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) 引起的下尿路症状 (LUTS) 在老年男性中非常常见，并且在发病率和医疗保健资源利用方面都带来了相当大的医疗保健负担。除了标准疗法经尿道前列腺电切术（TURP）外，过去十年还开发了微创手术疗法（MIST），并得到了不同程度的应用。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、5α 还原酶抑制剂 (5 ARI) 和植物治疗剂。 α受体阻滞剂的使用得到长达 12 个月持续时间的随机对照试验和长达 60 个月持续时间的开放标签延伸试验的支持。 5 ARI 的使用得到长达 48 个月持续时间的随机对照试验和长达 72 个月的开放标签延伸试验的支持。期间。在许多不同的可用植物治疗制剂中，很少有经过随机安慰剂对照试验的研究，通常持续时间为 6 个月或更短。最常用的制剂是锯棕榈提取物，它经过了最广泛的测试，包括长达 12 个月的随机试验，与 α 阻滞剂直接比较，但不与安慰剂进行比较。鉴于这些非处方制剂的广泛使用，迫切需要有关最常用化合物的相对安全性和有效性的数据。该联盟的目的是开发并开展涉及这些化合物的相关临床试验。建议对锯棕榈提取物和非洲臀果木进行一项随机、安慰剂对照试验，并进行 4 至 6 年的随访期，在参与中心招募约 3,000 名患者，其目标如下： 确定锯棕榈和非洲臀果木与安慰剂相比在预防 LUTS 和 BPH 进展方面的功效（定义 (1) 作为 AUA 症状指数的两次验证增加） 与基线相比有四个或更多点，(2) 出现自发性或突发性急性尿潴留 (AUR)，(3) 需要对 BPH 进行 MIST 或手术治疗，无论有或没有 AUR 的前期发作，(4) 出现肾功能不全（由于 BPH）、复发性尿路感染 (UTI)（由于 BPH）或失禁。 (5) 确定锯棕榈和非洲臀果木与安慰剂相比，从基线到研究结束在改善 AUA SI、其他人文问卷、性功能、总体主观评估和最大尿流率方面的功效。 (7) 确定基线参数是否能够预测对不同疗法的反应。 (8) 确定与安慰剂相比，锯棕榈或非洲臀果木是否引起前列腺体积、移行区体积、血清 PSA 和其他基于血清或组织的 BPH 生物标志物的可测量变化。