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 Does the addition of Serenoa repens to tamsulosin improve its therapeutical efficacy in benign prostatic hyperplasia? Saw palmetto (Serenoa repens) in men with lower urinary tract symptoms: effects on urodynamic parameters and voiding symptoms. Comparison of Tamsulosin Plus Serenoa Repens with Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in Korean Men: 1-Year Randomized Open Label Study 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 [Associating Serenoa repens, Urtica dioica and Pinus pinaster. Safety and efficacy in the treatment of lower urinary tract symptoms. Prospective study on 320 patients]. Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. Evaluation of the clinical benefit of permixon and tamsulosin in severe BPH patients-PERMAL study subset analysis. [Comparison of a phytotherapeutic agent (Permixon) with an alpha-blocker (Tamsulosin) in the treatment of benign prostatic hyperplasia: a 1-year randomized international study]. Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial Early urodynamic effects of the lipido-sterolic extract of Serenoa repens (Permixon®) in patients with lower urinary tract symptoms due to benign prostatic hyperplasia Comparative effects of alfuzosin versus Serenoa repens in the treatment of symptomatic benign prostatic hyperplasia. 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. Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic hyperplasia. Multicentre study on the efficacy and tolerability of an extract of Serenoa repens in patients with chronic benign prostate conditions associated with inflammation. Efficacy and safety of combined therapy with terazosin and tolteradine for patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective study [Tamsulosin with or without Serenoa repens in benign prostatic hyperplasia: the OCOS trial]. 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). 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) Combination therapy with doxazosin and tenoxicam for the management of lower urinary tract symptoms. Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies. Storage (irritative) and voiding (obstructive) symptoms as predictors of benign prostatic hyperplasia progression and related outcomes. Crossover comparison study on the therapeutic effects of tamsulosin hydrochloride and naftopidil in lower urinary tract symptoms associated with benign prostatic hyperplasia. Tadalafil Administered Once Daily for Treatment of Lower Urinary Tract Symptoms in Korean men with Benign Prostatic Hyperplasia: Results from a Placebo-Controlled Pilot Study Using Tamsulosin as an Active Control. Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: subgroup analyses of pooled data from 4 multinational, randomized, placebo-controlled clinical studies. Serenoa repens treatment modifies bax/bcl-2 index expression and caspase-3 activity in prostatic tissue from patients with benign prostatic hyperplasia. Evaluation of Tadalafil effect on lower urinary tract symptoms of benign prostatic hyperplasia in patients treated with standard medication.
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 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 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 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 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 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 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 OBJECTIVE To compare the efficacy of the lipido-sterolic extract of Serenoa repens , Permixon , to that of the alpha-blocker , tamsulosin , in the treatment of severe low urinary tract symptoms ( LUTS ) of benign prostatic hyperplasia ( BPH ) . METHODS In a 12-month , double-blind , r and omized study that showed equivalent efficacy of Permixon 320 mg/day and tamsulosin 0.4 mg/day ( " PERMAL study ") , 685 BPH patients with IPSS > or = 10 had been analyzed for efficacy . Of these , the 124 patients with severe LUTS ( IPSS > 19 ) at r and omization were retained for this subset analysis . After a 4-week run-in period , 59 and 65 patients had been r and omized to tamsulosin and Permixon groups , respectively . Both treatment groups were compared regarding the evolution from baseline of total IPSS and its irritative and obstructive subscores , LUTS-related QoL , prostate volume , Q(max ) and MSF-4 ( sexual activity question naire ) at different time points over 1 year . An analysis of variance of changes from baseline to end point was performed for all the parameters . The over-time evolutions of total , irritative and obstructive IPSS were further compared using a variance analysis for repeated measurements . RESULTS At 12 months , total IPSS decreased by 7.8 with Permixon and 5.8 with tamsulosin ( p=0.051 ) ; the irritative symptoms improved significantly more ( p=0.049 ) with Permixon ( -2.9 versus -1.9 with tamsulosin ) . The superiority of Permixon in reducing irritative symptoms appeared as soon as month 3 and was maintained up to month 12 ( p=0.03 ) . CONCLUSION Permixon 320 mg/day was shown to be slightly superior to tamsulosin 0.4 mg/day in reducing LUTS in severe BPH patients after 3 months and up to 12 months of treatment OBJECTIVE While the lipidosterolic extract ( LSESr ) of Serenoa repens -- Permixon -- has been shown to have an equivalent efficacy to finasteride in patients with benign prostatic hyperplasia ( BPH ) , to date , there has been no valid comparison of phytotherapy with alpha-blockers . The aim of this study was to assess the equivalent efficacy of Permixon and tamsulosin . METHODS Eight hundred and eleven men with symptomatic BPH ( international prost date symptom score , I-PSS > or = 10 ) were recruited in 11 European countries for a 12-month , double-blind r and omized trial . After a 4-week run-in period , 704 patients were r and omly assigned to either tamsulosin 0.4 mg per day ( N = 354 ) or Permixon 320 mg per day ( N = 350 ) . I-PSS , QoL and maximum urinary flow rate ( Qmax ) were evaluated at baseline and periodically for 1 year . Prostate volume and serum prostate-specific antigen ( PSA ) were measured at selection and at endpoint . The endpoint analysis was performed on the per- protocol ( PP ) population of 542 patients ( tamsulosin : N = 273 ; Permixon : N = 269 ) . RESULTS At 12 months , I-PSS decreased by 4.4 in each group and no differences were observed in either irritative or obstructive symptom improvements . The increase in Qmax was similar in both treatment groups ( 1.8 ml/s Permixon , 1.9 ml/s tamsulosin ) . PSA remained stable while prostate volume decreased slightly in the Permixon-treated patients . The two compounds were well tolerated , however , ejaculation disorders occurred more frequently in the tamsulosin group . CONCLUSION This study demonstrated that Permiwon and tamsulosin are equivalent in the medical treatment of lower urinary tract symptoms in men with BPH , during and up to 12 months of therapy CONTEXT Saw palmetto fruit extracts are widely used for treating lower urinary tract symptoms attributed to benign prostatic hyperplasia ( BPH ) ; however , recent clinical trials have question ed their efficacy , at least at st and ard doses ( 320 mg/d ) . OBJECTIVE To determine the effect of saw palmetto extract ( Serenoa repens , from saw palmetto berries ) at up to 3 times the st and ard dose on lower urinary tract symptoms attributed to BPH . DESIGN , SETTING , AND PARTICIPANTS A double-blind , multicenter , placebo-controlled r and omized trial at 11 North American clinical sites conducted between June 5 , 2008 , and October 10 , 2010 , of 369 men aged 45 years or older , with a peak urinary flow rate of at least 4 mL/s , an American Urological Association Symptom Index ( AUASI ) score of between 8 and 24 at 2 screening visits , and no exclusions . INTERVENTIONS One , 2 , and then 3 doses ( 320 mg/d ) of saw palmetto extract or placebo , with dose increases at 24 and 48 weeks . MAIN OUTCOME MEASURES Difference in AUASI score between baseline and 72 weeks . Secondary outcomes included measures of urinary bother , nocturia , peak uroflow , postvoid residual volume , prostate-specific antigen level , participants ' global assessment s , and indices of sexual function , continence , sleep quality , and prostatitis symptoms . RESULTS Between baseline and 72 weeks , mean AUASI scores decreased from 14.42 to 12.22 points ( -2.20 points ; 95 % CI , -3.04 to -1.36 ) [corrected]with saw palmetto extract and from 14.69 to 11.70 points ( -2.99 points ; 95 % CI , -3.81 to -2.17 ) with placebo . The group mean difference in AUASI score change from baseline to 72 weeks between the saw palmetto extract and placebo groups was 0.79 points favoring placebo ( upper bound of the 1-sided 95 % CI most favorable to saw palmetto extract was 1.77 points , 1-sided P = .91 ) . Saw palmetto extract was no more effective than placebo for any secondary outcome . No clearly attributable adverse effects were identified . CONCLUSION Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00603304 To compare the effect of a Serenoa repens extract with placebo for symptoms of benign prostatic hyperplasia ( BPH ) This prospect i ve , controlled study was undertaken to evaluate the early urodynamic and symptomatic impact of the lipido-sterolic extract of Serenoa repens ( Permixon ® ) in the treatment of patients with benign prostatic hyperplasia ( BPH ) . A total of 75 patients , aged 52–78 y with lower urinary tract symptoms due to mild/moderate BPH ( mean International Prostate Symptom Score ( I-PSS ) 8.2 ) were included in the study , of which 57 received Permixon ® 160 mg twice daily for 9 weeks . Urodynamic evaluation , including maximum urinary flow rate ( Qmax ) and detrusor pressure ( DP ) , was performed at baseline and endpoint . Prostate volume and post-void residual urine volume were assessed by transrectal and transabdominal ultrasound respectively . In addition , the I-PSS and its associated quality of life ( QoL ) score were determined and adverse events were recorded . Baseline parameters were comparable between the active treatment and control groups . After 9 weeks of Permixon ® treatment Qmax increased ( 6.0 % , P<0.001 ) , and there were reductions in DP at maximum flow ( 12.8 % , P<0.001 ) , opening DP ( 12.6 % , P<0.001 ) , and residual urine volume ( 12.6 % , P<0.05 ) . In addition , the I-PSS and QoL score both decreased significantly from baseline in the active treatment group ( 26.8 % and 18.2 % respectively , P<0.001 ) . None of these parameters improved significantly in control patients . There were also improvements in prostate volume ( 2.7 % ) and maximum DP ( 5.2 % ) in the Permixon ® group which did not reach significance . Three patients receiving Permixon ® experienced gastrointestinal disturbances but these did not lead to withdrawal or require additional therapy . In patients with mild/moderate BPH  , Permixon ® treatment reduced infravesical obstruction and produced a rapid improvement in urodynamic parameters and symptoms . The drug was well tolerated . These data support the use of Permixon ® as first-line therapy in patients with uncomplicated symptomatic BPH OBJECTIVES Sixty-three patients suffering from benign prostatic hyperplasia ( BPH ) entered a double-blind , comparative , parallel-groups study lasting 3 weeks , carried out to compare the efficacy and safety of alfuzosin 2.5 mg tid ( n = 32 ) vs serenoa repens 160 mg bid ( n = 31 ) in BPH . METHODS Efficacy was assessed both on clinical symptoms ( Boyarsky 's scale , visual analogue scale , clinical global impression ) , urinary flow rates ( uroflowmetry ) and residual urinary volume ( transabdominal ultrasound ) . Events and reported signs were recorded throughout the entire study . RESULTS Statistically significant and clinical ly relevant differences were found between the two treatments in favour of alfuzosin for Boyarsky 's total score ( decrease from 9.6 + /- 3.0 to 5.9 + /- 3.0 , 38.8 % for alfuzosin and from 9.3 + /- 2.5 to 6.8 + /- 2.8 , 26.9 % for serenoa repens ) and obstructive score ( decrease from 4.9 + /- 2.1 to 3.0 + /- 1.9 , 37.8 % for alfuzosin ; from 4.4 + /- 1.7 to 3.4 + /- 1.8 , 23.1 % for Serenoa repens ; p = 0.01 for both ) . Clinical ly relevant differences were found between the two treatments for visual analogue scale and overall clinical impression at the end of the study . Furthermore , the increase in quality of micturition was better with alfuzosin . The proportion of responders ( increase on day 21 in peak flow rate of at least 25 % relative to the baseline values ) was in favour of alfuzosin ( 71.8 % and 48.4 % for alfuzosin and Serenoa repens , respectively ; p = 0.057 ) . Both treatments were well tolerated . No patient treated with alfuzosin complained of any adverse event at any time during the study . One patient in the Serenoa group complained of mild pruritus which cleared spontaneously . Systolic , diastolic blood pressure and heart rate did not show any clinical ly relevant change during treatment with alfuzosin . CONCLUSIONS The findings confirm the efficacy and safety of alfuzosin in symptomatic BPH and indicate the superiority of alfuzosin over Serenoa repens in the treatment of urinary signs and symptoms of BPH 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 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 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 The primary objectives of the treatment for the  lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) are to produce rapid , sustained , and safe improvements in the symptoms that affect the quality of life in the majority of men over 50 . In this study , we evaluated the efficacy and safety of the combined therapy with terazosin ( & agr;1‐adrenergic receptor antagonist ) and tolterodine ( anticholinergic agent ) for LUTS associated with BPH . Methods This combination study included 69 patients diagnosed with LUTS associated with BPH based on the International Prostate Symptom Scores ( IPSS ) , urinary flow rate , prostate volume , urinary residual , and their serum prostate‐specific antigen levels .  Initially , 191 patients were treated with terazosin 2 mg once daily for one week . Those patients with continued LUTS after the initial treatment were allocated r and omly into two groups : terazosin group ( n=36 ) in which patients were treated with terazosin 2 mg once daily for six weeks , and combination group ( n=33 ) in which patients were treated with both terazosin 2 mg once daily and tolterodine 2 mg twice daily for 6 weeks . Results The IPSS were significantly improved in both groups after treatment , and the reduction of IPSS in the combination group was significantly greater than that in the terazosin group ( P<0.01 ) . A decrease in urgency , frequency and nocturia were the main contributory factors causing the reduction of IPSS in the combination group . The differences about the peak urinary flow rate and the residual urine from the baseline values were noted in both groups after treatment , but were not significant between the two groups . The incidence of adverse effects in the combination group was higher than that in the terazosin group . As expected the most common adverse effect was mouth dryness which was associated with anticholinergic drugs such as tolterodine . Conclusions Patients with LUTS associated BPH appear the improved IPSS after combined therapy with terazosin and tolterodine . This study , although short term and limited numbers of patients , provides evidence that the combined therapy with terazosin plus tolterodine is a good approach for meeting the objectives of rapid , sustained , and safe improvements in the LUTS associated with BPH . And the profile of patients in this study might be used as the indication of such combined therapy for LUTS associated with BPH without urodynamic evaluation OBJECTIVE In the treatment of the symptoms of benign prostatic hyperplasia ( BPH ) , a French guideline opposes the use of drugs in conjunction , in the absence of proven utility . The OCOS trial therefore compared one of the possible drug combinations ( tamsulosin and Serenoa repens ) with tamsulosin alone , to see if there was any difference in effectiveness and to evaluate the clinical tolerance of each in patients with symptoms of BPH . MATERIAL AND METHODS In this double-blind , r and omised trial , patients had to have an IPSS ( International Prostate Symptom Score ) > or = 13 and a Qmax between 7 and 15 mL/s .  Tamsulosin ( 0.4 mg ) was to be administered once a day for 52 weeks , with , twice daily , a placebo ( TAM ) or Serenoa repens 160 mg ( TAM + SR ) . RESULTS 352 patients were recruited by 47 centres ; 329 ( average age 65 ) were r and omised : 161 into the TAM group and 168 into the TAM + SR group . No statistically significant difference was found between the two groups , neither for the major end-point [ change in total IPSS between the baseline value and the final evaluation ( TAM : -5.2 ; TAM + SR : -6.0 ; p = 0.286 ) ] , nor for the secondary end-points [ changes in the voiding scores ( p = 0.239 ) and in filling scores ( p = 0.475 ) of the IPSS , Qmax ( p = 0.564 ) , percentage of respondents according to the IPSS ( p = 0.361 ) , improvement in quality of life ( IPSS-QoL : p = 0.091 ; UROLIFE BPH QoL : p = 0.442 ) , safety ] . CONCLUSION The addition of Serenoa repens to tamsulosin did not provide any significant benefit to the patients : the OCOS trial does not cast doubt on the guideline applicable to the treatment of BPH 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 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 ) OBJECTIVE To compare the efficacy and safety of a combination therapy , doxazosin plus tenoxicam , and doxazosin alone for lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia ( BPH ) , as various combination therapies increase the efficacy of medical therapy . Alpha blocker agents have been widely used for the treatment of LUTS secondary to BPH . METHOD Fifty-seven patients complaining of LUTS secondary to BPH were enrolled in this clinical trial . Patients were r and omly assigned to receive doxazosin 4 mg or doxazosin 4 mg plus tenoxicam 20 mg treatment . Patients were evaluated for BPH according to the European Association of Urology and American Urological Association clinical guidelines . In addition , patients were assessed with Overactive Bladder Symptom Score ( OABSS ) and International Index of Erectile Function ( IIEF ) . Patients were reevaluated after a 6-week treatment course . The International Prostatic Symptom Score ( IPSS ) , IPSS- Quality of Life ( IPSS-QoL ) , maximal urinary flow rates ( Q(max ) ) , and average urinary flow rates ( AFR ) were determined at baseline and again at 6 weeks as efficacy parameters . RESULTS The total IPSS , IPSS-QoL , and OABSS decreased significantly in both tenoxicam plus doxazosin group and doxazosin alone group compared with baseline ( P < .01 ) . Also , Q(max ) and AFR significantly improved in both groups ( P < .01 ) . The improvements in IPSS , IPSS-QoL , and OABSS were significantly better in patients treated with combination therapy ( P < .05 ) . CONCLUSIONS COX-2 inhibitors in combination with an alpha blocker may increase the effectiveness of the therapy for LUTS secondary to BPH without significant effects on side effect profile INTRODUCTION Erectile dysfunction ( ED ) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) are common in aging males and frequently occur together . Tadalafil has demonstrated efficacy in treating both conditions . AIM The study aims to evaluate the efficacy and safety of tadalafil 5 mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men . We also assessed relationships of baseline disease severity and prostate specific antigen ( PSA ) to outcomes . METHODS Data were pooled from four multinational , r and omized studies of men ≥45 years with LUTS/BPH , with analyses restricted to sexually active men with ED . R and omization ( baseline ) followed a 4-week placebo run-in ; changes from baseline were assessed vs. placebo using analysis of covariance . MAIN OUTCOME MEASURES International Prostate Symptom Score ( IPSS ) , IPSS subscores , Quality -of-Life Index ( IPSS-QoL ) , BPH Impact Index ( BII ) , and International Index of Erectile Function-Erectile Function ( IIEF-EF ) Domain score were used in this study . RESULTS Tadalafil ( N = 505 ) significantly improved total IPSS vs. placebo ( N = 521 ) ; mean changes from baseline were -6.0 and -3.6 , respectively ( P < 0.001 ) . Improvements in IIEF-EF Domain score  ( tadalafil , 6.4 ; placebo , 1.4 ) were also significant vs. placebo , as were the IPSS storage and voiding subscores , IPSS-QoL , and BII ( all P < 0.001 ) . No significant impact of baseline ED severity or PSA category on IPSS response was observed ( interaction P values , 0.463 and 0.149 , respectively ) . Similarly , improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category ( interaction P values , 0.926 and 0.230 , respectively ) . Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated ( r = -0.229 ) . Treatment-emergent adverse events were consistent with previous reports . CONCLUSIONS Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions . Improvements in both conditions were significant regardless of baseline severity . Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated OBJECTIVES To assess the utility of voiding and filling symptom subscores in predicting features of benign prostatic hyperplasia ( BPH ) progression , including acute urinary retention ( AUR ) and prostate surgery . METHODS The Proscar Long-term Efficacy and Safety Study ( PLESS ) was a 4-year study design ed to evaluate the effects of finasteride versus placebo in men with lower urinary tract symptoms ( LUTS ) , clinical evidence of BPH , and no evidence of prostate cancer . A self-administered question naire was employed to quantify LUTS at baseline . Receiver operating characteristics ( ROC ) curves were used to assess baseline characteristics from patients treated with placebo as predictors of outcomes . The characteristics assessed included the overall symptom score ( Quasi-AUA SI ) , separate voiding and filling subscores , prostate volume ( PV ) and serum prostate-specific antigen ( PSA ) levels . RESULTS PV and PSA were superior to the symptom scores at predicting episodes of spontaneous AUR and all types of AUR . The Quasi-AUA SI and the filling and voiding subscores were effective at predicting progression to surgery ; however , PSA was more effective at predicting this outcome . To better evaluate symptoms as predictors of surgery , patients who experienced a preceding episode of AUR were excluded from the surgery analysis . In the absence of preceding AUR , the best predictors of future surgery were the Quasi-AUA SI and the filling subscore . CONCLUSIONS Among men with LUTS , clinical BPH and no history of AUR , the overall symptom score and storage subscore are useful parameters to aid clinicians in identifying patients at risk for future prostate surgery . PV and PSA were the best predictors of AUR , while PSA was the best predictor of prostate surgery ( for all indications ) There is no consensus on the evaluated efficacy of individual alpha(1)-blockers in the treatment of lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . This study compared the clinical benefits of tamsulosin hydrochloride with those of naftopidil in BPH . Men aged 54 - 84 years with a main complaint of BPH were r and omly assigned to receive consecutive treatment with tamsulosin then naftopidil ( T-N group , 25 patients ) , or naftopidil then tamsulosin hydrochloride ( N-T group , 20 patients ) . The therapeutic effects were compared in a crossover design . Administration was continued for 28 days in each treatment period . Both groups showed similar improvements during the first treatment period . However , during the second treatment period after crossover , therapeutic effects were greater in the N-T group . Tamsulosin was more effective than naftopidil on intermittency , nocturia and quality of life scores .  Tamsulosin and naftopidil have different efficacy profiles for LUTS associated with BPH OBJECTIVES Assess the efficacy and safety of once-daily tadalafil or tamsulosin versus placebo during 12 weeks on lower urinary tract symptoms ( LUTS ) in Korean men with benign prostatic hyperplasia ( BPH ) . METHODS Following a 4-week placebo run-in period , 151 Korean men were r and omly assigned to receive once-daily tadalafil 5 mg , tamsulosin 0.2 mg , or placebo for 12 weeks . RESULTS The International Prostate Symptom Score ( IPSS ) least squares mean changes from baseline to endpoint were numerically but not significantly improved in the tadalafil ( -5.8 ) and tamsulosin ( -5.4 ) groups compared with placebo ( -4.2 , P > 0.05 ) . Decreases in IPSS obstructive and irritative subscores , IPSS Quality of Life score , and BPH Impact Index from baseline to endpoint were largest in the tadalafil group followed by tamsulosin , though none separated significantly from placebo . Increases in maximum urinary flow rate were small and not significantly different than placebo ; the increase was largest in the tadalafil group ( 2.5 mL/sec ) , followed by the placebo ( 2.3 mL/sec ) and tamsulosin ( 2.1 mL/sec ) groups . The percentage of subjects reporting at least one treatment-emergent adverse event was 26.5 , 13.7 and 3.9 % in the tamsulosin , tadalafil and placebo groups , respectively . CONCLUSIONS In this pilot study in Korean men , those with BPH and treated with tadalafil 5 mg or tamsulosin 0.2 mg once daily experienced a reduction in LUTS , which was numerically ( but not statistically ) significant compared with the placebo . Tadalafil was well tolerated and few subjects discontinued the study due to treatment-emergent adverse events . Larger studies in Asian men with BPH and LUTS treated with phosphodiesterase type 5 inhibitors are needed OBJECTIVE To assess the efficacy and safety of tadalafil , a phosphodiesterase 5 ( PDE5 ) inhibitor efficacious for erectile dysfunction and lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) , in population subgroups , using pooled data from 4 international , r and omized , placebo-controlled studies in men with LUTS/BPH . METHODS The safety data base included 1500 men r and omized to tadalafil 5 mg once daily or placebo for 12 weeks . Changes in total International Prostate Symptom Score ( IPSS ) , IPSS- quality of life index , and BPH impact index were examined overall , and changes in IPSS or adverse events ( AEs ) were examined across subgroups of interest . Treatment-group differences were assessed using analysis of covariance . RESULTS Results of pooled data confirmed that tadalafil ( N = 752 ) result ed in significant improvements from baseline vs placebo ( N = 746 ) in IPSS ( mean difference -2.3 ; P < .001 ) , and also in BPH impact index and IPSS- quality of life index ( both P < .001 ) . Subgroup analyses demonstrated that IPSS improvements were significant regardless of baseline LUTS severity ( IPSS < 20/≥20 ) , age ( ≤65/>65 years ) , recent previous use of α-blockers or PDE5 inhibitors , total testosterone level ( < 300/≥300 ng/dL ) , or prostate-specific antigen predicted prostate volume ( < 40/≥40 mL ) . [ corrected ] Rates of treatment emergent AEs were comparable between subgroups of baseline age ( ≤65/>65 years ) , previous PDE5 inhibitor use , and the presence or absence of pre-existing diabetes , hypertension , or cardiovascular disease ( including hypertension ) , but somewhat higher for recent previous α-blocker use . CONCLUSION In these pooled data analyses , tadalafil 5 mg improved LUTS/BPH across subgroups of age , LUTS severity , testosterone levels , and prostate volume . Rates of AEs were similar across the subgroups assessed PURPOSE Permixon is a lipidosterolic extract of Serenoa repens ( SR ) widely used to treat men with benign prostatic hyperplasia ( BPH ) . We tested the effect of this drug on molecular mechanisms associated with apoptosis , such as the Bax-to-Bcl-2 expression ratio and caspase-3 activity , in prostatic tissue from men with symptomatic BPH treated for 3 months before surgery . MATERIAL S AND METHODS An open , multicenter pilot study of 2 parallel groups of patients with BPH was done . They were r and omized to be followed for 3 weeks without any treatment before surgery ( control group ) or to receive 160 mg SR orally twice daily for a 3-month period preceding the same surgery . Surgery was ultimately performed in 17 controls and 12 patients by transurethral prostate resection or retropubic adenomectomy .  Bax and Bcl-2 expression , and caspase-3 activity were determined by Western blot in 15 controls and 10 patients , and reported in blinded fashion . RESULTS The Bax-to-Bcl-2 ratio , which is used as an apoptotic index , was significantly increased in the prostatic tissue of treated patients . The level of the intact 116 kDa poly ( adenosine diphosphate-ribose ) polymerase form , an enzyme involved in the cell death apoptotic pathway , was also found to be decreased in prostatic tissue from SR treated patients , suggesting increased caspase 3 activity in the prostate . CONCLUSIONS Permixon increased molecular markers involved in the apoptotic process , ie the Bax-to-Bcl-2 expression ratio and caspase-3 activity . This could have clinical relevance due to the improvement in symptoms produced by treatment with this drug OBJECTIVES To evaluate safety and efficacy of tadalafil on  lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) in patients treated with st and ard medication . MATERIAL S AND METHODS In this case-controlled r and omized clinical trial , from November 2008 to August 2009 , 132 patients with obstructive and irritative urinary tract symptoms due to BPH , IPSS ≥ 8 , no indication for surgical intervention and that reached plateau levels of response to treatment were selected . These patients were r and omly allocated in two groups ( each containing 66 patients ) . The treatment group received st and ard treatment of BPH and tadalafil ( 10 mg nightly ) ; the placebo group received only st and ard treatment of BPH . IPSS , maximum urinary flow rate ( Qmax ) and quality of life were assessed before and after a 3-month period of study . RESULTS Before treatment , mean IPSS , Qmax and quality of life values in the treatment and placebo groups were 13.06 ± 4.37 and 13.66 ± 4.25 , 8.92 ± 2.96 mL/s and 9.09 ± 2.91 mL/s , 2.93 ± 0.86 and 2.66 ± 0.78 , respectively . After treatment , mean IPSS , Qmax , and quality of life values in treatment group were 7.66 ± 3.99 , 9.99 ± 4.76 mL/s and 1.80 ± 0.98 , respectively . These findings were compared to corresponding values of the placebo group ( 11.37 ± 3.64 , 8.73 ± 2.22 mL/s and 2.19 ± 0.53 , respectively ) : IPSS and quality of life were significantly different but Qmax did n't show a significant change . CONCLUSIONS Tadalafil  improves quality of life and urinary symptoms in patients with LUTS suggestive of BPH , but does n't have any significant effect on Qmax . Therefore , this drug may be effectively used in combination with st and ard medical therapies for BPH
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 .