Phytotherapy for Benign Prostatic Hyperplasia

植物疗法治疗良性前列腺增生

• 批准号: 6801411
• 负责人: Andrew L Avins
• 金额: $ 37.48万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 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/6801411
• 关键词: alternative medicine; benign prostate hyperplasia; chemotherapy; clinical research; clinical trials; cooperative study; human therapy evaluation; male; medicinal plants; patient oriented research; plant extracts; prostate specific antigen

DESCRIPTION (provided by applicant): The use of herbal extracts for treatment of benign prostatic hyperplasia (BPH) is growing rapidly in the United States. Numerous small clinical studies, carried out primarily in Europe, suggest that some of these extracts have great potential for providing relief of symptoms and, possibly, altering the natural course of BPH. The size and quality of prior studies, however, make it impossible to provide firm evidence-based recommendations to patients; the need for higher-quality, longer-term studies is compelling. This proposal describes plans to establish a Clinical Evaluation and Treatment Center in response to RFA # DK-02-026. We plan to bring the substantial patient population and scientific resources of the Northern California Kaiser-Permanente (NCKP) Division of Research (DOR) to support the successful completion of this important multicenter randomized clinical trial. While the final details of the research protocol will be established by the trial's Steering and Planning Committee, the approach described in this proposal is based on prior successful trials of BPH therapeutics and an ongoing NIH-funded randomized, double-blind, placebo-controlled trial of saw palmetto currently being conducted by our group. Participants will be recruited from five NCKP clinical facilities, which serve over 100,000 men aged 50 and older who are unlikely to meet exclusion criteria. Entry criteria include male participants at least 50 years old with an American Urological Association Symptom Index (AUASI) Score >7, no prior history of prostate cancer or prostate surgery, PSA below the age-adjusted upper limit (or PSA<10 with negative prostate biopsy), and creatinine<2.0mg/dl. Patients on current medical therapy will undergo a wash-out phase prior to final eligibility determination. Eligible patients will undergo a one-month single-blind run-in period; those demonstrating adequate adherence will be randomized in equal proportions to saw palmetto, pygeum, or placebo. Patients will be followed at four-month intervals for a period of four-to-six years. Primary endpoints are those specified in the RFA (acute urinary retention, BPH-related renal insufficiency, recurrent urinary tract infections, incontinence, and an increase of at least 4 points in the AUASI); secondary endpoints include symptom scores, uroflow measurements, and adverse effects. A systematic, multifaceted approach will be used to promote participant adherence to the study protocol.

描述（由申请人提供）： 在美国，使用草药提取物治疗良性前列腺增生（BPH）正在迅速生长。主要在欧洲进行的许多小型临床研究表明，其中一些提取物具有减轻症状的巨大潜力，并可能改变了BPH的自然过程。但是，先前研究的规模和质量使得不可能向患者提供基于证据的建议；对更高质量的长期研究的需求令人信服。 该提案描述了针对RFA＃DK-02-026建立临床评估和治疗中心的计划。我们计划将北加州Kaiser-permanente（NCKP）研究（DOR）的大量患者人口和科学资源带来支持，以支持这项重要的多中心随机临床试验的成功完成。虽然研究方案的最终细节将由试验的指导和计划委员会确定，但本提案中描述的方法基于先前对BPH Therapeutics的成功试验，以及正在进行的NIH资助的随机，双盲，安慰剂对照试验的SAW Palmetto目前正在我们小组进行的。 参与者将从五个NCKP临床设施中招募，这些设施为100,000多名50岁及以上的男性服务，不太可能符合排除标准。入学标准包括至少50岁的男性参与者，具有美国泌尿科协会症状指数（AUASI）得分> 7，没有前列腺癌或前列腺手术的先前史，PSA低于年龄调整后的上限（或PSA <10，具有阴性前列腺活检）和肌酐<2.0mg/dl。当前的医疗疗法患者将在最终资格确定之前进行洗涤阶段。符合条件的患者将经历一个月的单盲跑期；那些表现出足够的依从性的人将与锯棕榈，pyge或安慰剂相等地随机分配。 患者将在四到六年的时间内以四个月的间隔进行。主要终点是RFA中指定的（急性尿位率，与BPH相关的肾脏不足，反复发作的尿路感染，尿失禁和AUASI中至少4分的增加）；次要终点包括症状评分，尿流测量和不良影响。系统的多方面方法将用于促进参与者遵守研究方案。