Alternative Therapies for BPH, Multiethnic Variablility

描述（由申请人提供）： 良性前列腺增生 (BPH) 是 50 岁以上男性最常见的疾病。替代疗法（特别是植物治疗剂）用于治疗 BPH 的使用迅速增加。已发表的研究重点关注这些疗法的相对疗效，即症状、尿流率和夜尿以及副作用。迄今为止，还没有研究描述接受植物治疗剂（如锯棕榈浆果）或 Pygeurn africanum（非洲李树）治疗的患者 BPH 进展的自然史。此外，不同年龄和种族群体中良性前列腺增生的自​​然病史尚不清楚。 纽约长老会医院前列腺中心和整体泌尿外科中心每年评估和治疗 3,200 多名患有 BPH 继发下尿路症状的不同种族男性。在这项重要的多中心、为期 7 年的试验中，作为 CETC，它有能力满足招募和保留患者的目标。这项试验将为未经治疗的人群（即安慰剂与植物治疗剂治疗的人群）中 BPH 和相关症状的进展提供深入的了解。这一点特别重要，因为只有了解未经治疗的 BPH 自然史才能真正确定疗效。我们的主要目标是确定锯棕榈或非洲臀果木是否能延迟或阻止 BPH 的临床进展。患者将被分类为 1) 疾病进展，定义为以下之一：基线 AUA 症状评分上升 4 分；尿潴留；失禁;或反复尿路感染； 2) 与已知疗法交叉，即在临床进展之前进行药物或侵入性治疗； 3) 不遵守编码药物治疗方案，包括选择观察等待或开放标签植物疗法的患者。次要结果包括锯棕榈和非洲臀果木之间的疗效比较（根据症状和尿动力学测量确定）。 通过这项全面的 BPH 试验，我们希望确定：A) 植物治疗剂对 BPH 临床进展的影响（如果有的话），B) 治疗 BPH 的最佳时间干预措施，C) 特定种族群体是否表现出不同形式的 BPH，从而导致不同的进展速度和对治疗的不同反应？ D) BPH 的植物治疗干预是否会影响伴随的前列腺疾病，例如前列腺炎？

DESCRIPTION (provided by applicant): Benign prostatic hyperplasia (BPH) is the most common affliction of men over the age of 50. There has been a rapid increase in the use of alternative therapies and specifically, phytotherapuetic agents, to treat BPH. Published studies have focused on the relative efficacy, i.e. symptoms, urinary flow rate and nocturia and side effect profile of these therapies. To date, there have been no studies which have described the natural history of BPH progression in those who are treated with phytotherapeutic agents such as Serenoa repens (Saw palmetto berry) or Pygeurn africanum (African plum tree). Moreover, the natural history of BPH in various age and ethnic groups have been poorly characterized. The Prostate Canter and the The Center for Holistic Urology at The New York Presbyterian Hospital evaluates and treats an ethnically diverse group of more than 3,200 men per year with lower urinary tract symptoms secondary to BPH. It is well positioned to meet the recruitment and patient retention goals as a CETC in this important multi - center, 7 year trial. This trial will provide enormous insight into the progression of BPH and related symptoms in both an untreated population, i.e. placebo versus one treated with phytotherapeutic agents. This is of particular importance because efficacy can be truly determined only with an understanding of the untreated natural history of BPH. Our primary objective is to ascertain if Serenoa repens or Pygeum africanum delays or prevents the clinical progression of BPH. Patients will be classified as 1) Progression of disease as defined by one of the following: rise in baseline AUA Symptom Score of 4 points; urinary retention; incontinence; or recurrent urinary tract infections; 2) Crossover to known therapy, i.e. medical or invasive prior to clinical progression; 3) non - compliance with the coded medication treatment regimen including patients who elect watchful waiting or open - label phytotherapy. Secondary outcomes include comparative efficacy between Serenoa repens and Pygeum africanum as defined by symptoms and urodynamic measurements. Through this full scale BPH trial, we hope to ascertain: A) the effects, if any, of phytotherapeutic agents on the clinical progression of BPH, B) the optimal temporal intervention in the treatment of BPH, C) whether specific ethnic groups manifest various forms of BPH resulting in different rates of progression and differential response to therapy? and, D) whether concomitant prostate conditions such as prostatitis are effected by phytotherapeutic intervention for BPH?