Ishani A, MacDonald R, Nelson D, Rutks I, Wilt T J
Minneapolis Veterans Affairs Center for Chronic Disease Outcomes Research and the VA Coordinating Center for the Cochrane Review Group in Prostate Diseases and Urologic Malignancies, Minneapolis, Minnesota, USA.
Am J Med. 2000 Dec 1;109(8):654-64. doi: 10.1016/s0002-9343(00)00604-5.
To conduct a systematic review and quantitative meta-analysis of the therapeutic efficacy and tolerability of Pygeum africanum in men with symptomatic benign prostatic hyperplasia.
Studies were identified through the search of Medline (1966 to 2000), Embase, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with relevant authors and drug companies. Randomized trials were included if participants had symptomatic benign prostatic hyperplasia, the intervention was a preparation of P. africanum alone or in combination with other phytotherapeutic agents, a control group received placebo or other pharmacologic therapies for benign prostatic hyperplasia, and treatment duration was at least 30 days. Two investigators independently extracted key data on design features, subject characteristics, and therapy allocation.
A total of 18 randomized controlled trials involving 1,562 men met the inclusion criteria and were analyzed. Many studies did not report results in a method that permitted meta-analysis. Only 1 of the studies reported a method of treatment allocation concealment, although 17 were double-blinded. The mean study duration was 64 days (range 30 to 122). Compared with placebo in 6 studies, P. africanum provided a moderately large improvement in the combined outcome of urologic symptoms and flow measures as assessed by an effect size defined by the difference of the mean change for each outcome divided by the pooled standard deviation for each outcome (-0.8 SD [95% confidence interval (CI): -1.4 to -0.3]). Summary estimates of individual outcomes were also improved by P. africanum. Men were more than twice as likely to report an improvement in overall symptoms (risk ratio = 2.1, 95% CI: 1.40 to 3.1). Nocturia was reduced by 19% and residual urine volume by 24%; peak urine flow was increased by 23%. Adverse effects due to P. africanum were mild and similar to placebo. The overall dropout rate was 12% and was similar for P. africanum (13%), placebo (11%), and other controls (8%; P = 0.4 versus placebo and P = 0.5 versus other controls).
The literature on P. africanum for the treatment of benign prostatic hyperplasia is limited by the short duration of studies and the variability in study design, the use of phytotherapeutic preparations, and the types of reported outcomes. However, the evidence suggests that P. africanum modestly, but significantly, improves urologic symptoms and flow measures. Further research is needed using standardized preparations of P. africanum to determine its long-term effectiveness and ability to prevent complications associated with benign prostatic hyperplasia.
对非洲臀果木治疗有症状的良性前列腺增生症男性的疗效和耐受性进行系统评价和定量荟萃分析。
通过检索Medline（1966年至2000年）、Embase、Phytodok、Cochrane图书馆、已识别试验和综述文章的参考文献，并与相关作者和制药公司联系来识别研究。纳入的随机试验需满足以下条件：参与者患有有症状的良性前列腺增生症；干预措施为单独使用非洲臀果木制剂或与其他植物治疗剂联合使用；对照组接受安慰剂或其他治疗良性前列腺增生症的药物治疗；治疗持续时间至少30天。两名研究者独立提取关于设计特征、受试者特征和治疗分配的关键数据。
共有18项涉及1562名男性的随机对照试验符合纳入标准并进行了分析。许多研究未以允许进行荟萃分析的方法报告结果。只有1项研究报告了治疗分配隐藏方法，尽管有17项研究为双盲试验。平均研究持续时间为64天（范围30至122天）。在6项研究中，与安慰剂相比，非洲臀果木在泌尿系统症状和流量测量的综合结果方面有中度较大改善，通过效应量评估，效应量定义为每个结果的平均变化差异除以每个结果的合并标准差（-0.8标准差[95%置信区间（CI）：-1.4至-0.3]）。非洲臀果木也改善了各个结果的汇总估计值。男性报告总体症状改善的可能性是安慰剂组的两倍多（风险比=2.1，95%CI：1.40至3.1）。夜尿减少了19%，残余尿量减少了24%；最大尿流率增加了23%。非洲臀果木引起的不良反应轻微，与安慰剂相似。总体脱落率为12%，非洲臀果木组（13%）与安慰剂组（11%）和其他对照组（8%）相似（与安慰剂组相比P=0.4，与其他对照组相比P=0.5）。
关于非洲臀果木治疗良性前列腺增生症的文献受限于研究持续时间短、研究设计的变异性、植物治疗制剂的使用以及报告结果的类型。然而，证据表明非洲臀果木能适度但显著地改善泌尿系统症状和流量测量。需要使用标准化的非洲臀果木制剂进行进一步研究，以确定其长期有效性以及预防与良性前列腺增生症相关并发症的能力。
