Alternative Therapies for BPH, Multiethnic Variablility

描述(由申请人提供)： 良性前列腺增生症(BPH)是50岁以上男性最常见的疾病。治疗良性前列腺增生症的替代疗法，特别是植物疗法的使用迅速增加。已发表的研究集中在这些疗法的相对疗效，即症状、尿流率和夜尿以及副作用方面。到目前为止，还没有研究描述那些接受植物治疗剂治疗的人BPH进展的自然历史，如Serenoa epens(锯棕榈浆果)或Pygeurn African anum(非洲李树)。此外，不同年龄和种族的前列腺增生症的自然历史特征也很差。 前列腺癌和纽约长老会医院的整体泌尿学中心每年评估和治疗3200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的CETC，它处于很好的地位，能够满足招募和患者保留的目标。这项试验将对未接受治疗的人群(即安慰剂和植物治疗剂治疗的人群)中BPH的进展和相关症状提供巨大的洞察力。这一点特别重要，因为只有了解BPH未经治疗的自然病史才能真正确定疗效。我们的主要目标是确定塞雷诺阿是否会延缓或阻止BPH的临床进展。患者将被归类为1)疾病的进展，其定义如下：基线AUA症状评分上升4分；尿潴留；尿失禁；或反复尿路感染；2)交叉使用已知的治疗方法，即临床进展之前的内科或侵入性治疗；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治疗的患者。次要结果包括根据症状和尿动力学测量确定的Serenoa epens和Pygeum Africa anum之间的比较疗效。 通过这项全面的BPH试验，我们希望确定：A)植物治疗药物对BPH临床进展的影响(如果有的话)，B)治疗BPH的最佳时间干预，C)特定民族是否表现出不同形式的BPH，导致不同的进展速度和不同的治疗反应？以及，D)前列腺增生症的植物治疗干预是否会影响前列腺炎等伴随的前列腺病？

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?