Alternate Therapies for Benign Prostate Symptoms

良性前列腺症状的替代疗法

• 批准号: 6587434
• 负责人: CLAUS G ROEHRBORN
• 金额: $ 13.5万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 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 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6587434
• 关键词: aging; alternative medicine; benign prostate hyperplasia; chemotherapy; clinical research; clinical trials; cooperative study; drug screening /evaluation; human subject; human therapy evaluation; longitudinal human study; male; medicinal plants; plant extracts; prostate specific antigen; urinary tract disorder; urinary tract infection; urinary tract obstruction; urination disorder

DESCRIPTION (provided by applicant): Lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) are very common findings in aging men and present a considerable health care burden both in terms of morbidity as well as health care resource utilization. Aside from the standard therapy transurethral resection of the prostate (TURP), minimally invasive surgical therapies (MIST) have been developed over the past decade, which are utilized to varying degrees. In addition, three classes of medications are currently being utilized for the treatment of LUTS and BPH: alpha adrenergic receptor blocker, 5 alpha reductase inhibitors (5 ARI), and phytotherapeutic agents. The use of alpha blocker is supported by RCTs of up to 12 mo duration and open label extension trials up to 60 mo duration. Use of the 5 ARI is supported by RCTs of up to 48 mo duration and open label extension trials up to 72 mo. duration. Of the many different phytotherapeutic preparations available, few have been studied in randomized placebo-controlled trials usually 6 mo or shorter in duration. The most commonly used preparation is saw palmetto extract, which has undergone the most extensive testing including randomized trials of up to 12 mo duration in direct comparison to an alpha blocker, however, not against placebo. Given the widespread use of these over the counter preparation data regarding the relative safety and efficacy of the most commonly used compounds are urgently needed. The purpose of the consortium is to develop and carry out a relevant clinical trial involving these compounds. A randomized, placebo-controlled trial of saw pametto extract and pygeum africanum with a 4 to 6 yrs follow-up period is proposed enrolling approx 3,000 patients at the participating centers with the following objectives: Determine the efficacy.of saw palmetto and pygeum africanum compared with placebo in preventing the progression of LUTS and BPH defined (1) as a twice validated increase in the AUA Symptom Index by four or more points from baseline, (2) as the development of either spontaneous or precipitated acute urinary retention (AUR), (3) as the need for MIST or surgical therapy for BPH with or without a preceding episode of AUR, (4) as the development of renal insufficiency ( due to BPH), recurrent urinary tract infection (UTI) (due to BPH), or incontinence. (5) Determine the efficacy of saw palmetto and pygeum africanum compared with placebo in terms of improving the AUA SI, other humanistic questionnaires, sexual functioning, global subjective assessment and maximum urinary flow rate from baseline to end of study. (7) Determine whether baseline parameters are able to predict response to the different therapies administered. (8) Determine whether saw palmetto or pygeum africanum compared to placebo induce measurable changes in prostate volume, transition zone volume, serum PSA and other serum or tissue based biomarkers of BPH.

描述（由申请人提供）： 由良性前列腺增生（BPH）引起的较低的尿路症状（LUTS）在老龄化男性中非常普遍，并且在发病率和医疗保健资源利用方面都表现出相当大的医疗保健负担。除了前列腺（TURP）的标准疗法经尿道切除外，在过去的十年中已经开发了微创手术疗法（MIST），这些手术疗法已在不同程度上使用。此外，目前正在使用三类药物来治疗LUTS和BPH：α肾上腺素能受体阻滞剂，5种α还原酶抑制剂（5 ARI）和植物治疗剂。 Alpha阻滞剂的使用由最多12个月的RCT和开放标签扩展试验支持高达60 mo的持续时间。 5 ARI的使用由高达48个月的RCT支持，开放标签的扩展试验高达72 mo。期间。在可用的许多不同的植物治疗制剂中，很少有人在安慰剂对照的试验中进行研究，通常在持续时间为6个月或较短。最常用的制剂是SAW Palmetto提取物，它进行了最广泛的测试，包括与Alpha阻滞剂直接比较的随机试验，最多为12 mo，而不是与安慰剂相对。鉴于这些对最常用化合物的相对安全性和有效性的广泛使用在计数器准备数据上的广泛使用。财团的目的是开发和进行涉及这些化合物的相关临床试验。提出了一项4至6年随访期的锯木果提取物和非洲的随机，安慰剂对照试验，该试验的随访期为4至6年，在参与中心的患者约有3,000名患者，具有以下目标：确定saw palmetto和pygeum非洲的效果。基线的四个或更多点，（2）作为自发性或急性急性尿位retention留（AUR）的发展，（3）是对BPH进行雾气或手术治疗的需求，或者没有AUR的前一集，（4）作为肾脏不足（由于BPH）的发展（由于BPH）的发展，肾上腺反复感染，或尿液中的感染（uti）（uti）（bph）（BPH）（BPH）（BPH），（BPH），（BPH），（BPH），（BPH）。 （5）在改善AUA SI，其他人文化问卷，性功能，全球主观评估以及从基线到研究结束的最大尿流量方面，与安慰剂相比，确定了SAW Palmetto和Africanum的疗效。 （7）确定基线参数是否能够预测对给予不同疗法的反应。 （8）确定与安慰剂相比，SAW Palmetto或Pygeum Africanum是否会引起前列腺体积，过渡区体积，血清PSA以及其他血清或组织基于BPH的生物标志物的可测量变化。