Alternative Therapies for Benign Prostatic Hyperplasia

描述（由申请人提供）：锯叶棕（锯棕榈）和非洲臀果木似乎对已确定的良性前列腺增生（BPH）的病理生理学具有适度的益处，但更重要的是，这些药物可能影响疾病进展过程的发病机制。几乎每一项单独的研究，系统评价和荟萃分析报告分析了这些植物治疗剂对BPH的影响，得出了相同的结论：需要进一步的研究来确定长期的安全性和有效性以及预防与进行性BPH相关的并发症的能力。本研究的主要目的是确定与安慰剂治疗相比，锯叶木或非洲臀果木是否延迟或预防良性前列腺增生的临床进展。次要目的将比较这两种治疗的相对疗效，并确定这两种药物中的任一种是否改善BPH症状，改善BPH特异性生活质量，改善最大尿流率并减少BPH男性的残余尿。不希望或不需要立即药物或手术治疗的轻度至中度BPH症状的男性将在安慰剂导入后随机分配至安慰剂、锯叶苔或非洲臀果木组，并随访疾病进展至少4年。进展将定义为AUA症状评分较基线增加4分或以上，或发生以下任何BPH并发症：急性尿潴留、失禁、阻塞性尿路病（测量为肌酐升高）或BPH相关尿路感染。加拿大BPH研究小组（Canadian CETC）在设计和实施BPH多中心临床试验方面拥有丰富的经验和专业知识，是加拿大招募患者参加多中心BPH试验的最成功的研究小组。主要研究者在NIH-NIDDK资助的研究中是一个成功和有效的合作者。这个小组的成员已经证明了他们的意愿和能力，在合作的国际多中心研究，包括美国国立卫生研究院赞助的合作小组，以有效和适宜的方式工作。加拿大BPH研究小组将成为NIH植物治疗BPH预防试验的重要合作伙伴。

DESCRIPTION (provided by applicant): Serenoa repens (saw palmetto) and Pygeum africanum appear to have modest benefit on the pathophysiology of established benign prostatic hyperplasia (BPH) but even more importantly these agents may affect the pathogenesis of the progressive disease process. Almost every individual study, systematic review and meta-analysis report analyzing the effect of these phytotherapeutic agents on BPH have come to the same conclusion: further research is needed to determine the long term safety and effectiveness and ability to prevent complications associated with progressive BPH. The primary objective of this study is to determine if serenoa repens or pygeum africanum delays or prevents clinical progression of benign prostatic hyperplasia compared to placebo treatment. Secondary objectives will compare relative efficacy of these two treatments and also determine whether either of these agents ameliorate symptoms of BPH, improve BPH specific quality of life, improve maximum flow rate and reduce residual urine in men with BPH. Men with mild to moderate symptoms of BPH who do not desire or require immediate medical or surgical treatment will be randomized to placebo, serenoa repens or pygeum africanum after placebo run in and will be followed for disease progression for a minimum of four years. Progression will be defined as an increase in AUA symptom score of 4 or more points from baseline, or occurrence of any of the following complications of BPH; acute urinary retention, incontinence, obstructive uropathy (measured as increased creatinine) or BPH related urinary tract infection. The Canadian BPH Research Group (Canadian CETC) have demonstrated experience and expertise in designing and implementing multi-center clinical trials in BPH and are the most successful research group in Canada in recruiting patients to multi-center BPH trials. The principal investigator has been a successful and effective collaborator in studies funded by NIH-NIDDK. The members of this group have demonstrated their willingness and ability to work in an effective and congenial manner in collaborative international multi-center studies including NIH sponsored collaborative groups. The Canadian BPH study group would be a valuable partner in the proposed NIH phytotherapeutic BPH prevention trial.