[Combined extract of Sabal palm and nettle in the treatment of patients with lower urinary tract symptoms in double blind, placebo-controlled trial].

Abstract

A multicenter, prospective clinical trial was performed to study efficacy and tolerance of a compound drug PRO 160/120 in the elderly men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). A total of 257 patients were randomized into two groups. Group 1 of 129 patients received PRO 160/120; group 2 of 128 patients received placebo. In 2-week induction blind phase of placebo the patients received for 24 weeks 1 capsule of the drug or placebo twice a day in conditions of double blind study. The double blind phase was followed by an open control period for 24 weeks when all the patients received PRO 160/120. Treatment efficacy evaluation was based on I-PSS, quality of life index, urodynamic and ultrasonography evidence. PRO 160/120 was superior to placebo by attenuating LUTS assessed by I-PSS, improved obstructive and irritative symptoms, was effective in patients with moderate and severe symptoms. Tolerance of the plant extract was good.

• Authors: N A Lopatkin, A V Sivkov, A A Medvedev, K Walter, S Schlefke, Iu I Avdeĭchuk, G V Golubev, K P Mel'nik, N A Elenberger, U Engelman
• Journal: Urologiia (Moscow, Russia : 1999) (Urologiia) 2006 Mar-Apr Issue 2 Pg. 12, 14-9 ISSN: 1728-2985 [Print] Russia (Federation)
• PMID: 16708583 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• PRO 160-120
• Placebos
• Plant Extracts

Topics

• Aged
• Double-Blind Method
• Humans
• Male
• Middle Aged
• Placebos
• Plant Extracts (therapeutic use)
• Prostatic Hyperplasia (complications, diagnostic imaging, drug therapy)
• Quality of Life
• Serenoa (chemistry)
• Severity of Illness Index
• Treatment Outcome
• Ultrasonography
• Urinary Tract (physiopathology)
• Urination Disorders (drug therapy, etiology)
• Urodynamics (drug effects)
• Urtica dioica (chemistry)