Multicentre study on the efficacy and tolerability of an extract of Serenoa repens in patients with chronic benign prostate conditions associated with inflammation. Serenoa repens + selenium + lycopene vs tadalafil 5 mg for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction: a Phase IV, non‐inferiority, open‐label, clinical study (SPRITE study) Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic hyperplasia. Effects of hexanic extract of serenoa repens (permixon® 160 mg) on inflammation biomarkers in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia The lipidosterolic extract ofSerenoa repens in the treatment of benign prostatic hyperplasia: A comparison of two dosage regimens Efficacy and tolerability of the lipidosterolic extract of Serenoa repens (Permixon) in benign prostatic hyperplasia: a double-blind comparison of two dosage regimens. A prospective study of the efficacy of Serenoa repens, Tamsulosin, and Serenoa repens plus Tamsulosin treatment for patients with benign prostate hyperplasia [Associating Serenoa repens, Urtica dioica and Pinus pinaster. Safety and efficacy in the treatment of lower urinary tract symptoms. Prospective study on 320 patients]. Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial). Early urodynamic effects of the lipido-sterolic extract of Serenoa repens (Permixon®) in patients with lower urinary tract symptoms due to benign prostatic hyperplasia Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial Comparison of Tamsulosin Plus Serenoa Repens with Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in Korean Men: 1-Year Randomized Open Label Study 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 Comparative effects of alfuzosin versus Serenoa repens in the treatment of symptomatic benign prostatic hyperplasia. [Tamsulosin with or without Serenoa repens in benign prostatic hyperplasia: the OCOS trial]. Does the addition of Serenoa repens to tamsulosin improve its therapeutical efficacy in benign prostatic hyperplasia? Analysis of the results obtained with a new phytotherapeutic association for LUTS versus control. [corrected].
INTRODUCTION Chronic benign prostate diseases are very common and certainly feature significantly in urological practice .The treatment of chronic benign prostate diseases is a common problem in clinical practice : few studies have been conducted in routine clinical practice to evaluate the efficacy of the treatments for this clinical condition . The objective of this study was to evaluate the efficacy of an extract of Serenoa repens ( Permixon ) in the treatment of lower urinary tract symptoms ( LUTS ) in patients with chronic benign prostate diseases with associated inflammation , also taking into consideration the influence of treatment on sexual function and , therefore , on patients ' quality of life . MATERIAL S AND METHODS All the 591 eligible subjects were evaluated on entering the study ; after a screening visit , including medical history , physical examination , physical examination and digital rectal examination ( DRE ) and laboratory tests , the patients underwent uroflowmetry . The subjects under investigation were also asked to complete the IPSS , NIH-CPSI and IIEF-5 question naires , for the purpose of evaluating urinary symptoms and erectile function in relation to sexual activity in the previous 6 months . RESULTS The analysis of the uroflowmetry results showed that treatment with extract of Serenoa repens distinctly improves bladder voiding and lower urinary tract symptoms , as highlighted also by the improvement in the scores for the IPSS and NIH-CPSI question naires which serve as a basis for evaluating the urinary symptoms of patients with prostatic hyperplasia and chronic prostatitis respectively . The results also suggest that using an extract of Serenoa repens for 6 months in patients with chronic benign prostate diseases gives rise to an improvement in erectile function , as demonstrated by the increase in the scores for the IIEF-5 question naire after 6 months of treatment . CONCLUSIONS The results of this study demonstrate how treatment for 6 months with an extract of Serenoa repens in routine clinical practice gives rise to a statistically significant improvement in Qmax values and in the IPSS , NHI-CPSI and IIEF-5 question naire scores , result ing not only in an improvement in urinary symptoms but also in an overall improvement in patients ' quality of life To compare in a r and omised , open‐label , non‐inferiority clinical study , the efficacy and tolerability  of Serenoa repens ( SeR ) + selenium ( Se ) + lycopene ( Ly ) ( SeR‐Se‐Ly ) therapy vs tadalafil 5 mg in men with lower urinary tract symptoms ( LUTS ) Permixon , the lipidosterolic extract of Serenoa repens , is widely used for the treatment of symptoms associated with benign prostatic hyperplasia ( BPH ) . This open study assessed the efficacy and tolerability of Permixon 160 mg twice daily administered for 2 years . One hundred fifty-five men with clinical ly diagnosed BPH and complaints of prostatic symptoms were enrolled in the study . At 6 , 12 , 18 , and 24 months , the International Prostate Symptom Score ( I-PSS ) , quality of life , and sexual function score were recorded , and urodynamics and biologic values were measured . Adverse events were recorded every 3 months . I-PSS and quality of life improved significantly from baseline at each evaluation time point . At the end of the study and at each evaluation , maximum urinary flow also improved significantly . Prostate size decreased . Sexual function remained stable during the first year of treatment and significantly improved ( P = .001 ) during the second year . Prostate-specific antigen was not affected , and no changes in plasma hormone levels were observed . Nine patients reported 10  adverse events  , none related to treatment . Improvements in efficacy parameters began at 6 months and were maintained up to 24 months . These data demonstrate the long-term efficacy and tolerability of Permixon and support its use as a first-line medical therapy for uncomplicated symptomatic BPH Background Chronic prostatic inflammation ( CPI ) could be a cause of symptomatic or complicated benign prostatic hyperplasia ( BPH ) . In previous in vitro and in vivo studies , Hexanic Extract of Serenoa repens ( HESr ) namely Permixon ® has demonstrated potent anti‐inflammatory properties . With the aim to provide new insight onto HESr anti‐inflammatory properties in human we explore its effect on CPI biomarkers in men with lower urinary tract symptoms ( LUTS ) related to BPH using a non‐invasive method and investigate links between biomarkers and clinical symptoms . Methods An international , r and omized , double‐blind , parallel‐group , tamsulosin‐controlled study was carried out in 206 men with BPH‐related LUTS . Patients received oral daily HESr 320 mg or tamsulosin 0.4 mg during 3 months . The first urine stream after digital rectal examination ( DRE ) was collected at Day 1 and Day 90 and mRNA was extracted from prostatic epithelial cells desquaming in the lumen of the gl and s and seminal plasma fluid after DRE . mRNA quantification of the 29 most significant published inflammation markers in BPH and protein detection in urine was performed . Results At D90 , a decrease in mean gene expression was observed for 65.4 % of the markers detected in the HESr group versus 46.2 % in the tamsulosin group . In the 15 most frequently expressed genes , this difference was higher ( 80 % vs. 33 % respectively ) . Three proteins ( MCP‐1/CCL2 , IP‐10/CXCL10 , and MIF ) were detected . At D90 , a decrease in the number of patients who expressed MCP‐1/CCL2 and IP‐10/CXCL10 was observed only in the HESr group . Moreover , MIF expression was significantly reduced by HESr compared with tamsulosin ( P = 0.007 ) . Finally , in contrast to tamsulosin , the subgroup of patients treated by HESr and who over expressed MIF at baseline , had a higher response to the International Prostate Symptom Score ( I‐PSS ) than those who did not over express this protein ( mean I‐PSS change : −6.4 vs. −4.5 respectively ) . As the study is exploratory , results should be confirmed in a powered clinical study . Conclusions These results showed for the first time at clinical level the anti‐inflammatory properties of HESr , already indicated in BPH‐related LUTS . Thus , HESr could be of interest to prevent unfavourable evolution in patients with CPI . Prostate 75:1857–1867 , 2015 . © 2015 The Authors . The Prostate Published by Wiley Periodicals , 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 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 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 INTRODUCTION Serenoa repens ( saw palmetto ) has been employed for the treatment of lower urinary tract symptoms ( LUTS ) for several years . Its mechanism of action is believed to be due to anti and rogenic , antiproliferative and antinflammatory properties . An association of Serenoa with the nettle " Urtica dioica " showing antiproliferative activity and the pine " Pinus pinaster " derivative , showing antinflammatory action , has been proposed in recent years . Such an action is hoped to act not only by reducing LUTS but also by preventing the development of prostate cancer . MATERIAL AND METHODS During the years 2007 and 2008 , 320 patients suffering from LUTS were treated with an association of Serenoa repens 320 mg , Urtica dioica 120 mg and Pinus pinaster 5 mg , named IPBTRE . This treatment was administered to all patients for a minimal duration of 30 days to a maximum of a year , either alone or in association with antibiotics or alpha-blockers , if needed . Outcome analysis was based on evaluation of symptoms , prostate volume and maximum flow rate ( Qmax ) . RESULTS From a careful analysis of the data collected in our data base , the following observations can be made : ages varied between 19 and 78 years . The patients were affected by BPH in 46 % of cases , chronic prostatitis syndrome in 43 % , chronic genital-pelvic pain in 7 % and other conditions in 4 % , the absolute numbers being 147 , 138 , 22 and 7 patients , respectively . No untoward side effect was reported in any case . Variations in symptom score could be fully evaluated only in 80 of 320 patients ( 25 % ) , of whom 68 ( 85 % ) reported a significant benefit , with special reference to an improvement of pain , urgency , strangury and nocturia . Data on variations in prostate volume , as measured by digital rectal examination , were available in 84 ( 26.5 % ) patients . No significant change was observed . Qmax after treatment was measured in 83 ( 26 % ) patients . It did not show significant changes from the initial values . DISCUSSION The association tested in our study appeared to be safe and well tolerated . No changes in flow rate and prostate volume were observed , but a marked reduction of LUTS was observed in 85 % of evaluable cases , especially with regard to pain and irritative symptoms . Whether or not such an association may display a prevention of prostate cancer , may be investigated in additional studies BACKGROUND Phytotherapy has been used to treat patients with lower urinary tract symptoms ( LUTS ) . We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens ( SeR ) , Lycopene ( Ly ) , and Selenium ( Se ) + tamsulosin versus single therapies . METHODS PROCOMB trial ( IS RCT N78639965 ) was a r and omized double-blinded , double-dummy multicenter study of 225 patients between 55 and 80 years old , PSA ≤ 4 ng/ml , IPSS ≥12 , prostate volume ≤60 cc , Qmax ≤15 ml/sec , postvoid residual urine ( PVR ) < 150 ml . Participants were r and omized group A ( SeR-Se-Ly ) , group B ( tamsulosin 0.4 mg ) , group C ( SeR-Se-Ly + tamsulosin 0.4 mg ) . The primary endpoints of the study were the reduction of IPSS , PVR , and increase of Qmax in group C versus monotherapy groups . RESULTS The decrease for combination therapy was significantly greater versus group A ( P < 0.05 ) and group B ( P < 0.01 ) for IPSS and versus group A ( P < 0.01 ) for PVR from baseline to 6 months . A greater decrease in IPSS was observed for Group C versus group A ( P < 0.01 ) and increase in Qmax versus group B ( P < 0.01 ) , from 6 months to 12 months . At one year , the changes of IPSS and Qmax were greater for Group C versus monotherapies ( each comparison < 0.05 ) . The proportions of men with a decrease of at least three points ( each comparison P < 0.05 ) and decrease of 25 % for IPSS ( each comparison P < 0.01 ) were greater for Group C. CONCLUSION SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS 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 To compare the effect of a Serenoa repens extract with placebo for symptoms of benign prostatic hyperplasia ( BPH ) Introduction : In Korea , increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH . Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies . The present study was design ed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH . Material s and Methods : One hundred forty men with symptomatic BPH ( IPSS ≥10 ) were recruited in our hospital for a 12-month , open-label , r and omized trial . Patients were r and omly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day ( n = 60 ) or tamsulosin 0.2 mg/day only ( n = 60 ) . Prostate volume and PSA were measured at baseline and at end-point , whereas total IPSS , and its storage and voiding subscores , LUTS-related QoL , Qmax , and PVR were evaluated at baseline and later every 6 months . Results : Total 103 patients were finally available : 50 in the TAM + SR group and 53 in the TAM group . At 12 months , total IPSS decreased by 5.8 with TAM + SR and 5.5 with TAM ( p = 0.693 ) ; the storage symptoms improved significantly more with TAM + SR ( -1.7 vs. -0.8 with TAM , p = 0.024 ) . This benefit with regard to storage symptom in the TAM + SR group lasts at 12 months ( -1.9 vs. -0.9 , p = 0.024 ) . The changes of voiding subscore , LUTS-related QoL , Qmax , PVR , PSA , and prostate volume showed no significant differences between the TAM + SR and TAM groups . During the treatment period , 8 patients ( 16.9 % ) with TAM and 10 ( 20 % ) with TAM + SR had drug-related adverse reactions , which included ejaculatory disorders , postural hypotension , dizziness , headache , gastro-intestinal disorders , rhinitis , fatigue and asthenia . Conclusions : The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment 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 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 OBJECTIVE In the treatment of the symptoms of benign prostatic hyperplasia ( BPH ) , a French guideline opposes the use of drugs in conjunction , in the absence of proven utility . The OCOS trial therefore compared one of the possible drug combinations ( tamsulosin and Serenoa repens ) with tamsulosin alone , to see if there was any difference in effectiveness and to evaluate the clinical tolerance of each in patients with symptoms of BPH . MATERIAL AND METHODS In this double-blind , r and omised trial , patients had to have an IPSS ( International Prostate Symptom Score ) > or = 13 and a Qmax between 7 and 15 mL/s .  Tamsulosin ( 0.4 mg ) was to be administered once a day for 52 weeks , with , twice daily , a placebo ( TAM ) or Serenoa repens 160 mg ( TAM + SR ) . RESULTS 352 patients were recruited by 47 centres ; 329 ( average age 65 ) were r and omised : 161 into the TAM group and 168 into the TAM + SR group . No statistically significant difference was found between the two groups , neither for the major end-point [ change in total IPSS between the baseline value and the final evaluation ( TAM : -5.2 ; TAM + SR : -6.0 ; p = 0.286 ) ] , nor for the secondary end-points [ changes in the voiding scores ( p = 0.239 ) and in filling scores ( p = 0.475 ) of the IPSS , Qmax ( p = 0.564 ) , percentage of respondents according to the IPSS ( p = 0.361 ) , improvement in quality of life ( IPSS-QoL : p = 0.091 ; UROLIFE BPH QoL : p = 0.442 ) , safety ] . CONCLUSION The addition of Serenoa repens to tamsulosin did not provide any significant benefit to the patients : the OCOS trial does not cast doubt on the guideline applicable to the treatment of BPH BACKGROUND / AIM It has been observed that a large number of patients with low urinary tract symptoms due to benign prostatic hyperplasia ( LUTS/BPH ) ) has been treated with a combination of tamsulosin ( TAM ) + Serenoa repens ( SR ) ( TAM + SR ) . The aim of this study was to compare a combination TAM + SR with TAM and SR alone , to see if there was any difference in efficacy and tolerance of each in patients with LUTS/BPH . METHODS In this prospect i ve study patients had to have prostate volume ( PV ) < 50 mL , International Prostate Symptom Score ( IPSS ) of 7 - 18 , Quality of Life score ( QoLs ) > 3 , a maximal flow rate ( Qmax ) of 5 - 15 mL/s , with post voiding residual volume ( PVR ) < 150 mL and serum prostatic antigen ( PSA ) < 4 ng/mL.  TAM ( 0.4 mg ) was administered once a day , SR ( 320 mg ) daily or SR ( 320 mg ) + TAM ( 0.4 mg ) daily for a median period of 6 months . RESULTS A total of 297 patients were recruited , whereas 265 patients were fully available : 87 into the group TAM , 97 into the group SR and 81 into the group TAM + SR .  There was no statistically significant difference between the treatment groups in the sense of demographic and other baseline parameters . No difference was found among the 3 treatment groups , neither in the major endpoint of the study in the sense of a change between baseline and final evaluation in total IPSS , obstructive and irritative subscores , improvement of QoLs , increase in Qmax , nor for the second endpoint including diminution of PV , PSA and PVR . During the treatment period 20 ( 23 % ) of the patients managed with TAM and 17 ( 21 % ) with TAM + SR had drug- treated with related adverse reactions . No adverse effect was detected in the group SR . CONCLUSION Treatment of BPH by both SR and TAM seems to be efficacious alone . None of them had superiority over another and , additionally , a combined therapy ( TAM + SR ) does not provide extra benefits . Furthermore , SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS/BPH INTRODUCTION Benign prostatic hypertrophy ( BPH ) is a common disease whose frequency has risen throughout the world in concomitance with the increase in life expectancy . BPH causes voiding disturbances known by the acronym LUTS ( lower urinary tract symptoms ) , which heavily influence the quality of life in the elderly . The treatment for LUTS is mainly divided into medical and surgical , the latter usually represented by prostate ablation . Medical therapy includes synthetic molecules that interfere with the hormonal control of BPH or act on the bladder neck tonus , as well as natural remedies based on plant extracts from Serenoa Repens and /or Urtica Dioica . MATERIAL AND METHODS Two groups of patients who were c and i date s for surgery for BPH-induced LUTS , were r and omly recruited in a six-month trial aim ed at comparing outcome of treatment with a new combination of plants extracts ( Pluvio ® ) , which differs from the previous ones in that it also contains avocado and soya oil , as well as a high dose of Urtica Dioica , with no therapy . Age , IPSS score , maximal uroflow , prostate volume , PSA , free-to-total PSA ratio , post voiding residual urine and number of nocturia episodes were recorded and statistically evaluated using a NCSS 60 ® program . RESULT A marked benefit in terms of quality of life , measured by IPSS score , uroflow , residual urine and nocturia , was observed in the treated group compared to controls . PSA and prostate volume were not significantly affected . No noteworthy adverse events were observed . CONCLUSIONS The new phytotherapeutic combination evaluated in the present study would seem to be highly effective for the treatment of LUTS in BPH patients and does not have negative side effects . Its use could therefore be strongly advocated in this setting
In this network meta- analysis , we demonstrated that SeR did not show clinical ly meaningful improvement in LUTS and PF .
PATIENT SUMMARY In the present study , we found no clinical ly meaningful improvement of Serenoa repens for the treatment of lower urinary tract symptoms/benign prostatic enlargement .
CONTEXT International guidelines do not make any specific recommendations on Serenoa repens ( SeR ) for the treatment of male lower urinary tract symptoms ( LUTS ) secondary to benign prostatic enlargement ( BPE ) , due to product heterogeneity and method ological limitations of the published trials and meta-analyses .
OBJECTIVE We aim ed to compare the clinical efficacy of hexanic extract of SeR ( HESr ) versus non-HESr ( nHESr ) versus placebo versus alpha-blockers ( ABs ) in patients affected by LUTS secondary to BPE through a network meta- analysis method .