title: 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) Randomized, double-blind, placebo-controlled trial of saw palmetto in men with lower urinary tract symptoms. Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia. Safety and efficacy of doxazosin in benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies. 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 Effects of pumpkin seed oil and saw palmetto oil in Korean men with symptomatic 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 Effect of saw palmetto soft gel capsule on lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized trial in Shanghai, China. Update on the american urological association guidelines for the treatment of benign prostatic hyperplasia. 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). Silodosin, a new α1A‐adrenoceptor‐selective antagonist for treating benign prostatic hyperplasia: results of a phase III randomized, placebo‐controlled, double‐blind study in Japanese men Efficacy and safety of two doses (10 and 15 mg) of alfuzosin or tamsulosin (0.4 mg) once daily for treating symptomatic benign prostatic hyperplasia Tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a randomized placebo- and tamsulosin-controlled 12-week study in Asian men. Efficacy and safety of once-daily alfuzosin in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: a randomized, placebo-controlled trial. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. Efficacy and safety of a new prolonged release formulation of alfuzosin 10 mg once daily versus alfuzosin 2.5 mg thrice daily and placebo in patients with symptomatic benign prostatic hyperplasia. ALFORTI Study Group. Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe. Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial.
abstract: 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 ) OBJECTIVES To assess the effects of saw palmetto on urinary symptoms , sexual function , and urinary flow rate in men with lower urinary tract symptoms using a double-blind , r and omized , placebo-controlled trial . METHODS The eligible patients were 45 years of age or older and had an International Prostate Symptom Score of 8 or greater . After a 1-month placebo run-in period , 85 men were r and omized to receive saw palmetto or placebo for 6 months . Patients were evaluated using the International Prostate Symptom Score , a sexual function question naire , and by measurement of the urinary flow rate . RESULTS The mean symptom score decreased from 16.7 to 12.3 in the saw palmetto group compared with 15.8 to 13.6 in the placebo group ( P = 0.038 ) . The quality -of-life score improved to a greater degree in the saw palmetto group , but this difference was not statistically significant . No change occurred in the sexual function question naire results in either group . The peak flow rate increased by 1.0 mL/s and 1.4 mL/s in the saw palmetto and placebo groups , respectively ( P = 0.73 ) . CONCLUSIONS Saw palmetto led to a statistically significant improvement in urinary symptoms in men with lower urinary tract symptoms compared with placebo . Saw palmetto had no measurable effect on the urinary flow rates . The mechanism by which saw palmetto improves urinary symptoms remains unknown PURPOSE We tested the effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia ( BPH ) via a r and omized , placebo controlled trial . MATERIAL S AND METHODS We r and omized 44 men 45 to 80 years old with symptomatic BPH into a trial of a saw palmetto herbal blend versus placebo . End points included routine clinical measures ( symptom score , uroflowmetry and post-void residual urine volume ) , blood chemistry studies ( prostate specific antigen , sex hormones and multiphasic analysis ) , prostate volumetrics by magnetic resonance imaging , and prostate biopsy for zonal tissue morphometry and semiquantitative histology studies . RESULTS Saw palmetto herbal blend and placebo groups had improved clinical parameters with a slight advantage in the saw palmetto group ( not statistically significant ) . Neither prostate specific antigen nor prostate volume changed from baseline . Prostate epithelial contraction was noted , especially in the transition zone , where percent epithelium decreased from 17.8 % at baseline to 10.7 % after 6 months of saw palmetto herbal blend ( p < 0.01 ) . Histological studies showed that the percent of atrophic gl and s increased from 25 . 2 % to 40.9 % after treatment with saw palmetto herbal blend ( p < 0.01 ) . The mechanism of action appeared to be nonhormonal but it was not identified by tissue studies of apoptosis , cellular proliferation , angiogenesis , growth factors or and rogen receptor expression . We noted no adverse effects of saw palmetto herbal blend . When the study was no longer blinded , 41 men elected to continue therapy in an open label extension . CONCLUSIONS Saw palmetto herbal blend appears to be a safe , highly desirable option for men with moderately symptomatic BPH . The secondary outcome measures of clinical effect in our study were only slightly better for saw palmetto herbal blend than placebo ( not statistically significant ) . However , saw palmetto herbal blend therapy was associated with epithelial contraction , especially in the transition zone ( p < 0.01 ) , indicating a possible mechanism of action underlying the clinical significance detected in other studies OBJECTIVES To present the results of a pooled analysis of three double-blind , placebo-controlled studies of doxazosin in benign prostatic hyperplasia ( BPH ) . Heterogeneous symptom and bother score data collected using different symptom indices were transformed to enable a comparison of the data and to conduct a pooled , in-depth analysis . METHODS Urinary flow rates , and symptom and bother score data were shown by analysis of covariance methods to give consistent estimates of the efficacy of doxazosin across different studies , thus confirming the validity of pooling the results . Prior to analysis , symptom and bother score data were transformed so that all scales started from zero ( least symptoms or bother ) and were expressed as a percentage of the maximum score . RESULTS Doxazosin produced a significantly greater improvement than placebo in peak urinary flow rate ( P = 0.0017 ) , symptom severity ( P < 0.0001 ) , and bother caused by symptoms ( P < 0.0001 ) . Stratification showed that a greater improvement was obtained during doxazosin treatment by those with more severe symptoms at baseline ( P = 0.0001 ) . Stratification by age showed that age did not affect the capacity to benefit from treatment . Analysis of the pooled peak flow-rate data showed that doxazosin produced a consistently greater increase in flow compared with placebo . Doxazosin was well tolerated , with 10 % of patients having withdrawn due to adverse events versus 4 % with placebo ( P < 0.05 ) . CONCLUSIONS Doxazosin is well tolerated and effective in the treatment of BPH . Pooling of data has enabled more extensive and robust conclusions to be drawn than was possible for each one of the individual three 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 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 , This study was to investigate the role of complementary and alternative medicine in the prevention and treatment of benign prostatic hyperplasia . For this purpose , a r and omized , double-blind , placebo-controlled trial was performed over 12 months on 47 benign prostatic hyperplasia patients with average age of 53.3 years and international prostate symptom score over 8 . Subjects received either sweet potato starch ( group A , placebo , 320 mg/day ) , pumpkin seed oil ( group B , 320 mg/day ) , saw palmetto oil ( group C , 320 mg/day ) or pumpkin seed oil plus saw palmetto oil ( group D , each 320 mg/day ) . International prostate symptom score , quality of life , serum prostate specific antigen , prostate volume and maximal urinary flow rate were measured . In groups B , C and D , the international prostate symptom score were reduced by 3 months . Quality of life score was improved after 6 months in group D , while those of groups B and C were improved after 3 months , compared to the baseline value . Serum prostate specific antigen was reduced only in group D after 3 months , but no difference was observed in prostate volume in all treatment groups . Maximal urinary flow rate were gradually improved in groups B and C , with statistical significance after 6 months in group B and after 12 months in group C. None of the parameters were significantly improved by combined treatment with pumpkin seed oil and saw palmetto oil . From these results , it is suggested that administrations of pumpkin seed oil and saw palmetto oil are clinical ly safe and may be effective as complementary and alternative medicine treatments for benign prostatic hyperplasia 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 PURPOSE We determined the effect of Prostataplex in men with lower urinary tract symptoms associated with benign prostatic hyperplasia . MATERIAL S AND METHODS A total of 92 Chinese men between 49 and 75 years old with lower urinary tract symptoms were r and omly assigned in this double-blind , placebo controlled trial . The 46 patients in the intervention group were given 2 Prostataplex soft gels daily for 12 weeks , while the 46 in the control group were given 2 placebo soft gels for the same time . RESULTS The treated and control groups appeared to have more than a 95 % compliance rate , as judged by counting the remaining pills in the bottle collected at the end of trial months 1 to 3 . After 12 weeks of intervention the mean + /- SD maximum urinary flow rate was significantly higher in the treatment group than in the control group ( 14.07 + /- 2.56 vs 11.74 + /- 1.23 ml per second , p < 0.001 ) , while relative urinary resistance was significantly lower in the treatment group than in the control group ( 2.35 + /- 0.83 vs 3.02 + /- 1.18 , p = 0.002 ) . While there was no significant difference in mean prostate volume or International Prostate Symptom Score between the 2 groups , 18 of 46 patients ( 39.1 % ) in the treatment group showed an International Prostate Symptom Score improvement ( decrease of 3 or greater ) after intervention , whereas only 1 of 46 ( 2.2 % ) in the control group showed an International Prostate Symptom Score improvement ( chi-square test p < 0.001 ) . CONCLUSIONS Prostataplex may have short-term effects in improving symptoms and objective measures in Chinese men with lower urinary tract symptoms associated with benign prostatic hyperplasia 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 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 This section contains papers from Japan , Austria , the UK , and joint papers from France , Denmark , Switzerl and , Australia and the USA . A wide variety of lower urinary tract topics is covered , from BPH to overactive bladder and urodynamic stress incontinence To evaluate the efficacy and safety of two doses ( 10 and 15 mg ) of alfuzosin once daily and tamsulosin ( 0.4 mg ) once daily , compared with placebo , in men with benign prostatic hyperplasia ( BPH ) OBJECTIVES To examine the efficacy and safety of tadalafil in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia . METHODS Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were r and omized to once-daily placebo ( n=154 ) , tadalafil 2.5 mg ( n=151 ) , tadalafil 5.0 mg ( n=155 ) or tamsulosin 0.2 mg ( active control , n=152 ) for 12 weeks . RESULTS Total International Prostate Symptom Score least-squares mean changes from baseline to end-point significantly improved with tadalafil 2.5 mg ( -4.8 , P=0.003 ) and 5 mg ( -4.7 , P=0.004 ) versus placebo ( -3.0 ) . Significant improvement in the International Prostate Symptom Score versus placebo was observed earlier ( week 2 ) for tadalafil 5.0 mg than for tadalafil 2.5 mg ( week 8) . Significant improvements ( P<0.05 ) in both tadalafil groups versus placebo were observed for the International Prostate Symptom Score voiding subscore , International Prostate Symptom Score Quality of Life , and for Patient and Clinician Global Impressions of Improvement . Significant improvements versus placebo were observed in the International Prostate Symptom Score storage subscore for tadalafil 5.0 mg ( -1.7 , P=0.021 ) , but not tadalafil 2.5 mg ( -1.5 , P=0.072 ) . No significant improvements in benign prostatic hyperplasia Impact Index or improvements in peak urinary flow rates were observed with tadalafil 2.5 mg or 5.0 mg versus placebo . Tamsulosin treatment result ed in significant improvements versus placebo across all efficacy parameters , except for peak urinary flow rates . Safety results were consistent with the known tadalafil and tamsulosin safety profiles . CONCLUSIONS Tadalafil once daily represents an effective and well tolerated medical treatment for Asian men presenting with lower urinary tract symptoms suggestive of benign prostatic hyperplasia OBJECTIVES To assess the efficacy and safety , and determine the optimal dosage , of a once-daily ( OD ) formulation of the clinical ly uroselective alpha(1)-blocker , alfuzosin , in patients with lower urinary tract symptoms and symptomatic benign prostatic hyperplasia . METHODS Five hundred thirty-six patients were r and omized to receive alfuzosin ( 10 mg OD or 15 mg OD ) , without initial dose titration , or placebo in a 3-month double-blind trial conducted in North America . The primary efficacy criteria were improvement in symptoms ( International Prostate Symptom Score ) and peak urinary flow rate . RESULTS Alfuzosin was significantly more effective than placebo in improving the symptoms and peak urinary flow rate from the first follow-up visit ( day 28 ) . The mean change in the International Prostate Symptom Score from baseline at endpoint was -3.6 and -3.4 with alfuzosin 10 mg and 15 mg , respectively , compared with -1.6 with placebo ( alfuzosin 10 mg versus placebo , P = 0.001 ; alfuzosin 15 mg versus placebo , P = 0.004 ) . The median increase in the peak urinary flow rate was + 1.1 mL/s and + 1.0 mL/s with alfuzosin 10 mg and 15 mg , respectively , compared with 0.0 mL/s with placebo ( P = 0.0006 versus placebo for both dose groups ) . The patients ' quality of life also significantly improved with both alfuzosin doses . Overall , alfuzosin at both doses was well tolerated . The incidence of orthostatic hypotension as determined by systematic blood pressure measurements with both doses of alfuzosin was similar to placebo . No clinical ly relevant ejaculation disorders were observed with alfuzosin . CONCLUSIONS Alfuzosin 10 mg OD , administered without dose titration , provides effective relief from the symptoms of benign prostatic hyperplasia with no additional benefit from a 15-mg dose . It is well tolerated from a cardiovascular viewpoint and is not associated with abnormal ejaculation OBJECTIVES To evaluate the efficacy and safety of two once-daily doses of tamsulosin , the first selective alpha1A-antagonist studied in clinical trials . METHODS Patients with benign prostatic hyperplasia ( BPH ) were r and omized to receive either tamsulosin ( 0.4 and 0.8 mg/day ) or placebo ( n = 756 ) . Primary efficacy parameters were improvement in the total American Urological Association ( AUA ) symptom score and peak urinary flow ( Qmax ) . Secondary efficacy parameters were improvement in measurements at individual double-blind visits corresponding to the primary efficacy parameters ; percentage of patients with a 3-mL/s increase in Qmax ; total AUA irritative , obstructive , and bother scores ; individual AUA symptom scores ; total , irritative , obstructive , and individual Boyarsky symptom scores ; average urinary flow rate and other uroflowmetric parameters ; and investigator 's global assessment . RESULTS Statistically significant improvements in all efficacy parameters were observed in tamsulosin-treated compared with placebo-treated patients . Additionally , the 0.4-mg/day dose demonstrated a rapid onset of action ( 4 to 8 hours ) based on Qmax after the first dose of double-blind medication . A review of the safety parameters demonstrated excellent tolerance at 1 week after the initial 0.4-mg/day dose and continued tolerance during the additional 12 weeks of 0.4- and 0.8-mg/day dosing . The incidence of positive orthostatic test results in the tamsulosin groups was comparable to that observed in the placebo group . Adverse events were comparable in the 0.4-mg/day tamsulosin and placebo groups and were somewhat higher in the 0.8-mg/day tamsulosin group . CONCLUSIONS Tamsulosin was effective , safe , and well tolerated in the target BPH population at both the 0.4- and 0.8-mg/day dose levels , without the blood pressure-lowering effects typical of nonselective alpha-adrenergic antagonists BACKGROUND Men with benign prostatic hyperplasia can be treated with alpha 1-adrenergic-antagonist drugs that relax prostatic smooth muscle or with drugs that inhibit 5 alpha-reductase and therefore reduce tissue and rogen concentrations . However , the effects of the two types of drugs have not been compared . METHODS We compared the safety and efficacy of placebo , terazosin ( 10 mg daily ) , finasteride ( 5 mg daily ) , and the combination of both drugs in 1229 men with benign prostatic hyperplasia .  American Urological Association symptom scores and peak urinary-flow rates were determined at base line and periodically for one year . RESULTS The mean changes from base line in the symptom scores in the placebo , finasteride , terazosin , and combination-therapy groups at one year were decreases of 2.6 , 3.2 , 6.1 , and 6.2 points , respectively ( P<0.001 for the comparisons of both terazosin and combination therapy with finasteride and with placebo ) . The mean changes at one year in the peak urinary-flow rates were increases of 1.4 , 1.6 , 2.7 , and 3.2 ml per second , respectively ( P<0.001 for the comparisons of both terazosin and combination therapy with finasteride and with placebo ) . Finasteride had no more effect on either measure than placebo . In the placebo group , 1.6 percent of the men discontinued the study because of adverse effects , as did 4.8 to 7.8 percent of the men in the other three groups . CONCLUSIONS In men with benign prostatic hyperplasia , terazosin was effective therapy , whereas finasteride was not , and the combination of terazosin and finasteride was no more effective than terazosin alone OBJECTIVES To assess the efficacy and safety of a new prolonged release formulation of the uroselective alpha(1)-blocker alfuzosin for a once-daily dosing regimen in patients with lower urinary tract symptoms ( LUTS ) suggestive of symptomatic benign prostatic hyperplasia ( BPH ) . METHODS After a 1-month run-in period , 447 patients were r and omly allocated in a double-blind placebo-controlled study to receive alfuzosin 10 mg once daily ( n = 143 ) , alfuzosin 2.5 mg thrice daily ( n = 150 ) or placebo ( n = 154 ) for 3 months . At inclusion , 46 % of the r and omised population had concomitant cardiovascular disease and 30 % received an antihypertensive treatment .  Uroflowmetry was performed close to trough plasma concentration of alfuzosin once daily to demonstrate the 24-hour coverage with this formulation . RESULTS Both alfuzosin formulations significantly improved urinary symptoms versus placebo assessed using the International Prostate Symptom Score ( alfuzosin 10 mg once daily : -6.9 ; alfuzosin 2.5 mg thrice daily : -6.4 ; placebo : -4.9 , p = 0.005 ) . Peak flow rate increased significantly with alfuzosin 10 mg once daily ( + 2.3 ml/s , p = 0.03 vs. placebo ) and with alfuzosin 2.5 mg thrice daily ( + 3.2ml/s , p<0.0001 vs. placebo ) compared to placebo ( + 1.4 ml/s ) . Overall both formulations of alfuzosin were well tolerated in comparison with placebo . In addition , vasodilatory adverse events appeared to be less frequent with the once daily than the thrice daily formulation ( 6.3 vs. 9.4 % , respectively ) . No first-day effect was reported with alfuzosin once daily and the effect on blood pressure did not differ from those observed in placebo , both in normotensive and hypertensive patients . No specific sexual dysfunction including ejaculation disorder was reported in the alfuzosin 10 mg once-daily group . CONCLUSION The new once-daily formulation of alfuzosin administered at a dose of 10 mg daily is an effective 24-hour treatment of LUTS associated with BPH . Alfuzosin is as effective as the immediate formulation and shows a better cardiovascular safety . The better safety profile enables the same dose to be used in all patients , providing the patients with the benefits of a once-daily administration BACKGROUND Silodosin is a new selective therapy with a high pharmacologic selectivity for the α(1A)-adrenoreceptor . OBJECTIVE Our aim was to test silodosin 's superiority to placebo and noninferiority to tamsulosin and discuss the findings in the context of a comprehensive literature review of the new compound silodosin . DESIGN , SETTING , AND PARTICIPANTS We conducted a multicenter double-blind , placebo- and active-controlled parallel group study . A total of 1228 men ≥50 yr of age with an International Prostate Symptom Score ( IPSS ) ≥13 and a urine maximum flow rate ( Q(max ) ) > 4 and ≤15 ml/s were selected at 72 sites in 11 European countries . The patients were entered into a 2-wk wash-out and a 4-wk placebo run-in period . A total of 955 patients were r and omized ( 2:2:1 ) to silodosin 8 mg ( n=381 ) , tamsulosin 0.4 mg ( n=384 ) , or placebo ( n=190 ) once daily for 12 wk . MEASUREMENTS We calculated the change from baseline in IPSS total score ( primary ) , storage and voiding subscores , quality of life ( QoL ) due to urinary symptoms , and Q(max ) . Responders were defined on the basis of IPSS and Q(max ) by a decrease of ≥25 % and an increase of ≥30 % from baseline , respectively . RESULTS AND LIMITATIONS The change from baseline in the IPSS total score with silodosin and tamsulosin was significantly superior to that with placebo ( p<0.001 ) : difference active placebo of -2.3 ( 95 % confidence interval [ CI ] , -3.2 , -1.4 ) with silodosin and -2.0 ( 95 % CI,-2.9 , -1.1 ) with  tamsulosin . Responder rates according to total IPSS were significantly higher ( p<0.001 ) with silodosin ( 66.8 % ) and tamsulosin ( 65.4 % ) than with placebo ( 50.8 % ) . Active treatments were also superior to  placebo in the IPSS storage and voiding subscore analyses , as well as in QoL due to urinary symptoms . Of note , only silodosin significantly reduced nocturia versus placebo ( the change from baseline was -0.9 , -0.8 , and -0.7 for silodosin , tamsulosin , and placebo , respectively ; p=0.013 for silodosin vs placebo ) . An increase in Q(max ) was observed in all groups . The adjusted mean change from baseline to end point was 3.77 ml/s for silodosin , 3.53 ml/s for tamsulosin , and 2.93 ml/s for placebo , but the change for silodosin and tamsulosin was not statistically significant versus placebo because of a particularly high placebo response ( silodosin vs placebo : p=0.089 ; tamsulosin vs placebo : p=0.221 ) . At end point , the percentage of responders by Q(max ) was 46.6 % , 46.5 % , and 40.5 % in the silodosin , tamsulosin , and placebo treatment groups , respectively . This difference was not statistically significantly ( p=0.155 silodosin vs placebo and p=0.141 tamsulosin vs placebo ) . Active treatments were well tolerated , and discontinuation rates due to adverse events were low in all groups ( 2.1 % , 1.0 % , and 1.6 % with silodosin , tamsulosin , and placebo , respectively ) . The most frequent adverse event with silodosin was a reduced or absent ejaculation during orgasm ( 14 % ) , a reversible effect as a consequence of the potent and selective α(1A)-adrenoreceptor antagonism of the drug . The incidence was higher than that observed with tamsulosin ( 2 % ) ; however , only 1.3 % of silodosin-treated patients discontinued treatment due to this adverse event . CONCLUSIONS Silodosin is an effective and well-tolerated treatment for the relief of both voiding and storage symptoms in patients with lower urinary tract symptoms suggestive of bladder outlet obstruction thought to be associated with benign prostatic hyperplasia . Its overall efficacy is not inferior to tamsulosin . Only silodosin showed a significant effect on nocturia over placebo . TRIAL REGISTRATION Clinical Trials.gov Identifier NCT00359905 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
target: In this network meta- analysis , we demonstrated that SeR did not show clinical ly meaningful improvement in LUTS and PF .
  PATIENT SUMMARY In the present study , we found no clinical ly meaningful improvement of Serenoa repens for the treatment of lower urinary tract symptoms/benign prostatic enlargement .
background: CONTEXT International guidelines do not make any specific recommendations on Serenoa repens ( SeR ) for the treatment of male lower urinary tract symptoms ( LUTS ) secondary to benign prostatic enlargement ( BPE ) , due to product heterogeneity and method ological limitations of the published trials and meta-analyses .
  OBJECTIVE We aim ed to compare the clinical efficacy of hexanic extract of SeR ( HESr ) versus non-HESr ( nHESr ) versus placebo versus alpha-blockers ( ABs ) in patients affected by LUTS secondary to BPE through a network meta- analysis method .