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 .
Efficacy and safety of a new prolonged release formulation of alfuzosin 10 mg once daily versus alfuzosin 2.5 mg thrice daily and placebo in patients with symptomatic benign prostatic hyperplasia. ALFORTI Study Group.
OBJECTIVES To assess the efficacy and safety of a new prolonged release formulation of the uroselective alpha(1)-blocker alfuzosin for a once-daily dosing regimen in patients with lower urinary tract symptoms ( LUTS ) suggestive of symptomatic benign prostatic hyperplasia ( BPH ) . METHODS After a 1-month run-in period , 447 patients were r and omly allocated in a double-blind placebo-controlled study to receive alfuzosin 10 mg once daily ( n = 143 ) , alfuzosin 2.5 mg thrice daily ( n = 150 ) or placebo ( n = 154 ) for 3 months . At inclusion , 46 % of the r and omised population had concomitant cardiovascular disease and 30 % received an antihypertensive treatment .  Uroflowmetry was performed close to trough plasma concentration of alfuzosin once daily to demonstrate the 24-hour coverage with this formulation . RESULTS Both alfuzosin formulations significantly improved urinary symptoms versus placebo assessed using the International Prostate Symptom Score ( alfuzosin 10 mg once daily : -6.9 ; alfuzosin 2.5 mg thrice daily : -6.4 ; placebo : -4.9 , p = 0.005 ) . Peak flow rate increased significantly with alfuzosin 10 mg once daily ( + 2.3 ml/s , p = 0.03 vs. placebo ) and with alfuzosin 2.5 mg thrice daily ( + 3.2ml/s , p<0.0001 vs. placebo ) compared to placebo ( + 1.4 ml/s ) . Overall both formulations of alfuzosin were well tolerated in comparison with placebo . In addition , vasodilatory adverse events appeared to be less frequent with the once daily than the thrice daily formulation ( 6.3 vs. 9.4 % , respectively ) . No first-day effect was reported with alfuzosin once daily and the effect on blood pressure did not differ from those observed in placebo , both in normotensive and hypertensive patients . No specific sexual dysfunction including ejaculation disorder was reported in the alfuzosin 10 mg once-daily group . CONCLUSION The new once-daily formulation of alfuzosin administered at a dose of 10 mg daily is an effective 24-hour treatment of LUTS associated with BPH . Alfuzosin is as effective as the immediate formulation and shows a better cardiovascular safety . The better safety profile enables the same dose to be used in all patients , providing the patients with the benefits of a once-daily administration
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 .