[Combined extract of Sabal palm and nettle in the treatment of patients with lower urinary tract symptoms in double blind, placebo-controlled trial].
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.
Lopatkin
N A
NA
Sivkov
A V
AV
Medvedev
A A
AA
Walter
K
K
Schlefke
S
S
Avdeĭchuk
Iu I
IuI
Golubev
G V
GV
Mel'nik
K P
KP
Elenberger
N A
NA
Engelman
U
U
D000368:Aged; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D010936:Plant Extracts / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy*; D011788:Quality of Life; D028024:Serenoa / Q000737:chemistry; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014463:Ultrasonography; D014551:Urinary Tract / Q000503:physiopathology*; D014555:Urination Disorders / Q000188:drug therapy* / Q000209:etiology; D014563:Urodynamics / Q000187:drug effects; D026982:Urtica dioica / Q000737:chemistry
C476336:PRO 160-120; D010919:Placebos; D010936:Plant Extracts