Efficacy and safety of a combination of Sabal and Urtica extract in lower urinary tract symptoms--long-term follow-up of a placebo-controlled, double-blind, multicenter trial.

Abstract	In an open-label extension of a randomized, double-blind clinical trial, the long-term 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) were investigated in elderly men with moderate or severe lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). Two hundred and fifty-seven patients were randomly treated with 2 x 1 capsule/day PRO 160/120 or placebo for 24 weeks, followed by a 24-week control period and a 48-week follow-up period in which all patients received PRO 160/120. Efficacy measures included the assessment of LUTS [International Prostate Symptom Score ((I-PSS) self-rating questionnaire] and uroflow and sonographic parameters. Two hundred and nineteen subjects participated in the follow-up. Between baseline and end of observation (week 96) the I-PSS total score was reduced by 53% (P < 0.001), peak and average urinary flow increased by 19% (P < 0.001), and residual urine volume decreased by 44% (P = 0.03). The incidence of adverse events during follow-up was one in 1,181 treatment days; in only one event a causal relationship with intake of PRO 160/120 could not be excluded. Treatment with PRO 160/120 thus provides a clinically relevant benefit over a period of 96 weeks.
Authors	Nikolai Lopatkin, Andrey Sivkov, Sandra Schläfke, Petra Funk, Alexander Medvedev, Udo Engelmann
Journal	International urology and nephrology (Int Urol Nephrol) Vol. 39 Issue 4 Pg. 1137-46 ( 2007) ISSN: 0301-1623 [Print] Netherlands
PMID	18038253 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References	Plant Extracts
Topics	Aged Disease Progression Double-Blind Method Follow-Up Studies Humans Male Phytotherapy (methods) Plant Extracts (adverse effects, therapeutic use) Prostatic Hyperplasia (complications) Serenoa Severity of Illness Index Statistics, Nonparametric Time Factors Treatment Outcome Urination Disorders (drug therapy, etiology, physiopathology) Urodynamics Urtica dioica

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