Abstract | OBJECTIVES: To determine, by analysing all available clinical trial data, the clinical efficacy against placebo of an extract from the fruit of the American dwarf palm tree, Serenoa repens ( Permixon, Pierre Fabre Médicament, Castres, France), as there is controversy about the use of phytotherapeutic agents in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). METHODS: All clinical trial data published on Permixon, comprising 14 randomized clinical trials and three open-label trials, involving 4280 patients, were analysed. These trials were of different size (22-1100 patients) and duration (21-720 days). The peak urinary flow rate and nocturia were the two common endpoints. The statistical analysis was based on a random-effects meta-analysis. RESULTS:
Permixon was associated with a mean (sem) reduction in the International Prostate Symptom Score (IPSS) of 4.78 (0.41). The mean placebo effect on peak urinary flow rate was an increase of 1.20 (0.49) mL/s. The estimated effect of Permixon was a further increase of 1.02 (0.50) mL/s (P = 0.042). Placebo was associated with a reduction in the mean number of nocturnal voids of 0.63 (0.14); there was a further reduction attributable to Permixon of 0.38 (0.07) (P < 0.001). There was some heterogeneity among the studies for nocturia; one over 2 years involving 396 patients and showing no difference between placebo and Permixon had a large effect on the results. CONCLUSIONS: This meta-analysis of all available published trials of Permixon for treating men with BPH showed a significant improvement in peak flow rate and reduction in nocturia above placebo, and a 5-point reduction in the IPSS.
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Authors | P Boyle, C Robertson, F Lowe, C Roehrborn |
Journal | BJU international
(BJU Int)
Vol. 93
Issue 6
Pg. 751-6
(Apr 2004)
ISSN: 1464-4096 [Print] England |
PMID | 15049985
(Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
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Chemical References |
- Androgen Antagonists
- Plant Extracts
- saw palmetto extract
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Topics |
- Androgen Antagonists
(therapeutic use)
- Clinical Trials as Topic
- Humans
- Male
- Phytotherapy
(methods)
- Plant Extracts
(therapeutic use)
- Prostatic Hyperplasia
(drug therapy)
- Randomized Controlled Trials as Topic
- Serenoa
- Treatment Outcome
- Urination
(drug effects)
- Urination Disorders
(drug therapy)
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