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 .
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).
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
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 .