评估非洲臀果木提取物与荨麻（异株荨麻）提取物联合治疗良性前列腺增生（BPH）的疗效：双盲、随机、安慰剂对照试验。

Evaluating the efficiency of a combination of Pygeum africanum and stinging nettle (Urtica dioica) extracts in treating benign prostatic hyperplasia (BPH): double-blind, randomized, placebo controlled trial.

作者信息

Melo Ezer A, Bertero Eduardo B, Rios Luiz A S, Mattos Demerval

机构信息

Division of Urology, Hospital do Servidor Público Estadual de São Paulo, SP, Brazil.

出版信息

Int Braz J Urol. 2002 Sep-Oct;28(5):418-25.

PMID:15748367

Abstract

OBJECTIVES

In spite of its historical use, published data about phytotherapic products is characterized by the absence of well conducted studies, leading to conflictive and indefinite results about efficiency and safety of theses drugs. In that sense, we have analyzed the results of a combination of Pygeum africanum and stinging nettle (Urtica dioica) extracts in patients with benign prostatic hyperplasia (BPH), based in a double-blind, randomized, placebo-controlled protocol.

MATERIALS AND METHODS

We have selected, according to inclusion and exclusion criteria, only patients with >or=50 years, presenting urinary symptoms assessed by the International Prostatic Symptoms Score (IPSS), with minimum score of 12, and Quality of Life (QoL) index of at least 3 points, rectal examination consistent with BPH, and maximum urinary flow rate (Q(max)) between 5 and 15 mL/s. Phytotherapic and placebo groups were formed by 27 and 22 patients, respectively. The major variables analyzed during the study were IPSS variation, Q(max), and side effects. Reduction of >or=30% and >or=50% in IPSS were the parameters used to define a clinically significant response (CSR). We have also analyzed >or=30% and >or=50% Q(max) increases.

RESULTS

After six months of treatment we did not observe significant differences in clinical improvement potential between the phytotherapic combination and placebo groups. Percent IPSS drop of 21.6% in the phytotherapic group was similar to 19.7% obtained in the placebo group (p=0.928). Neither we observed any difference (p=0.530) for QoL improvement between phytotherapic (9.26%) and placebo (5.98%) groups. The alterations of Q(max) followed the trend line observed in clinical data, with no significant difference (p=0.463) in Q(max) increasing percent between phytotherapic (17.2%) and placebo (13.3%) groups. The CSR evaluation of clinical and urodynamic data was also similar between the groups.

CONCLUSION

The combination of 25mg Pygeum africanum and 300mg stinging nettle extracts produced clinical and urodynamic effects similar to placebo in a group of HBP patients.

摘要

目的

尽管植物疗法产品有其历史用途，但已发表的关于这些产品的数据的特点是缺乏精心设计的研究，导致关于这些药物的有效性和安全性的结果相互矛盾且不明确。从这个意义上说，我们基于双盲、随机、安慰剂对照方案，分析了非洲臀果木和荨麻（荨麻科荨麻属）提取物联合使用对良性前列腺增生（BPH）患者的治疗结果。

材料与方法

根据纳入和排除标准，我们仅选择了年龄≥50岁、经国际前列腺症状评分（IPSS）评估有排尿症状（最低评分为12分）、生活质量（QoL）指数至少为3分、直肠检查符合BPH且最大尿流率（Q(max)）在5至15毫升/秒之间的患者。植物疗法组和安慰剂组分别由27名和22名患者组成。研究期间分析的主要变量为IPSS变化、Q(max)和副作用。IPSS降低≥30%和≥50%是用于定义临床显著反应（CSR）的参数。我们还分析了Q(max)增加≥30%和≥50%的情况。

结果

治疗六个月后，我们未观察到植物疗法联合组与安慰剂组在临床改善潜力方面存在显著差异。植物疗法组IPSS下降百分比为21.6%，与安慰剂组的19.7%相似（p = 0.928）。我们也未观察到植物疗法组（9.26%）和安慰剂组（5.98%）在QoL改善方面有任何差异（p = 0.530）。Q(max)的变化遵循临床数据中观察到的趋势线，植物疗法组（17.2%）和安慰剂组（13.3%）在Q(max)增加百分比方面无显著差异（p = 0.463）。两组之间临床和尿动力学数据的CSR评估也相似。