Saw palmetto (Serenoa repens) in men with lower urinary tract symptoms: effects on urodynamic parameters and voiding symptoms. Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia. Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic 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]. Effect of saw palmetto soft gel capsule on lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized trial in Shanghai, China. Saw palmetto for benign prostatic hyperplasia. Analysis of the results obtained with a new phytotherapeutic association for LUTS versus control. [corrected]. The lipidosterolic extract ofSerenoa repens in the treatment of benign prostatic hyperplasia: A comparison of two dosage regimens Recruitment of participants to a clinical trial of botanical therapy for 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 Effects of pumpkin seed oil and saw palmetto oil in Korean men with symptomatic benign prostatic hyperplasia Multicentre study on the efficacy and tolerability of an extract of Serenoa repens in patients with chronic benign prostate conditions associated with inflammation. Randomized trial of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) on symptoms of benign prostatic hyperplasia (BPH) Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto. Using a treatment satisfaction measure in an early trial to inform the evaluation of a new treatment for benign prostatic hyperplasia. Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia: Combined Treatment with Fesoterodine Fumarate Extended-Release and Tamsulosin - A Prospective Study [A Crossover Comparison Study on Lower Urinary Tract Symptoms with Overactive Bladder Secondary to Benign Prostatic Hyperplasia: Naftopidil versus Tamsulosin with Solifenacin].
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 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 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 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 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 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 . ) 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 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 OBJECTIVES The timely recruitment of study participants is a critical component of successful trials . Benign prostatic hyperplasia ( BPH ) , a common nonmalignant urologic condition among older men , is characterized by lower urinary tract symptoms ( LUTS ) . Successful recruitment methods for a trial of medical therapy for BPH , Medical Therapy of Prostate Symptoms ( MTOPS ) , were mass mailing and advertising . The Complementary and Alternative Medicines Trial for Urological Symptoms ( CAMUS ) was design ed to evaluate a botanical therapy , saw palmetto , for the treatment of BPH . The objective of this study was to evaluate recruitment strategies for CAMUS and to contrast the baseline characteristics of CAMUS participants with those recruited to a similar trial using conventional medical therapy . DESIGN CAMUS is a r and omized , double-blind , placebo-controlled trial design ed to evaluate the effects of saw palmetto given at escalating doses over an 18-month period on relief from LUTS . SUBJECTS The target enrollment goal was 350 men with LUTS from 11 clinical centers over a 12-month period . The recruitment techniques used and participants contacted , screened , and r and omized through each technique were obtained from the clinical centers . Baseline characteristics of the CAMUS participants were compared with participants in the MTOPS trial who met the CAMUS eligibility criteria for LUTS . RESULTS The target enrollment goal was achieved in 11 months . The overall monthly recruitment rate per site was 3.7 and ranged from 2.4 to 8.0 . The most successful recruitment methods were mass mailing and advertising , which accounted for 39 % and 35 % of the study participants , respectively . In comparison to MTOPS participants , CAMUS participants were younger , more highly educated , more diverse , and had less severe urinary symptoms . CONCLUSIONS Successful recruitment methods for CAMUS were similar to those in MTOPS . The use of botanical therapy attracted a less symptomatic and more educated study population 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 This study was to investigate the role of complementary and alternative medicine in the prevention and treatment of benign prostatic hyperplasia . For this purpose , a r and omized , double-blind , placebo-controlled trial was performed over 12 months on 47 benign prostatic hyperplasia patients with average age of 53.3 years and international prostate symptom score over 8 . Subjects received either sweet potato starch ( group A , placebo , 320 mg/day ) , pumpkin seed oil ( group B , 320 mg/day ) , saw palmetto oil ( group C , 320 mg/day ) or pumpkin seed oil plus saw palmetto oil ( group D , each 320 mg/day ) . International prostate symptom score , quality of life , serum prostate specific antigen , prostate volume and maximal urinary flow rate were measured . In groups B , C and D , the international prostate symptom score were reduced by 3 months . Quality of life score was improved after 6 months in group D , while those of groups B and C were improved after 3 months , compared to the baseline value . Serum prostate specific antigen was reduced only in group D after 3 months , but no difference was observed in prostate volume in all treatment groups . Maximal urinary flow rate were gradually improved in groups B and C , with statistical significance after 6 months in group B and after 12 months in group C. None of the parameters were significantly improved by combined treatment with pumpkin seed oil and saw palmetto oil . From these results , it is suggested that administrations of pumpkin seed oil and saw palmetto oil are clinical ly safe and may be effective as complementary and alternative medicine treatments for benign prostatic hyperplasia 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 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 OBJECTIVES This report assesses participant perception of treatment assignment in a r and omized , double-blind , placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia ( BCM ) . DESIGN Participants r and omized to receive saw palmetto  were instructed to take one 320 mg gelcap daily for the first 24 weeks , two 320 mg gelcaps daily for the second 24 weeks , and three 320 mg gelcaps daily for the third 24 weeks . Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period . At 24 , 48 , and 72 weeks postr and omization , the American Urological Association Symptom Index ( AUA-SI ) was administered and participants were asked to guess their treatment assignment . SETTING S The study was conducted at 11 clinical centers in North America . PARTICIPANTS Study participants were men , 45 years and older , with moderate to low severe BPH symptoms , r and omized to saw palmetto ( N=151 ) or placebo ( N=155 ) . OUTCOME MEASURES Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment . RESULTS For participants assigned to saw palmetto , 22.5 % , 24.7 % , and 29.8 % correctly thought they were taking saw palmetto , and 37.3 % , 40.0 % , and 44.4 % incorrectly thought they were on placebo at 24 , 48 , and 72 weeks , respectively . For placebo participants , 21.8 % , 27.4 % , and 25.2 % incorrectly thought they were on saw palmetto , and 41.6 % , 39.9 % , and 42.6 % correctly thought they were on placebo at 24 , 48 , and 72 weeks , respectively . The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto ( p=0.823 ) or placebo ( p=0.893 ) . Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto . CONCLUSIONS Blinding of treatment assignment was successful in this study . Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto OBJECTIVE This article describes the results of an exploratory analysis of treatment satisfaction data from a phase 2 study to inform the evaluation of a new treatment for benign prostatic hyperplasia ( BPH ) . METHODS The study was a r and omized , placebo-controlled , double blind trial comparing three doses ( low , medium , and high ) of a new uro-selective alpha-blocker with an active comparator . A total of 536 men aged 40 years and older with lower urinary tract symptoms ( LUTS ) result ing from BPH were r and omized into the study . Patients ' perceptions of satisfaction with efficacy , dosing , and side effects were explored using a vali date d disease-specific instrument , the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia ( TSS-BPH ) . The TSS-BPH was administered at the end of the study or at withdrawal . RESULTS Compared with placebo , the medium and high doses showed the greatest efficacy on the primary endpoint , the International Prostate Symptom Score ( IPSS ) . Patient satisfaction with efficacy at these doses was significantly better than that for placebo . Nevertheless , adverse events were most frequent in the high dose group . Satisfaction with side effects was significantly worse than placebo for this group , and this was reflected in the total scores on the TSS-BPH , with patients being most satisfied overall with the medium dose . CONCLUSIONS Exploring patients ' treatment satisfaction with medication in early trials using multidimensional measures provides an overall evaluation of efficacy and side effects , and can be used to inform the selection of doses for later trials . This is especially useful for products that require adherence with medication over long periods of time Objective : To evaluate the efficacy and safety of fesoterodine extended-release ( ER ) plus tamsulosin in men with lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . Patients and Methods : Men aged ≥50 years , with LUTS , prostate volume ≤60 ml and International Prostate Symptom Score ( IPSS ) ≥13 were enrolled in this study . 173 consecutive patients were treated initially with tamsulosin ( 0.4 mg ) for 1 week . At the second visit , 47 patients out of the sample of 173 who were still experiencing inconvenient LUTS were r and omized into two groups . The first group received a therapy with tamsulosin and fesoterodine combination ( group 1 , n = 24 ) while the second continued the therapy with the single administration of tamsulosin ( group 2 , n = 23 ) for an additional 4-week period . Results : There was no statistically significant difference in age , prostate volume , Qmax , and postvoid residual urine between the two groups . A statistical significance appeared in the combination group regarding the storage and the total IPSS values among the second and third visits ( 10.5 ± 1.4 to 8.5 ± 1.3 and 16.1 ± 1.8 to 13.7 ± 1.5 respectively ) . Conclusion : Regarding bothersome LUTS and storage symptoms  , fesoterodine ER and tamsulosin combination was significantly more effective than the single administration of tamsulosin We compared the efficacy of naftopidil monotherapy with combination therapy using tamsulosin hydrochloride and solifenacin succinate in the treatment of lower urinary tract symptoms ( LUTS ) with overactive bladder ( OAB ) secondary to benign prostatic hyperplasia ( BPH ) . Thirty one patients were enrolled in a r and omized crossover study . Fourteen patients were initially prescribed naftopidil 75 mg ( N ) for 8 weeks , followed by tamsulosin 0.2 mg and solifenacin 5 mg ( TS ) for 8 weeks ( group N ) ; another 17 were initially prescribed TS , followed by N ( group TS ) . The efficacy variables were the changes in international prostate symptom score ( I-PSS ) , quality of life ( QOL ) score , overative bladder symptom score ( OABSS ) , and post-void residual ( PVR ) urine volume . After the study , a question naire survey was carried out about the choice of treatment . After treatment with each agent , total I-PSS , storage symptom score , QOL score and OABSS except for the daytime frequency were significantly improved from baseline . PVR was significantly increased after TS treatment . There were no significant differences between the two treatments except for PVR . As a result of the question naire survey , 13 patients chose N and 17 chose TS . In conclusion , N monotherapy can be expected to have an equal effect in the treatment of LUTS with OAB secondary to BPH in comparison with TS combination therapy
S. repens is safe in its application .
We suggest that strong placebo effect , potentially influenced by positive patients ' expectation on S. repens , shapes both the clinical practice outcomes and the findings of clinical trials .
Hitherto , the totality of evidence continues to suggest that S. repens is a prudent therapeutic option as part of the naturopathic treatment for LUTS/BPH .
OBJECTIVES Benign prostatic hyperplasia ( BPH ) commonly affects men above 40 years old .
The progression of BPH is often accompanied with lower urinary tract symptoms ( LUTS ) that can significantly affect the quality of life of the patients .
Serenoa repens ( saw palmetto ) is a popular herbal remedy indicated for LUTS/BPH .
We review ed the current research on the efficacy of S. repens on LUTS/BPH as a monotherapy as well as combination therapies .
RESULTS The latest evidence , based largely on the Cochrane review , suggests that S. repens is not superior to placebo in treating LUTS/BPH as a monotherapy , even at double and triple doses .
Initial clinical trials on treatment of LUTS/BPH using S. repens with lycopene and selenium , as well as S. repens with Urtica Dioica , have shown positive results .