The Experts below are selected from a list of 48 Experts worldwide ranked by ideXlab platform
Udo Engelmann - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of a combination of sabal and Urtica Extract in lower urinary tract symptoms a randomized double blind study versus tamsulosin
Drug Research, 2011Co-Authors: Udo Engelmann, Petra Funk, Carola Walther, B Bondarenko, Sandra SchlafkeAbstract:The aim of this prospective, randomized, double-blind, double-dummy, multicenter clinical trial was to investigate the efficacy and safety of PRO 160/120 (Prostagutt® forte), a fixed combination preparation of 160 mg Sabal fruit Extract WS® 1473 and 120 mg Urtica root Extract WS® 1031 per capsule, in comparison to the α1-adrenoceptor antagonist tamsulosin (CAS 106463-17-6) in lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). 140 elderly out-patients suffering from LUTS caused by BPH, with an initial score ≥ 13 points in the International Prostate Symptom Score (I-PSS), received 2 × 1 capsule/d PRO 160/120 or 1 × 0.4 mg/d tamsulosin and were treated for 60 weeks with interim visits at weeks 8, 16, 24, 36, and 48. The primary outcome measure for efficacy was the change in I-PSS total score, the percentage of patients with an I-PSS score ≤ 7 points at endpoint ('re-sponders') was analyzed as well. During 60 weeks of randomized treatment the I-PSS total score was reduced by a median of 9 points in both groups. In total, 32.4 % of the patients in the PRO 160/120 group and 27.9 % in the tamsulosin group were responders (test for non-inferiority of PRO 160/120: p = 0.034; non-inferiority margin 10 %). Both drugs were well tolerated, with one adverse event in 1514 treatment days for PRO 160/120 and one event in 1164 days for tamsulosin. The study supports non-inferiority of PRO 160/120 in comparison to tamsulosin in the treatment of LUTS caused by BPH.
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Efficacy and safety of a combination of Sabal and Urtica Extract in lower urinary tract symptoms—long-term follow-up of a placebo-controlled, double-blind, multicenter trial
International Urology and Nephrology, 2007Co-Authors: N Lopatkin, Petra Funk, Sandra Schlafke, A Sivkov, A Medvedev, Udo EngelmannAbstract:In an open-label extension of a randomized, 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 randomly 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 questionnaire] 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
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Efficacy and safety of a combination of Sabal and Urtica Extract in lower urinary tract symptoms--long-term follow-up of a placebo-controlled, double-blind, multicenter trial.
International urology and nephrology, 2007Co-Authors: N Lopatkin, Petra Funk, Sandra Schlafke, A Sivkov, A Medvedev, Udo EngelmannAbstract:In an open-label extension of a randomized, 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 randomly 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 questionnaire] 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 1,181 treatment days; in only one event a causal relationship with intake of PRO 160/120 could not be excluded. Treatment with PRO 160/120 thus provides a clinically relevant benefit over a period of 96 weeks.
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long term efficacy and safety of a combination of sabal and Urtica Extract for lower urinary tract symptoms a placebo controlled double blind multicenter trial
World Journal of Urology, 2005Co-Authors: N Lopatkin, Carola Walther, Sandra Schlafke, A Sivkov, A Medvedev, J Avdeichuk, G Golubev, K Melnik, N Elenberger, Udo EngelmannAbstract: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 prospective multicenter trial. A total of 257 patients (129 and 128, respectively) were randomized 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 x 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 questionnaire 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 randomized 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.
N Lopatkin - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and safety of a combination of Sabal and Urtica Extract in lower urinary tract symptoms—long-term follow-up of a placebo-controlled, double-blind, multicenter trial
International Urology and Nephrology, 2007Co-Authors: N Lopatkin, Petra Funk, Sandra Schlafke, A Sivkov, A Medvedev, Udo EngelmannAbstract:In an open-label extension of a randomized, 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 randomly 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 questionnaire] 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
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Efficacy and safety of a combination of Sabal and Urtica Extract in lower urinary tract symptoms--long-term follow-up of a placebo-controlled, double-blind, multicenter trial.
International urology and nephrology, 2007Co-Authors: N Lopatkin, Petra Funk, Sandra Schlafke, A Sivkov, A Medvedev, Udo EngelmannAbstract:In an open-label extension of a randomized, 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 randomly 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 questionnaire] 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 1,181 treatment days; in only one event a causal relationship with intake of PRO 160/120 could not be excluded. Treatment with PRO 160/120 thus provides a clinically relevant benefit over a period of 96 weeks.
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long term efficacy and safety of a combination of sabal and Urtica Extract for lower urinary tract symptoms a placebo controlled double blind multicenter trial
World Journal of Urology, 2005Co-Authors: N Lopatkin, Carola Walther, Sandra Schlafke, A Sivkov, A Medvedev, J Avdeichuk, G Golubev, K Melnik, N Elenberger, Udo EngelmannAbstract: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 prospective multicenter trial. A total of 257 patients (129 and 128, respectively) were randomized 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 x 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 questionnaire 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 randomized 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.
Sandra Schlafke - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of a combination of sabal and Urtica Extract in lower urinary tract symptoms a randomized double blind study versus tamsulosin
Drug Research, 2011Co-Authors: Udo Engelmann, Petra Funk, Carola Walther, B Bondarenko, Sandra SchlafkeAbstract:The aim of this prospective, randomized, double-blind, double-dummy, multicenter clinical trial was to investigate the efficacy and safety of PRO 160/120 (Prostagutt® forte), a fixed combination preparation of 160 mg Sabal fruit Extract WS® 1473 and 120 mg Urtica root Extract WS® 1031 per capsule, in comparison to the α1-adrenoceptor antagonist tamsulosin (CAS 106463-17-6) in lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). 140 elderly out-patients suffering from LUTS caused by BPH, with an initial score ≥ 13 points in the International Prostate Symptom Score (I-PSS), received 2 × 1 capsule/d PRO 160/120 or 1 × 0.4 mg/d tamsulosin and were treated for 60 weeks with interim visits at weeks 8, 16, 24, 36, and 48. The primary outcome measure for efficacy was the change in I-PSS total score, the percentage of patients with an I-PSS score ≤ 7 points at endpoint ('re-sponders') was analyzed as well. During 60 weeks of randomized treatment the I-PSS total score was reduced by a median of 9 points in both groups. In total, 32.4 % of the patients in the PRO 160/120 group and 27.9 % in the tamsulosin group were responders (test for non-inferiority of PRO 160/120: p = 0.034; non-inferiority margin 10 %). Both drugs were well tolerated, with one adverse event in 1514 treatment days for PRO 160/120 and one event in 1164 days for tamsulosin. The study supports non-inferiority of PRO 160/120 in comparison to tamsulosin in the treatment of LUTS caused by BPH.
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Efficacy and safety of a combination of Sabal and Urtica Extract in lower urinary tract symptoms—long-term follow-up of a placebo-controlled, double-blind, multicenter trial
International Urology and Nephrology, 2007Co-Authors: N Lopatkin, Petra Funk, Sandra Schlafke, A Sivkov, A Medvedev, Udo EngelmannAbstract:In an open-label extension of a randomized, 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 randomly 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 questionnaire] 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
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Efficacy and safety of a combination of Sabal and Urtica Extract in lower urinary tract symptoms--long-term follow-up of a placebo-controlled, double-blind, multicenter trial.
International urology and nephrology, 2007Co-Authors: N Lopatkin, Petra Funk, Sandra Schlafke, A Sivkov, A Medvedev, Udo EngelmannAbstract:In an open-label extension of a randomized, 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 randomly 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 questionnaire] 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 1,181 treatment days; in only one event a causal relationship with intake of PRO 160/120 could not be excluded. Treatment with PRO 160/120 thus provides a clinically relevant benefit over a period of 96 weeks.
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long term efficacy and safety of a combination of sabal and Urtica Extract for lower urinary tract symptoms a placebo controlled double blind multicenter trial
World Journal of Urology, 2005Co-Authors: N Lopatkin, Carola Walther, Sandra Schlafke, A Sivkov, A Medvedev, J Avdeichuk, G Golubev, K Melnik, N Elenberger, Udo EngelmannAbstract: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 prospective multicenter trial. A total of 257 patients (129 and 128, respectively) were randomized 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 x 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 questionnaire 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 randomized 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.
Petra Funk - One of the best experts on this subject based on the ideXlab platform.
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ws pro 160 i 120 mg a combination of sabal and Urtica Extract in patients with luts related to bph
Therapeutic Advances in Urology, 2019Co-Authors: Ruth Kirschnerhermanns, Petra Funk, Nadine LeistnerAbstract:Introduction:Lower urinary tract symptoms (LUTS) caused by prostatic enlargement are a common impairing condition in men aged 50 years and older. In the management of LUTS related to benign prostat...
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efficacy and safety of a combination of sabal and Urtica Extract in lower urinary tract symptoms a randomized double blind study versus tamsulosin
Drug Research, 2011Co-Authors: Udo Engelmann, Petra Funk, Carola Walther, B Bondarenko, Sandra SchlafkeAbstract:The aim of this prospective, randomized, double-blind, double-dummy, multicenter clinical trial was to investigate the efficacy and safety of PRO 160/120 (Prostagutt® forte), a fixed combination preparation of 160 mg Sabal fruit Extract WS® 1473 and 120 mg Urtica root Extract WS® 1031 per capsule, in comparison to the α1-adrenoceptor antagonist tamsulosin (CAS 106463-17-6) in lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). 140 elderly out-patients suffering from LUTS caused by BPH, with an initial score ≥ 13 points in the International Prostate Symptom Score (I-PSS), received 2 × 1 capsule/d PRO 160/120 or 1 × 0.4 mg/d tamsulosin and were treated for 60 weeks with interim visits at weeks 8, 16, 24, 36, and 48. The primary outcome measure for efficacy was the change in I-PSS total score, the percentage of patients with an I-PSS score ≤ 7 points at endpoint ('re-sponders') was analyzed as well. During 60 weeks of randomized treatment the I-PSS total score was reduced by a median of 9 points in both groups. In total, 32.4 % of the patients in the PRO 160/120 group and 27.9 % in the tamsulosin group were responders (test for non-inferiority of PRO 160/120: p = 0.034; non-inferiority margin 10 %). Both drugs were well tolerated, with one adverse event in 1514 treatment days for PRO 160/120 and one event in 1164 days for tamsulosin. The study supports non-inferiority of PRO 160/120 in comparison to tamsulosin in the treatment of LUTS caused by BPH.
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Efficacy and safety of a combination of Sabal and Urtica Extract in lower urinary tract symptoms—long-term follow-up of a placebo-controlled, double-blind, multicenter trial
International Urology and Nephrology, 2007Co-Authors: N Lopatkin, Petra Funk, Sandra Schlafke, A Sivkov, A Medvedev, Udo EngelmannAbstract:In an open-label extension of a randomized, 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 randomly 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 questionnaire] 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
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Efficacy and safety of a combination of Sabal and Urtica Extract in lower urinary tract symptoms--long-term follow-up of a placebo-controlled, double-blind, multicenter trial.
International urology and nephrology, 2007Co-Authors: N Lopatkin, Petra Funk, Sandra Schlafke, A Sivkov, A Medvedev, Udo EngelmannAbstract:In an open-label extension of a randomized, 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 randomly 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 questionnaire] 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 1,181 treatment days; in only one event a causal relationship with intake of PRO 160/120 could not be excluded. Treatment with PRO 160/120 thus provides a clinically relevant benefit over a period of 96 weeks.
A Sivkov - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and safety of a combination of Sabal and Urtica Extract in lower urinary tract symptoms—long-term follow-up of a placebo-controlled, double-blind, multicenter trial
International Urology and Nephrology, 2007Co-Authors: N Lopatkin, Petra Funk, Sandra Schlafke, A Sivkov, A Medvedev, Udo EngelmannAbstract:In an open-label extension of a randomized, 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 randomly 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 questionnaire] 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
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Efficacy and safety of a combination of Sabal and Urtica Extract in lower urinary tract symptoms--long-term follow-up of a placebo-controlled, double-blind, multicenter trial.
International urology and nephrology, 2007Co-Authors: N Lopatkin, Petra Funk, Sandra Schlafke, A Sivkov, A Medvedev, Udo EngelmannAbstract:In an open-label extension of a randomized, 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 randomly 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 questionnaire] 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 1,181 treatment days; in only one event a causal relationship with intake of PRO 160/120 could not be excluded. Treatment with PRO 160/120 thus provides a clinically relevant benefit over a period of 96 weeks.
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long term efficacy and safety of a combination of sabal and Urtica Extract for lower urinary tract symptoms a placebo controlled double blind multicenter trial
World Journal of Urology, 2005Co-Authors: N Lopatkin, Carola Walther, Sandra Schlafke, A Sivkov, A Medvedev, J Avdeichuk, G Golubev, K Melnik, N Elenberger, Udo EngelmannAbstract: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 prospective multicenter trial. A total of 257 patients (129 and 128, respectively) were randomized 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 x 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 questionnaire 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 randomized 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.