title: Why patients use alternative medicine: results of a national study. Randomized, double-blind, placebo-controlled trial of saw palmetto in men with lower urinary tract symptoms. Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic hyperplasia. Does the addition of Serenoa repens to tamsulosin improve its therapeutical efficacy in benign prostatic hyperplasia? Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial A prospective study of the efficacy of Serenoa repens, Tamsulosin, and Serenoa repens plus Tamsulosin treatment for patients with benign prostate hyperplasia [Comparison of a phytotherapeutic agent (Permixon) with an alpha-blocker (Tamsulosin) in the treatment of benign prostatic hyperplasia: a 1-year randomized international study]. 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). Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial.
abstract: CONTEXT Research both in the United States and abroad suggests that significant numbers of people are involved with various forms of alternative medicine . However , the reasons for such use are , at present , poorly understood . OBJECTIVE To investigate possible predictors of alternative health care use . METHODS Three primary hypotheses were tested . People seek out these alternatives because ( 1 ) they are dissatisfied in some way with conventional treatment ; ( 2 ) they see alternative treatments as offering more personal autonomy and control over health care decisions ; and ( 3 ) the alternatives are seen as more compatible with the patients ' values , worldview , or beliefs regarding the nature and meaning of health and illness . Additional predictor variables explored included demographics and health status . DESIGN A written survey examining use of alternative health care , health status , values , and attitudes toward conventional medicine . Multiple logistic regression analyses were used in an effort to identify predictors of alternative health care use . SETTING AND PARTICIPANTS A total of 1035 individuals r and omly selected from a panel who had agreed to participate in mail surveys and who live throughout the United States . MAIN OUTCOME MEASURE Use of alternative medicine within the previous year . RESULTS The response rate was 69 % . The following variables emerged as predictors of alternative health care use  : more education ( odds ratio [ OR ] , 1.2 ; 95 % confidence interval [ CI ] , 1.1 - 1.3 ) ; poorer health status ( OR , 1.3 ; 95 % CI , 1.1 - 1.5 ) ; a holistic orientation to health ( OR , 1.4 ; 95 % CI , 1.1 - 1.9 ) ; having had a transformational experience that changed the person 's worldview ( OR , 1 .8 ; 95 % CI , 1 .3 - 2.5 ) ; any of the following health problems : anxiety ( OR , 3.1 ; 95 % CI , 1.6 - 6.0 ) ; back problems ( OR , 2.3 ; 95 % CI , 1 .7 - 3.2 ) ; chronic pain ( OR , 2.0 ; 95 % CI , 1.1 -3.5 ) ; urinarytract problems ( OR , 2.2 ; 95 % CI , 1.3 - 3.5 ) ; and classification in a cultural group identifiable by their commitment to environmentalism , commitment to feminism , and interest in spirituality and personal growth psychology ( OR , 2.0 ; 95 % CI , 1.4 - 2.7 ) . Dissatisfaction with conventional medicine did not predict use of alternative medicine . Only 4.4 % of those surveyed reported relying primarily on alternative therapies . CONCLUSION Along with being more educated and reporting poorer health status , the majority of alternative medicine users appear to be doing so not so much as a result of being dissatisfied with conventional medicine but largely because they find these health care alternatives to be more congruent with their own values , beliefs , and philosophical orientations toward health and life 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 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 / 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 To compare the effect of a Serenoa repens extract with placebo for symptoms of benign prostatic hyperplasia ( BPH ) 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 OBJECTIVE While the lipidosterolic extract ( LSESr ) of Serenoa repens -- Permixon -- has been shown to have an equivalent efficacy to finasteride in patients with benign prostatic hyperplasia ( BPH ) , to date , there has been no valid comparison of phytotherapy with alpha-blockers . The aim of this study was to assess the equivalent efficacy of Permixon and tamsulosin . METHODS Eight hundred and eleven men with symptomatic BPH ( international prost date symptom score , I-PSS > or = 10 ) were recruited in 11 European countries for a 12-month , double-blind r and omized trial . After a 4-week run-in period , 704 patients were r and omly assigned to either tamsulosin 0.4 mg per day ( N = 354 ) or Permixon 320 mg per day ( N = 350 ) . I-PSS , QoL and maximum urinary flow rate ( Qmax ) were evaluated at baseline and periodically for 1 year . Prostate volume and serum prostate-specific antigen ( PSA ) were measured at selection and at endpoint . The endpoint analysis was performed on the per- protocol ( PP ) population of 542 patients ( tamsulosin : N = 273 ; Permixon : N = 269 ) . RESULTS At 12 months , I-PSS decreased by 4.4 in each group and no differences were observed in either irritative or obstructive symptom improvements . The increase in Qmax was similar in both treatment groups ( 1.8 ml/s Permixon , 1.9 ml/s tamsulosin ) . PSA remained stable while prostate volume decreased slightly in the Permixon-treated patients . The two compounds were well tolerated , however , ejaculation disorders occurred more frequently in the tamsulosin group . CONCLUSION This study demonstrated that Permiwon and tamsulosin are equivalent in the medical treatment of lower urinary tract symptoms in men with BPH , during and up to 12 months of therapy 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 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: Studies reported that Serenoa repens was effective in relieving lower urinary tract symptoms ( LUTS ) .
  This study indicated that Serenoa repens had the same effect in treating BPH compared with tamsulosin in terms of IPSS , QoL , and PVR after at least 6-month treatment cycle , however , the latter had a greater improvement in PV compared with the former .
  And Serenoa repens did not increase the risk of adverse events especially with respect to ejaculation disorders and libido decrease
background: nan