Alternative Therapies for BPH, Multiethnic Variablility

BPH 的替代疗法、多种族差异

• 批准号: 7418209
• 负责人: STEVEN A KAPLAN
• 金额: $ 12.66万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7418209
• 关键词: Adverse effects; African; Age; Alternative Therapies; Benign; Benign Prostatic Hypertrophy; Berry; Bladder Dysfunction; Clinical; Clinical Trials; Code; Complex; Condition; Disease; Disease Progression; Disease regression; Ethnic group; Functional disorder; Goals; Hispanics; Histologic; Hospitals; Incontinence; Intervention; Invasive; Knowledge; Label; Measurement; Medical; Natural History; New York; Nocturia; Outcome; Patient Recruitments; Patient observation; Patients; Personal Satisfaction; Pharmaceutical Preparations; Phytotherapy; Placebos; Plum; Population; Positioning Attribute; Presbyterian Church; Principal Investigator; Prostate; Prostatic hypertrophy; Prunus africana; Publishing; Qualifying; Quality of life; Rate; Recruitment Activity; Recurrence; Relative (related person); Research; Residual state; Role; Sabal serrulata; Score; Secondary to; Severities; Severity of illness; Site; Symptoms; Therapeutic; Time; Transrectal Ultrasound; Treatment Protocols; Trees; Urinary Retention; Urinary tract infection; Urination; Urine; Urodynamics; Urology; bis(beta-carboxyethyl)tin dichloride; comparative; disease natural history; insight; lower urinary tract symptoms; men; prevent; programs; prostatitis; response; size; urinary

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?

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。替代疗法的使用迅速增加，特别是植物治疗剂，以治疗BPH。已发表的研究集中于这些疗法的相对疗效，即症状、尿流率和排尿和副作用特征。迄今为止，还没有研究描述了那些用植物治疗剂如Serenoa repens（锯棕榈浆果）或Pygeurn africanum（非洲李子树）治疗的人的BPH进展的自然史。此外，BPH在不同年龄和种族群体中的自然史特征很差。 前列腺坎特和纽约长老会医院整体泌尿学中心每年评估和治疗一个种族多样化的群体，其中有3,200多名男性继发于BPH的下尿路症状。在这项重要的多中心、7年试验中，作为CETC，它处于良好的位置，能够满足招募和患者保留目标。这项试验将提供巨大的洞察BPH和相关症状的进展，在两个未经治疗的人口，即安慰剂与一个与植物治疗剂治疗。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。我们的主要目的是确定Serenoa repens或Pygeum africanum是否延迟或阻止BPH的临床进展。患者将被分类为1）疾病进展，如由以下之一定义的：基线AUA症状评分上升4分;尿潴留;失禁;或复发性尿路感染; 2）交叉至已知治疗，即在临床进展之前的药物或侵入性治疗; 3）不依从编码的药物治疗方案，包括选择观察等待或开放标签植物疗法的患者。次要结果包括根据症状和尿动力学测量结果确定的锯叶木和非洲臀果木之间的比较疗效。 通过这项全面的BPH试验，我们希望确定：A）植物治疗剂对BPH临床进展的影响（如果有的话），B）BPH治疗中的最佳时间干预，C）特定种族群体是否表现出导致不同进展率和对治疗的不同反应的各种形式的BPH？以及，D）BPH的植物治疗干预是否会影响伴随的前列腺疾病如前列腺炎？