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: In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials 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 This was a multicenter r and omized trial to investigate the clinical efficacy and the impact on sexual function of alpha-1A selective silodosin and alpha-1D selective naftopidil for treatment of benign prostatic hyperplasia . A total of 97 patients with lower urinary tract symptoms/benign prostatic hyperplasia who had an International Prostate Symptom Score of 8 or more were r and omly assigned to receive silodosin ( 8 mg/day , n = 53 ) or naftopidil ( 75 mg/day , n = 44 ) . Before and 4 , 8 and 12 weeks after treatment , International Prostate Symptom Score and its quality of life score were used to assess lower urinary tract symptoms . Also , International Index of Erectile Function-5 , and an original question naire were used to evaluate erectile function and ejaculation for sexually active patients , respectively . The silodosin group showed advantages in terms of voiding symptoms and quality of life of International Prostate Symptom Score when compared with the naftopidil group . Both silodosin and naftopidil showed no significant effect on International Index of Erectile Function-5 . A total of 23 sexually active patients in the silodosin group experienced more ejaculatory impairment than 21 patients in the naftopidil group , with a decrease of ejaculation volume ( 87 % vs 40 % , P = 0.003 ) , prolonged time to ejaculation ( 56 % vs 33 % , P = 0.027 ) and decrease of orgasm ( 50 % vs 39 % , P = 0.027 ) . These results suggest that alpha-1A selective blockers are more effective for voiding symptoms , whereas alpha-1D selective blockers offer a minor degree of ejaculatory dysfunction To compare the efficacy and safety of two α1a/α1d adrenoceptor ( AR ) antagonists with different affinity for the α1AR subtypes , tamsulosin and naftopidil , in the treatment of benign prostatic hyperplasia ( BPH ) We compared the efficacy of naftopidil monotherapy with combination therapy using tamsulosin hydrochloride and solifenacin succinate in the treatment of lower urinary tract symptoms ( LUTS ) with overactive bladder ( OAB ) secondary to benign prostatic hyperplasia ( BPH ) . Thirty one patients were enrolled in a r and omized crossover study . Fourteen patients were initially prescribed naftopidil 75 mg ( N ) for 8 weeks , followed by tamsulosin 0.2 mg and solifenacin 5 mg ( TS ) for 8 weeks ( group N ) ; another 17 were initially prescribed TS , followed by N ( group TS ) . The efficacy variables were the changes in international prostate symptom score ( I-PSS ) , quality of life ( QOL ) score , overative bladder symptom score ( OABSS ) , and post-void residual ( PVR ) urine volume . After the study , a question naire survey was carried out about the choice of treatment . After treatment with each agent , total I-PSS , storage symptom score , QOL score and OABSS except for the daytime frequency were significantly improved from baseline . PVR was significantly increased after TS treatment . There were no significant differences between the two treatments except for PVR . As a result of the question naire survey , 13 patients chose N and 17 chose TS . In conclusion , N monotherapy can be expected to have an equal effect in the treatment of LUTS with OAB secondary to BPH in comparison with TS combination therapy Naftopidil , approved only in Japan , is an α1-adrenergic receptor antagonist ( α1-blocker ) used to treat lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) . Different from tamsulosin hydrochloride and silodosin , in that it has higher and extremely higher affinity respectively , for the α1A-adrenergic receptor subtype than for the α1D type , naftopidil has distinct characteristics because it has a three times greater affinity for the α1D-adrenergic receptor subtype than for the α1A subtype . Although well- design ed large-scale r and omized controlled studies are lacking and the optimal dosage of naftopidil is not always completely determined , previous reports from Japan have shown that naftopidil has superior efficacy to a placebo and comparable efficacy to other α1-blockers such as tamsulosin . On the other h and , the incidences of ejaculatory disorders and intraoperative floppy iris syndrome induced by naftopidil may be lower than for tamsulosin and silodosin having high affinity for the α1A-adrenergic receptor subtype . However , it remains unknown if the efficacy and safety of naftopidil in Japanese is applicable to white , black and Hispanic men having LUTS/BPH in western countries OBJECTIVE To compare the differences of the efficacy and different therapeutic drugs on the treatment of benign prostatic hyperplasia ( BPH ) in order to ensure the optimal indication for different BPH patients . METHODS A r and omized , parallel-controlled , multicenter clinical trial was conducted . From September 2002 to December 2003 906 BPH patients were enrolled into 7 therapeutic groups , including selective-adrenoceptor antagonist ( terazosin , doxazosin tamsulosin and naftopidil ) , 5 alpha-reductase inhibitor ( finasteride and epristeride ) and natural product ( cernilton ) . International Prostate Symptom Score ( IPSS ) and Quality of Life ( QOL ) , uroflowmetry , total prostatic volume ( TPV ) and transitional zone volume and residual urine  were used as efficacy criteria . RESULTS According to the baseline , the IPSS and Qmax were significantly correlated to the prostatic volume and transitional zone volume ( P < 0.01 ) . At average follow-up of 6 months , significant improvements in IPSS , QOL , Qmax and residual urine volume were observed in each therapeutic group , and no difference in IPSS improvement was found among the groups . Prostatic volume and transitional zone volume were significant decreased in 5alpha-reductase inhibitor groups ( P < 0.05 ) . In patients with baseline TPV greater than 35.5 cm3 , the improvement of Qmax was more significant than that in patients with TPV less than 35.5 cm3 in finasteride group ( P < 0.01 ) ( 5.7 ml/s and 2.2 ml/s respectively ) , and more significant symptomatic improvements were also found in cernilton , doxazosin and naftopidil group . In each group , the improvement of symptom were more significant in patients with IPSS higher than 20 points ( P < 0.01 ) . CONCLUSIONS Each drug observed in this study can improve the subjective and objective symptoms significantly for BPH patients , especially for patients with higher IPSS baseline . When using 5alpha-reductase inhibitor , prostatic volume can be decreased significantly and more obviously subjective and objective improvement can be found in the patients with TPV greater than 35.5 cm3 We compared the efficacy of naftopidil with that of tamsulosin hydrochloride for benign prostatic hyperplasia patients . Eighty-five patients without improvement of quality of life ( QOL ) score by the administration of 50 - 75 mg naftopidil for more than four weeks were assigned to receive doses of 0.1 - 0.2 mg tamsulosin hydrochloride and 89 patients without improvement of QOL score by the administration of 0.1 - 0.2 mg tamsulosin hydrochloride for more than four weeks were assigned to receive doses of 50 - 75 mg naftopidil once a day for 8 weeks . International prostate symptom score , maximum flow rate , residual urine volume and side effect profile were determined before the administration of the first medicine , before the administration of the second medicine and after 8 weeks of treatment with the second medicine . In the group without improvement of QOL score by naftopidil , significant improvements in symptoms of urgency , weak stream and straining were observed after 8 weeks of treatment with tamsulosin hydrochloride . In the group without improvement of QOL score by tamsulosin hydrochloride , significant improvements in symptoms of incomplete emptying , intermittency and nocturia were observed after 8 weeks of treatment with naftopidil . In conclusion , improvement of symptoms by each alpha 1-blocker differs symptom by symptom . Tamsulosin hydrochloride was superior to naftopidil for the symptoms of urine flow and naftopidil was superior to tamsulosin hydrochloride for the symptom of nocturia PURPOSE We analyzed data from the placebo arm of the MTOPS trial to determine clinical predictors of BPH progression . MATERIAL S AND METHODS A total of 3,047 patients with LUTS were r and omized to either placebo , doxazosin ( 4 to 8 mg ) , finasteride ( 5 mg ) , or a combination of doxazosin and finasteride . Average length of followup was 4.5 years . The primary outcome was time to overall clinical progression of BPH , defined as either a confirmed 4-point or greater increase in AUA SS , acute urinary retention , incontinence , renal insufficiency , or recurrent urinary tract infection . We analyzed BPH progression event data from the 737 men who were r and omized to placebo . RESULTS The rate of overall clinical progression of BPH events in the placebo group was 4.5 per 100 person-years , for a cumulative incidence ( among men who had at least 4 years of followup data ) of 17 % . The risk of 
    Output:
    
agent
Naftopidil appears to have similar effects in the urological symptom scores and QoL compared to tamsulosin and silodosin .
Naftopidil has similar sexual adverse events compared to tamsulosin but has fewer compared to silodosin
***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: In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials 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 This was a multicenter r and omized trial to investigate the clinical efficacy and the impact on sexual function of alpha-1A selective silodosin and alpha-1D selective naftopidil for treatment of benign prostatic hyperplasia . A total of 97 patients with lower urinary tract symptoms/benign prostatic hyperplasia who had an International Prostate Symptom Score of 8 or more were r and omly assigned to receive silodosin ( 8 mg/day , n = 53 ) or naftopidil ( 75 mg/day , n = 44 ) . Before and 4 , 8 and 12 weeks after treatment , International Prostate Symptom Score and its quality of life score were used to assess lower urinary tract symptoms . Also , International Index of Erectile Function-5 , and an original question naire were used to evaluate erectile function and ejaculation for sexually active patients , respectively . The silodosin group showed advantages in terms of voiding symptoms and quality of life of International Prostate Symptom Score when compared with the naftopidil group . Both silodosin and naftopidil showed no significant effect on International Index of Erectile Function-5 . A total of 23 sexually active patients in the silodosin group experienced more ejaculatory impairment than 21 patients in the naftopidil group , with a decrease of ejaculation volume ( 87 % vs 40 % , P = 0.003 ) , prolonged time to ejaculation ( 56 % vs 33 % , P = 0.027 ) and decrease of orgasm ( 50 % vs 39 % , P = 0.027 ) . These results suggest that alpha-1A selective blockers are more effective for voiding symptoms , whereas alpha-1D selective blockers offer a minor degree of ejaculatory dysfunction To compare the efficacy and safety of two α1a/α1d adrenoceptor ( AR ) antagonists with different affinity for the α1AR subtypes , tamsulosin and naftopidil , in the treatment of benign prostatic hyperplasia ( BPH ) We compared the efficacy of naftopidil monotherapy with combination therapy using tamsulosin hydrochloride and solifenacin succinate in the treatment of lower urinary tract symptoms ( LUTS ) with overactive bladder ( OAB ) secondary to benign prostatic hyperplasia ( BPH ) . Thirty one patients were enrolled in a r and omized crossover study . Fourteen patients were initially prescribed naftopidil 75 mg ( N ) for 8 weeks , followed by tamsulosin 0.2 mg and solifenacin 5 mg ( TS ) for 8 weeks ( group N ) ; another 17 were initially prescribed TS , followed by N ( group TS ) . The efficacy variables were the changes in international prostate symptom score ( I-PSS ) , quality of life ( QOL ) score , overative bladder symptom score ( OABSS ) , and post-void residual ( PVR ) urine volume . After the study , a question naire survey was carried out about the choice of treatment . After treatment with each agent , total I-PSS , storage symptom score , QOL score and OABSS except for the daytime frequency were significantly improved from baseline . PVR was significantly increased after TS treatment . There were no significant differences between the two treatments except for PVR . As a result of the question naire survey , 13 patients chose N and 17 chose TS . In conclusion , N monotherapy can be expected to have an equal effect in the treatment of LUTS with OAB secondary to BPH in comparison with TS combination therapy Naftopidil , approved only in Japan , is an α1-adrenergic receptor antagonist ( α1-blocker ) used to treat lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) . Different from tamsulosin hydrochloride and silodosin , in that it has higher and extremely higher affinity respectively , for the α1A-adrenergic receptor subtype than for the α1D type , naftopidil has distinct characteristics because it has a three times greater affinity for the α1D-adrenergic receptor subtype than for the α1A subtype . Although well- design ed large-scale r and omized controlled studies are lacking and the optimal dosage of naftopidil is not always completely determined , previous reports from Japan have shown that naftopidil has superior efficacy to a placebo and comparable efficacy to other α1-blockers such as tamsulosin . On the other h and , the incidences of ejaculatory disorders and intraoperative floppy iris syndrome induced by naftopidil may be lower than for tamsulosin and silodosin having high affinity for the α1A-adrenergic receptor subtype . However , it remains unknown if the efficacy and safety of naftopidil in Japanese is applicable to white , black and Hispanic men having LUTS/BPH in western countries OBJECTIVE To compare the differences of the efficacy and different therapeutic drugs on the treatment of benign prostatic hyperplasia ( BPH ) in order to ensure the optimal indication for different BPH patients . METHODS A r and omized , parallel-controlled , multicenter clinical trial was conducted . From September 2002 to December 2003 906 BPH patients were enrolled into 7 therapeutic groups , including selective-adrenoceptor antagonist ( terazosin , doxazosin tamsulosin and naftopidil ) , 5 alpha-reductase inhibitor ( finasteride and epristeride ) and natural product ( cernilton ) . International Prostate Symptom Score ( IPSS ) and Quality of Life ( QOL ) , uroflowmetry , total prostatic volume ( TPV ) and transitional zone volume and residual urine  were used as efficacy criteria . RESULTS According to the baseline , the IPSS and Qmax were significantly correlated to the prostatic volume and transitional zone volume ( P < 0.01 ) . At average follow-up of 6 months , significant improvements in IPSS , QOL , Qmax and residual urine volume were observed in each therapeutic group , and no difference in IPSS improvement was found among the groups . Prostatic volume and transitional zone volume were significant decreased in 5alpha-reductase inhibitor groups ( P < 0.05 ) . In patients with baseline TPV greater than 35.5 cm3 , the improvement of Qmax was more significant than that in patients with TPV less than 35.5 cm3 in finasteride group ( P < 0.01 ) ( 5.7 ml/s and 2.2 ml/s respectively ) , and more significant symptomatic improvements were also found in cernilton , doxazosin and naftopidil group . In each group , the improvement of symptom were more significant in patients with IPSS higher than 20 points ( P < 0.01 ) . CONCLUSIONS Each drug observed in this study can improve the subjective and objective symptoms significantly for BPH patients , especially for patients with higher IPSS baseline . When using 5alpha-reductase inhibitor , prostatic volume can be decreased significantly and more obviously subjective and objective improvement can be found in the patients with TPV greater than 35.5 cm3 We compared the efficacy of naftopidil with that of tamsulosin hydrochloride for benign prostatic hyperplasia patients . Eighty-five patients without improvement of quality of life ( QOL ) score by the administration of 50 - 75 mg naftopidil for more than four weeks were assigned to receive doses of 0.1 - 0.2 mg tamsulosin hydrochloride and 89 patients without improvement of QOL score by the administration of 0.1 - 0.2 mg tamsulosin hydrochloride for more than four weeks were assigned to receive doses of 50 - 75 mg naftopidil once a day for 8 weeks . International prostate symptom score , maximum flow rate , residual urine volume and side effect profile were determined before the administration of the first medicine , before the administration of the second medicine and after 8 weeks of treatment with the second medicine . In the group without improvement of QOL score by naftopidil , significant improvements in symptoms of urgency , weak stream and straining were observed after 8 weeks of treatment with tamsulosin hydrochloride . In the group without improvement of QOL score by tamsulosin hydrochloride , significant improvements in symptoms of incomplete emptying , intermittency and nocturia were observed after 8 weeks of treatment with naftopidil . In conclusion , improvement of symptoms by each alpha 1-blocker differs symptom by symptom . Tamsulosin hydrochloride was superior to naftopidil for the symptoms of urine flow and naftopidil was superior to tamsulosin hydrochloride for the symptom of nocturia PURPOSE We analyzed data from the placebo arm of the MTOPS trial to determine clinical predictors of BPH progression . MATERIAL S AND METHODS A total of 3,047 patients with LUTS were r and omized to either placebo , doxazosin ( 4 to 8 mg ) , finasteride ( 5 mg ) , or a combination of doxazosin and finasteride . Average length of followup was 4.5 years . The primary outcome was time to overall clinical progression of BPH , defined as either a confirmed 4-point or greater increase in AUA SS , acute urinary retention , incontinence , renal insufficiency , or recurrent urinary tract infection . We analyzed BPH progression event data from the 737 men who were r and omized to placebo . RESULTS The rate of overall clinical progression of BPH events in the placebo group was 4.5 per 100 person-years , for a cumulative incidence ( among men who had at least 4 years of followup data ) of 17 % . The risk of 
    Output:
    