Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia

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.     

Knowledge and prevalence of use of saw palmetto and other herbal products among men with prostate disease in Trinidad and Tobago

Objective

To investigate the knowledge and prevalence of use of saw palmetto and other herbal products among men attending the urology outpatient clinic at San Fernando General Hospital.

What do I tell patients about saw palmetto for benign prostatic hyperplasia?

Saw palmetto is widely used to treat lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). Although there is passionate support for herbal and complementary therapies for LUTS, clinical evidence is mixed. Because there is a well-recognized, profound placebo effect in tests of efficacy for agents treating LUTS, it is imperative that all therapies be tested in placebo-controlled trials. This article reviews evidence of the efficacy and safety of saw palmetto for men with LUTS caused by BPH, with particular emphasis on published randomized clinical trials and the upcoming Complementary and Alternative Medicine for Urologic Symptoms (CAMUS) trial.     

Saw Palmetto (Serenoa repens) in Men with Lower Urinary Tract Symptoms: Effects on Urodynamic Parameters and Voiding Symptoms

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.     

Randomized trial of a combination of natural products (cernitin,saw palmetto,B-sitosterol,vitamin E) on symptoms of benign prostatic hyperplasia (BPH)

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.     

Phytotherapie bei benignem Prostatasyndrom und Prostatakarzinom

In some countries plant extracts have belonged to the most popular drugs for the treatment of the benign prostatic syndrome (BPS) for decades; however, only few of the large number of published studies meet the criteria of the WHO benign prostatic hyperplasia (BPH) consensus conference. The few placebo-controlled long-term (study period >6 months) studies suggest a positive effect of some extracts (saw palmetto fruit, ??-sitosterol, urtica, rye grass and a saw palmetto/urtica combination) on lower urinary tract symptoms (LUTS), urinary flow rate, post-void residual volume but effects on prostate volume or prostate-specific antigen (PSA) were only inconsistently demonstrable. To date no study has proven an effect on disease progression, such as acute urinary retention or need for surgical interventions. Due to the controversial data various extraction techniques and compositions of various products, neither American, European, British nor German BPH guidelines recommend plant extracts for the indication BPS although some placebo-controlled trials provided encouraging data. Further prospective studies according to WHO standards are required to determine the role of plant extracts for the management of BPS. For the indication of prostate cancer (PCa) plant extracts have been evaluated for disease prevention and management of several tumor stages but none of these studies have provided convincing evidence that plant extracts are superior to placebo and none of the Pica guidelines have recommended their use. Based on current knowledge plant extracts can never supplement evidence-based PCa management and should be used only in addition to the standard treatment. There is no scientific evidence for the use of dietary supplementation with high doses of vitamins or selenium-containing products.     

Phytotherapie bei BPS

For decades, plant extracts have been amongst to the most popular drugs for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH)/benign prostatic enlargement (BPE). Only a few of the many published studies meet the criteria of the WHO-BPH consensus conference. The few placebo-controlled, long-term (>/=6 months) studies suggest a positive effect of some extracts (saw palmetto, beta-sitosterol, urtica, rye-grass, saw palmetto/urtica combination) on LUTS; an effect on uroflow, post-void residual volume, prostate volume and PSA was not consistently demonstrable. Randomised trials against an active comparator (alpha1-blocker, 5alpha-reductase inhibitors) are difficult to interpret. Due to the lack of prospective studies, several meta-analyses have been published that can not, however, replace prospective studies. None of the BPH-guidelines currently recommend plant extracts, yet universally conclude that this is an interesting approach. Further prospective studies using WHO standards are required to reliably determine the role of such extracts in the management of elderly men with LUTS due to BPH/BPE.     

Saw palmetto and lower urinary tract symptoms: What is the latest evidence?

The use of dietary supplements for treating a wide range of health conditions has grown rapidly in the United States. In the field of men’s health, the most common dietary supplement used is an extract of the berry of the saw palmetto plant, with which men commonly selfmedicate in order to treat lower urinary tract symptoms. Throughout the past two decades, substantial literature has emerged examining the biologic and clinical effects of saw palmetto extracts. Several lines of evidence suggest that 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, more recent studies are less consistent and the precise clinical value of saw palmetto for treating lower urinary tract symptoms remains undefined. Overall, there appear to be few safety concerns with short-term use of this herbal medicine, although large-scale and longer-term safety studies have not been performed. Higher-quality studies are currently underway to better define the potential benefits and risks of plant-based extracts for treating symptoms related to benign prostatic hyperplasia.     

Saw palmetto for the treatment of men with lower urinary tract symptoms

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.     

Benign prostatic hyperplasia treated with saw palmetto: a literature search and an experimental case study

European physicians treat benign prostatic hyperplasia (BPH) with saw palmetto extract (SPE), while American physicians generally disregard SPE because "research is lacking." The authors investigated this discrepancy with a literature search and a clinical trial. The literature search began with MEDLINE, then expanded to "alternative" databases, including AGRICOLA, EMBASE, IBIS, and Cochrane, plus a manual search of unindexed herbal journals. The clinical trial was an experimental case study in which a 67-year-old man with symptomatic BPH was randomly administered SPE (160 mg standardized extract twice daily) or placebo. Outcome measures included the American Urological Association Symptom Index (AUASI), serum prostate-specific antigen, and prostate volume. Our expanded literature search revealed 58 clinical trials, whereas MEDLINE yielded only 19 clinical trials, or 33% of the total. Our clinical trial measured a baseline AUASI score of 20, which improved to 7 after unblinded administration of SPE. Subsequent double-blinded placebo produced a score of 14, and final single-blinded allotment of SPE produced a score of 11. Prostate-specific antigen was 10.3 ng/mL at baseline and 10.7 ng/mL at trial's conclusion. Baseline prostatic volume was 92 mL, and end volume was 75 mL. In conclusion, MEDLINE proved inadequate as a stand-alone search engine for locating information about an herbal medicine. Our experimental case study, similar to N = 1 research methodology, proved suitable for clinical evaluation of an herbal medicine in a rural private practice. SPE improved the patient's BPH. Unstandardized look-alike herbs may act as nontherapeutic placebos and may undermine consumer confidence in herbal medicine.     

Randomized, double-blind, placebo-controlled trial of saw palmetto in men with lower urinary tract symptoms

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.     

锯叶棕果实提取物治疗BPH引起的下尿路症状疗效观察

目的:探讨锯叶棕果实提取物治疗BPH引起的下尿路症状的疗效。方法:采用锯叶棕果实提取物单药治疗30例前列腺增生伴下尿路症状患者8周,分别比较患者治疗前后的最大尿流率、前列腺体积、剩余尿量、IPSS评分及QOL评分的变化情况。结果:治疗8周后,患者的最大尿流率、剩余尿量、IPSS评分及QOL评分均有明显改善,前列腺体积则无明显变化。所有患者均无明显不良反应。结论:锯叶棕果实提取物能有效改善BPH患者的下尿路症状。     

A prospective, 1-year trial using saw palmetto versus finasteride in the treatment of category III prostatitis/chronic pelvic pain syndrome

PURPOSE: This study was designed to assess the safety and efficacy of saw palmetto or finasteride in men with category III prostatitis/chronic pelvic pain syndrome (CP/CPPS). MATERIALS AND METHODS: A prospective, randomized, open label, 1-year study was designed to assess the safety and efficacy of saw palmetto and finasteride in the treatment of men diagnosed with CP/CPPS. Patients were randomized to finasteride (5 mg once daily) or saw palmetto (325 mg daily) for 1 year. Patients were evaluated using the National Institutes of Health Chronic Prostatitis Symptom Index, individual domains (pain, urinary symptoms, quality of life and mean pain score) and the American Urological Association Symptom Score at baseline, 3, 6 and 12 months. RESULTS: A total of 64 consecutive men 24 to 58 years old (mean age 43.2) with a diagnosis of CP/CPPS were equally randomized to the 2 treatment arms. All 64 men had previously received antibiotics (duration of 3 to 93 weeks), 52 (82%) had been on alpha-blockade. There were 61, 57 and 56 patients evaluable at 3, 6 and 12 months, respectively. At 1 year mean total National Institutes of Health Chronic Prostatitis Symptom Index score decreased from 23.9 to 18.1 in the finasteride group (p <0.003), and from 24.7 to 24.6 in the saw palmetto arm (p = 0.41). In the finasteride arm the quality of life and pain domains were significantly improved at 1 year; however, urination was not. Adverse events included headache (3 cases) in the saw palmetto group and decreased libido (2 cases) in the finasteride group. At the end of the trial 13 of 32 (41%) and 21 of 32 (66%) opted to continue saw palmetto and finasteride, respectively. CONCLUSIONS: CP/CPPS treated with saw palmetto had no appreciable long-term improvement. In contrast, patients treated with finasteride had significant and durable improvement in all various parameters except voiding. Further studies are warranted to ascertain the mechanism and reproducibility of these effects in a placebo controlled trial.     

The role of a lipido-sterolic extract of Serenoa repens in the management of lower urinary tract symptoms associated with benign prostatic hyperplasia

OBJECTIVE To examine the clinical profile of medication derived from a lipido-sterolic extract of Serenoa repens (saw palmetto) for managing lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). METHODS We reviewed clinical trials involving extracts of S. repens, focusing on the benefit/risk ratio in patients with BPH. RESULTS S. repens extract significantly reduces the symptoms of BPH, increases urinary flow, improves the quality of life and is well tolerated. CONCLUSION Analysis of the overall clinical database indicates that extract of S. repens may be considered a viable first-line therapy for treating LUTS.     

Phytotherapy: emerging therapeutic option in urologic disease

Phytotherapy belongs to the area of complementary and alternative medicine (CAM) and the definition of phytotherapy is the use of plants or plant extracts for medicinal uses. Interest in phytotherapy is growing in both Asian and western countries for its use in the prevention and management of disease, improvement of general health and anti-aging. And also, there are several studies about the efficacy of phytotherapy in urologic diseases like benign prostatic hyperplasia (BPH), erectile dysfunction (ED), late-onset hypogonadism (LOH) and infertility in males. Phytotherapy for BPH including saw palmetto, pygeum, and nettles, is under vigorous research for the therapeutic effect. No solid evidence showing better effective treatment modality for ED than placebo has been found yet for phytotherapy. Recently, a potent NO donor, L-arginine is under research with promising results. Phytotherapy is used by a number of patients with urological disease, and urologists need to have accurate knowledge about phytotherapy as well as keep a cautious approach. The possible effects and side effects should be defined and related to urologic patients by urologists.     

Benign prostatic hyperplasia: racial differences in treatment patterns and prostate cancer prevalence

Study Type – Prevalence (prospective cohort with good follow‐up) Level of Evidence 1b What’s known on the subject? and What does the study add? Previous studies evaluating racial differences in BPH treatment and outcomes have concluded that more attention in the management of lower urinary tract symptoms should be directed at African Americans. Although the relationship between BPH and the development of prostate cancer is inconclusive, longitudinal studies have indicated racial disparities in the incidence of prostate cancer. This is the first long‐term follow‐up study in a BPH population to assess the incidence of prostate cancer among African American and Caucasian men under “real‐world” clinical practice circumstances. This study suggests that African Americans with BPH have a much greater risk of developing prostate cancer than similar Caucasian men, highlighting the need for education, prevention and early detection.

OBJECTIVE

? To compare prostate cancer, prostate‐related surgery and acute urinary retention rates, as well as associated healthcare resource use over 11 years in African American and Caucasian men with benign prostatic hyperplasia (BPH).

PATIENTS AND METHODS

? The BPH‐related medical and surgical charges and events were determined for 398 African American men and 1656 Caucasian men followed for a mean of 10.2 years within a health maintenance organization. ? Racial differences in clinical outcomes were evaluated using time‐to‐event analysis, stratifying results by baseline prostate‐specific antigen (PSA) values.

RESULTS

? Risk of a prostate cancer diagnosis was 2.2 times greater in African American than Caucasian men (95% CI 1.48–3.35, P < 0.001) in analyses adjusting for serum PSA level. ? Although African Americans were more likely to receive medical therapy for symptoms of BPH than Caucasians (43.5% vs 37.2%, respectively; P= 0.029), there were no clinically meaningful differences with respect to subsequent acute urinary retention or BPH‐related surgery between them, or BPH‐related medical charges (US $407 vs US $405 per month).

CONCLUSION

? As evidenced by this analysis of ‘real‐world’ clinical practice, African Americans with BPH have a much greater risk of developing prostate cancer than similar Caucasian men highlighting the need for education and early detection in this population.     

Lower urinary tract symptoms, benign prostatic hyperplasia, and obesity

Obesity has emerged as a global public health challenge. During the past 20 years, there has been a dramatic increase in obesity in the United States. In 2007, only one state had a prevalence of obesity less than 20%. In this growing epidemic of national concern is an emerging relationship between lower urinary tract symptoms (LUTS), benign prostatic hyperplasia (BPH), and obesity. BPH is the most common neoplastic condition afflicting men and constitutes a major factor impacting the health of the American male. Associations among obesity, physical inactivity, and BPH/LUTS resulting from epidemiological studies have not been explored via clinical trial methodology. A review of the available data appears to support a strong independent relationship between obesity and BPH/LUTS. This review also indicates that gene expression within the prostate varies with prostate size and can be affected by lifestyle modifications. Future studies may lead to office detection of a patient’s particular polymorphisms, which may help guide individual treatment and lifestyle modifications that are more likely to succeed.     

Do saw palmetto extracts block human alpha1-adrenoceptor subtypes in vivo?

BACKGROUND: To test whether saw palmetto extracts, which act as alpha1-adrenoceptor antagonists in vitro, also do so in vivo in man. METHODS: In a placebo-controlled, double-blind, four-way cross-over study 12 healthy young men were treated with three different saw palmetto extract preparations (320 mg o.d.) for 8 days each. On the last day, before and 2, 4 and 6 hr after drug intake blood pressure and heart rate were determined and blood samples obtained, which were used in an ex vivo radioreceptor assay with cloned human alpha1-adrenoceptor subtypes. RESULTS: Saw palmetto extract treatment did not result in alpha1-adrenoceptor subtype occupancy in the radioreceptor assay. Although the saw palmetto extracts caused minor reductions of supine blood pressure, they did not affect blood pressure during orthostatic stress testing and did not alter heart rate under either condition. Moreover, plasma catecholamines remained largely unaltered. CONCLUSIONS: 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.     

Treatment on Nature’s lap: Use of herbal products in the management of hyperglycemia

Diabetes mellitus (DM) is characterized by persistently elevated blood glucose concentration that lead to multisystem complications. There are about 400 medicinal plants cited to have a beneficial effect on DM. We must choose products wisely based on data derived from scientific studies. However, a major obstacle in the amalgamation of herbal medicine in modern medical practices is the lack of clinical data on its safety, efficacy and drug interaction. Trials of these herbal products often underreport the side effects and other crucial intervention steps deviating from the standards set by Consolidated Standards of Reporting Trials. Due to a lack of knowledge of the active compounds present in most herbal medicines, product standardization is difficult. Cost-effectiveness is another issue that needs to be kept in mind. In this mini-review, we focus on the anti-hyperglycemic effect of herbal products that are commonly used, along with the concerns stated above.     

Treatment of Memory Loss with Herbal Remedies

Increased rates of dementia throughout the world are creating an emergent need for successful preventive and treatment strategies. Despite a lack of any significant scientific basis, herbal remedies and other types of “complementary and alternative medicine” (CAM) are being aggressively marketed for both prophylactic and therapeutic effects in regard to memory disorders. In the past few years, a small number of controlled studies have explored the effectiveness of some of the more popular herbal and CAM remedies, including gingko biloba, phosphatidylcholine, phosphatidylserine, and omega-3 fatty acids. To date, the bulk of evidence suggests that such approaches are not successful in preventing or delaying cognitive decline or dementia, and there is little reason to prescribe these remedies for the treatment of established cognitive impairment. Some very preliminary evidence suggests that Gingko biloba may be useful in treating behavioral problems in demented people. It is likely that the absence of regulatory controls on the sale of herbal and CAM preparations will foster continued use of these agents and perhaps even accelerated use as the dementia epidemic increases, assuming no imminent breakthroughs in pharmacotherapy.