Abstract | PURPOSE: To determine the effects of the herbal fixed-dose combination PRO 160/120 (extracts from saw palmetto fruits and stinging nettle roots) on nocturnal voiding frequency, as measured by question 7 of the IPSS questionnaire, in patients with moderate-to-severe LUTS/BPH after 24 weeks of treatment compared to placebo, to the α-blocker tamsulosin, or to the 5α-reductase inhibitor finasteride. METHODS: The study is about post hoc evaluation of four published randomized, double-blind clinical trials on PRO 160/120, two compared with placebo, one with finasteride and one with tamsulosin. In addition, a pooled data analysis of the two placebo-controlled trials was conducted. RESULTS: We analyzed data from a total of 922 patients with a mean age of 66 years and a mean baseline nocturnal voiding frequency of 2.1. In the pooled analysis of placebo-controlled trials, nocturnal voids improved by 0.8 (29 %) with PRO 160/120 compared to 0.6 (18 %) with placebo (p = 0.015, Wilcoxon test, one-tailed). The 69 % responder rate to PRO 160/120 was significantly superior to the placebo response (52 %; p = 0.003, χ (2)-test, two-tailed). The majority of responders improved by 1 void/night. Absolute improvements and response rates were consistently higher with PRO 160/120 than with placebo over a range of baseline nocturnal voiding frequencies. There were no differences between PRO 160/120 and finasteride or tamsulosin regarding absolute improvement of nocturnal voids or responds rates. CONCLUSION:
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Authors | Matthias Oelke, Richard Berges, Sandra Schläfke, Martin Burkart |
Journal | World journal of urology
(World J Urol)
Vol. 32
Issue 5
Pg. 1149-54
(Oct 2014)
ISSN: 1433-8726 [Electronic] Germany |
PMID | 24938176
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Drug Combinations
- PRO 160-120
- Plant Extracts
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Topics |
- Aged
- Double-Blind Method
- Drug Combinations
- Humans
- Lower Urinary Tract Symptoms
(complications)
- Male
- Nocturia
(drug therapy, etiology)
- Phytotherapy
- Plant Extracts
(administration & dosage)
- Prostatic Hyperplasia
(complications)
- Remission Induction
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