Saw palmetto and Pygeum africanum on BPH Progression

描述（由申请人提供）： 该提案是对NIH-NIDDK研究项目（合作协议）的回应，供10个临床评价和治疗中心（CETC）之一考虑，形成一个联盟，以开发和进行随机安慰剂对照试验，以评价使用锯棕榈（SP）或非洲臀果木（PA）是否可以预防BPH的进展。 健康相关性：BPH是困扰男性的最常见的肿瘤疾病，是影响美国人的主要因素。目前的研究估计，30%的美国男性将需要外科手术来纠正这个问题在他们的生活中的某个时候。越来越多的关注已经支付给植物提取物（或植物疗法）使用的病人自我治疗医疗疾病，如前列腺增生症。在进行更适当的试验之前，植物治疗剂的功效将仍然未经证实。这项研究对于回答这个问题以及其他与BPH进展有关的问题至关重要。 具体目的：本研究的主要目的是探讨SP或PA是否会改变BPH进展或只是延迟手术治疗的时间。积累的数据应提供这些治疗对BPH客观参数（包括AUA症状评分、最大尿流率或前列腺大小）的长期影响的证据，以及这些药物对其影响的比较。 设计和方法：在三个治疗组中，1000例有BPH症状的患者将被分配到SP、PA或安慰剂组，并随访4-6年。进展参数将包括：1）AUA症状评分的变化，2）尿潴留，3）复发性UTI，4）肾功能不全，5）尿失禁或6）交叉至已知治疗。BPH的客观参数包括前列腺大小、最大尿流率和AUA症状评分。 次要目的：本次提交的独特之处在于主诉分析、睡眠量表测量或直接/间接医疗保健成本分析是否提供了可靠或有用的信息。

DESCRIPTION (provided by applicant): The proposal is a response for a research project (cooperative agreement) by the NIH-NIDDK for consideration for one of 10 Clinical Evaluation and Treatment Centers (CETC) forming a consortium to develop and conduct a randomized placebo controlled trial to evaluate whether the use of Saw palmetto (SP) or Pygeum africanum (PA) can prevent the progression of BPH. Health Relatedness: BPH is the most common neoplastic condition afflicting men and constitutes a major factor impacting Americans. Current studies estimate 30% of American males will require a surgical procedure to correct this problem sometime in their life. Increasing attention has been paid to plant extracts (or phytotherapy) use by patients to self-treat medical ailments such as BPH. Until more appropriately conducted trials are undertaken, the efficacy of phytotherapeutic agents will remain unproven. This study will be crucial to answering that question as well as others pertaining to the progression of BPH. Specific Aims: The primary aim of this study is to address whether SP or PA alter BPH progression or simply delay the time to surgical therapy. The data accumulated should provide evidence regarding long term effects of these therapies on objective parameters of BPH including the AUA symptom score, maximal urinary flow rates, or prostate size and how these medications compare in their impact on the same. Design and Method: In three treatment arms 1000 patients with symptoms of BPH will be assigned to either SP, PA or placebo and followed for 4-6 years. Progression parameters will include: 1) changes in the AUA symptom score, 2) urinary retention, 3) recurrent UTI, 4) renal insufficiency, 5) urinary incontinence or 6) crossover to known therapy. Objective parameters of BPH will include prostate size, maximal urinary flow rates, and AUA symptom score. Secondary Aim: Unique to this submission is whether a chief complaint analysis, sleep scale measures or direct/indirect healthcare costs analysis provides reliable or useful information.