improved by 48% with Serenoa (160 mg bid); 72% with alfuzosin (2.5 mg tid) in a 3 week, double-blind study of 63 BPH patients (summarized below).
Grasso 1995
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Sabal extract WS 1473 + Urtica extract WS 1031 improved symptoms for most of 2080 BPH patients in an open prospective study.
Schneider 1995
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Improvement in urinary flow, less residual urine, and reduced prostate size in 88% of patients taking saw palmetto for 3 months. [Braeckman , J., .]
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For 32 healthy men, ages 20-30, finasteride reduced serum dihydrotestosterone by 65% while no effect was found for Serenoa extract or placebo
Strauch 1994
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256 patients in clinical trial with Serenoa plus cyproterone acetate. Outcome not available in abstract
Di Silverio 1993
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In a 3 month trial with 45 BPH patients, Serenoa was nearly as beneficial as Prazosin for irritative symptoms
Adriazola 1992
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35 BPH patients, for 3 months prior to surgery, took either Serenoa extract (160 mg td) or placebo. Estrogen and progesterone receptor binding was lower in the Serenoa treated group
Di Silverio 1992
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20 BPH patients taking 160 mg liposterol extract twice a day for 30 days had no changes in plasma levels of testosterone, follicle-stimulating hormone (FSH), or luteinizing hormone (LH).
Casarosa 1988
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Novel treatment with a hexane extract of Serenoa repens in the treatment of benign prostatic hypertrophy
Olle Carreras 1987
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Double-blind study found improvement of urinary symptoms and flow rates in 43% of patients for Serenoa extract vs. 15% for placebo.
Tasca 1985
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110 BPH patients taking 160 mg twice a day of Serenoa extract in double-blind, placebo-controlled study had reduced urinary complaints
Champault 1984
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Observational Studies/Case Reports
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[Saw palmetto for benign prostatic hyperplasia.]
Casner 2006
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[Proven and unproven therapy for benign prostatic hyperplasia.]
DiPaola 2006
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Extracts from Pygeum africanum, Serenoa repens and Cucurbita pepo were used in the treatment of benign prostatic hyperplasia (BPH) and prostate cancer and their antiandrogenic activity was assessed using an AR responsive reporter gene assay for drug discovery.
Schleich 2006
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Evidence-based systematic review of saw palmetto by Natural Standard Research Collaboration including written & statistical analysis of literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, & dosing are presented.
Ulbricht 2006
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A case report of severe intraoperative haemorrhage in a patient who was taking the herb Saw Palmetto.
Cheema 2001
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PC-SPES is an herbal mixture, composed of eight different herbs. PC-SPES has shown a strong estrogenic in vitro and in vivo activity and may be an alternative tool in the management of prostate cancer.
de la Taille 2000
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Dr Julian Whitaker recommends use of the extract at 360 mg a day, along with zinc along with antioxidant vitamins and minerals, observing lowered PSA with this.
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Study of males with genetically deficiency of dihydrotestosterone-producing enzyme, 5 alpha-reductase, implicated it in BPH. Inhibition as a pharmacological strategy led to development of Proscar (finasteride).
Metcalf 1989
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Traditional and Folk Use
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A study to measure the self-reported intake of vitamins, selenium, vitamin E, and saw palmetto supplements in African-American men revealed that almost one half (46%) took multivitamin supplements. About 34% took vitamin E supplements, 6% took selenium supplements, and 7% took saw palmetto.
Weinrich 2004
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A study on use of complementary / alternative medicine by men diagnosed with prostate cancer revealed that 29.8% reported using complementary/alternative medicine for their prostate cancer care. 26.5% of the respondents used products like vitamin E, saw palmetto, and selenium.
Boon 2003
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In a review of literature relative to use of herbal therapies including Serenoa repens in treatment of benign prostatic hyperplasia, the questions remain are: long-term beneficial & adverse effects, prevention of complications, standardization of extracts, & use with other "mainstream" medications.
Dvorkin 2002
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A review has shown that saw palmetto, Pygeum africanum, curbicin, and isoflavone-containing supplements (red clover [Trifoleum pratense] and soy), are widely used in patients with BPH. Consumption of isoflavones has been correlated with lower rates of BPH and prostate cancer among Asian men.
Katz 2002
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A review has shown that zinc, cernilton (bee pollen), quercetin, and saw palmetto are the commonly used phytotherapies in prostatitis patients. Although many of these therapies appear promising in small preliminary studies they require scientific validation.
Shoskes 2002
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Medical research has shown traditional uses have been found to have a scientific basis for treating problems of the genitourinary tract. Use of cranberry for recurrent cystitis in women and saw palmetto for prostatism are examples of plants we can now use with some confidence.
Pinn 2001
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Ethnobotanical report that Mikasuki Seminole used the fruit as food. Sturtevant, W. The Mikasuki Seminole: Medical Beliefs and Practices. Yale University, PhD Thesis 1954
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Search "A Modern Herbal" by Mrs. M. Grieve for serenoa used as a mild diuretic
(Botanical.com)
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Adverse Effects & Toxicity
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A probable case of Saw palmetto induced acute hepatitis and pancreatitis was reported. Patient had BPH for which he intermittently took Saw palmetto for four years. Two similar episodes of improvements followed by recurrence were noted with discontinuations &
restarting of Saw Palmetto.
Jibrin 2006
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Review of several herbs concluded that, although Saw palmetto has been shown in short-term trials to be efficacious in reducing the symptoms of benign prostatic hyperplasia, none of the reviewed herbal medicines can be declared safe because the evidence is incomplete.
Ernst 2002
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A 24-year-old woman with androgenetic alopecia who became sensitized to topical minoxidil following use of minoxidil 4% subsequently also became sensitized to saw palmetto (Serenoa repens), a topical herbal extract promoted for the treatment of hair loss.
Sinclair 2002
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In review of commonly used herbal medicines, Saw palmetto generally recognized as beneficial with no known adverse effects.
Petry 2001
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Zona-free hamster oocytes were incubated for 1 hour in saw palmetto (Serenoa repens), echinacea purpura, ginkgo biloba, St. John's wort (Hypericum perforatum), or control medium before sperm-oocyte interaction. Saw palmetto had no effect.
Ondrizek 1999
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Studies suggest a possible benefit for the use of phytotherapeutic preparations in the treatment of BPH.
Lowe 1998
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Review of the literature in 1996 found that 160 mg twice daily of the extract has only minor gastrointestinal problems (e.g. nausea and abdominal pain).
Plosker 1996
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1 out of 32 BPH patients in the Serenoa group complained of mild pruritus which cleared spontaneously.
Grasso 1995
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Interactions
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Documented Interactions between saw palmetto and prescription medications have been discussed, as use of both medicinals simultaneously has a potential for adverse interactions.
Bressler 2005
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Literature searches were performed from databases: Medline (via Pubmed), Cochrane Library, Embase and phytobase (all from their inception to July 2000). All data relating to herb-drug interactions were included. No interactions were found for saw palmetto (Serenoa repens).
Izzo 2001
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Animal Studies
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36 rats treated for 2 or 4 weeks with a placebo or saw palmetto at doses of 9.14 or 22.86 mg/kg/body wt./day (2 x and 5 x the maximum recommended daily human dosages) showed that at the doses & time periods tested, saw palmetto did not produce any effect on the markers of liver toxicity.
Singh 2007
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In phenylephrine-induced atypical prostatic hyperplasia, rat model D-004 (Lipid extract of fruits of Roystonea regia) was moderately more effective than Saw palmetto, a phytotherapeutic standard used to treat BPH, but less effective than tamsulosin a selective alpha(1A)-adrenoceptor antagonist.
Arruzazabala 2006
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Prostatilen (1 mg per kg) & permixon
(100 mg of Serenoa repens extract per kg) prevented increase in prostate mass & volume, of the lipid hydroperoxides, & in glutathione peroxidase activity in prostate in rats with hyperprolactinemia-induced prostatic hyperplasia. [Article in Russian]
Belostotskaia 2006
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Antiproliferative effects of 3 homeopathic preparations including Sabal serrulata (SS), in vivo on nude-mouse xenografts & in vitro on PC-3 & DU-145 human prostate & MDA-MB-231 human breast cancer cell lines were tested which revealed in vivo, prostate tumor size was reduced in SS treated mice.
MacLaughlin 2006
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A study on therapeutic effect of D-004, a lipid extract from Roystonea regia fruits, or Saw palmetto (400 mg/kg) on prostate hyperplasia induced in rats showed that D-004 (400 mg/kg) was more effective than Saw palmetto (400 mg/kg).
Carbajal 2005
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Effects of saw palmetto extract on micturition reflex of rats revealed significant increase in the micturition interval, micturition volume and bladder capacity. Autonomic receptor binding activity showed inhibition of specific binding of H N-methyl-H]scopolamine methyl chloride and [H]prazosin.
Oki 2005
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A 90 day test found Permixon to significantly reduce mast cell accumulation and provoke epithelium atrophy within the central area of rats ventral prostate.
Mitropoulos 2002
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Products containing extracts of S repens are used for men with prostatic hyperplasia. Beneficial or harmful effects of this plant extract were not found in dogs with prostatic hyperplasia.
Barsanti 2000
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The orally administered hexane lipid-sterol extract of Serenoa (Permixon) facilitates distribution of 14C labeled oleic acid to the prostate.
Chevalier 1997
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Permixon extract inhibits testosterone stimulated prostate enlargement in rats.
Paubert-Braquet 1996
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5AR (EC 1.3.99.5) level is regulated by androgens. Finasteride given to rats decreased 5AR activity by 87% and prostate weight by 55%. It counters testosterone but not DHT mediated stimulation.
George 1991
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Pharmacodynamics
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Ethanolic extract of Serenoae repens tested in hormone-sensitive LNCaP, MCF-7 & hormone-insensitive DU 145, MDA MB231 prostate, breast carcinoma cell lines, renal Caki-1, urinary bladder J82, colon HCT 116 & lung A 549 cancer cells revealed anti-proliferative effect.
Hostanska 2007
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Analysis of interactions of extract combinations of Scutellaria baicalensis, Rabdosia rubescens, Panax-pseudo ginseng, Dendranthema morifolium, Glycyrrhiza uralensis & Serenoa repens were studied against viability of prostate cancer cell lines using a luminescent ATP cell viability assay.
Adams 2006
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An investigation of the enzymatic inhibition of 5alpha-reduction and growth of prostatic carcinoma cell line LNCap-FGC by natural astaxanthin and Saw Palmetto lipid extract in vitro revealed that Astaxanthin added to SPLE shows greater inhibition of 5alpha-reductase than SPLE alone in vitro.
Anderson 2005
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Serenoa repens is an effective dual inhibitor of 5alpha-reductase activity in human prostate cancer(PC) cell lines.It induces its effects without interfering with secretion of PSA hence permits continuous PSA measurements as an useful biomarker for PC screening & for evaluating tumour progression.
Habib 2005
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A study on the effect of Permixon in androgen-independent PC-3 prostate cancer cells, androgen-sensitive LNCaP prostate cancer cells & MCF-7 breast cancer cells in vitro showed significant decrease in the rate of cell growth & had no effect on apoptosis induction in prostate cancer cell lines.
Hill 2004
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Pretreatment with Serenoa repens, before transurethral resection of prostate procedure, improves efficacy of procedure itself and reduces risk of complications, in particular perioperative bleeding and duration of postoperative catheterization. [Article in Italian].
Pecoraro 2004
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A number of short-term randomised trials and metaanalyses in the recent literature suggest clinical efficacy and good tolerability for extracts from Serenoa repens and Pygeum africanum, products with high concentrations of beta-sitosterol, and pumpkin seeds.
Dreikorn 2002
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There is growing evidence from well-conducted clinical trials that phytotherapeutic agents may lead to subjective and objective symptom improvement beyond a placebo effect in men with BPH.
Gerber 2002
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It unlikely that the activity of a single herb can account for the overall effects of PC-SPES. Only Glycyrrhiza uralensis Fisch, Scutellaria baicalensis Georgi and Serenoa repens lowered intracellular and secreted PSA, while the remaining herbs actually increased PSA expression.
Hsieh 2002
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In different cell systems, the lipido-sterolic extract of Serenoa repens (LSESr) Permixon inhibited both type 1 and type 2 5alpha-reductase activity and dual inhibitory activity of LSESr on 5alpha-reductase type 1 and type 2 can be attributed to its high content in free fatty acids.
Raynaud 2002
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6 months of Saw palmetto herbal blend treatment alter the DNA chromatin structure & organization in prostate epithelial cells by causing contraction of prostate epithelial cells & suppression of tissue dihydrotestosterone levels in men with symptomatic benign prostatic hyperplasia.
Veltri 2002
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Reduced cellular growth after Saw Palmetto Berry Extract (SPBE) treatment of of cell lines may relate to decreased expression of Cox-2. SPBE may provide a basis for further investigation of its use against BPH and in prostatic cancer chemoprevention.
Goldmann 2001
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Found extract from S. repens and myristoleic acid induces mixed cell death of apoptosis and necrosis in LNCaP cells.
Iguchi 2001
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Data suggest that the extract from S. repens specifically inhibits the uPA activity and may therefore be useful for the therapeutic treatment of prostate cancer.
Ishii 2001
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European countries commonly use phytopharmaceuticals for management of BPH and LUTS and may represent up to 80% of all drugs prescribed for this disorder. Extracts of saw palmetto fruit and roots of stinging nettle are popular. Evidence for efficacy and favourable safety profile has been found.
Koch 2001
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The saw palmetto herbal blend 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.
Marks 2001
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This investigation demonstrated the selectivity of the action of Permixon(R) for prostate cells. The morphological changes in the prostate are accompanied by an increase in the apoptotic index along with an inhibition in the activity of the nuclear membrane bound 5alphaR isoenzymes.
Bayne 2000
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Herbs used to enhance physical performance regardless of scientific evidence of effect are: Chinese, Korean,American and Siberian ginsengs; mahuang or Chinese ephedra; ashwagandha; Rhodiola; Yohimbe; Cordyceps, Smilax, wild oats; Muira puama, Tribulus terrestris; saw palmetto, and wild yam.
Bucci 2000
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The 5-alpha reductase activity and inflammatory aspects in the prostate tissue can be controlled with the use of standardized plant extracts (Pygeum africanum, Serenoa repens, etc.), which yield excellent results in prophylaxis and treatment of symptoms linked to prostate hypertrophy.
Cristoni 2000
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Serenoa repens (Permixon), a lipido-sterol extract of dwarf palm is one of phytotherapeutic agents most widely studied clinically to determine their efficacy,and reseached to identify the mechanism(s) of action.
Levin 2000
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Induction of apoptosis and inhibition of cell proliferation are likely to be the basis for the clinical efficacy of LSESr (Permixon).
Vacherot 2000
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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.
Wilt 2000
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Lipido-sterolic extract of Serenoa inhibits b-fibroblast growth factor induced proliferation of prostate cells in vitro.
Paubert Braquet 1998
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Serenoa extract, at concentrations as low as 5 ug/ml, inhibits inflammation by inhibiting 5-lipoxygenase, resulting in less leukotriene B4 (LTB4) and 5-hydroxyeicosatetraenoic acid (5-HETE). The effect remains with added arachidonic acid (20 ug/ml) suggesting that the inhibition is unrelated to phospholipase A2 blockage and independent of the stimulating agent.
Paubert-Braquet 1997
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The Permixon extract induces differentiation in an androgen responsive prostate cell line, LNCaP. It lacks effect on androgen unresponsive PC3 cells until androgen receptors are added by transfection. This indicates a role of androgen receptors in the effect.
Ravenna 1996
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5AR enzyme is responsible for the formation of DHT from testosterone. DHT has been the major
androgen implicated in the pathogenesis of benign prostatic hyperplasia, male pattern baldness, acne, and female hirsutism.
Tenover 1991
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Permixon reduced testosterone uptake by 40% in 11 different tissue specimens.
el-Sheikh 1988
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Permixon (Serenoa repens extract) is a competitive inhibitor of androgen binding to cytosolic rat prostate androgen receptors while other vegetable oils are inactive.
Carilla 1984
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Analytical Chemistry
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A study to assess extent to which published randomized controlled trials of herbal preparations had characterized and verified the content revealed that only 15% reported performing tests to quantify actual contents, & 4% provided adequate data to compare actual with expected content.
Wolsko 2005
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Sablacaurin A [25-ethyl,23-methyl-19-nor-24-methylene-3,4-seco-4(28)-lanosten-10,3-olide] & sablacaurin B [24-ethyl,24-methyl-19-nor-3,4-seco-4(28),25(26)-lanostadiene-10,3-olide] were isolated from Sabal causiarum leaves & S.blackburniana respectively & their structures established by spectroscopy.
El-Dib 2004
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Mass spectrometry detection of alcohols in Saw Palmetto fruit.
Van Berkel 1998
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Contains two monoacylglycerides, 1-monolaurin and 1-monomyristin which have borderline activity against three tumor cell lines.
Shimada 1997
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Pharmacokinetics (ADME)
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A clinical study conducted on 12 healthy volunteers revealed that Botanical supplements containing C aurantium, milk thistle, or saw palmetto extracts appear to pose a minimal risk for CYP-mediated herb-drug interactions in humans.
Gurley 2005
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A study to know the extent by which the three herbs Ginkgo biloba, Echinacea purpurea, and Serenoa repens inhibit in vitro enzymatic activity of three drug metabolizing enzymes, cytochrome P450 (CYP) 3A4, 2D6, and 2C9 revealed that Serenoa repens, was a potent inhibitor of all three CYPs examined.
Yale 2005
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Treatment by extract from the fruit of saw palmetto may relieve symptoms of BPH, in part, by inhibiting specific components of the IGF-I signaling pathway and inducing JNK activation, thus mediating antiproliferative and proapoptotic effects on prostate epithelia.
Wadsworth 2004
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Genetics & Molecular Biology
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Permixon is an effective inhibitor of 5-alpha-reductase isoenzyme activities in the prostate. Unlike other 5-alpha-reductase inhibitors, Permixon induces this effect without interfering with the secretion of PSA, thus permitting the continued use of PSA measurements for prostate cancer screening.
Bayne 1999
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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.
Di Silverio 1998
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Serenoa extract, at 7.2 microg/ml abd 4.9 microg/ml, respectively, inhibits both type 1 and type 2 human 5-alpha-reductase iso-enzymes so it has broader activity than finasteride which only inhibits type 2.
Iehle 1995
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Serenoa extract inhibits both type 1 and type 2 human 5-alpha-reductase.
Delos 1994
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Serenoa repens extract strongly inhibits 3 ketosteroid reductase mediated conversion of (DHT) to 5
alpha-androstane-3 alpha, 17 beta-diol in human fibroblasts.
Sultan 1984
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The DHT product of 5AR enzyme binds to androgen receptors in prostate cells causing stimulation of growth and cell division. High 5AR enzyme levels often seen in BPH makes it a logical target to inhibit and that is the target of widely used Proscar (finasteride)
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Contemporary Formulas
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A review on comparison of selected components of 14 brands of Serenoa extract showed that not all brands are created equal & had significantly different proportional content of free fatty acids, methyl & ethyl esters, long-chain esters & glycerides which may have an impact on efficacy & safety.
Habib 2004
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A double blind comparison of Sabal+Urtica vs. finasteride for 48 weeks with 543 patients had comparable results for urine urine flow increase (1.9 vs. 2.4 ml/sec) and symptom decrease (see below) .
Sokeland 1997
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Modern Mixture: Serenoa extract, Pumpkin seeds, Urtica or Pollinis siccae extract are approved in Germany.
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