Alternative Therapies for Benign Prostatic Hyperplasia

描述（由申请人提供）：Serenoa repens（锯棕榈）和Pygeum africanum似乎对已建立的良性前列腺增生（BPH）的病理生理有一定的益处，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。几乎每一项研究、系统回顾和荟萃分析报告都分析了这些植物治疗药物对BPH的影响，得出了相同的结论：需要进一步的研究来确定其长期安全性、有效性以及预防进展性BPH相关并发症的能力。本研究的主要目的是确定与安慰剂治疗相比，serenoa rereis或pygeum africum是否延迟或阻止良性前列腺增生的临床进展。次要目的是比较这两种治疗方法的相对疗效，并确定这两种药物是否能改善前列腺增生症的症状，改善前列腺增生症的特定生活质量，提高前列腺增生症男性的最大尿流量和减少残留尿。患有轻度至中度前列腺增生症状的男性，不希望或不需要立即进行药物或手术治疗，在安慰剂试验后，将随机分为安慰剂组、serenoa repens组或pygeum africum组，并将对疾病进展进行至少4年的随访。进展将定义为AUA症状评分比基线增加4分或更多，或出现以下任何BPH并发症；急性尿潴留、尿失禁、梗阻性尿病（以肌酐升高测量）或BPH相关的尿路感染。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具有丰富的经验和专业知识，是加拿大在招募患者进行多中心BPH试验方面最成功的研究小组。在NIH-NIDDK资助的研究中，首席研究员是一个成功而有效的合作者。这个小组的成员已经证明了他们的意愿和能力，以有效和和谐的方式在合作的国际多中心研究中工作，包括NIH赞助的合作小组。加拿大BPH研究小组将是拟议的NIH植物治疗BPH预防试验的宝贵合作伙伴。

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.