Analysis of the results obtained with a new phytotherapeutic association for LUTS versus control. [corrected]. [Associating Serenoa repens, Urtica dioica and Pinus pinaster. Safety and efficacy in the treatment of lower urinary tract symptoms. Prospective study on 320 patients]. A prospective study of the efficacy of Serenoa repens, Tamsulosin, and Serenoa repens plus Tamsulosin treatment for patients with benign prostate hyperplasia Comparison of Tamsulosin Plus Serenoa Repens with Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in Korean Men: 1-Year Randomized Open Label Study Does the addition of Serenoa repens to tamsulosin improve its therapeutical efficacy in 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). Saw palmetto (Serenoa repens) in men with lower urinary tract symptoms: effects on urodynamic parameters and voiding symptoms. 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 Evaluation of the clinical benefit of permixon and tamsulosin in severe BPH patients-PERMAL study subset analysis. 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) 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. 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 Comparative effects of alfuzosin versus Serenoa repens in the treatment of symptomatic benign prostatic hyperplasia. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic hyperplasia. Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. The lipidosterolic extract ofSerenoa repens in the treatment of benign prostatic hyperplasia: A comparison of two dosage regimens [Tamsulosin with or without Serenoa repens in benign prostatic hyperplasia: the OCOS trial]. Randomized Controlled Trial to Assess the Efficacy of the Combination Therapy of Alfuzosin and Tadalafil in Patients with Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Long-term efficacy and safety of tamsulosin hydrochloride for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia: data from China. 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.
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 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 Introduction Increasing attention has been focused on the use of phytotherapeutic agents to alleviate the symptoms of benign prostatic hyperplasia ( BPH ) in recent times . The best described and studied phytotherapeutic agent is Serenoa repens ( SR ) . Material s and methods This prospect i ve study was design ed to have 3 arms including SR 320 mg per day ( N = 20 ) , Tamsulosin ( TAM ) 0.4 mg per day ( N = 20 ) and SR + TAM ( N = 20 ) to reveal the superiority or equivalence between these treatment regimens in BPH . Results The groups were not statistically different with regard to increase in maximal urinary flow rate ( Qmax ) and decrease in International Prostate Symptom Score ( I-PSS ) ( P > 0.05 ) . No adverse effect was detected in SR therapy group . Conclusion Treatment of BPH by both SR and TAM seems to be effective alone . None of them had superiority to another and additionally , combined therapy ( SR + TAM ) does not provide extra benefits . Furthermore SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS due to BPH Introduction : In Korea , increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH . Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies . The present study was design ed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH . Material s and Methods : One hundred forty men with symptomatic BPH ( IPSS ≥10 ) were recruited in our hospital for a 12-month , open-label , r and omized trial . Patients were r and omly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day ( n = 60 ) or tamsulosin 0.2 mg/day only ( n = 60 ) . Prostate volume and PSA were measured at baseline and at end-point , whereas total IPSS , and its storage and voiding subscores , LUTS-related QoL , Qmax , and PVR were evaluated at baseline and later every 6 months . Results : Total 103 patients were finally available : 50 in the TAM + SR group and 53 in the TAM group . At 12 months , total IPSS decreased by 5.8 with TAM + SR and 5.5 with TAM ( p = 0.693 ) ; the storage symptoms improved significantly more with TAM + SR ( -1.7 vs. -0.8 with TAM , p = 0.024 ) . This benefit with regard to storage symptom in the TAM + SR group lasts at 12 months ( -1.9 vs. -0.9 , p = 0.024 ) . The changes of voiding subscore , LUTS-related QoL , Qmax , PVR , PSA , and prostate volume showed no significant differences between the TAM + SR and TAM groups . During the treatment period , 8 patients ( 16.9 % ) with TAM and 10 ( 20 % ) with TAM + SR had drug-related adverse reactions , which included ejaculatory disorders , postural hypotension , dizziness , headache , gastro-intestinal disorders , rhinitis , fatigue and asthenia . Conclusions : The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment 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 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 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 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 , 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 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 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 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 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 BACKGROUND Tadalafil improved lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ; LUTS/BPH ) in clinical studies but has not been evaluated together with an active control in an international clinical study . OBJECTIVE Assess tadalafil or tamsulosin versus placebo for LUTS/BPH . DESIGN , SETTING , AND PARTICIPANTS A r and omised , double-blind , international , placebo-controlled , parallel-group study assessed men ≥45 yr of age with LUTS/BPH , International Prostate Symptom Score ( IPSS ) ≥13 , and maximum urinary flow rate ( Q(max ) ) ≥4 to ≤15ml/s . Following screening and washout , if needed , subjects completed a 4-wk placebo run-in before r and omisation to placebo ( n=172 ) , tadalafil 5 mg ( n=171 ) , or tamsulosin 0.4 mg ( n=168 ) once daily for 12 wk . MEASUREMENTS Outcomes were assessed using analysis of covariance ( ANCOVA ) or ranked analysis of variance ( ANOVA ) ( continuous variables ) and Cochran-Mantel-Haenszel test or Fisher exact test ( categorical variables ) . RESULTS AND LIMITATIONS IPSS significantly improved versus placebo through 12 wk with tadalafil ( -2.1 ; p=0.001 ; primary efficacy outcome ) and tamsulosin ( -1.5 ; p=0.023 ) and as early as 1 wk ( tadalafil and tamsulosin both -1.5 ; p<0.01 ) . BPH Impact Index significantly improved versus placebo at first assessment ( week 4 ) with tadalafil ( -0.8 ; p<0.001 ) and tamsulosin ( -0.9 ; p<0.001 ) and through 12 wk ( tadalafil -0.8 , p=0.003 ; tamsulosin -0.6 , p=0.026 ) . The IPSS Quality -of-Life Index and the Treatment Satisfaction Scale-BPH improved significantly versus placebo with tadalafil ( both p<0.05 ) but not with tamsulosin ( both p>0.1 ) . The International Index of Erectile Function-Erectile Function domain improved versus placebo with tadalafil ( 4.0 ; p<0.001 ) but not tamsulosin ( -0.4 ; p=0.699 ) . Q(max ) increased significantly versus placebo with both tadalafil ( 2.4ml/s ; p=0.009 ) and tamsulosin ( 2.2ml/s ; p=0.014 ) . Adverse event profiles were consistent with previous reports . This study was limited in not being powered to directly compare tadalafil versus tamsulosin . CONCLUSIONS Monotherapy with tadalafil or tamsulosin result ed in significant and numerically similar improvements versus placebo in LUTS/BPH and Q(max ) . However , only tadalafil improved erectile dysfunction . TRIAL REGISTRATION Clinical trials.gov ID NCT00970632 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 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 To compare the effect of a Serenoa repens extract with placebo for symptoms of benign prostatic hyperplasia ( BPH ) BACKGROUND Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) and prostatic enlargement . OBJECTIVE To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention ( AUR ) , BPH-related surgery , and BPH clinical progression over 4 yr in men at increased risk of progression . DESIGN , SETTING , AND PARTICIPANTS The Combination of Avodart and Tamsulosin ( CombAT ) study was a 4-yr , multicenter , r and omised , double-blind , parallel-group study in 4844 men > or = 50 yr of age with a clinical diagnosis of BPH , International Prostate Symptom Score > or = 12 , prostate volume > or = 30 cm(3 ) , prostate-specific antigen 1.5 - 10 ng/ml , and maximum urinary flow rate ( Q(max ) ) > 5 and < or = 15 ml/s with minimum voided volume > or = 125 ml . INTERVENTION Oral daily tamsulosin , 0.4 mg ; dutasteride , 0.5 mg ; or a combination of both . MEASUREMENTS The 4-yr primary end point was time to first AUR or BPH-related surgery . Secondary end points included BPH clinical progression , symptoms , Q(max ) , prostate volume , safety , and tolerability . RESULTS AND LIMITATIONS Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery . Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression . Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr . Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies , with the exception of an imbalance in the composite term of cardiac failure among the three study arms . The lack of placebo control is a study limitation . CONCLUSIONS The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement . CLINICAL TRIALS.GOV IDENTIFIER : NCT00090103 ( http://www . clinical trials.gov/ct2/show/NCT00090103 ) This 6-month double-blind , r and omized , parallel-group study compared two dose regimens of Libeprosta ® , the lipidosterolic extract ofSerenoa repens in 100 male out patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( BPH ) . The patients received two 80-mg tablets twice daily or two 80-mg tablets three times daily . Baseline evaluations included maximum and mean urinary flow rates , postvoid residual urine volume , and International Prostate Symptom Score ( I-PSS ) total and quality -of-life scores . Both regimens significantly reduced the I-PSS mean total score from baseline values ( P < .001 ) ; improvements achieved statistical significance after month 3 and were maintained for the duration of the study . Significant improvements from baseline also occurred in quality -of-life scores , maximum and mean urinary flow rates , and residual urine volume ( P < .05 ) . The decrease in residual urine with both regimens was highly significant ( P < .001 ) . No significant differences in efficacy were noted between the two dose groups , and no treatment-related complications or clinical adverse events occurred . In this clinical study , the lipidosterolic extract ofSerenoa repens was a well-tolerated agent that may significantly improve lower urinary tract symptoms and flow measurements in men with BPH OBJECTIVE 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 OBJECTIVE The purpose of our study was to evaluate the effect of alfuzosin and tadalafil as combination therapy compared with each monotherapy , in patients with lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) . METHODS Men over the age of 50 years with LUTS secondary to BPH and an International Prostate Symptom Score ( IPSS ) 8 or higher , were r and omized to receive 10 mg alfuzosin ( n = 25 ) , 10 mg tadalafil ( n = 25 ) or the combination of both the drugs ( n = 25 ) once daily for 3 months . Symptoms were assessed at baseline , 6 weeks and 3 months . The primary endpoint was the change in IPSS from the baseline . Secondary endpoints were changes in IPSS storage and voiding subscores , peak urinary flow rate , residual urine volume , IPSS quality of life score and erectile domain score . RESULTS There were significant improvements in all IPSS scores , peak urinary flow rate and IPSS quality of life score from baseline at both 6 weeks and 3 months in all the three groups ( P < 0.003 ) . Combination therapy was better than monotherapy in improving IPSS scores and reducing post-void residual urine volume ( P < 0.005 ) . Combination therapy was similar to alfuzosin regarding improvement in maximum urine flow rate ( P = 0.22 ) , similar to tadalafil in improvement on erectile function ( P = 0.22 ) and better than each monotherapy in improving the IPSS quality of life ( P ≤ 0.015 ) . CONCLUSION Alfuzosin and tadalafil combination therapy provides greater symptomatic improvement as compared to either monotherapy in men with LUTS due to BPH BACKGROUND Tamsulosin hydrochloride can significantly improve benign prostatic hyperplasia ( BPH ) symptoms after the first dose and achieve long-term efficacy in European and American population s ; however , the corresponding studies from China are rarely seen . The purpose of this study was to evaluate the long-term efficacy and safety of tamsulosin hydrochloride 0.2 mg once daily in patients with lower urinary tract symptoms ( LUTS ) suggestive of BPH in China . METHODS Chinese patients with LUTS suggestive of BPH were enrolled in a 4-week placebo run-in period and subsequent 60-week open-label study . Tamsulosin hydrochloride 0.2 mg was administered daily during the period of the study . The efficacy and safety parameters were evaluated at the end of treatment period I ( 0 - 12 weeks ) and period II ( 13 - 60 weeks ) . The BPH patients were divided into tamsulosin monotherapy group and combination therapy group which received concomitant medication of finasteride 5 mg once daily after the evaluation at the end of treatment period I. RESULTS A total of 113 patients were recruited to the study . Eighty-two patients received tamsulosin monotherapy and twenty-nine received combination therapy during the treatment period II . Tamsulosin hydrochloride produced a great improvement in mean maximum urinary flow rate ( Q(max ) ) ( 1.7 ml/s , 3 ml/s ) and a significant decrease in mean international prostate symptom score ( IPSS ) ( 4.1 , 6.4 ) after 12-week and 60-week treatments , respectively . At the end of treatment period II , there were significant improvement in IPSS , quality of life ( QOL ) score , Q(max ) and average flow rate ( Q(ave ) ) for combination therapy group compared with the treatment period I ( all P < 0.05 ) . No serious adverse events ( SAE ) were recorded during the study . CONCLUSION Long-term tamsulosin hydrochloride therapy is a safe , effective and well-tolerated method for the treatment for LUTS suggestive of BPH in China 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
S. repens is safe in its application .
We suggest that strong placebo effect , potentially influenced by positive patients ' expectation on S. repens , shapes both the clinical practice outcomes and the findings of clinical trials .
Hitherto , the totality of evidence continues to suggest that S. repens is a prudent therapeutic option as part of the naturopathic treatment for LUTS/BPH .
OBJECTIVES Benign prostatic hyperplasia ( BPH ) commonly affects men above 40 years old .
The progression of BPH is often accompanied with lower urinary tract symptoms ( LUTS ) that can significantly affect the quality of life of the patients .
Serenoa repens ( saw palmetto ) is a popular herbal remedy indicated for LUTS/BPH .
We review ed the current research on the efficacy of S. repens on LUTS/BPH as a monotherapy as well as combination therapies .
RESULTS The latest evidence , based largely on the Cochrane review , suggests that S. repens is not superior to placebo in treating LUTS/BPH as a monotherapy , even at double and triple doses .
Initial clinical trials on treatment of LUTS/BPH using S. repens with lycopene and selenium , as well as S. repens with Urtica Dioica , have shown positive results .