human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Objectives : To evaluate the efficacy and safety of Serenoa repens + selenium and lycopene ( Profluss ® ) versus S. repens alone for the treatment of category IIIa chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS ) . Patients and Methods : 102 patients with IIIa CP/CPPS were enrolled and r and omized into two groups each to receive Profluss or S. repens alone for 8 weeks . Evaluation was based on results of the National Institutes of Health-Chronic Prostatitis Symptom Index ( NIH-CPSI ) , IPSS , maximum peak flow rate ( MPFR ) , and PSA measurements at baseline and at weeks 4 , 8 and 8 after the end of treatment . The primary endpoint was a > 50 % reduction in NIH-CPSI score . Secondary endpoints evaluated were MPFR , IPSS , PSA and white blood cell count . Results : No patients withdrew from the study . The mean NIH-CPSI score decreased significantly ( p < 0.001 ) in both groups ; we observed a decrease in the total score from 27.45 to 13.27 in group 1 ( –51.64 % ) and from 27.76 to 20.62 in group 2 ( –26.06 % ) . IPSS improved significantly ( p < 0.001 ) in both arms , but more in group 1 . PSA and white blood cell count decreased significantly ( p < 0.007 ) only in group 1 . The MPFR improved more in group 1 ( p < 0.005 ) . Conclusion : Profluss is a triple therapy that is safe and well tolerated . It ameliorates symptoms associated with IIIa CP/CPPS PURPOSE Saw palmetto extracts are used to treat lower urinary tract symptoms in men despite level I evidence that saw palmetto is ineffective in reducing these lower urinary tract symptoms . We determined whether higher doses of saw palmetto as studied in the CAMUS ( Complementary and Alternative Medicine for Urologic Symptoms ) trial affect serum prostate specific antigen levels . MATERIAL S AND METHODS The CAMUS trial was a r and omized , placebo controlled , double-blind , multicenter , North American trial conducted between June 5 , 2008 and October 10 , 2012 , in which 369 men older than 45 years with an AUA symptom score of 8 to 24 were r and omly assigned to placebo or dose escalation of saw palmetto , which consisted of 320 mg for the first 24 weeks , 640 mg for the next 24 weeks and 960 mg for the last 24 weeks of this 72-week trial . Serum prostate specific antigen levels were obtained at baseline and at weeks 24 , 48 and 72 , and were compared between treatment groups using the pooled t test and Fisher 's exact test . RESULTS Serum prostate specific antigen was similar at baseline for the placebo ( mean ± SD 1.93 ± 1.59 ng/ml ) and saw palmetto groups ( 2.20 ± 1.95 , p = 0.16 ) . Changes in prostate specific antigen during the study were similar , with a mean change in the placebo group of 0.16 ± 1.08 ng/ml and 0.23 ± 0.83 ng/ml in the saw palmetto group ( p = 0.50 ) . In addition , no differential effect on serum prostate specific antigen was observed between treatment arms when the groups were stratified by baseline prostate specific antigen . CONCLUSIONS Saw palmetto extract does not affect serum prostate specific antigen more than placebo , even at relatively high doses BACKGROUND / AIM It has been observed that a large number of patients with low urinary tract symptoms due to benign prostatic hyperplasia ( LUTS/BPH ) ) has been treated with a combination of tamsulosin ( TAM ) + Serenoa repens ( SR ) ( TAM + SR ) . The aim of this study was to compare a combination TAM + SR with TAM and SR alone , to see if there was any difference in efficacy and tolerance of each in patients with LUTS/BPH . METHODS In this prospect i ve study patients had to have prostate volume ( PV ) < 50 mL , International Prostate Symptom Score ( IPSS ) of 7 - 18 , Quality of Life score ( QoLs ) > 3 , a maximal flow rate ( Qmax ) of 5 - 15 mL/s , with post voiding residual volume ( PVR ) < 150 mL and serum prostatic antigen ( PSA ) < 4 ng/mL.  TAM ( 0.4 mg ) was administered once a day , SR ( 320 mg ) daily or SR ( 320 mg ) + TAM ( 0.4 mg ) daily for a median period of 6 months . RESULTS A total of 297 patients were recruited , whereas 265 patients were fully available : 87 into the group TAM , 97 into the group SR and 81 into the group TAM + SR .  There was no statistically significant difference between the treatment groups in the sense of demographic and other baseline parameters . No difference was found among the 3 treatment groups , neither in the major endpoint of the study in the sense of a change between baseline and final evaluation in total IPSS , obstructive and irritative subscores , improvement of QoLs , increase in Qmax , nor for the second endpoint including diminution of PV , PSA and PVR . During the treatment period 20 ( 23 % ) of the patients managed with TAM and 17 ( 21 % ) with TAM + SR had drug- treated with related adverse reactions . No adverse effect was detected in the group SR . CONCLUSION Treatment of BPH by both SR and TAM seems to be efficacious alone . None of them had superiority over another and , additionally , a combined therapy ( TAM + SR ) does not provide extra benefits . Furthermore , SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS/BPH Background Chronic prostatic inflammation ( CPI ) could be a cause of symptomatic or complicated benign prostatic hyperplasia ( BPH ) . In previous in vitro and in vivo studies , Hexanic Extract of Serenoa repens ( HESr ) namely Permixon ® has demonstrated potent anti‐inflammatory properties . With the aim to provide new insight onto HESr anti‐inflammatory properties in human we explore its effect on CPI biomarkers in men with lower urinary tract symptoms ( LUTS ) related to BPH using a non‐invasive method and investigate links between biomarkers and clinical symptoms . Methods An international , r and omized , double‐blind , parallel‐group , tamsulosin‐controlled study was carried out in 206 men with BPH‐related LUTS . Patients received oral daily HESr 320 mg or tamsulosin 0.4 mg during 3 months . The first urine stream after digital rectal examination ( DRE ) was collected at Day 1 and Day 90 and mRNA was extracted from prostatic epithelial cells desquaming in the lumen of the gl and s and seminal plasma fluid after DRE . mRNA quantification of the 29 most significant published inflammation markers in BPH and protein detection in urine was performed . Results At D90 , a decrease in mean gene expression was observed for 65.4 % of the markers detected in the HESr group versus 46.2 % in the tamsulosin group . In the 15 most frequently expressed genes , this difference was higher ( 80 % vs. 33 % respectively ) . Three proteins ( MCP‐1/CCL2 , IP‐10/CXCL10 , and MIF ) were detected . At D90 , a decrease in the number of patients who expressed MCP‐1/CCL2 and IP‐10/CXCL10 was observed only in the HESr group . Moreover , MIF expression was significantly reduced by HESr compared with tamsulosin ( P = 0.007 ) . Finally , in contrast to tamsulosin , the subgroup of patients treated by HESr and who over expressed MIF at baseline , had a higher response to the International Prostate Symptom Score ( I‐PSS ) than those who did not over express this protein ( mean I‐PSS change : −6.4 vs. −4.5 respectively ) . As the study is exploratory , results should be confirmed in a powered clinical study . Conclusions These results showed for the first time at clinical level the anti‐inflammatory properties of HESr , already indicated in BPH‐related LUTS . Thus , HESr could be of interest to prevent unfavourable evolution in patients with CPI . Prostate 75:1857–1867 , 2015 . © 2015 The Authors . The Prostate Published by Wiley Periodicals , Introduction Increasing attention has been focused on the use of phytotherapeutic agents to alleviate the symptoms of benign prostatic hyperplasia ( BPH ) in recent times . The best described and studied phytotherapeutic agent is Serenoa repens ( SR ) . Material s and methods This prospect i ve study was design ed to have 3 arms including SR 320 mg per day ( N = 20 ) , Tamsulosin ( TAM ) 0.4 mg per day ( N = 20 ) and SR + TAM ( N = 20 ) to reveal the superiority or equivalence between these treatment regimens in BPH . Results The groups were not statistically different with regard to increase in maximal urinary flow rate ( Qmax ) and decrease in International Prostate Symptom Score ( I-PSS ) ( P > 0.05 ) . No adverse effect was detected in SR therapy group . Conclusion Treatment of BPH by both SR and TAM seems to be effective alone . None of them had superiority to another and additionally , combined therapy ( SR + TAM ) does not provide extra benefits . Furthermore SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS due to BPH Introduction : In Korea , increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH . Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies . The present study was design ed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH . Material s and Methods : One hundred forty men with symptomatic BPH ( IPSS ≥10 ) were recruited in our hospital for a 12-month , open-label , r and omized trial . Patients were r and omly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day ( n = 60 ) or tamsulosin 0.2 mg/day only ( n = 60 ) . Prostate volume and PSA were measured at baseline and at end-point , whereas total IPSS , and its storage and voiding subscores , LUTS-related QoL , Qmax , and PVR were evaluated at baseline and later every 6 months . Results : Total 103 patients were finally available : 50 in the TAM + SR group and 53 in the TAM group . At 12 months , total IPSS decreased by 5.8 with TAM + SR and 5.5 with TAM ( p = 0.693 ) ; the storage symptoms improved significantly more with TAM + SR ( -1.7 vs. -0.8 with TAM , p = 0.024 ) . This benefit with regard to storage symptom in the TAM + SR group lasts at 12 months ( -1.9 vs. -0.9 , p = 0.024 ) . The changes of voiding subscore , LUTS-related QoL , Qmax , PVR , PSA , and prostate volume showed no significant differences between the TAM + SR and TAM groups . During the treatment period , 8 patients ( 16.9 % ) with TAM and 10 ( 20 % ) with TAM + SR had drug-related adverse reactions , which included ejaculatory disorders , postural hypotension , dizziness , headache , gastro-intestinal disorders , rhinitis , fatigue and asthenia . Conclusions : The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment In an open-label extension of a r and omized , double-blind clinical trial , the long-term efficacy and tolerability of a fixed combination of 160 mg Sabal fruit extract WS 1473 and 120 mg Urtica root extract WS 1031 per capsule ( PRO 160/120 ) were investigated in elderly men with moderate or severe lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia ( BPH ) . Two hundred and fifty-seven patients were r and omly treated with 2 × 1 capsule/day PRO 160/120 or placebo for 24 weeks , followed by a 24-week control period and a 48-week follow-up period in which all patients received PRO 160/120 . Efficacy measures included the assessment of LUTS [ International Prostate Symptom Score ( ( I-PSS ) self-rating question naire ] and uroflow and sonographic parameters . Two hundred and nineteen subjects participated in the follow-up . Between baseline and end of observation ( week 96 ) the I-PSS total score was reduced by 53 % ( P < 0.001 ) , peak and average urinary flow increased by 19 % ( P < 0.001 ) , and residual urine volume decreased by 44 % ( P = 0.03 ) . The incidence of adverse events during follow-up was one in 1,18 
    Output:
    
agent
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 .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Objectives : To evaluate the efficacy and safety of Serenoa repens + selenium and lycopene ( Profluss ® ) versus S. repens alone for the treatment of category IIIa chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS ) . Patients and Methods : 102 patients with IIIa CP/CPPS were enrolled and r and omized into two groups each to receive Profluss or S. repens alone for 8 weeks . Evaluation was based on results of the National Institutes of Health-Chronic Prostatitis Symptom Index ( NIH-CPSI ) , IPSS , maximum peak flow rate ( MPFR ) , and PSA measurements at baseline and at weeks 4 , 8 and 8 after the end of treatment . The primary endpoint was a > 50 % reduction in NIH-CPSI score . Secondary endpoints evaluated were MPFR , IPSS , PSA and white blood cell count . Results : No patients withdrew from the study . The mean NIH-CPSI score decreased significantly ( p < 0.001 ) in both groups ; we observed a decrease in the total score from 27.45 to 13.27 in group 1 ( –51.64 % ) and from 27.76 to 20.62 in group 2 ( –26.06 % ) . IPSS improved significantly ( p < 0.001 ) in both arms , but more in group 1 . PSA and white blood cell count decreased significantly ( p < 0.007 ) only in group 1 . The MPFR improved more in group 1 ( p < 0.005 ) . Conclusion : Profluss is a triple therapy that is safe and well tolerated . It ameliorates symptoms associated with IIIa CP/CPPS PURPOSE Saw palmetto extracts are used to treat lower urinary tract symptoms in men despite level I evidence that saw palmetto is ineffective in reducing these lower urinary tract symptoms . We determined whether higher doses of saw palmetto as studied in the CAMUS ( Complementary and Alternative Medicine for Urologic Symptoms ) trial affect serum prostate specific antigen levels . MATERIAL S AND METHODS The CAMUS trial was a r and omized , placebo controlled , double-blind , multicenter , North American trial conducted between June 5 , 2008 and October 10 , 2012 , in which 369 men older than 45 years with an AUA symptom score of 8 to 24 were r and omly assigned to placebo or dose escalation of saw palmetto , which consisted of 320 mg for the first 24 weeks , 640 mg for the next 24 weeks and 960 mg for the last 24 weeks of this 72-week trial . Serum prostate specific antigen levels were obtained at baseline and at weeks 24 , 48 and 72 , and were compared between treatment groups using the pooled t test and Fisher 's exact test . RESULTS Serum prostate specific antigen was similar at baseline for the placebo ( mean ± SD 1.93 ± 1.59 ng/ml ) and saw palmetto groups ( 2.20 ± 1.95 , p = 0.16 ) . Changes in prostate specific antigen during the study were similar , with a mean change in the placebo group of 0.16 ± 1.08 ng/ml and 0.23 ± 0.83 ng/ml in the saw palmetto group ( p = 0.50 ) . In addition , no differential effect on serum prostate specific antigen was observed between treatment arms when the groups were stratified by baseline prostate specific antigen . CONCLUSIONS Saw palmetto extract does not affect serum prostate specific antigen more than placebo , even at relatively high doses BACKGROUND / AIM It has been observed that a large number of patients with low urinary tract symptoms due to benign prostatic hyperplasia ( LUTS/BPH ) ) has been treated with a combination of tamsulosin ( TAM ) + Serenoa repens ( SR ) ( TAM + SR ) . The aim of this study was to compare a combination TAM + SR with TAM and SR alone , to see if there was any difference in efficacy and tolerance of each in patients with LUTS/BPH . METHODS In this prospect i ve study patients had to have prostate volume ( PV ) < 50 mL , International Prostate Symptom Score ( IPSS ) of 7 - 18 , Quality of Life score ( QoLs ) > 3 , a maximal flow rate ( Qmax ) of 5 - 15 mL/s , with post voiding residual volume ( PVR ) < 150 mL and serum prostatic antigen ( PSA ) < 4 ng/mL.  TAM ( 0.4 mg ) was administered once a day , SR ( 320 mg ) daily or SR ( 320 mg ) + TAM ( 0.4 mg ) daily for a median period of 6 months . RESULTS A total of 297 patients were recruited , whereas 265 patients were fully available : 87 into the group TAM , 97 into the group SR and 81 into the group TAM + SR .  There was no statistically significant difference between the treatment groups in the sense of demographic and other baseline parameters . No difference was found among the 3 treatment groups , neither in the major endpoint of the study in the sense of a change between baseline and final evaluation in total IPSS , obstructive and irritative subscores , improvement of QoLs , increase in Qmax , nor for the second endpoint including diminution of PV , PSA and PVR . During the treatment period 20 ( 23 % ) of the patients managed with TAM and 17 ( 21 % ) with TAM + SR had drug- treated with related adverse reactions . No adverse effect was detected in the group SR . CONCLUSION Treatment of BPH by both SR and TAM seems to be efficacious alone . None of them had superiority over another and , additionally , a combined therapy ( TAM + SR ) does not provide extra benefits . Furthermore , SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS/BPH Background Chronic prostatic inflammation ( CPI ) could be a cause of symptomatic or complicated benign prostatic hyperplasia ( BPH ) . In previous in vitro and in vivo studies , Hexanic Extract of Serenoa repens ( HESr ) namely Permixon ® has demonstrated potent anti‐inflammatory properties . With the aim to provide new insight onto HESr anti‐inflammatory properties in human we explore its effect on CPI biomarkers in men with lower urinary tract symptoms ( LUTS ) related to BPH using a non‐invasive method and investigate links between biomarkers and clinical symptoms . Methods An international , r and omized , double‐blind , parallel‐group , tamsulosin‐controlled study was carried out in 206 men with BPH‐related LUTS . Patients received oral daily HESr 320 mg or tamsulosin 0.4 mg during 3 months . The first urine stream after digital rectal examination ( DRE ) was collected at Day 1 and Day 90 and mRNA was extracted from prostatic epithelial cells desquaming in the lumen of the gl and s and seminal plasma fluid after DRE . mRNA quantification of the 29 most significant published inflammation markers in BPH and protein detection in urine was performed . Results At D90 , a decrease in mean gene expression was observed for 65.4 % of the markers detected in the HESr group versus 46.2 % in the tamsulosin group . In the 15 most frequently expressed genes , this difference was higher ( 80 % vs. 33 % respectively ) . Three proteins ( MCP‐1/CCL2 , IP‐10/CXCL10 , and MIF ) were detected . At D90 , a decrease in the number of patients who expressed MCP‐1/CCL2 and IP‐10/CXCL10 was observed only in the HESr group . Moreover , MIF expression was significantly reduced by HESr compared with tamsulosin ( P = 0.007 ) . Finally , in contrast to tamsulosin , the subgroup of patients treated by HESr and who over expressed MIF at baseline , had a higher response to the International Prostate Symptom Score ( I‐PSS ) than those who did not over express this protein ( mean I‐PSS change : −6.4 vs. −4.5 respectively ) . As the study is exploratory , results should be confirmed in a powered clinical study . Conclusions These results showed for the first time at clinical level the anti‐inflammatory properties of HESr , already indicated in BPH‐related LUTS . Thus , HESr could be of interest to prevent unfavourable evolution in patients with CPI . Prostate 75:1857–1867 , 2015 . © 2015 The Authors . The Prostate Published by Wiley Periodicals , Introduction Increasing attention has been focused on the use of phytotherapeutic agents to alleviate the symptoms of benign prostatic hyperplasia ( BPH ) in recent times . The best described and studied phytotherapeutic agent is Serenoa repens ( SR ) . Material s and methods This prospect i ve study was design ed to have 3 arms including SR 320 mg per day ( N = 20 ) , Tamsulosin ( TAM ) 0.4 mg per day ( N = 20 ) and SR + TAM ( N = 20 ) to reveal the superiority or equivalence between these treatment regimens in BPH . Results The groups were not statistically different with regard to increase in maximal urinary flow rate ( Qmax ) and decrease in International Prostate Symptom Score ( I-PSS ) ( P > 0.05 ) . No adverse effect was detected in SR therapy group . Conclusion Treatment of BPH by both SR and TAM seems to be effective alone . None of them had superiority to another and additionally , combined therapy ( SR + TAM ) does not provide extra benefits . Furthermore SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS due to BPH Introduction : In Korea , increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH . Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies . The present study was design ed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH . Material s and Methods : One hundred forty men with symptomatic BPH ( IPSS ≥10 ) were recruited in our hospital for a 12-month , open-label , r and omized trial . Patients were r and omly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day ( n = 60 ) or tamsulosin 0.2 mg/day only ( n = 60 ) . Prostate volume and PSA were measured at baseline and at end-point , whereas total IPSS , and its storage and voiding subscores , LUTS-related QoL , Qmax , and PVR were evaluated at baseline and later every 6 months . Results : Total 103 patients were finally available : 50 in the TAM + SR group and 53 in the TAM group . At 12 months , total IPSS decreased by 5.8 with TAM + SR and 5.5 with TAM ( p = 0.693 ) ; the storage symptoms improved significantly more with TAM + SR ( -1.7 vs. -0.8 with TAM , p = 0.024 ) . This benefit with regard to storage symptom in the TAM + SR group lasts at 12 months ( -1.9 vs. -0.9 , p = 0.024 ) . The changes of voiding subscore , LUTS-related QoL , Qmax , PVR , PSA , and prostate volume showed no significant differences between the TAM + SR and TAM groups . During the treatment period , 8 patients ( 16.9 % ) with TAM and 10 ( 20 % ) with TAM + SR had drug-related adverse reactions , which included ejaculatory disorders , postural hypotension , dizziness , headache , gastro-intestinal disorders , rhinitis , fatigue and asthenia . Conclusions : The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment In an open-label extension of a r and omized , double-blind clinical trial , the long-term efficacy and tolerability of a fixed combination of 160 mg Sabal fruit extract WS 1473 and 120 mg Urtica root extract WS 1031 per capsule ( PRO 160/120 ) were investigated in elderly men with moderate or severe lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia ( BPH ) . Two hundred and fifty-seven patients were r and omly treated with 2 × 1 capsule/day PRO 160/120 or placebo for 24 weeks , followed by a 24-week control period and a 48-week follow-up period in which all patients received PRO 160/120 . Efficacy measures included the assessment of LUTS [ International Prostate Symptom Score ( ( I-PSS ) self-rating question naire ] and uroflow and sonographic parameters . Two hundred and nineteen subjects participated in the follow-up . Between baseline and end of observation ( week 96 ) the I-PSS total score was reduced by 53 % ( P < 0.001 ) , peak and average urinary flow increased by 19 % ( P < 0.001 ) , and residual urine volume decreased by 44 % ( P = 0.03 ) . The incidence of adverse events during follow-up was one in 1,18 
    Output:
    