Analysis of the results obtained with a new phytotherapeutic association for LUTS versus control. [corrected]. A prospective study of the efficacy of Serenoa repens, Tamsulosin, and Serenoa repens plus Tamsulosin treatment for patients with benign prostate hyperplasia Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic hyperplasia. The lipidosterolic extract ofSerenoa repens in the treatment of benign prostatic hyperplasia: A comparison of two dosage regimens Combined sabal and urtica extract compared with finasteride in men with benign prostatic hyperplasia: analysis of prostate volume and therapeutic outcome Multicentre study on the efficacy and tolerability of an extract of Serenoa repens in patients with chronic benign prostate conditions associated with inflammation. Saw palmetto (Serenoa repens) in men with lower urinary tract symptoms: effects on urodynamic parameters and voiding symptoms. Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial Treatment of benign prostatic hyperplasia with phytosterols. Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. [Associating Serenoa repens, Urtica dioica and Pinus pinaster. Safety and efficacy in the treatment of lower urinary tract symptoms. Prospective study on 320 patients]. Does the addition of Serenoa repens to tamsulosin improve its therapeutical efficacy in benign prostatic hyperplasia? Efficacy and tolerability of the lipidosterolic extract of Serenoa repens (Permixon) in benign prostatic hyperplasia: a double-blind comparison of two dosage regimens. Update on the american urological association guidelines for the treatment of benign prostatic hyperplasia. Serenoa repens + selenium + lycopene vs tadalafil 5 mg for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction: a Phase IV, non‐inferiority, open‐label, clinical study (SPRITE study) Long-term efficacy and safety of a combination of sabal and urtica extract for lower urinary tract symptoms—a placebo-controlled, double-blind, multicenter trial Using a treatment satisfaction measure in an early trial to inform the evaluation of a new treatment for benign prostatic hyperplasia.
INTRODUCTION Benign prostatic hypertrophy ( BPH ) is a common disease whose frequency has risen throughout the world in concomitance with the increase in life expectancy . BPH causes voiding disturbances known by the acronym LUTS ( lower urinary tract symptoms ) , which heavily influence the quality of life in the elderly . The treatment for LUTS is mainly divided into medical and surgical , the latter usually represented by prostate ablation . Medical therapy includes synthetic molecules that interfere with the hormonal control of BPH or act on the bladder neck tonus , as well as natural remedies based on plant extracts from Serenoa Repens and /or Urtica Dioica . MATERIAL AND METHODS Two groups of patients who were c and i date s for surgery for BPH-induced LUTS , were r and omly recruited in a six-month trial aim ed at comparing outcome of treatment with a new combination of plants extracts ( Pluvio ® ) , which differs from the previous ones in that it also contains avocado and soya oil , as well as a high dose of Urtica Dioica , with no therapy . Age , IPSS score , maximal uroflow , prostate volume , PSA , free-to-total PSA ratio , post voiding residual urine and number of nocturia episodes were recorded and statistically evaluated using a NCSS 60 ® program . RESULT A marked benefit in terms of quality of life , measured by IPSS score , uroflow , residual urine and nocturia , was observed in the treated group compared to controls . PSA and prostate volume were not significantly affected . No noteworthy adverse events were observed . CONCLUSIONS The new phytotherapeutic combination evaluated in the present study would seem to be highly effective for the treatment of LUTS in BPH patients and does not have negative side effects . Its use could therefore be strongly advocated in this setting Introduction Increasing attention has been focused on the use of phytotherapeutic agents to alleviate the symptoms of benign prostatic hyperplasia ( BPH ) in recent times . The best described and studied phytotherapeutic agent is Serenoa repens ( SR ) . Material s and methods This prospect i ve study was design ed to have 3 arms including SR 320 mg per day ( N = 20 ) , Tamsulosin ( TAM ) 0.4 mg per day ( N = 20 ) and SR + TAM ( N = 20 ) to reveal the superiority or equivalence between these treatment regimens in BPH . Results The groups were not statistically different with regard to increase in maximal urinary flow rate ( Qmax ) and decrease in International Prostate Symptom Score ( I-PSS ) ( P > 0.05 ) . No adverse effect was detected in SR therapy group . Conclusion Treatment of BPH by both SR and TAM seems to be effective alone . None of them had superiority to another and additionally , combined therapy ( SR + TAM ) does not provide extra benefits . Furthermore SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS due to BPH 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 clinical ly 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 This 6-month double-blind , r and omized , parallel-group study compared two dose regimens of Libeprosta ® , the lipidosterolic extract ofSerenoa repens in 100 male out patients 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 ofSerenoa repens was a well-tolerated agent that may significantly improve lower urinary tract symptoms and flow measurements in men with BPH Objective To test the hypothesis that in patients with benign prostatic hyperplasia ( BPH ) , the outcome of drug therapy with finasteride may be predictable from the baseline prostate volume and that positive clinical effects might be expected only in patients with prostate volumes of > 40 mL , using a subgroup analysis of results from a previously reported clinical trial of finasteride and phytotherapy INTRODUCTION Chronic benign prostate diseases are very common and certainly feature significantly in urological practice .The treatment of chronic benign prostate diseases is a common problem in clinical practice : few studies have been conducted in routine clinical practice to evaluate the efficacy of the treatments for this clinical condition . The objective of this study was to evaluate the efficacy of an extract of Serenoa repens ( Permixon ) in the treatment of lower urinary tract symptoms ( LUTS ) in patients with chronic benign prostate diseases with associated inflammation , also taking into consideration the influence of treatment on sexual function and , therefore , on patients ' quality of life . MATERIAL S AND METHODS All the 591 eligible subjects were evaluated on entering the study ; after a screening visit , including medical history , physical examination , physical examination and digital rectal examination ( DRE ) and laboratory tests , the patients underwent uroflowmetry . The subjects under investigation were also asked to complete the IPSS , NIH-CPSI and IIEF-5 question naires , for the purpose of evaluating urinary symptoms and erectile function in relation to sexual activity in the previous 6 months . RESULTS The analysis of the uroflowmetry results showed that treatment with extract of Serenoa repens distinctly improves bladder voiding and lower urinary tract symptoms , as highlighted also by the improvement in the scores for the IPSS and NIH-CPSI question naires which serve as a basis for evaluating the urinary symptoms of patients with prostatic hyperplasia and chronic prostatitis respectively . The results also suggest that using an extract of Serenoa repens for 6 months in patients with chronic benign prostate diseases gives rise to an improvement in erectile function , as demonstrated by the increase in the scores for the IIEF-5 question naire after 6 months of treatment . CONCLUSIONS The results of this study demonstrate how treatment for 6 months with an extract of Serenoa repens in routine clinical practice gives rise to a statistically significant improvement in Qmax values and in the IPSS , NHI-CPSI and IIEF-5 question naire scores , result ing not only in an improvement in urinary symptoms but also in an overall improvement in patients ' quality of life 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 To compare the effect of a Serenoa repens extract with placebo for symptoms of benign prostatic hyperplasia ( BPH ) In a r and omised , double-blind study , the preparation Curbicin , obtained from pumpkin seeds and dwarf palm plants ( Cucurbita pepo L. and Sabal serrulata ) , was compared with a placebo in the treatment of symptoms caused by prostatic hyperplasia ; 53 patients took part in the study , which was carried out over a 3-month period .  Urinary flow , micturition time , residual urine , frequency of micturition and a subjective assessment of the effect of treatment were all significantly improved in the treatment group . No untoward side effects were noted OBJECTIVES The timely recruitment of study participants is a critical component of successful trials . Benign prostatic hyperplasia ( BPH ) , a common nonmalignant urologic condition among older men , is characterized by lower urinary tract symptoms ( LUTS ) . Successful recruitment methods for a trial of medical therapy for BPH , Medical Therapy of Prostate Symptoms ( MTOPS ) , were mass mailing and advertising . The Complementary and Alternative Medicines Trial for Urological Symptoms ( CAMUS ) was design ed to evaluate a botanical therapy , saw palmetto , for the treatment of BPH . The objective of this study was to evaluate recruitment strategies for CAMUS and to contrast the baseline characteristics of CAMUS participants with those recruited to a similar trial using conventional medical therapy . DESIGN CAMUS is a r and omized , double-blind , placebo-controlled trial design ed to evaluate the effects of saw palmetto given at escalating doses over an 18-month period on relief from LUTS . SUBJECTS The target enrollment goal was 350 men with LUTS from 11 clinical centers over a 12-month period . The recruitment techniques used and participants contacted , screened , and r and omized through each technique were obtained from the clinical centers . Baseline characteristics of the CAMUS participants were compared with participants in the MTOPS trial who met the CAMUS eligibility criteria for LUTS . RESULTS The target enrollment goal was achieved in 11 months . The overall monthly recruitment rate per site was 3.7 and ranged from 2.4 to 8.0 . The most successful recruitment methods were mass mailing and advertising , which accounted for 39 % and 35 % of the study participants , respectively . In comparison to MTOPS participants , CAMUS participants were younger , more highly educated , more diverse , and had less severe urinary symptoms . CONCLUSIONS Successful recruitment methods for CAMUS were similar to those in MTOPS . The use of botanical therapy attracted a less symptomatic and more educated study population INTRODUCTION Serenoa repens ( saw palmetto ) has been employed for the treatment of lower urinary tract symptoms ( LUTS ) for several years . Its mechanism of action is believed to be due to anti and rogenic , antiproliferative and antinflammatory properties . An association of Serenoa with the nettle " Urtica dioica " showing antiproliferative activity and the pine " Pinus pinaster " derivative , showing antinflammatory action , has been proposed in recent years . Such an action is hoped to act not only by reducing LUTS but also by preventing the development of prostate cancer . MATERIAL AND METHODS During the years 2007 and 2008 , 320 patients suffering from LUTS were treated with an association of Serenoa repens 320 mg , Urtica dioica 120 mg and Pinus pinaster 5 mg , named IPBTRE . This treatment was administered to all patients for a minimal duration of 30 days to a maximum of a year , either alone or in association with antibiotics or alpha-blockers , if needed . Outcome analysis was based on evaluation of symptoms , prostate volume and maximum flow rate ( Qmax ) . RESULTS From a careful analysis of the data collected in our data base , the following observations can be made : ages varied between 19 and 78 years . The patients were affected by BPH in 46 % of cases , chronic prostatitis syndrome in 43 % , chronic genital-pelvic pain in 7 % and other conditions in 4 % , the absolute numbers being 147 , 138 , 22 and 7 patients , respectively . No untoward side effect was reported in any case . Variations in symptom score could be fully evaluated only in 80 of 320 patients ( 25 % ) , of whom 68 ( 85 % ) reported a significant benefit , with special reference to an improvement of pain , urgency , strangury and nocturia . Data on variations in prostate volume , as measured by digital rectal examination , were available in 84 ( 26.5 % ) patients . No significant change was observed . Qmax after treatment was measured in 83 ( 26 % ) patients . It did not show significant changes from the initial values . DISCUSSION The association tested in our study appeared to be safe and well tolerated . No changes in flow rate and prostate volume were observed , but a marked reduction of LUTS was observed in 85 % of evaluable cases , especially with regard to pain and irritative symptoms . Whether or not such an association may display a prevention of prostate cancer , may be investigated in additional studies BACKGROUND / AIM It has been observed that a large number of patients with low urinary tract symptoms due to benign prostatic hyperplasia ( LUTS/BPH ) ) has been treated with a combination of tamsulosin ( TAM ) + Serenoa repens ( SR ) ( TAM + SR ) . The aim of this study was to compare a combination TAM + SR with TAM and SR alone , to see if there was any difference in efficacy and tolerance of each in patients with LUTS/BPH . METHODS In this prospect i ve study patients had to have prostate volume ( PV ) < 50 mL , International Prostate Symptom Score ( IPSS ) of 7 - 18 , Quality of Life score ( QoLs ) > 3 , a maximal flow rate ( Qmax ) of 5 - 15 mL/s , with post voiding residual volume ( PVR ) < 150 mL and serum prostatic antigen ( PSA ) < 4 ng/mL.  TAM ( 0.4 mg ) was administered once a day , SR ( 320 mg ) daily or SR ( 320 mg ) + TAM ( 0.4 mg ) daily for a median period of 6 months . RESULTS A total of 297 patients were recruited , whereas 265 patients were fully available : 87 into the group TAM , 97 into the group SR and 81 into the group TAM + SR .  There was no statistically significant difference between the treatment groups in the sense of demographic and other baseline parameters . No difference was found among the 3 treatment groups , neither in the major endpoint of the study in the sense of a change between baseline and final evaluation in total IPSS , obstructive and irritative subscores , improvement of QoLs , increase in Qmax , nor for the second endpoint including diminution of PV , PSA and PVR . During the treatment period 20 ( 23 % ) of the patients managed with TAM and 17 ( 21 % ) with TAM + SR had drug- treated with related adverse reactions . No adverse effect was detected in the group SR . CONCLUSION Treatment of BPH by both SR and TAM seems to be efficacious alone . None of them had superiority over another and , additionally , a combined therapy ( TAM + SR ) does not provide extra benefits . Furthermore , SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS/BPH This 3-month double-blind , r and omized , parallel-group study compared the efficacy and tolerability of two regimens of the lipido-sterolic extract of Serenoa repens ( Permixon ) ( two 160-mg capsules once daily [ OD ] and one 160-mg capsule twice daily [ BID ] ) in 100 out patients with symptomatic benign prostatic hyperplasia ( BPH ) . Both regimens significantly ( P < .0001 ) reduced the International Prostate Symptom Score ( I-PSS ) mean total score from baseline ; improvements achieved statistical significance after the first month and were maintained for the duration of the study . Significant ( P < .05 ) and rapid improvements from baseline to the end of month 1 also occurred in I-PSS quality -of-life ( QoL ) scores , maximum and mean urinary flow rates , and residual urine volume ; this benefit was further increased at month 3 for I-PSS total score and QoL and residual volume , and was maintained for maximum and mean flow rates . A highly significant decrease ( P < .001 ) in residual urine was observed in both groups . No significant differences were noted between regimens . Clinical adverse events occurred at a similar incidence in both groups ( BID , 24 % ; OD , 22 % ) and were deemed unrelated or unlikely to be related to Permixon The up date d 2003 American Urological Association ( AUA ) Guidelines for the treatment of  benign prostatic hyperplasia ( BPH ) are the culmination of an exhaustive effort predicated on scientifically accepted methods of review ing the medical literature . In this second publication of the guidelines , a multidisciplinary panel review ed a new meta- analysis of outcome data from the BPH literature from before and after 1994 . The major differences between the 2 guidelines are the changes in our underst and ing of the biology of the prostate and the introduction of new therapies . The vast majority of r and omized controlled trials , particularly with respect to minimally invasive therapies and progression of BPH , were performed after the release of the 1994 guidelines . Also , the most recent AUA panel carefully review ed unpublished data to make the guidelines as timely as possible . Studies that were subsequently published included those on the value of combination medical therapy for BPH . The panel agreed on up date d recommendations for the treatment of moderate-to-severe lower urinary tract symptoms associated with BPH , and diagnostic algorithms were revised . The durability and utility of the present guidelines should exceed that of its predecessor To compare in a r and omised , open‐label , non‐inferiority clinical study , the efficacy and tolerability  of Serenoa repens ( SeR ) + selenium ( Se ) + lycopene ( Ly ) ( SeR‐Se‐Ly ) therapy vs tadalafil 5 mg in men with lower urinary tract symptoms ( LUTS ) The efficacy and tolerability of a fixed combination of 160 mg sabal fruit extract WS 1473 and 120 mg urtica root extract WS 1031 per capsule ( PRO 160/120 ) was investigated in elderly , male patients suffering from lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia in a prospect i ve multicenter trial . A total of 257 patients ( 129 and 128 , respectively ) were r and omized to treatment with PRO 160/120 or placebo  ( 127 and 126 were evaluable for efficacy ) . Following a single-blind placebo run-in phase of 2 weeks , the patients received 2 × 1 capsule/day of the study medication under double-blind conditions over a period of 24 weeks . Double-blind treatment was followed by an open control period of 24 weeks during which all patients were administered PRO 160/120 . Outcome measures for treatment efficacy included the assessment of the patients ’ LUTS by means of the I-PSS self-rating question naire and a quality of life index as well as uroflow and sonographic parameters . Using the International Prostate Symptom Score ( I-PSS ) , patients treated with PRO 160/120 exhibited a substantially higher total score reduction after 24 weeks of double-blind treatment than patients of the placebo group ( 6 points vs 4 points ; P=0.003 , one tailed ) with a tendency in the same direction after 16 weeks . This applied to obstructive as well as to irritative symptoms , and to patients with moderate or severe symptoms at baseline . Patients r and omized to placebo showed a marked improvement in LUTS ( as measured by the I-PSS ) after being switched to PRO 160/120 during the control period ( P=0.01 , one tailed , in comparison to those who had been treated with PRO 160/120 in the double-blind phase ) . The tolerability of PRO 160/120 was comparable to the placebo . In conclusion , PRO 160/120 was clearly superior to the placebo for the amelioration of LUTS as measured by the I-PSS . PRO 160/120 is advantageous in obstructive and irritative urinary symptoms and in patients with moderate and severe symptoms . The tolerability of the herbal extract was excellent OBJECTIVE This article describes the results of an exploratory analysis of treatment satisfaction data from a phase 2 study to inform the evaluation of a new treatment for benign prostatic hyperplasia ( BPH ) . METHODS The study was a r and omized , placebo-controlled , double blind trial comparing three doses ( low , medium , and high ) of a new uro-selective alpha-blocker with an active comparator . A total of 536 men aged 40 years and older with lower urinary tract symptoms ( LUTS ) result ing from BPH were r and omized into the study . Patients ' perceptions of satisfaction with efficacy , dosing , and side effects were explored using a vali date d disease-specific instrument , the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia ( TSS-BPH ) . The TSS-BPH was administered at the end of the study or at withdrawal . RESULTS Compared with placebo , the medium and high doses showed the greatest efficacy on the primary endpoint , the International Prostate Symptom Score ( IPSS ) . Patient satisfaction with efficacy at these doses was significantly better than that for placebo . Nevertheless , adverse events were most frequent in the high dose group . Satisfaction with side effects was significantly worse than placebo for this group , and this was reflected in the total scores on the TSS-BPH , with patients being most satisfied overall with the medium dose . CONCLUSIONS Exploring patients ' treatment satisfaction with medication in early trials using multidimensional measures provides an overall evaluation of efficacy and side effects , and can be used to inform the selection of doses for later trials . This is especially useful for products that require adherence with medication over long periods of time
Serenoa repens was not more effective than placebo for treatment of urinary symptoms consistent with BPH
BACKGROUND Benign prostatic hyperplasia ( BPH ) , a 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 is common .
The extract of the berry of the American saw palmetto , or dwarf palm plant , Serenoa repens ( also known by its botanical name of Sabal serrulatum ) , is one of several phytotherapeutic agents available for the treatment of BPH .
OBJECTIVES This systematic review aim ed to assess the effects of Serenoa repens in the treatment of LUTS consistent with BPH .