Boyle P, Robertson C, Lowe F, Roehrborn C
Department of Epidemiology and Biostatistics, European Institute of Oncology, via Ripamonti 435, 20141 Milan, Italy.
BJU Int. 2004 Apr;93(6):751-6. doi: 10.1111/j.1464-410X.2003.04735.x.
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).
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.
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.
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.
通过分析所有可用的临床试验数据，确定美洲矮棕榈树果实提取物（普适泰，法国皮埃尔法布雷制药公司，卡斯特尔）相对于安慰剂治疗提示良性前列腺增生（BPH）的下尿路症状（LUTS）男性患者的临床疗效，因为植物治疗药物在这类男性患者中的应用存在争议。
分析了所有发表的关于普适泰的临床试验数据，包括14项随机临床试验和3项开放标签试验，涉及4280例患者。这些试验规模不同（22 - 1100例患者），持续时间不同（21 - 720天）。最大尿流率和夜尿次数是两个常见的终点指标。统计分析基于随机效应荟萃分析。
普适泰使国际前列腺症状评分（IPSS）平均（标准误）降低4.78（0.41）。安慰剂对最大尿流率的平均效应是增加1.20（0.49）mL/s。普适泰的估计效应是进一步增加1.02（0.50）mL/s（P = 0.042）。安慰剂使夜间排尿平均次数减少0.63（0.14）；普适泰使其进一步减少0.38（0.07）（P < 0.001）。夜尿相关研究存在一定异质性；一项为期2年、涉及396例患者且显示安慰剂与普适泰无差异的研究对结果有较大影响。
这项对所有已发表的普适泰治疗BPH男性患者试验的荟萃分析表明，与安慰剂相比，最大尿流率有显著改善，夜尿次数减少，IPSS降低5分。
