title: Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome Category IIIA with Serenoa repens plus Selenium and Lycopene (Profluss®) versus S. repens Alone: An Italian Randomized Multicenter-Controlled Study The effect of increasing doses of saw palmetto fruit extract on serum prostate specific antigen: analysis of the CAMUS randomized trial. Does the addition of Serenoa repens to tamsulosin improve its therapeutical efficacy in benign prostatic hyperplasia? Effects of hexanic extract of serenoa repens (permixon® 160 mg) on inflammation biomarkers in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia A prospective study of the efficacy of Serenoa repens, Tamsulosin, and Serenoa repens plus Tamsulosin treatment for patients with benign prostate hyperplasia Comparison of Tamsulosin Plus Serenoa Repens with Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in Korean Men: 1-Year Randomized Open Label Study Efficacy and safety of a combination of Sabal and Urtica extract in lower urinary tract symptoms—long-term follow-up of a placebo-controlled, double-blind, multicenter trial Multicentre study on the efficacy and tolerability of an extract of Serenoa repens in patients with chronic benign prostate conditions associated with inflammation. Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial). Analysis of the results obtained with a new phytotherapeutic association for LUTS versus control. [corrected]. Effects of Difaprost® on voiding dysfunction, histology and inflammation markers in patients with benign prostatic hyperplasia who are candidates for surgical treatment. A phase II randomised double-blind placebo-controlled clinical trial investigating the efficacy and safety of ProstateEZE Max: a herbal medicine preparation for the management of symptoms of benign prostatic hypertrophy. Effects of Serenoa repens, selenium and lycopene (Profluss®) on chronic inflammation associated with benign prostatic hyperplasia: results of "FLOG" (Flogosis and Profluss in Prostatic and Genital Disease), a multicentre Italian study. [Associating Serenoa repens, Urtica dioica and Pinus pinaster. Safety and efficacy in the treatment of lower urinary tract symptoms. Prospective study on 320 patients]. Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto.
abstract: Objectives : To evaluate the efficacy and safety of Serenoa repens + selenium and lycopene ( Profluss ® ) versus S. repens alone for the treatment of category IIIa chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS ) . Patients and Methods : 102 patients with IIIa CP/CPPS were enrolled and r and omized into two groups each to receive Profluss or S. repens alone for 8 weeks . Evaluation was based on results of the National Institutes of Health-Chronic Prostatitis Symptom Index ( NIH-CPSI ) , IPSS , maximum peak flow rate ( MPFR ) , and PSA measurements at baseline and at weeks 4 , 8 and 8 after the end of treatment . The primary endpoint was a > 50 % reduction in NIH-CPSI score . Secondary endpoints evaluated were MPFR , IPSS , PSA and white blood cell count . Results : No patients withdrew from the study . The mean NIH-CPSI score decreased significantly ( p < 0.001 ) in both groups ; we observed a decrease in the total score from 27.45 to 13.27 in group 1 ( –51.64 % ) and from 27.76 to 20.62 in group 2 ( –26.06 % ) . IPSS improved significantly ( p < 0.001 ) in both arms , but more in group 1 . PSA and white blood cell count decreased significantly ( p < 0.007 ) only in group 1 . The MPFR improved more in group 1 ( p < 0.005 ) . Conclusion : Profluss is a triple therapy that is safe and well tolerated . It ameliorates symptoms associated with IIIa CP/CPPS PURPOSE Saw palmetto extracts are used to treat lower urinary tract symptoms in men despite level I evidence that saw palmetto is ineffective in reducing these lower urinary tract symptoms . We determined whether higher doses of saw palmetto as studied in the CAMUS ( Complementary and Alternative Medicine for Urologic Symptoms ) trial affect serum prostate specific antigen levels . MATERIAL S AND METHODS The CAMUS trial was a r and omized , placebo controlled , double-blind , multicenter , North American trial conducted between June 5 , 2008 and October 10 , 2012 , in which 369 men older than 45 years with an AUA symptom score of 8 to 24 were r and omly assigned to placebo or dose escalation of saw palmetto , which consisted of 320 mg for the first 24 weeks , 640 mg for the next 24 weeks and 960 mg for the last 24 weeks of this 72-week trial . Serum prostate specific antigen levels were obtained at baseline and at weeks 24 , 48 and 72 , and were compared between treatment groups using the pooled t test and Fisher 's exact test . RESULTS Serum prostate specific antigen was similar at baseline for the placebo ( mean ± SD 1.93 ± 1.59 ng/ml ) and saw palmetto groups ( 2.20 ± 1.95 , p = 0.16 ) . Changes in prostate specific antigen during the study were similar , with a mean change in the placebo group of 0.16 ± 1.08 ng/ml and 0.23 ± 0.83 ng/ml in the saw palmetto group ( p = 0.50 ) . In addition , no differential effect on serum prostate specific antigen was observed between treatment arms when the groups were stratified by baseline prostate specific antigen . CONCLUSIONS Saw palmetto extract does not affect serum prostate specific antigen more than placebo , even at relatively high doses 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 Background Chronic prostatic inflammation ( CPI ) could be a cause of symptomatic or complicated benign prostatic hyperplasia ( BPH ) . In previous in vitro and in vivo studies , Hexanic Extract of Serenoa repens ( HESr ) namely Permixon ® has demonstrated potent anti‐inflammatory properties . With the aim to provide new insight onto HESr anti‐inflammatory properties in human we explore its effect on CPI biomarkers in men with lower urinary tract symptoms ( LUTS ) related to BPH using a non‐invasive method and investigate links between biomarkers and clinical symptoms . Methods An international , r and omized , double‐blind , parallel‐group , tamsulosin‐controlled study was carried out in 206 men with BPH‐related LUTS . Patients received oral daily HESr 320 mg or tamsulosin 0.4 mg during 3 months . The first urine stream after digital rectal examination ( DRE ) was collected at Day 1 and Day 90 and mRNA was extracted from prostatic epithelial cells desquaming in the lumen of the gl and s and seminal plasma fluid after DRE . mRNA quantification of the 29 most significant published inflammation markers in BPH and protein detection in urine was performed . Results At D90 , a decrease in mean gene expression was observed for 65.4 % of the markers detected in the HESr group versus 46.2 % in the tamsulosin group . In the 15 most frequently expressed genes , this difference was higher ( 80 % vs. 33 % respectively ) . Three proteins ( MCP‐1/CCL2 , IP‐10/CXCL10 , and MIF ) were detected . At D90 , a decrease in the number of patients who expressed MCP‐1/CCL2 and IP‐10/CXCL10 was observed only in the HESr group . Moreover , MIF expression was significantly reduced by HESr compared with tamsulosin ( P = 0.007 ) . Finally , in contrast to tamsulosin , the subgroup of patients treated by HESr and who over expressed MIF at baseline , had a higher response to the International Prostate Symptom Score ( I‐PSS ) than those who did not over express this protein ( mean I‐PSS change : −6.4 vs. −4.5 respectively ) . As the study is exploratory , results should be confirmed in a powered clinical study . Conclusions These results showed for the first time at clinical level the anti‐inflammatory properties of HESr , already indicated in BPH‐related LUTS . Thus , HESr could be of interest to prevent unfavourable evolution in patients with CPI . Prostate 75:1857–1867 , 2015 . © 2015 The Authors . The Prostate Published by Wiley Periodicals , 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 Introduction : In Korea , increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH . Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies . The present study was design ed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH . Material s and Methods : One hundred forty men with symptomatic BPH ( IPSS ≥10 ) were recruited in our hospital for a 12-month , open-label , r and omized trial . Patients were r and omly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day ( n = 60 ) or tamsulosin 0.2 mg/day only ( n = 60 ) . Prostate volume and PSA were measured at baseline and at end-point , whereas total IPSS , and its storage and voiding subscores , LUTS-related QoL , Qmax , and PVR were evaluated at baseline and later every 6 months . Results : Total 103 patients were finally available : 50 in the TAM + SR group and 53 in the TAM group . At 12 months , total IPSS decreased by 5.8 with TAM + SR and 5.5 with TAM ( p = 0.693 ) ; the storage symptoms improved significantly more with TAM + SR ( -1.7 vs. -0.8 with TAM , p = 0.024 ) . This benefit with regard to storage symptom in the TAM + SR group lasts at 12 months ( -1.9 vs. -0.9 , p = 0.024 ) . The changes of voiding subscore , LUTS-related QoL , Qmax , PVR , PSA , and prostate volume showed no significant differences between the TAM + SR and TAM groups . During the treatment period , 8 patients ( 16.9 % ) with TAM and 10 ( 20 % ) with TAM + SR had drug-related adverse reactions , which included ejaculatory disorders , postural hypotension , dizziness , headache , gastro-intestinal disorders , rhinitis , fatigue and asthenia . Conclusions : The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment In an open-label extension of a r and omized , double-blind clinical trial , the long-term 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 ) were investigated in elderly men with moderate or severe lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia ( BPH ) . Two hundred and fifty-seven patients were r and omly treated with 2 × 1 capsule/day PRO 160/120 or placebo for 24 weeks , followed by a 24-week control period and a 48-week follow-up period in which all patients received PRO 160/120 . Efficacy measures included the assessment of LUTS [ International Prostate Symptom Score ( ( I-PSS ) self-rating question naire ] and uroflow and sonographic parameters . Two hundred and nineteen subjects participated in the follow-up . Between baseline and end of observation ( week 96 ) the I-PSS total score was reduced by 53 % ( P < 0.001 ) , peak and average urinary flow increased by 19 % ( P < 0.001 ) , and residual urine volume decreased by 44 % ( P = 0.03 ) . The incidence of adverse events during follow-up was one in 1,181 treatment days ; in only one event a causal relationship with intake of PRO 160/120 could not be excluded . Treatment with PRO 160/120 thus provides a clinical ly relevant benefit over a period of 96 weeks 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 BACKGROUND Phytotherapy has been used to treat patients with lower urinary tract symptoms ( LUTS ) . We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens ( SeR ) , Lycopene ( Ly ) , and Selenium ( Se ) + tamsulosin versus single therapies . METHODS PROCOMB trial ( IS RCT N78639965 ) was a r and omized double-blinded , double-dummy multicenter study of 225 patients between 55 and 80 years old , PSA ≤ 4 ng/ml , IPSS ≥12 , prostate volume ≤60 cc , Qmax ≤15 ml/sec , postvoid residual urine ( PVR ) < 150 ml . Participants were r and omized group A ( SeR-Se-Ly ) , group B ( tamsulosin 0.4 mg ) , group C ( SeR-Se-Ly + tamsulosin 0.4 mg ) . The primary endpoints of the study were the reduction of IPSS , PVR , and increase of Qmax in group C versus monotherapy groups . RESULTS The decrease for combination therapy was significantly greater versus group A ( P < 0.05 ) and group B ( P < 0.01 ) for IPSS and versus group A ( P < 0.01 ) for PVR from baseline to 6 months . A greater decrease in IPSS was observed for Group C versus group A ( P < 0.01 ) and increase in Qmax versus group B ( P < 0.01 ) , from 6 months to 12 months . At one year , the changes of IPSS and Qmax were greater for Group C versus monotherapies ( each comparison < 0.05 ) . The proportions of men with a decrease of at least three points ( each comparison P < 0.05 ) and decrease of 25 % for IPSS ( each comparison P < 0.01 ) were greater for Group C. CONCLUSION SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS 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 AIM Although previous studies assessed the effects of Serenoa repens , quercetin and β-sitosterol on inflammatory parameters , no r and omized studies have tested the combination of these agents neither on BPH symptoms nor on the inflammatory pattern . The aim of this trial was to evaluate the effects of Difaprost ® on voiding dysfunction , histological inflammatory alterations and apoptotic molecular mechanisms in BPH patients . METHODS We included 36 patients affected by BPH with obstructive symptoms eligible for surgery . Patients were r and omly assigned to two groups : 18 patients received Difaprost ® for three months before surgery , and 18 patients did not receive any additional therapy and were scheduled for surgery . All patients receiving Difaprost ® were evaluated with uroflowmetry with post-void residual volume ( PVR ) evaluation , serum PSA , and IPSS question naire before and after treatment . Moreover , we evaluated inflammatory patterns in prostatic specimens at final pathology . RESULTS Even without statistically significant differences on inflammatory pattern between patients receiving Difaprost ® and controls , patients receiving Difaprost ® had lower presence of edema and angiectasia at histological evaluation of prostate specimens . Moreover , patients included in the treatment group had a clinical ly significant reduction of PVR ( 46.1 vs. 25.2 mL ; P=0.1 ) and a slight increase in Qmed ( 5.6 vs. 6.5 mL/s ; P=0.9 ) after three months of chronic treatment with Difaprost ® . No statistically significant differences were recorded in other clinical parameters between patients receiving Difaprost ® and controls . CONCLUSION Although not statistically significant , patients treated with Difaprost ® showed an improvement in voiding function compared to controls ( namely , an increase in Qmed and a reduction of PVR ) . Future trials with a larger number of patients and a longer treatment period could be necessary to evaluate the clinical efficacy of Difaprost ® OBJECTIVE The aim of the clinical trial was to evaluate the efficacy and safety of ProstateEZE Max , an orally dosed herbal preparation containing Cucurbita pepo , Epilobium parviflorum , lycopene , Pygeum africanum and Serenoa repens in the management of symptoms of medically diagnosed benign prostate hypertrophy ( BPH ) . DESIGN This was a short-term phase II r and omized double-blind placebo controlled clinical trial . SETTING The trial was conducted on 57 otherwise healthy males aged 40 - 80 years that presented with medically diagnosed BPH . INTERVENTION The trial participants were assigned to receive 3 months of treatment ( 1 capsule per day ) with either the herbal preparation ( n = 32 ) or a matched placebo capsule ( n = 25 ) . OUTCOME MEASURES The primary outcome measure was the international prostate specific score ( IPSS ) measured at baseline , 1 , 2 and 3 months . The secondary outcomes were the specific questions of the IPSS and day-time and night-time urinary frequency . RESULTS There was a significant reduction in IPSS total median score in the active group of 36 % as compared to 8 % for the placebo group , during the 3-months intervention ( p < 0.05 ) . The day-time urinary frequency in the active group also showed a significant reduction over the 3-months intervention ( 7.0 - 5.9 times per day , a reduction of 15.6 % compared to no significant reduction change for the placebo group ( 6.2 - 6.3 times per day ) ( p < 0.03 ) . The night-time urinary frequency was also significantly reduced in the active group ( 2.9 - 1.8 , 39.3 % compared to placebo ( 2.8 - 2.6 times , 7 % ) ( p < 0.004 ) . CONCLUSION The herbal preparation ( ProstateEZE Max ) was shown to be well tolerated and have a significant positive effect on physical symptoms of BPH when taken over 3 months , a clinical ly significant outcome in otherwise healthy men OBJECTIVE To evaluate the efficacy of Profluss ® on prostatic chronic inflammation ( PCI ) . MATERIAL S AND METHODS We prospect ively enrolled 168 subjects affected by LUTS due to bladder outlet obstruction su bmi tted to 12 cores prostatic biopsy for suspected prostate cancer + 2 cores collected for PCI valuation . First group consisted of 108 subjects , with histological diagnosis of PCI associated with BPH and high grade PIN and /or ASAP , r and omly assigned to 1:1 ratio to  daily Profluss ®  ( group I ) for 6 months or to control group ( group Ic ) . Second group consisted of 60 subjects , with histological diagnosis of BPH , r and omly assigned to 1:1 ratio to daily Profluss ® + a-blockers treatment ( group II ) for 3 months or to control group ( group IIc ) . After 6 months first group underwent 24 cores prostatic re-biopsy + 2 cores for PCI while after 3 months second group underwent two-cores prostatic for PCI . Specimens were evaluated for changes in inflammation parameters and for density of T-cells ( CD3 , CD8 ) , B-cells ( CD20 ) and macrophages ( CD68 ) . RESULTS At follow-up there were statistical significant reductions of extension and grading of flogosis , mean values of CD20 , CD3 , CD68 and mean PSA value in group I compared to Ic , while extension and grading of flogosis in group II were inferior to IIc but not statistical significant . A statistically significant reduction in the density of CD20 , CD3 , CD68 , CD8 was demonstrated in group II in respect to control IIc . CONCLUSIONS Serenoa repens+Selenium+Lycopene may have an anti-inflammatory activity that could be of interest in the treatment of PCI in BPH and /or PIN/ASAP patients 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 OBJECTIVES This report assesses participant perception of treatment assignment in a r and omized , double-blind , placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia ( BCM ) . DESIGN Participants r and omized to receive saw palmetto  were instructed to take one 320 mg gelcap daily for the first 24 weeks , two 320 mg gelcaps daily for the second 24 weeks , and three 320 mg gelcaps daily for the third 24 weeks . Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period . At 24 , 48 , and 72 weeks postr and omization , the American Urological Association Symptom Index ( AUA-SI ) was administered and participants were asked to guess their treatment assignment . SETTING S The study was conducted at 11 clinical centers in North America . PARTICIPANTS Study participants were men , 45 years and older , with moderate to low severe BPH symptoms , r and omized to saw palmetto ( N=151 ) or placebo ( N=155 ) . OUTCOME MEASURES Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment . RESULTS For participants assigned to saw palmetto , 22.5 % , 24.7 % , and 29.8 % correctly thought they were taking saw palmetto , and 37.3 % , 40.0 % , and 44.4 % incorrectly thought they were on placebo at 24 , 48 , and 72 weeks , respectively . For placebo participants , 21.8 % , 27.4 % , and 25.2 % incorrectly thought they were on saw palmetto , and 41.6 % , 39.9 % , and 42.6 % correctly thought they were on placebo at 24 , 48 , and 72 weeks , respectively . The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto ( p=0.823 ) or placebo ( p=0.893 ) . Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto . CONCLUSIONS Blinding of treatment assignment was successful in this study . Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto
target: S. repens is safe in its application .
  We suggest that strong placebo effect , potentially influenced by positive patients ' expectation on S. repens , shapes both the clinical practice outcomes and the findings of clinical trials .
  Hitherto , the totality of evidence continues to suggest that S. repens is a prudent therapeutic option as part of the naturopathic treatment for LUTS/BPH .
background: OBJECTIVES Benign prostatic hyperplasia ( BPH ) commonly affects men above 40 years old .
  The progression of BPH is often accompanied with lower urinary tract symptoms ( LUTS ) that can significantly affect the quality of life of the patients .
  Serenoa repens ( saw palmetto ) is a popular herbal remedy indicated for LUTS/BPH .
  We review ed the current research on the efficacy of S. repens on LUTS/BPH as a monotherapy as well as combination therapies .
  RESULTS The latest evidence , based largely on the Cochrane review , suggests that S. repens is not superior to placebo in treating LUTS/BPH as a monotherapy , even at double and triple doses .
  Initial clinical trials on treatment of LUTS/BPH using S. repens with lycopene and selenium , as well as S. repens with Urtica Dioica , have shown positive results .