Boyle P, Robertson C, Lowe F, Roehrborn C
Division of Epidemiology, European Institute of Oncology, Milan, Italy.
Urology. 2000 Apr;55(4):533-9. doi: 10.1016/s0090-4295(99)00593-2.
Permixon is a compound extracted from the fruit of the American dwarf palm tree, Serenoa repens. Controversy regarding the use of phytotherapeutic agents in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia is significant. We analyzed all available clinical trial data of the Permixon preparation to determine its clinical efficacy compared with placebo.
All published clinical trial data on Permixon (11 randomized clinical trials and 2 open label trials), involving 2859 patients, were used. These trials were disparate in size (from 22 to 592 patients) and duration (from 21 to 180 days). Peak urinary flow rate and nocturia were the two common end points. The statistical analysis was based on a random effects meta-analysis.
The average +/- SE placebo effect on the peak urinary flow rate was an increase of 0.51 +/- 0.51 mL/s. The estimated effect of Permixon was a further increase of 2.20 +/- 0.51 mL/s (P <0.001). Placebo was associated with a reduction in the mean number +/- SE of nocturnal urinations of 0.69 +/- 0.15. A further reduction of 0.50 +/- 0.01 episodes of urination (P <0.001) occurred that was attributable to Permixon. Some heterogeneity was found among the studies. Treatment duration did not appear to impact either of these effects.
This meta-analysis of all available published trials of Permixon in the treatment of men with benign prostatic hyperplasia revealed a significant improvement in peak flow rate and reduction in nocturia greater than with placebo.
Permixon是从美洲矮棕榈树（锯叶棕）果实中提取的一种化合物。对于在有提示良性前列腺增生的下尿路症状的男性中使用植物治疗剂存在重大争议。我们分析了Permixon制剂的所有可用临床试验数据，以确定其与安慰剂相比的临床疗效。
使用了所有已发表的关于Permixon的临床试验数据（11项随机临床试验和2项开放标签试验），涉及2859名患者。这些试验在规模（从22名至592名患者）和持续时间（从21天至180天）上各不相同。最大尿流率和夜尿是两个常见的终点。统计分析基于随机效应荟萃分析。
安慰剂对最大尿流率的平均±标准误效应是增加0.51±0.51 mL/s。Permixon的估计效应是进一步增加2.20±0.51 mL/s（P<0.001）。安慰剂与夜间排尿平均次数±标准误减少0.69±0.15有关。Permixon导致排尿次数进一步减少0.50±0.01次（P<0.001）。研究之间发现了一些异质性。治疗持续时间似乎对这些效应均无影响。
这项对所有已发表的Permixon治疗良性前列腺增生男性的可用试验的荟萃分析显示，与安慰剂相比，最大尿流率有显著改善，夜尿减少。
