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Zhongbao Zhou - One of the best experts on this subject based on the ideXlab platform.
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comparison of Serenoa repens with tamsulosin in the treatment of benign prostatic hyperplasia a systematic review and meta analysis
American Journal of Men's Health, 2020Co-Authors: Shaoxia Yu, Qian Li, Zhongbao ZhouAbstract:Studies reported that Serenoa repens was effective in relieving lower urinary tract symptoms (LUTS). This article carried out a systematic review and meta-analysis to compare Serenoa repens with ta...
Giuseppe Morgia - One of the best experts on this subject based on the ideXlab platform.
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Serenoa repens lycopene and selenium a triple therapeutic approach to manage benign prostatic hyperplasia
Current Medicinal Chemistry, 2013Co-Authors: Letteria Minutoli, Alessandra Bitto, Natasha Irrera, Herbert Marini, Francesco Squadrito, Giuseppe Morgia, Annamaria Passantino, Domenica AltavillaAbstract:Benign prostatic hyperplasia (BPH) is a major health concern that is likely to have an increasing impact in line with the gradual aging of the population. BPH is characterized by smooth muscle and epithelial proliferation primarily within the prostatic transition zone that can cause a variety of problems for patients, the most frequent are the lower urinary tract symptoms. BPH is thought to involve in disruption of dihydrotestosterone (DHT)-supported homeostasis between cell proliferation and cell death, and, as a result, proliferative processes predominate and apoptotic processes are inhibited. Phytotherapeutic supplements, mainly based on Saw Palmetto-derived Serenoa repens (SeR), are numerous and used frequently. Serenoa repens reduces inflammation and decreases in vivo the androgenic support to prostatic cell growth. Furthermore, SeR stimulates the apoptotic machinery; however, data supporting efficacy is limited, making treatment recommendations difficult. Besides SeR, selenium (Se), an essential trace element mainly functioning through selenoproteins and able to promote an optimal antioxidant/oxidant balance, and lycopene (Ly), a dietary carotenoid synthesized by plants, fruits, and microorganisms with a strong antioxidant activity, has been shown to exert beneficial effects in prostate disease. SeR is frequently associated with Ly and Se, in order to increase its therapeutic activity in benign prostatic hyperplasia (BPH). It has been shown that the Ly-Se-SeR association has a greater and enhanced antiinflammatory activity that might be of particular interest in the treatment of BPH. The Ly-Se-SeR association is also more effective than SeR alone in reducing prostate weight and hyperplasia, in augmenting the pro-apoptotic Bax and caspase-9 and blunting the anti-apoptotic Bcl-2 mRNA. In addition, Ly-Se-SeR more efficiently suppresses the EGF and Vascular Endothelial Growth Factor (VEGF) expressions in hyperplastic prostates. Therefore, SeR particularly when combined with Se and Ly may have a greater potential for the management of benign prostate hyperplasia.
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the combination of Serenoa repens selenium and lycopene is more effective than Serenoa repens alone to prevent hormone dependent prostatic growth
The Journal of Urology, 2011Co-Authors: Domenica Altavilla, Alessandra Bitto, Francesca Polito, Natasha Irrera, Herbert Marini, Salvatore Arena, Vincenzo Favilla, Francesco Squadrito, Giuseppe Morgia, Letteria MinutoliAbstract:Purpose: Serenoa repens is frequently combined with other natural compounds, such as the carotenoid lycopene and the essential trace element Se, to increase its therapeutic activity in benign prostatic hyperplasia. We noted that the lycopene-Se-Serenoa repens combination has greater, enhanced anti-inflammatory activity, which might be of particular interest for benign prostatic hyperplasia treatment. Testosterone administration in rats is a suitable tool for investigating hormone dependent benign prostatic hyperplasia. We performed a comparison experiment between Serenoa repens and the lycopene-Se-Serenoa repens combination on prostate growth induced in rats by testosterone administration.Materials and Methods: Rats were treated daily with testosterone propionate (3 mg/kg subcutaneously) or its vehicle for 14 days. Testosterone administered animals were randomized to receive vehicle, Serenoa repens (25 mg/kg subcutaneously) or the combination of lycopene (3 mg/kg subcutaneously), Se (3 mg/kg subcutaneousl...
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The association of Serenoa repens, lycopene and selenium is superior to Serenoa repens alone in reducing benign prostatic hyperplasia
Rivista Urologia, 2011Co-Authors: Francesco Squadrito, Giuseppe MorgiaAbstract:: Serenoa repens (SeR) is frequently associated with other natural compounds, such as lycopene (Ly), a carotenoid, and selenium (Se), an essential trace element, to increase its therapeutic activity in benign prostatic hyperplasia (BPH). The LY-Se-SeR association has a greater and stronger anti-inflammatory activity than SeR alone. In addition, the LY-Se-SeR combination is more effective than SeR alone in reducing prostate weight and hyperplasia, augmenting apoptosis, and reducing cell proliferation and growth factor expression. This experimental evidence suggests that Ly-Se-SeR association is superior to SeR alone in reducing benign prostate growth.
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treatment of chronic prostatitis chronic pelvic pain syndrome category iiia with Serenoa repens plus selenium and lycopene profluss versus s repens alone an italian randomized multicenter controlled study
Urologia Internationalis, 2010Co-Authors: Giuseppe Morgia, Giuseppe Mucciardi, Alessandro Gali, Massimo Madonia, F Marchese, A Di Benedetto, G Romano, Giulio Bonvissuto, Tommaso Castelli, Luciano MacchioneAbstract:Objectives: To evaluate the efficacy and safety of Serenoa repens + selenium and lycopene (Profluss®) versus S. repens alone for the treatment
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Treatment of chronic prostatitis/chronic pelvic pain syndrome category IIIA with Serenoa repens plus selenium and lycopene (Profluss) versus S. repens alone: an Italian randomized multicenter-controlled study.
Urologia Internationalis, 2010Co-Authors: Giuseppe Morgia, Giuseppe Mucciardi, Alessandro Gali, Massimo Madonia, F Marchese, A Di Benedetto, G Romano, Giulio Bonvissuto, Tommaso Castelli, Luciano MacchioneAbstract:Objectives: To evaluate the efficacy and safety of Serenoa repens + selenium and lycopene (Profluss®) versus S. repens alone for the treatment
Domenica Altavilla - One of the best experts on this subject based on the ideXlab platform.
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Serenoa repens lycopene and selenium a triple therapeutic approach to manage benign prostatic hyperplasia
Current Medicinal Chemistry, 2013Co-Authors: Letteria Minutoli, Alessandra Bitto, Natasha Irrera, Herbert Marini, Francesco Squadrito, Giuseppe Morgia, Annamaria Passantino, Domenica AltavillaAbstract:Benign prostatic hyperplasia (BPH) is a major health concern that is likely to have an increasing impact in line with the gradual aging of the population. BPH is characterized by smooth muscle and epithelial proliferation primarily within the prostatic transition zone that can cause a variety of problems for patients, the most frequent are the lower urinary tract symptoms. BPH is thought to involve in disruption of dihydrotestosterone (DHT)-supported homeostasis between cell proliferation and cell death, and, as a result, proliferative processes predominate and apoptotic processes are inhibited. Phytotherapeutic supplements, mainly based on Saw Palmetto-derived Serenoa repens (SeR), are numerous and used frequently. Serenoa repens reduces inflammation and decreases in vivo the androgenic support to prostatic cell growth. Furthermore, SeR stimulates the apoptotic machinery; however, data supporting efficacy is limited, making treatment recommendations difficult. Besides SeR, selenium (Se), an essential trace element mainly functioning through selenoproteins and able to promote an optimal antioxidant/oxidant balance, and lycopene (Ly), a dietary carotenoid synthesized by plants, fruits, and microorganisms with a strong antioxidant activity, has been shown to exert beneficial effects in prostate disease. SeR is frequently associated with Ly and Se, in order to increase its therapeutic activity in benign prostatic hyperplasia (BPH). It has been shown that the Ly-Se-SeR association has a greater and enhanced antiinflammatory activity that might be of particular interest in the treatment of BPH. The Ly-Se-SeR association is also more effective than SeR alone in reducing prostate weight and hyperplasia, in augmenting the pro-apoptotic Bax and caspase-9 and blunting the anti-apoptotic Bcl-2 mRNA. In addition, Ly-Se-SeR more efficiently suppresses the EGF and Vascular Endothelial Growth Factor (VEGF) expressions in hyperplastic prostates. Therefore, SeR particularly when combined with Se and Ly may have a greater potential for the management of benign prostate hyperplasia.
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the combination of Serenoa repens selenium and lycopene is more effective than Serenoa repens alone to prevent hormone dependent prostatic growth
The Journal of Urology, 2011Co-Authors: Domenica Altavilla, Alessandra Bitto, Francesca Polito, Natasha Irrera, Herbert Marini, Salvatore Arena, Vincenzo Favilla, Francesco Squadrito, Giuseppe Morgia, Letteria MinutoliAbstract:Purpose: Serenoa repens is frequently combined with other natural compounds, such as the carotenoid lycopene and the essential trace element Se, to increase its therapeutic activity in benign prostatic hyperplasia. We noted that the lycopene-Se-Serenoa repens combination has greater, enhanced anti-inflammatory activity, which might be of particular interest for benign prostatic hyperplasia treatment. Testosterone administration in rats is a suitable tool for investigating hormone dependent benign prostatic hyperplasia. We performed a comparison experiment between Serenoa repens and the lycopene-Se-Serenoa repens combination on prostate growth induced in rats by testosterone administration.Materials and Methods: Rats were treated daily with testosterone propionate (3 mg/kg subcutaneously) or its vehicle for 14 days. Testosterone administered animals were randomized to receive vehicle, Serenoa repens (25 mg/kg subcutaneously) or the combination of lycopene (3 mg/kg subcutaneously), Se (3 mg/kg subcutaneousl...
Letteria Minutoli - One of the best experts on this subject based on the ideXlab platform.
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Serenoa repens lycopene and selenium a triple therapeutic approach to manage benign prostatic hyperplasia
Current Medicinal Chemistry, 2013Co-Authors: Letteria Minutoli, Alessandra Bitto, Natasha Irrera, Herbert Marini, Francesco Squadrito, Giuseppe Morgia, Annamaria Passantino, Domenica AltavillaAbstract:Benign prostatic hyperplasia (BPH) is a major health concern that is likely to have an increasing impact in line with the gradual aging of the population. BPH is characterized by smooth muscle and epithelial proliferation primarily within the prostatic transition zone that can cause a variety of problems for patients, the most frequent are the lower urinary tract symptoms. BPH is thought to involve in disruption of dihydrotestosterone (DHT)-supported homeostasis between cell proliferation and cell death, and, as a result, proliferative processes predominate and apoptotic processes are inhibited. Phytotherapeutic supplements, mainly based on Saw Palmetto-derived Serenoa repens (SeR), are numerous and used frequently. Serenoa repens reduces inflammation and decreases in vivo the androgenic support to prostatic cell growth. Furthermore, SeR stimulates the apoptotic machinery; however, data supporting efficacy is limited, making treatment recommendations difficult. Besides SeR, selenium (Se), an essential trace element mainly functioning through selenoproteins and able to promote an optimal antioxidant/oxidant balance, and lycopene (Ly), a dietary carotenoid synthesized by plants, fruits, and microorganisms with a strong antioxidant activity, has been shown to exert beneficial effects in prostate disease. SeR is frequently associated with Ly and Se, in order to increase its therapeutic activity in benign prostatic hyperplasia (BPH). It has been shown that the Ly-Se-SeR association has a greater and enhanced antiinflammatory activity that might be of particular interest in the treatment of BPH. The Ly-Se-SeR association is also more effective than SeR alone in reducing prostate weight and hyperplasia, in augmenting the pro-apoptotic Bax and caspase-9 and blunting the anti-apoptotic Bcl-2 mRNA. In addition, Ly-Se-SeR more efficiently suppresses the EGF and Vascular Endothelial Growth Factor (VEGF) expressions in hyperplastic prostates. Therefore, SeR particularly when combined with Se and Ly may have a greater potential for the management of benign prostate hyperplasia.
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the combination of Serenoa repens selenium and lycopene is more effective than Serenoa repens alone to prevent hormone dependent prostatic growth
The Journal of Urology, 2011Co-Authors: Domenica Altavilla, Alessandra Bitto, Francesca Polito, Natasha Irrera, Herbert Marini, Salvatore Arena, Vincenzo Favilla, Francesco Squadrito, Giuseppe Morgia, Letteria MinutoliAbstract:Purpose: Serenoa repens is frequently combined with other natural compounds, such as the carotenoid lycopene and the essential trace element Se, to increase its therapeutic activity in benign prostatic hyperplasia. We noted that the lycopene-Se-Serenoa repens combination has greater, enhanced anti-inflammatory activity, which might be of particular interest for benign prostatic hyperplasia treatment. Testosterone administration in rats is a suitable tool for investigating hormone dependent benign prostatic hyperplasia. We performed a comparison experiment between Serenoa repens and the lycopene-Se-Serenoa repens combination on prostate growth induced in rats by testosterone administration.Materials and Methods: Rats were treated daily with testosterone propionate (3 mg/kg subcutaneously) or its vehicle for 14 days. Testosterone administered animals were randomized to receive vehicle, Serenoa repens (25 mg/kg subcutaneously) or the combination of lycopene (3 mg/kg subcutaneously), Se (3 mg/kg subcutaneousl...
T Wilt - One of the best experts on this subject based on the ideXlab platform.
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Serenoa repens for benign prostatic hyperplasia.
The Cochrane database of systematic reviews, 2020Co-Authors: T Wilt, A Ishani, G Stark, R Macdonald, C MulrowAbstract:This systematic review aimed to assess the effects of Serenoa repens in the treatment of Benign Prostatic Hyperplasia (BPH). Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library, Phytodok), by checking bibliographies, and by contacting manufacturers and researchers. Trials were eligible if they (1) randomized men with BPH to receive preparations of Serenoa repens (alone or in combination) in comparison with placebo or other BPH medications, and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements. Eligibility was assessed by at least two independent observers. Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of Serenoa repens with placebo or other BPH medications was the change in urologic symptom scale scores. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for side effects was the number of men reporting side effects. 2939 men from18 randomized trials lasting 4 to 48 weeks were assessed. 16 trials were double-blinded and treatment allocation concealment was adequate in 9 studies. Compared with placebo, Serenoa repens improved urinary symptom scores, symptoms, and urinary flow measures. The weighted mean difference (WMD) for the urinary symptom score was -1.41 points (scale range 0-19), (95%CI = -2.52, -0.30, n = 1 study) and the risk ratio (RR) for self rated improvement was 1.75 (95%CI = 1.21, 2.54, n = 6 studies). The WMD for nocturia was -0.76 times per evening (95%CI = -1.22, -0.32; n = 10 studies). The WMD for peak urine flow was 1.93 ml/sec (95%CI = 0.72, 3.14, n = 8 studies). Compared with finasteride, Serenoa repens produced similar improvements in urinary symptom scores (WMD = 0.37 IPSS points (scale range 0-35), 95%CI = -0.45, 1.19, n = 2 studies) and peak urine flow (WMD = -0.74 ml/sec, 95%CI = -1.66, 0.18, n = 2 studies). Adverse effects due to Serenoa repens were mild and infrequent. Withdrawal rates in men assigned to placebo, Serenoa repens or finasteride were 7%, 9%, and 11%, respectively. The evidence suggests that Serenoa repens improves urologic symptoms and flow measures compared with placebo. Serenoa repens produced similar improvement in urinary symptoms and flow compared to finasteride and is associated with fewer adverse treatment events. The long term effectiveness, safety and ability to prevent BPH complications are not known.
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Serenoa repens for benign prostatic hyperplasia.
The Cochrane database of systematic reviews, 2020Co-Authors: T Wilt, A Ishani, R Mac DonaldAbstract:Benign prostatic hyperplasia (BPH), nonmalignant enlargement of the prostate, can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH has been growing steadily. The extract of the American saw palmetto or dwarf palm plant, Serenoa repens (also known by its botanical name of Sabal serrulatum), is one of the several phytotherapeutic agents available for the treatment of BPH. This systematic review aimed to assess the effects of Serenoa repens in the treatment of LUTS consistent with BPH. Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library, Phytodok), by checking bibliographies, and by contacting manufacturers and researchers. Trials were eligible if they (1) randomized men with BPH to receive preparations of Serenoa repens (alone or in combination) in comparison with placebo or other BPH medications, and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements. Eligibility was assessed by at least two independent observers. Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of Serenoa repens with placebo or other BPH medications was the change in urologic symptom scale scores. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for side effects was the number of men reporting side effects. In this update, 3 new trials involving 230 additional men (7.8%) have been included. 3139 men from 21 randomized trials lasting 4 to 48 weeks were assessed. 18 trials were double-blinded and treatment allocation concealment was adequate in 11 studies. Compared with placebo, Serenoa repens improved urinary symptom scores, symptoms, and flow measures. The weighted mean difference (WMD) for the urinary symptom score was -1.41 points (scale range 0-19), (95%CI = -2.52, -0.30, n = 1 study) and the risk ratio (RR) for self rated improvement was 1.76 (95%CI = 1.21, 2.54, n = 6 studies). The WMD for nocturia was -0.76 times per evening (95%CI = -1.22, -0.32; n = 10 studies). The WMD for peak urine flow was 1.86 ml/sec (95%CI = 0.60, 3.12, n = 9 studies). Compared with finasteride, Serenoa repens produced similar improvements in urinary symptom scores (WMD = 0.37 IPSS points (scale range 0-35), 95%CI = -0.45, 1.19, n = 2 studies) and peak urine flow (WMD = -0.74 ml/sec, 95%CI = -1.66, 0.18, n = 2 studies). Adverse effects due to Serenoa repens were mild and infrequent. Withdrawal rates in men assigned to placebo, Serenoa repens or finasteride were 7%, 9%, and 11%, respectively. The evidence suggests that Serenoa repens provides mild to moderate improvement in urinary symptoms and flow measures. Serenoa repens produced similar improvement in urinary symptoms and flow compared to finasteride and is associated with fewer adverse treatment events. The long term effectiveness, safety and ability to prevent BPH complications are not known. The results of this update are in agreement with our initial review.
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Serenoa repens for benign prostatic hyperplasia.
The Cochrane database of systematic reviews, 2012Co-Authors: James Tacklind, R Macdonald, Indulis Rutks, Judith U Stanke, T WiltAbstract:Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate, which can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto, or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH. This systematic review aimed to assess the effects and harms of Serenoa repens in the treatment of men with LUTS consistent with BPH. We searched for trials in general and in specialized databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE®, EMBASE, CINAHL®, Web of Science, SCOPUS, BIOSIS Previews®, LILACS, ClinicalTrials.gov, Controlled-Trials.com, World Health Organization (WHO), and Google Scholar. We also handsearched systematic reviews, references, and clinical practice guidelines. There were no language restrictions. Trials were eligible if they randomized men with symptomatic BPH to receive preparations of SR (alone or in combination) for at least four weeks in comparison with placebo or other interventions, and included clinical outcomes, such as urologic symptom scales, symptoms, and urodynamic measurements. Eligibility was assessed by at least two independent observers (JT, RM). One review author (JT) extracted Information on patients, interventions, and outcomes which was then checked by another review author (RM). The main outcome measure for comparing the effectiveness of SR with active or inert controls was change in urologic symptom-scale scores, with validated scores taking precedence over non validated ones. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for harms was the number of men reporting side effects. In a meta-analysis of two high quality long-term trials (n = 582), Serenoa repens therapy was not superior to placebo in reducing LUTS based on the AUA (mean difference (MD) 0.25 points, 95% confidence interval (CI) -0.58 to 1.07). A 72 week trial with high quality evidence, using the American Urological Association Symptom Score Index, reported that SR was not superior to placebo at double and triple doses. In the same trial the proportions of clinical responders (≥ three-point improvement) were nearly identical (42.6% and 44.2% for SR and placebo, respectively), and not significant (RR 0.96, 95% CI 0.76 to 1.22).This update, which did not change our previous conclusions, included two new trials with 444 additional men, an 8.5% (5666/5222) increase from our 2009 updated review, and a 28.8% (1988/1544) increase for our main comparison, SR monotherapy versus placebo control (17 trials). Overall, 5666 men were assessed from 32 randomized, controlled trials, with trial lengths from four to 72 weeks. Twenty-seven trials were double blinded and treatment allocation concealment was adequate in 14.In a trial of high quality evidence (N = 369), versus placebo, SR did not significantly decrease nightly urination on the AUA Nocturia scale (range zero to five) at 72 weeks follow-up (one-sided P = 0.19).The three high quality, moderate-to-long term trials found peak urine flow was not improved with Serenoa repens compared with placebo (MD 0.40 mL/s, 95% CI -0.30 to 1.09).Comparing prostate size (mean change from baseline), one high quality 12-month trial (N = 225) reported no significant difference between SR and placebo (MD -1.22 cc, 95% CI -3.91 to 1.47). Serenoa repens, at double and triple doses, did not improve urinary flow measures or prostate size in men with lower urinary tract symptoms consistent with BPH.
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Serenoa repens for benign prostatic hyperplasia
Cochrane Database of Systematic Reviews, 2012Co-Authors: James Tacklind, R Macdonald, Indulis Rutks, Judith U Stanke, T WiltAbstract:Background Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate, which can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto, or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH. Objectives This systematic review aimed to assess the effects and harms of Serenoa repens in the treatment of men with LUTS consistent with BPH. Search methods We searched for trials in general and in specialized databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE®, EMBASE, CINAHL®, Web of Science, SCOPUS, BIOSIS Previews®, LILACS, ClinicalTrials.gov, Controlled-Trials.com, World Health Organization (WHO), and Google Scholar. We also handsearched systematic reviews, references, and clinical practice guidelines. There were no language restrictions. Selection criteria Trials were eligible if they randomized men with symptomatic BPH to receive preparations of SR (alone or in combination) for at least four weeks in comparison with placebo or other interventions, and included clinical outcomes, such as urologic symptom scales, symptoms, and urodynamic measurements. Eligibility was assessed by at least two independent observers (JT, RM). Data collection and analysis One review author (JT) extracted Information on patients, interventions, and outcomes which was then checked by another review author (RM). The main outcome measure for comparing the effectiveness of SR with active or inert controls was change in urologic symptom-scale scores, with validated scores taking precedence over non validated ones. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for harms was the number of men reporting side effects. Main results In a meta-analysis of two high quality long-term trials (n = 582), Serenoa repens therapy was not superior to placebo in reducing LUTS based on the AUA (mean difference (MD) 0.25 points, 95% confidence interval (CI) -0.58 to 1.07). A 72 week trial with high quality evidence, using the American Urological Association Symptom Score Index, reported that SR was not superior to placebo at double and triple doses. In the same trial the proportions of clinical responders (≥ three-point improvement) were nearly identical (42.6% and 44.2% for SR and placebo, respectively), and not significant (RR 0.96, 95% CI 0.76 to 1.22). This update, which did not change our previous conclusions, included two new trials with 444 additional men, an 8.5% (5666/5222) increase from our 2009 updated review, and a 28.8% (1988/1544) increase for our main comparison, SR monotherapy versus placebo control (17 trials). Overall, 5666 men were assessed from 32 randomized, controlled trials, with trial lengths from four to 72 weeks. Twenty-seven trials were double blinded and treatment allocation concealment was adequate in 14. In a trial of high quality evidence (N = 369), versus placebo, SR did not significantly decrease nightly urination on the AUA Nocturia scale (range zero to five) at 72 weeks follow-up (one-sided P = 0.19). The three high quality, moderate-to-long term trials found peak urine flow was not improved with Serenoa repens compared with placebo (MD 0.40 mL/s, 95% CI -0.30 to 1.09). Comparing prostate size (mean change from baseline), one high quality 12-month trial (N = 225) reported no significant difference between SR and placebo (MD -1.22 cc, 95% CI -3.91 to 1.47). Authors' conclusions Serenoa repens, at double and triple doses, did not improve urinary flow measures or prostate size in men with lower urinary tract symptoms consistent with BPH.
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Serenoa repens monotherapy for benign prostatic hyperplasia bph an updated cochrane systematic review
BJUI, 2012Co-Authors: R Macdonald, James Tacklind, Indulis Rutks, T WiltAbstract:Objective To estimate the effectiveness and harms of Serenoa repens monotherapy in the treatment of lower urinary tract symptoms (LUTS) consistent with benign prostatic hyperplasia (BPH). Materials and methods We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and other sources through to January 2012 to identify randomised trials. Trials were eligible if they randomised men with symptomatic BPH to receive Serenoa repens extract monotherapy for at least 4 weeks in comparison with placebo, and assessed clinical outcomes and urodynamic measurements. Our primary outcome was improvement in LUTS, based on change in urological symptom-scale scores. Results In all, 17 randomised controlled trials (N = 2008) assessing Serenoa repens monotherapy (typically 320 mg/day) vs placebo met inclusion criteria, although only five reported American Urological Association Symptom Index (AUASI) or International Prostate Symptom Scores (IPSS). Trial lengths ranged from 4 to 72 weeks. The mean age of all enrolees was 64.3 years and most participants were of White race. The mean baseline total score was 14 points, indicating moderately severe symptoms. In all, 16 trials were double blinded and adequate treatment allocation concealment was reported in six trials. In a meta-analysis of three high quality long-to-moderate term trials (n = 661), Serenoa repens therapy was no better than placebo in reducing LUTS based on the AUASI/IPSS (weighted mean difference [WMD] −0.16 points, 95% confidence interval [CI] −1.45 to 1.14) or maximum urinary flow rate (Qmax; WMD 0.40 mL/s, 95% CI −0.30 to 1.09). Based on mostly short-term studies, Qmax measured at study endpoint were also not significantly different between treatment groups (WMD 1.15 mL/s, 95% CI −0.23 to 2.53) with evidence of substantial heterogeneity (I2 58%). One long-term dose escalation trial (72 weeks) found double and triple doses of Serenoa repens extract did not improve AUASI compared with placebo and the proportions of clinical responders (≥ 3 point decrease in the AUASI) were nearly identical (43% vs 44% for Serenoa repens and placebo, respectively) with a corresponding risk ratio of 0.96 (95% CI 0.76–1.22). Long-term, Serenoa repens therapy was no better than placebo in improving nocturia in one high-quality study (P = 0.19). Pooled analysis of nine short-term Permixon® trials showed a reduction in the frequency of nocturia (WMD −0.79 times/night, 95% CI−1.28 to −0.29), although there was evidence of heterogeneity (I2 76%) Adverse events of Serenoa repens extracts were few and mild, and incidences were not statistically significantly different vs placebo. Study withdrawals occurred in ≈10% and did not differ between Serenoa repens and placebo. Conclusions Serenoa repens therapy does not improve LUTS or Qmax compared with placebo in men with BPH, even at double and triple the usual dose. Adverse events were generally mild and comparable to placebo. Keywords: Serenoa repens, benign prostatic hyperplasia, phytotherapy, systematic review Introduction Bothersome LUTS associated with BPH are common among ageing men and can interfere with daily activities and reduce quality of life. Phytotherapy is often used as a first-line treatment in Western countries [1,2]. In the USA use of phytotherapeutic agents has also markedly increased. In a 2002 survey, Serenoa repens was used by 2.5 million adults, ‘often for BPH’ [3]. One survey reported that one-third of men choosing non-surgical therapy for BPH were using herbal preparations alone or combined with prescription medications [4]. There are ≈30 phytotherapeutic compounds available for the treatment of symptomatic BPH, and some of the most widely used are extracts from the fruit of the American saw palmetto Serenoa repens. We have updated a previous a systematic review to address the effects and harms of monotherapeutic preparations of Serenoa repens in the treatment of LUTS associated with BPH [5].
