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: Objective To test the hypothesis that in patients with benign prostatic hyperplasia ( BPH ) , the outcome of drug therapy with finasteride may be predictable from the baseline prostate volume and that positive clinical effects might be expected only in patients with prostate volumes of > 40 mL , using a subgroup analysis of results from a previously reported clinical trial of finasteride and phytotherapy 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 In a r and omised , double-blind study , the preparation Curbicin , obtained from pumpkin seeds and dwarf palm plants ( Cucurbita pepo L. and Sabal serrulata ) , was compared with a placebo in the treatment of symptoms caused by prostatic hyperplasia ; 53 patients took part in the study , which was carried out over a 3-month period .  Urinary flow , micturition time , residual urine , frequency of micturition and a subjective assessment of the effect of treatment were all significantly improved in the treatment group . No untoward side effects were noted 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 Saw palmetto is used by over 2 million men in the United States for the treatment of benign prostatic hyperplasia and is commonly recommended as an alternative to drugs approved by the Food and Drug Administration . METHODS In this double-blind trial , we r and omly assigned 225 men over the age of 49 years who had moderate-to-severe symptoms of benign prostatic hyperplasia to one year of treatment with saw palmetto extract  ( 160 mg twice a day ) or placebo . The primary outcome measures were changes in the scores on the American Urological Association Symptom Index ( AUASI ) and the maximal urinary flow rate . Secondary outcome measures included changes in prostate size , residual urinary volume after voiding , quality of life , laboratory values , and the rate of reported adverse effects . RESULTS There was no significant difference between the saw palmetto and placebo groups in the change in AUASI scores ( mean difference , 0.04 point ; 95 percent confidence interval , -0.93 to 1.01 ) , maximal urinary flow rate ( mean difference , 0.43 ml per minute ; 95 percent confidence interval , -0.52 to 1.38 ) , prostate size , residual volume after voiding , quality of life , or serum prostate-specific antigen levels during the one-year study . The incidence of side effects was similar in the two groups . CONCLUSIONS In this study , saw palmetto did not improve symptoms or objective measures of benign prostatic hyperplasia . ( Clinical Trials.gov number , NCT00037154 . ) Because benign prostatic hyperplasia ( BPH ) is relatively common , it is important to discover safe and effective means to treat this often debilitating perturbation . Accordingly , we examined the effectiveness of a combination of natural products ( cernitin , saw palmetto , B-sitosterol , vitamin E ) in treating symptoms of BPH . We undertook a r and omized , placebo-controlled , double-blind study . Patients were enrolled from 3 urological practice s in the USA . 144 subjects were r and omized for study . 17 subjects eventually withdrew , leaving 70 patients in the test group and 57 in the placebo group to complete the study . Inclusion criteria consisted of a diagnosis of BPH , no evidence of cancer , and a maximal urinary flow rate between 5 and 15 ml/second . Patients received either placebo or the combined natural products for 3 months . Evaluations were performed via the American Urological Association ( AUA ) Symptom Index score , urinary flow rate , PSA measurement , and residual bladder volume . Nocturia showed a markedly significant decrease in severity in patients receiving the combined natural products compared to those taking placebo ( p < 0.001 ) . Daytime frequency was also lessened significantly ( p < 0.04 ) . When the average individual total AUA Symptom Index score in the test group was compared to that in the placebo group at the end of the study , the difference proved highly significant ( p < 0.014 ) . PSA measurements , maximal and average urinary flow rates , and residual volumes showed no statistically significant differences . When taken for 3 months , a combination of natural products ( cernitin , saw palmetto , B-sitosterol , vitamin E ) compared to placebo can significantly lessen nocturia and frequency and diminish overall symptomatology of BPH as indicated by an improvement in the total AUA Symptom Index score . The combination of natural products caused no significant adverse side effects The 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 ) was investigated in elderly , male patients suffering from lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia in a prospect i ve multicenter trial . A total of 257 patients ( 129 and 128 , respectively ) were r and omized to treatment with PRO 160/120 or placebo  ( 127 and 126 were evaluable for efficacy ) . Following a single-blind placebo run-in phase of 2 weeks , the patients received 2 × 1 capsule/day of the study medication under double-blind conditions over a period of 24 weeks . Double-blind treatment was followed by an open control period of 24 weeks during which all patients were administered PRO 160/120 . Outcome measures for treatment efficacy included the assessment of the patients ’ LUTS by means of the I-PSS self-rating question naire and a quality of life index as well as uroflow and sonographic parameters . Using the International Prostate Symptom Score ( I-PSS ) , patients treated with PRO 160/120 exhibited a substantially higher total score reduction after 24 weeks of double-blind treatment than patients of the placebo group ( 6 points vs 4 points ; P=0.003 , one tailed ) with a tendency in the same direction after 16 weeks . This applied to obstructive as well as to irritative symptoms , and to patients with moderate or severe symptoms at baseline . Patients r and omized to placebo showed a marked improvement in LUTS ( as measured by the I-PSS ) after being switched to PRO 160/120 during the control period ( P=0.01 , one tailed , in comparison to those who had been treated with PRO 160/120 in the double-blind phase ) . The tolerability of PRO 160/120 was comparable to the placebo . In conclusion , PRO 160/120 was clearly superior to the placebo for the amelioration of LUTS as measured by the I-PSS . PRO 160/120 is advantageous in obstructive and irritative urinary symptoms and in patients with moderate and severe symptoms . The tolerability of the herbal extract was excellent To compare the effect of a Serenoa repens extract with placebo for symptoms of benign prostatic hyperplasia ( BPH ) PURPOSE Permixon is a lipidosterolic extract of Serenoa repens ( SR ) widely used to treat men with benign prostatic hyperplasia ( BPH ) . We tested the effect of this drug on molecular mechanisms associated with apoptosis , such as the Bax-to-Bcl-2 expression ratio and caspase-3 activity , in prostatic tissue from men with symptomatic BPH treated for 3 months before surgery . MATERIAL S AND METHODS An open , multicenter pilot study of 2 parallel groups of patients with BPH was done . They were r and omized to be followed for 3 weeks without any treatment before surgery ( control group ) or to receive 160 mg SR orally twice daily for a 3-month period preceding the same surgery . Surgery was ultimately performed in 17 controls and 12 patients by transurethral prostate resection or retropubic adenomectomy .  Bax and Bcl-2 expression , and caspase-3 activity were determined by Western blot in 15 controls and 10 patients , and reported in blinded fashion . RESULTS The Bax-to-Bcl-2 ratio , which is used as an apoptotic index , was significantly increased in the prostatic tissue of treated patients . The level of the intact 116 kDa poly ( adenosine diphosphate-ribose ) polymerase form , an enzyme involved in the cell death apoptotic pathway , was also found to be decreased in prostatic tissue from SR treated patients , suggesting increased caspase 3 activity in the prostate . CONCLUSIONS Permixon increased molecular markers involved in the apoptotic process , ie the Bax-to- 
    Output:
    
agent
Serenoa repens was not more effective than placebo for treatment of urinary symptoms consistent with 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: Objective To test the hypothesis that in patients with benign prostatic hyperplasia ( BPH ) , the outcome of drug therapy with finasteride may be predictable from the baseline prostate volume and that positive clinical effects might be expected only in patients with prostate volumes of > 40 mL , using a subgroup analysis of results from a previously reported clinical trial of finasteride and phytotherapy 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 In a r and omised , double-blind study , the preparation Curbicin , obtained from pumpkin seeds and dwarf palm plants ( Cucurbita pepo L. and Sabal serrulata ) , was compared with a placebo in the treatment of symptoms caused by prostatic hyperplasia ; 53 patients took part in the study , which was carried out over a 3-month period .  Urinary flow , micturition time , residual urine , frequency of micturition and a subjective assessment of the effect of treatment were all significantly improved in the treatment group . No untoward side effects were noted 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 Saw palmetto is used by over 2 million men in the United States for the treatment of benign prostatic hyperplasia and is commonly recommended as an alternative to drugs approved by the Food and Drug Administration . METHODS In this double-blind trial , we r and omly assigned 225 men over the age of 49 years who had moderate-to-severe symptoms of benign prostatic hyperplasia to one year of treatment with saw palmetto extract  ( 160 mg twice a day ) or placebo . The primary outcome measures were changes in the scores on the American Urological Association Symptom Index ( AUASI ) and the maximal urinary flow rate . Secondary outcome measures included changes in prostate size , residual urinary volume after voiding , quality of life , laboratory values , and the rate of reported adverse effects . RESULTS There was no significant difference between the saw palmetto and placebo groups in the change in AUASI scores ( mean difference , 0.04 point ; 95 percent confidence interval , -0.93 to 1.01 ) , maximal urinary flow rate ( mean difference , 0.43 ml per minute ; 95 percent confidence interval , -0.52 to 1.38 ) , prostate size , residual volume after voiding , quality of life , or serum prostate-specific antigen levels during the one-year study . The incidence of side effects was similar in the two groups . CONCLUSIONS In this study , saw palmetto did not improve symptoms or objective measures of benign prostatic hyperplasia . ( Clinical Trials.gov number , NCT00037154 . ) Because benign prostatic hyperplasia ( BPH ) is relatively common , it is important to discover safe and effective means to treat this often debilitating perturbation . Accordingly , we examined the effectiveness of a combination of natural products ( cernitin , saw palmetto , B-sitosterol , vitamin E ) in treating symptoms of BPH . We undertook a r and omized , placebo-controlled , double-blind study . Patients were enrolled from 3 urological practice s in the USA . 144 subjects were r and omized for study . 17 subjects eventually withdrew , leaving 70 patients in the test group and 57 in the placebo group to complete the study . Inclusion criteria consisted of a diagnosis of BPH , no evidence of cancer , and a maximal urinary flow rate between 5 and 15 ml/second . Patients received either placebo or the combined natural products for 3 months . Evaluations were performed via the American Urological Association ( AUA ) Symptom Index score , urinary flow rate , PSA measurement , and residual bladder volume . Nocturia showed a markedly significant decrease in severity in patients receiving the combined natural products compared to those taking placebo ( p < 0.001 ) . Daytime frequency was also lessened significantly ( p < 0.04 ) . When the average individual total AUA Symptom Index score in the test group was compared to that in the placebo group at the end of the study , the difference proved highly significant ( p < 0.014 ) . PSA measurements , maximal and average urinary flow rates , and residual volumes showed no statistically significant differences . When taken for 3 months , a combination of natural products ( cernitin , saw palmetto , B-sitosterol , vitamin E ) compared to placebo can significantly lessen nocturia and frequency and diminish overall symptomatology of BPH as indicated by an improvement in the total AUA Symptom Index score . The combination of natural products caused no significant adverse side effects The 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 ) was investigated in elderly , male patients suffering from lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia in a prospect i ve multicenter trial . A total of 257 patients ( 129 and 128 , respectively ) were r and omized to treatment with PRO 160/120 or placebo  ( 127 and 126 were evaluable for efficacy ) . Following a single-blind placebo run-in phase of 2 weeks , the patients received 2 × 1 capsule/day of the study medication under double-blind conditions over a period of 24 weeks . Double-blind treatment was followed by an open control period of 24 weeks during which all patients were administered PRO 160/120 . Outcome measures for treatment efficacy included the assessment of the patients ’ LUTS by means of the I-PSS self-rating question naire and a quality of life index as well as uroflow and sonographic parameters . Using the International Prostate Symptom Score ( I-PSS ) , patients treated with PRO 160/120 exhibited a substantially higher total score reduction after 24 weeks of double-blind treatment than patients of the placebo group ( 6 points vs 4 points ; P=0.003 , one tailed ) with a tendency in the same direction after 16 weeks . This applied to obstructive as well as to irritative symptoms , and to patients with moderate or severe symptoms at baseline . Patients r and omized to placebo showed a marked improvement in LUTS ( as measured by the I-PSS ) after being switched to PRO 160/120 during the control period ( P=0.01 , one tailed , in comparison to those who had been treated with PRO 160/120 in the double-blind phase ) . The tolerability of PRO 160/120 was comparable to the placebo . In conclusion , PRO 160/120 was clearly superior to the placebo for the amelioration of LUTS as measured by the I-PSS . PRO 160/120 is advantageous in obstructive and irritative urinary symptoms and in patients with moderate and severe symptoms . The tolerability of the herbal extract was excellent To compare the effect of a Serenoa repens extract with placebo for symptoms of benign prostatic hyperplasia ( BPH ) PURPOSE Permixon is a lipidosterolic extract of Serenoa repens ( SR ) widely used to treat men with benign prostatic hyperplasia ( BPH ) . We tested the effect of this drug on molecular mechanisms associated with apoptosis , such as the Bax-to-Bcl-2 expression ratio and caspase-3 activity , in prostatic tissue from men with symptomatic BPH treated for 3 months before surgery . MATERIAL S AND METHODS An open , multicenter pilot study of 2 parallel groups of patients with BPH was done . They were r and omized to be followed for 3 weeks without any treatment before surgery ( control group ) or to receive 160 mg SR orally twice daily for a 3-month period preceding the same surgery . Surgery was ultimately performed in 17 controls and 12 patients by transurethral prostate resection or retropubic adenomectomy .  Bax and Bcl-2 expression , and caspase-3 activity were determined by Western blot in 15 controls and 10 patients , and reported in blinded fashion . RESULTS The Bax-to-Bcl-2 ratio , which is used as an apoptotic index , was significantly increased in the prostatic tissue of treated patients . The level of the intact 116 kDa poly ( adenosine diphosphate-ribose ) polymerase form , an enzyme involved in the cell death apoptotic pathway , was also found to be decreased in prostatic tissue from SR treated patients , suggesting increased caspase 3 activity in the prostate . CONCLUSIONS Permixon increased molecular markers involved in the apoptotic process , ie the Bax-to- 
    Output:
    