title: Combined sabal and urtica extract compared with finasteride in men with benign prostatic hyperplasia: analysis of prostate volume and therapeutic outcome Randomized, double-blind, placebo-controlled trial of saw palmetto in men with lower urinary tract symptoms. Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia. Treatment of benign prostatic hyperplasia with phytosterols. Safety and efficacy of doxazosin in benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies. Saw palmetto for benign prostatic hyperplasia. Randomized trial of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) on symptoms of benign prostatic hyperplasia (BPH) 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 Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial Serenoa repens treatment modifies bax/bcl-2 index expression and caspase-3 activity in prostatic tissue from patients with benign prostatic hyperplasia. A prospective study of the efficacy of Serenoa repens, Tamsulosin, and Serenoa repens plus Tamsulosin treatment for patients with benign prostate hyperplasia Evidence that Serenoa repens extract displays an antiestrogenic activity in prostatic tissue of benign prostatic hypertrophy patients. Effect of saw palmetto soft gel capsule on lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized trial in Shanghai, China. Early urodynamic effects of the lipido-sterolic extract of Serenoa repens (Permixon®) in patients with lower urinary tract symptoms due to benign prostatic hyperplasia Comparison of finasteride (Proscar) and Serenoa repens (Permixon) in the inhibition of 5-alpha reductase in healthy male volunteers. [Efficacy of pretreatment with Serenoa repens on bleeding associated with transurethral resection of prostate]. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. Comparative effects of alfuzosin versus Serenoa repens in the treatment of symptomatic benign prostatic hyperplasia. Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1,098 patients. Evaluation of the clinical benefit of permixon and tamsulosin in severe BPH patients-PERMAL study subset analysis. BPH and inflammation: pharmacological effects of Permixon on histological and molecular inflammatory markers. Results of a double blind pilot clinical assay. Saw palmetto (Serenoa repens) in men with lower urinary tract symptoms: effects on urodynamic parameters and voiding symptoms. Enzyme activities in tissue of human benign prostatic hyperplasia after three months' treatment with the Sabal serrulata extract IDS 89 (Strogen) or placebo. Efficacy and tolerability of the lipidosterolic extract of Serenoa repens (Permixon) in benign prostatic hyperplasia: a double-blind comparison of two dosage regimens. The lipidosterolic extract ofSerenoa repens in the treatment of benign prostatic hyperplasia: A comparison of two dosage regimens The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. Saw palmetto alters nuclear measurements reflecting DNA content in men with symptomatic BPH: evidence for a possible molecular mechanism. The value of permixon in benign prostatic hypertrophy. Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial.
abstract: 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-Bcl-2 expression ratio and caspase-3 activity . This could have clinical relevance due to the improvement in symptoms produced by treatment with this drug Introduction Increasing attention has been focused on the use of phytotherapeutic agents to alleviate the symptoms of benign prostatic hyperplasia ( BPH ) in recent times . The best described and studied phytotherapeutic agent is Serenoa repens ( SR ) . Material s and methods This prospect i ve study was design ed to have 3 arms including SR 320 mg per day ( N = 20 ) , Tamsulosin ( TAM ) 0.4 mg per day ( N = 20 ) and SR + TAM ( N = 20 ) to reveal the superiority or equivalence between these treatment regimens in BPH . Results The groups were not statistically different with regard to increase in maximal urinary flow rate ( Qmax ) and decrease in International Prostate Symptom Score ( I-PSS ) ( P > 0.05 ) . No adverse effect was detected in SR therapy group . Conclusion Treatment of BPH by both SR and TAM seems to be effective alone . None of them had superiority to another and additionally , combined therapy ( SR + TAM ) does not provide extra benefits . Furthermore SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS due to BPH A double-blind placebo-controlled study was performed in 35 benign prostatic hypertrophy ( BPH ) patients never treated before . The patients were r and omized into two groups , the 1st ( 18 cases ) receiving Serenoa repens extract ( 160 mg t.d . ) for 3 months up to the day before the operation of transvesical adenomectomy and the 2nd ( 17 cases ) receiving placebo .  Steroid receptors were evaluated in the nuclear ( n ) and cytosolic ( c ) fraction using the saturation analysis technique ( Scatchard analysis or single saturating-dose assay ) for and rogen ( AR ) and estrogen ( ER ) receptors and the enzyme immunoassay ( EIA ) for ER and progesterone receptors ( PgR ) . Scatchard analysis of ERc and ERn revealed the presence of two classes of binding sites , one with high-affinity low-capacity binding and the other with low-affinity high-capacity binding . In the untreated BPH group , ER were higher in the n than in the c fraction : ERn were positive in 14 cases and ERc in 12 of 17 cases . In the BPH group treated with S. repens extract on the contrary , ERn were negative for both binding classes in 17 cases and ERc in 6 of 18 cases . Using EIA , ERn and ERc were detected in all 15 sample s examined , but in the treated group , ERn were significantly ( p less than 0.01 ) lower than in the untreated group , whilst ERc remained almost unchanged . Similar results were obtained measuring PgR : the n fraction of the treated group prostatic sample s was significantly ( p less than 0.01 ) lower than that of the untreated group . ( ABSTRACT TRUNCATED AT 250 WORDS PURPOSE We determined the effect of Prostataplex in men with lower urinary tract symptoms associated with benign prostatic hyperplasia . MATERIAL S AND METHODS A total of 92 Chinese men between 49 and 75 years old with lower urinary tract symptoms were r and omly assigned in this double-blind , placebo controlled trial . The 46 patients in the intervention group were given 2 Prostataplex soft gels daily for 12 weeks , while the 46 in the control group were given 2 placebo soft gels for the same time . RESULTS The treated and control groups appeared to have more than a 95 % compliance rate , as judged by counting the remaining pills in the bottle collected at the end of trial months 1 to 3 . After 12 weeks of intervention the mean + /- SD maximum urinary flow rate was significantly higher in the treatment group than in the control group ( 14.07 + /- 2.56 vs 11.74 + /- 1.23 ml per second , p < 0.001 ) , while relative urinary resistance was significantly lower in the treatment group than in the control group ( 2.35 + /- 0.83 vs 3.02 + /- 1.18 , p = 0.002 ) . While there was no significant difference in mean prostate volume or International Prostate Symptom Score between the 2 groups , 18 of 46 patients ( 39.1 % ) in the treatment group showed an International Prostate Symptom Score improvement ( decrease of 3 or greater ) after intervention , whereas only 1 of 46 ( 2.2 % ) in the control group showed an International Prostate Symptom Score improvement ( chi-square test p < 0.001 ) . CONCLUSIONS Prostataplex may have short-term effects in improving symptoms and objective measures in Chinese men with lower urinary tract symptoms associated with benign prostatic hyperplasia This prospect i ve , controlled study was undertaken to evaluate the early urodynamic and symptomatic impact of the lipido-sterolic extract of Serenoa repens ( Permixon ® ) in the treatment of patients with benign prostatic hyperplasia ( BPH ) . A total of 75 patients , aged 52–78 y with lower urinary tract symptoms due to mild/moderate BPH ( mean International Prostate Symptom Score ( I-PSS ) 8.2 ) were included in the study , of which 57 received Permixon ® 160 mg twice daily for 9 weeks . Urodynamic evaluation , including maximum urinary flow rate ( Qmax ) and detrusor pressure ( DP ) , was performed at baseline and endpoint . Prostate volume and post-void residual urine volume were assessed by transrectal and transabdominal ultrasound respectively . In addition , the I-PSS and its associated quality of life ( QoL ) score were determined and adverse events were recorded . Baseline parameters were comparable between the active treatment and control groups . After 9 weeks of Permixon ® treatment Qmax increased ( 6.0 % , P<0.001 ) , and there were reductions in DP at maximum flow ( 12.8 % , P<0.001 ) , opening DP ( 12.6 % , P<0.001 ) , and residual urine volume ( 12.6 % , P<0.05 ) . In addition , the I-PSS and QoL score both decreased significantly from baseline in the active treatment group ( 26.8 % and 18.2 % respectively , P<0.001 ) . None of these parameters improved significantly in control patients . There were also improvements in prostate volume ( 2.7 % ) and maximum DP ( 5.2 % ) in the Permixon ® group which did not reach significance . Three patients receiving Permixon ® experienced gastrointestinal disturbances but these did not lead to withdrawal or require additional therapy . In patients with mild/moderate BPH  , Permixon ® treatment reduced infravesical obstruction and produced a rapid improvement in urodynamic parameters and symptoms . The drug was well tolerated . These data support the use of Permixon ® as first-line therapy in patients with uncomplicated symptomatic BPH A total of 32 healthy male volunteers ( age range 20 - 30 years ) were enrolled in a 1-week open , r and omized , placebo-controlled study comparing finasteride ( Proscar ) , a 5 alpha-reductase inhibitor , with Permixon , the plant extract of Serenoa repens . The objective of the study was to evaluate the effect of single and multiple doses of the drugs on the inhibition of 5 alpha-reductase as assessed by serum dihydrotestosterone level determination . Following baseline measurements on day 1 , the subjects were r and omized to finasteride 5 mg once a day ( n = 10 ) , Permixon 80 mg x 2 twice a day ( n = 11 ) , or to placebo once a day ( n = 11 ) for 7 days . Serum testosterone and dihydrotestosterone levels , were determined on day 1 ( baseline and 12 h ) and on days 2 ( 24 h ) , 3 ( 48 h ) , 4 ( 72 h ) , 6 ( 120 h ) , and 8 ( 168 h ) . After 12 h , a single dose of finasteride 5 mg reduced the serum dihydrotestosterone level by 65 % ( p < or = 0.01 ) . The decreases ranged from -52 to -60 % with multiple doses of finasteride 5 mg once a day ( p < or = 0.01 ) . As in the placebo group , there was no effect of Permixon on the serum dihydrotestosterone level . No significant difference was detected between finasteride and Permixon or between finasteride and placebo with respect to serum testosterone , except on days 3 and 6 , respectively ( p < or = 0.05 ) . However , the corresponding serum testosterone levels remained within the normal ranges . These data confirm the efficacy of finasteride as inhibitor of 5 alpha-reductase . ( ABSTRACT TRUNCATED AT 250 WORDS AIM Aim of the study is to evaluate the efficacy of a pretreatment with lipidic-sterolic extract of Serenoa repens ( Permixon ) to reduce bleeding during transurethral resection of prostate ( TURP ) in patients with benign prostatic hyperplasia . METHODS This is a monocentric , r and omised versus control group study . We enrolled 108 patients , r and omised either in the experimental group or in the control one . Patients in the experimental group received a pretreatment with Serenoa repens ( 320 mg/die of Permixon ) for at least 8 weeks before the TURP procedure . In the control group patients did not receive any medical treatment before the intervention . RESULTS Out of 108 enrolled patients , 88 were evaluated per protocol . In the pretreated group the perioperative bleeding was significantly lower than in the control one ( respectively 124 vs 287 ml ) and the need of transfusion decreased remarkably . Moreover , in the pretreated group , the duration of postoperative catheterization ( respectively 3 vs 5 days ) and the evaluated hematological parameters ( red cells 4.5 vs 4 million , hemoglobin 13.4 vs 11.9 g , hematocrit 40 % vs 35 % ) were significantly lower than in the control group . CONCLUSION The pretreatment with Serenoa repens , before TURP procedure , improves the efficacy of the procedure itself and reduces the risk of complications , in particular perioperative bleeding and duration of postoperative catheterization BACKGROUND Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists ( alpha-blockers ) or 5alpha-reductase inhibitors . The long-term effect of these drugs , singly or combined , on the risk of clinical progression is unknown . METHODS We conducted a long-term , double-blind trial ( mean follow-up , 4.5 years ) involving 3047 men to compare the effects of placebo , doxazosin , finasteride , and combination therapy on measures of the clinical progression of benign prostatic hyperplasia . RESULTS The risk of overall clinical progression -- defined as an increase above base line of at least 4 points in the American Urological Association symptom score , acute urinary retention , urinary incontinence , renal insufficiency , or recurrent urinary tract infection -- was significantly reduced by doxazosin ( 39 percent risk reduction , P<0.001 ) and finasteride ( 34 percent risk reduction , P=0.002 ) , as compared with placebo . The reduction in risk associated with combination therapy ( 66 percent for the comparison with placebo , P<0.001 ) was significantly greater than that associated with doxazosin ( P<0.001 ) or finasteride ( P<0.001 ) alone . The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy ( P<0.001 ) and finasteride ( P<0.001 ) but not by doxazosin . Doxazosin ( P<0.001 ) , finasteride ( P=0.001 ) , and combination therapy ( P<0.001 ) each result ed in significant improvement in symptom scores , with combination therapy being superior to both doxazosin ( P=0.006 ) and finasteride ( P<0.001 ) alone . CONCLUSIONS Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone . Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy OBJECTIVES Sixty-three patients suffering from benign prostatic hyperplasia ( BPH ) entered a double-blind , comparative , parallel-groups study lasting 3 weeks , carried out to compare the efficacy and safety of alfuzosin 2.5 mg tid ( n = 32 ) vs serenoa repens 160 mg bid ( n = 31 ) in BPH . METHODS Efficacy was assessed both on clinical symptoms ( Boyarsky 's scale , visual analogue scale , clinical global impression ) , urinary flow rates ( uroflowmetry ) and residual urinary volume ( transabdominal ultrasound ) . Events and reported signs were recorded throughout the entire study . RESULTS Statistically significant and clinical ly relevant differences were found between the two treatments in favour of alfuzosin for Boyarsky 's total score ( decrease from 9.6 + /- 3.0 to 5.9 + /- 3.0 , 38.8 % for alfuzosin and from 9.3 + /- 2.5 to 6.8 + /- 2.8 , 26.9 % for serenoa repens ) and obstructive score ( decrease from 4.9 + /- 2.1 to 3.0 + /- 1.9 , 37.8 % for alfuzosin ; from 4.4 + /- 1.7 to 3.4 + /- 1.8 , 23.1 % for Serenoa repens ; p = 0.01 for both ) . Clinical ly relevant differences were found between the two treatments for visual analogue scale and overall clinical impression at the end of the study . Furthermore , the increase in quality of micturition was better with alfuzosin . The proportion of responders ( increase on day 21 in peak flow rate of at least 25 % relative to the baseline values ) was in favour of alfuzosin ( 71.8 % and 48.4 % for alfuzosin and Serenoa repens , respectively ; p = 0.057 ) . Both treatments were well tolerated . No patient treated with alfuzosin complained of any adverse event at any time during the study . One patient in the Serenoa group complained of mild pruritus which cleared spontaneously . Systolic , diastolic blood pressure and heart rate did not show any clinical ly relevant change during treatment with alfuzosin . CONCLUSIONS The findings confirm the efficacy and safety of alfuzosin in symptomatic BPH and indicate the superiority of alfuzosin over Serenoa repens in the treatment of urinary signs and symptoms of BPH BACKGROUND Controversy regarding the relative efficacy of treatments for the relief of the symptoms of benign prostatic hyperplasia ( BPH ) . METHODS This was a 6-month double-blind r and omized equivalence study that compared the effects of a plant extract ( 320 mg Permixon ) with those of a 5 alpha-reductase inhibitor ( 5 mg finasteride ) in 1,098 men with moderate BPH using the International Prostate Symptom Score ( IPSS ) as the primary end-point . RESULTS Both Permixon and finasteride decreased the IPSS ( -37 % and -39 % , respectively ) , improved quality of life ( by 38 and 41 % ) , and increased peak urinary flow rate ( + 25 % and + 30 % , P = 0.035 ) , with no statistical difference in the percent of responders with a 3 ml/sec improvement . Finasteride markedly decreased prostate volume ( -18 % ) and serum PSA levels ( -41 % ) ; Permixon improved symptoms with little effect on volume ( -6 % ) and no change in PSA levels . Permixon fared better than finasteride in a sexual function question naire and gave rise to less complaints of decreased libido and impotence . CONCLUSIONS Both treatments relieve the symptoms of BPH in about two-thirds of patients but , unlike finasteride , Permixon has little effect on so-called and rogen-dependent parameters . This suggests that other pathways might also be involved in the symptomatology of BPH OBJECTIVE To compare the efficacy of the lipido-sterolic extract of Serenoa repens , Permixon , to that of the alpha-blocker , tamsulosin , in the treatment of severe low urinary tract symptoms ( LUTS ) of benign prostatic hyperplasia ( BPH ) . METHODS In a 12-month , double-blind , r and omized study that showed equivalent efficacy of Permixon 320 mg/day and tamsulosin 0.4 mg/day ( " PERMAL study ") , 685 BPH patients with IPSS > or = 10 had been analyzed for efficacy . Of these , the 124 patients with severe LUTS ( IPSS > 19 ) at r and omization were retained for this subset analysis . After a 4-week run-in period , 59 and 65 patients had been r and omized to tamsulosin and Permixon groups , respectively . Both treatment groups were compared regarding the evolution from baseline of total IPSS and its irritative and obstructive subscores , LUTS-related QoL , prostate volume , Q(max ) and MSF-4 ( sexual activity question naire ) at different time points over 1 year . An analysis of variance of changes from baseline to end point was performed for all the parameters . The over-time evolutions of total , irritative and obstructive IPSS were further compared using a variance analysis for repeated measurements . RESULTS At 12 months , total IPSS decreased by 7.8 with Permixon and 5.8 with tamsulosin ( p=0.051 ) ; the irritative symptoms improved significantly more ( p=0.049 ) with Permixon ( -2.9 versus -1.9 with tamsulosin ) . The superiority of Permixon in reducing irritative symptoms appeared as soon as month 3 and was maintained up to month 12 ( p=0.03 ) . CONCLUSION Permixon 320 mg/day was shown to be slightly superior to tamsulosin 0.4 mg/day in reducing LUTS in severe BPH patients after 3 months and up to 12 months of treatment INTRODUCTION The role of infiltrating cells ( I.C. ) , commonly observed in the adenoma interstitial tissue , is unknown . We tested the hypothesis that I.C. are related with BPH progression by : phenotypically characterising these cells ; quantifying the expression of lymphokines and growth factors ; investigating the response to Permixon ( P ) in a clinical study . Permixon is a lipido sterolic extract of Serenoa repens possessing pharmacological activities and widely used in the treatment of men with BPH . MATERIAL AND METHODS A multicenter open pilot study of two parallel groups on BPH patients was carried out . They were r and omized to receive either oral Permixon ( P ) 160 mg bid for three months or to be followed for 3 weeks without any treatment before surgery ( control group C ) . Strict inclusion and exclusion criteria were applied to conform homogeneous groups , avoiding interferences of inflammatory drugs or others . Baseline clinical profile was almost identical in both groups in terms of age ( 65.7+/-5.1 vs. 67.1+/-5.8 years ) , IPSS ( 19.8+/-6.1 vs. 19.0+/-5.8 ) , prostate volume ( 64.8+/-18.9 vs. 71.5+/-29.3cc ) , Q(max ) ( 9.6+/-3.2 vs. 10.6+/-2.6 ml/s ) , and Q(L ) ( 4.0+/-1.1 vs. 3.5+/-0.7 ) . Surgery was ultimately performed on 29 patients ( 17C , 12P ) by TURP or retropubic adenomectomy . Adenoma sample s were routinely stained with HE and later prepared for immunohistochemical studies using CD3 , CD20 and CD68 antibodies . Counting of positives cells , lymphoid aggregates and foci were done using EnVision technique and the Tech Mate processor . Cytokines , growth factors and eicosanoids were determined by Elisa kits following the manufactured recommendation . RESULTS HISTOLOGICAL : A difference was observed in the number of lymphocytes B between C ( 91.4+/-44.1 ) and P treated ( 58.2+/-53.7 ) groups ( p=0.097 ) . BIOLOGICAL MARKERS : TNFalpha and IL-1beta were dramatically lower in the Permixon treated group . Other parameters did not show significant changes . CLINICAL : IPSS in the Permixon treated group was significantly reduced ( p<0.006 ) from 20.0 + 5.9 to 14.9 + 3.8 after three months of treatment . COMMENTS The BPH inflammatory hypothesis was tested in humans . Our pilot study shows a significant reduction of some inflammatory parameters in prostatic tissues of patients treated with Permixon .  These biological findings justify a pharmacological effect of this drug on the inflammatory status of the adenoma . A correlation with clinical improvement was observed OBJECTIVES To assess the effects of saw palmetto on voiding symptoms and urodynamic parameters in men with lower urinary tract symptoms ( LUTS ) presumed secondary to benign prostatic hyperplasia ( BPH ) . METHODS Fifty men with previously untreated LUTS and a minimum International Prostate Symptom Score ( IPSS ) of 10 or greater were treated with a commercially available form of saw palmetto ( 160 mg twice per day ) for 6 months . The initial evaluation included measurement of peak urinary flow rate , postvoid residual urine volume , pressure-flow study , and serum prostate-specific antigen ( PSA ) level . Patients completed an IPSS , serum PSA was determined , and flow rate was measured every 2 months during the course of the study . A urodynamic evaluation was repeated at the completion of the 6-month trial . RESULTS The mean IPSS ( + /-SD ) improved from 19.5+/-5.5 to 12.5+/-7.0 ( P < 0.001 ) among the 46 men who completed the study . Significant improvement in the symptom score was noted after treatment with saw palmetto for 2 months . An improvement in symptom score of 50 % or greater after treatment with saw palmetto for 2 , 4 , and 6 months was noted in 21 % ( 10 of 48 ) , 30 % ( 14 of 47 ) , and 46 % ( 21 of 46 ) of patients , respectively . There was no significant change in peak urinary flow rate , postvoid residual urine volume , or detrusor pressure at peak flow among patients completing the study . No significant change in mean serum PSA level was noted . CONCLUSIONS Saw palmetto is a well-tolerated agent that may significantly improve lower urinary tract symptoms in men with BPH . However , we were unable to demonstrate any significant improvement in objective measures of bladder outlet obstruction . Placebo-controlled trials of saw palmetto are needed to evaluate the true effectiveness of this compound OBJECTIVE The mechanism of action of plant extracts used for the medical treatment of human benign prostatic hyperplasia ( BPH ) is still unknown . In this prospect i ve , r and omized , double-blind trial , we investigated the possible influence of the Sabal serrulata extract IDS 89 ( Strogen ) on epithelial and stromal enzyme activities of BPH tissue . METHODS 18 patients with BPH were r and omly assigned to receive 3 x 2 capsules Strogen uno ( 320 mg/capsule ) ( n = 8) or placebo ( n = 10 ) daily for 3 months . The activity ( Vmax and Km ) of 5 alpha-reductase . 3 alpha-HSORred , 3 beta-HSORred , and creatine kinase was determined in mechanically separated epithelium and stroma of human BPH . RESULTS The multivariate correlation analysis revealed a positive correlation between therapy and the following enzyme alterations : ( 1 ) In epithelium , the substrate affinity of the 5 alpha-reductase decreased slightly ( increase of Km value ) . ( 2 ) In stroma , the Vmax value of the 3 alpha-HSORred increased statistically distinctly , leading to a moderate increase of Vmax/Km . ( 3 ) In stroma , the Vmax value of the 3 beta-HSORred increased moderately , but not statistically significant . ( 4 ) In stroma , the Vmax value of creatine kinase increased significantly , leading to a statistically distinct increase of Vmax/Km . CONCLUSION This double-blind , placebo-controlled clinical trial with the S. serrulata extract IDS 89 revealed significant biochemical changes at the cellular level of BPH tissue . However , the alterations are merely moderate , their biochemical causes and consequences regarding the pathophysiology of BPH rather uncertain . Therefore , more studies are needed before plant extracts like IDS 89 become valid c and i date s likewise synthetic substances already used for medical treatment of human BPH This 3-month double-blind , r and omized , parallel-group study compared the efficacy and tolerability of two regimens of the lipido-sterolic extract of Serenoa repens ( Permixon ) ( two 160-mg capsules once daily [ OD ] and one 160-mg capsule twice daily [ BID ] ) in 100 out patients with symptomatic benign prostatic hyperplasia ( BPH ) . Both regimens significantly ( P < .0001 ) reduced the International Prostate Symptom Score ( I-PSS ) mean total score from baseline ; improvements achieved statistical significance after the first month and were maintained for the duration of the study . Significant ( P < .05 ) and rapid improvements from baseline to the end of month 1 also occurred in I-PSS quality -of-life ( QoL ) scores , maximum and mean urinary flow rates , and residual urine volume ; this benefit was further increased at month 3 for I-PSS total score and QoL and residual volume , and was maintained for maximum and mean flow rates . A highly significant decrease ( P < .001 ) in residual urine was observed in both groups . No significant differences were noted between regimens . Clinical adverse events occurred at a similar incidence in both groups ( BID , 24 % ; OD , 22 % ) and were deemed unrelated or unlikely to be related to Permixon This 6-month double-blind , r and omized , parallel-group study compared two dose regimens of Libeprosta ® , the lipidosterolic extract ofSerenoa repens in 100 male out patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( BPH ) . The patients received two 80-mg tablets twice daily or two 80-mg tablets three times daily . Baseline evaluations included maximum and mean urinary flow rates , postvoid residual urine volume , and International Prostate Symptom Score ( I-PSS ) total and quality -of-life scores . Both regimens significantly reduced the I-PSS mean total score from baseline values ( P < .001 ) ; improvements achieved statistical significance after month 3 and were maintained for the duration of the study . Significant improvements from baseline also occurred in quality -of-life scores , maximum and mean urinary flow rates , and residual urine volume ( P < .05 ) . The decrease in residual urine with both regimens was highly significant ( P < .001 ) . No significant differences in efficacy were noted between the two dose groups , and no treatment-related complications or clinical adverse events occurred . In this clinical study , the lipidosterolic extract ofSerenoa repens was a well-tolerated agent that may significantly improve lower urinary tract symptoms and flow measurements in men with BPH BACKGROUND Men with benign prostatic hyperplasia can be treated with alpha 1-adrenergic-antagonist drugs that relax prostatic smooth muscle or with drugs that inhibit 5 alpha-reductase and therefore reduce tissue and rogen concentrations . However , the effects of the two types of drugs have not been compared . METHODS We compared the safety and efficacy of placebo , terazosin ( 10 mg daily ) , finasteride ( 5 mg daily ) , and the combination of both drugs in 1229 men with benign prostatic hyperplasia .  American Urological Association symptom scores and peak urinary-flow rates were determined at base line and periodically for one year . RESULTS The mean changes from base line in the symptom scores in the placebo , finasteride , terazosin , and combination-therapy groups at one year were decreases of 2.6 , 3.2 , 6.1 , and 6.2 points , respectively ( P<0.001 for the comparisons of both terazosin and combination therapy with finasteride and with placebo ) . The mean changes at one year in the peak urinary-flow rates were increases of 1.4 , 1.6 , 2.7 , and 3.2 ml per second , respectively ( P<0.001 for the comparisons of both terazosin and combination therapy with finasteride and with placebo ) . Finasteride had no more effect on either measure than placebo . In the placebo group , 1.6 percent of the men discontinued the study because of adverse effects , as did 4.8 to 7.8 percent of the men in the other three groups . CONCLUSIONS In men with benign prostatic hyperplasia , terazosin was effective therapy , whereas finasteride was not , and the combination of terazosin and finasteride was no more effective than terazosin alone OBJECTIVES To examine the nuclear chromatin characteristics of epithelial cells , looking for an SPHB-mediated effect on nuclear DNA structure and organization . Saw palmetto herbal blend ( SPHB ) causes contraction of prostate epithelial cells and suppression of tissue dihydrotestosterone levels in men with symptomatic benign prostatic hyperplasia , but a fundamental mechanism remains unknown . METHODS A 6-month r and omized trial , comparing prostatic tissue of men treated with SPHB ( n = 20 ) or placebo ( n = 20 ) , was performed . At baseline , the two groups were similar in age ( 65 versus 64 years ) , symptoms ( International Prostate Symptom Score 18 versus 17 ) , uroflow ( maximal urinary flow rate 10 versus 11 mL/s ) , prostate volume ( 59 versus 58 cm(3 ) ) , prostate-specific antigen ( 4.2 versus 2.7 ng/mL ) , and percentage of epithelium ( 17 % versus 16 % ) . Prostatic tissue was obtained by sextant biopsy before and after treatment . Five-micron sections were Feulgen stained and quantitatively analyzed using the AutoCyte QUIC-DNA imaging system . Images were captured from 200 r and omly selected epithelial cell nuclei , and 60 nuclear morphometric descriptors ( NMDs ) ( eg , size , shape , DNA content , and textural features ) were determined for each nucleus . Logistic regression analysis was used to assess the differences in the variances of the NMDs between the treated and untreated prostate epithelial cells . RESULTS At baseline , the  SPHB  and placebo groups had similar NMD values . After 6 months of placebo , no significant change from baseline was found in the NMDs . However , after 6 months of SPHB , 25 of the 60 NMDs were significantly different compared with baseline , and a multivariate model for predicting treatment effect using 4 of the 25 was created ( P < 0.001 ) . The multivariate model had an area under the receiver operating characteristic curve of 94 % and an accuracy of 85 % . CONCLUSIONS Six months of SPHB treatment appears to alter the DNA chromatin structure and organization in prostate epithelial cells . Thus , a possible molecular basis for tissue changes and therapeutic effect of the compound is suggested A double-blind trial comparing the effect of  Permixon ( 160 mg bd ) against placebo in the treatment of benign prostatic hypertrophy is described . In both groups a significant improvement in flow rate and subjective assessment of symptoms was seen . There was no significant difference between the results of treatment in either group CONTEXT Saw palmetto fruit extracts are widely used for treating lower urinary tract symptoms attributed to benign prostatic hyperplasia ( BPH ) ; however , recent clinical trials have question ed their efficacy , at least at st and ard doses ( 320 mg/d ) . OBJECTIVE To determine the effect of saw palmetto extract ( Serenoa repens , from saw palmetto berries ) at up to 3 times the st and ard dose on lower urinary tract symptoms attributed to BPH . DESIGN , SETTING , AND PARTICIPANTS A double-blind , multicenter , placebo-controlled r and omized trial at 11 North American clinical sites conducted between June 5 , 2008 , and October 10 , 2010 , of 369 men aged 45 years or older , with a peak urinary flow rate of at least 4 mL/s , an American Urological Association Symptom Index ( AUASI ) score of between 8 and 24 at 2 screening visits , and no exclusions . INTERVENTIONS One , 2 , and then 3 doses ( 320 mg/d ) of saw palmetto extract or placebo , with dose increases at 24 and 48 weeks . MAIN OUTCOME MEASURES Difference in AUASI score between baseline and 72 weeks . Secondary outcomes included measures of urinary bother , nocturia , peak uroflow , postvoid residual volume , prostate-specific antigen level , participants ' global assessment s , and indices of sexual function , continence , sleep quality , and prostatitis symptoms . RESULTS Between baseline and 72 weeks , mean AUASI scores decreased from 14.42 to 12.22 points ( -2.20 points ; 95 % CI , -3.04 to -1.36 ) [corrected]with saw palmetto extract and from 14.69 to 11.70 points ( -2.99 points ; 95 % CI , -3.81 to -2.17 ) with placebo . The group mean difference in AUASI score change from baseline to 72 weeks between the saw palmetto extract and placebo groups was 0.79 points favoring placebo ( upper bound of the 1-sided 95 % CI most favorable to saw palmetto extract was 1.77 points , 1-sided P = .91 ) . Saw palmetto extract was no more effective than placebo for any secondary outcome . No clearly attributable adverse effects were identified . CONCLUSION Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00603304
target: Serenoa repens was not more effective than placebo for treatment of urinary symptoms consistent with BPH
background: BACKGROUND Benign prostatic hyperplasia ( BPH ) , a 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 is common .
  The extract of the berry of the American saw palmetto , or dwarf palm plant , Serenoa repens ( 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 aim ed to assess the effects of Serenoa repens in the treatment of LUTS consistent with BPH .