Alternative Therapies for BPH, Multiethnic Variability

BPH 的替代疗法、多种族差异

• 批准号: 7990717
• 负责人: STEVEN A KAPLAN
• 金额: $ 12.41万
• 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 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7990717
• 关键词: Adverse effects; Alternative Therapies; Benign Prostatic Hypertrophy; Bladder; Blood; Blood Chemical Analysis; Chronic Prostatitis; Complementary and alternative medicine; Complete Blood Count; Data Set; Double-Blind Method; Functional disorder; Goals; Health; Hospitals; Incontinence; Institutes; Measures; Morbidity - disease rate; Natural History; New York; Nocturia; Paper; Participant; Patient Recruitments; Placebos; Population; Positioning Attribute; Presbyterian Church; Principal Investigator; Prostate; Prostate-Specific Antigen; Protocols documentation; Publications; Quality of life; Randomized; Residual volume; Sabal serrulata; Safety; Secondary to; Sleep; Source; Specific qualifier value; Symptoms; Time; United States National Institutes of Health; arm; base; clinical effect; follow-up; indexing; insight; lower urinary tract symptoms; medical schools; meetings; men; older men; public health relevance; research clinical testing; treatment center; treatment duration; urologic

DESCRIPTION (provided by applicant): The Institute for Bladder and Prostate Health at Weill Cornell Medical College - New York-Presbyterian Hospital evaluates and treats an ethnically diverse group of more than 3,200 men per year with lower urinary tract symptoms (LUTS) secondary to benign prostatic hypertrophy (BPH). It has been well positioned to meet the recruitment and patient retention goals as a Clinical Evaluation and Treatment Center (CETC) in the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) trial. CAMUS is a randomized, double-blind, multi-center trial to determine if Serenoa repens reduces LUTS compared to placebo. Participants were randomized equally to one of two treatment arms: extract of Serenoa repens 320 mg once daily for 24 weeks (one gelcap), followed by 640 mg daily for 24 weeks (two gelcaps), followed by 960 mg daily for 24 weeks (three gelcaps) or placebo. Participants continue on study treatment until they meet a protocol defined reason for treatment discontinuation or complete the 72 week treatment period. This trial will provide enormous insight into the progression of BPH and related symptoms in both an untreated population, i.e. placebo vs. one treated with Serenoa repens. This is of particular importance because efficacy can be truly determined only with an understanding of the untreated natural history of BPH. The primary objective is to ascertain if Serenoa repens extract reduces the AUA symptom score compared to placebo over 72 weeks of treatment and is well tolerated. Secondary objectives are as follows: to determine if Serenoa repens has a beneficial effect on subjective global assessment; to assess the impact of Serenoa repens on the following measures over time: BPH Impact Index, Quality of Life item score from the IPSS, Nocturia item score from the IPSS, Peak uroflow. Post-void residual volume, PSA level. Erectile and ejaculatory function, ICSmale Incontinence scale, Jenkins Sleep Dysfunction scale and NIH Chronic Prostatitis Symptom Index; and to assess the impact of the assigned treatments on conhplete blood counts and basic blood chemistries. PUBLIC HEALTH RELEVANCE: LUTS related to BPH are common among older men, and represent a significant source of morbidity. Extracts of Serenoa repens may have a modest favorable effect on some LUTS with few side effects. However, the trials documenting both the safety and efficacy of this agent have many methodological problems, and the mechanism of their clinical effect, if any, remain undefined.

描述（由申请人提供）：威尔康奈尔医学院-纽约长老会医院膀胱和前列腺健康研究所每年评估和治疗3,200多名患有继发于良性前列腺肥大（BPH）的下尿路症状（LUTS）的男性。作为泌尿系统症状的补充和替代医学（CAMUS）试验的临床评价和治疗中心（CETC），它已处于良好的位置，以满足招募和患者保留目标。CAMUS是一项随机、双盲、多中心试验，旨在确定与安慰剂相比，Serenoa repens是否能降低LUTS。参与者被随机分为两个治疗组：Serenoa repens提取物320 mg，每天一次，持续24周（一个胶囊），然后是640 mg，每天24周（两个胶囊），然后是960 mg，每天24周（三个胶囊）或安慰剂。受试者继续接受研究治疗，直至符合方案规定的治疗中止原因或完成72周治疗期。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Serenoa repens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。主要目的是确定与安慰剂相比，Serenoa repens提取物在72周的治疗中是否降低了AUA症状评分，并且耐受性良好。次要目的如下：确定Serenoa repens是否对主观总体评估具有有益影响;评估Serenoa repens随时间推移对以下指标的影响：BPH影响指数、来自IPSS的生活质量项目评分、来自IPSS的夜尿症项目评分、尿流峰值。排尿后残余尿量，PSA水平。勃起和射精功能、ICSmale勃起功能量表、Jenkins睡眠障碍量表和NIH慢性前列腺炎症状指数;并评估分配的治疗对全血细胞计数和基本血生化的影响。 公共卫生相关性：与BPH相关的LUTS在老年男性中很常见，是发病率的重要来源。Serenoa repens的提取物可能对某些LUTS有适度的有利作用，副作用很少。然而，记录这种药物的安全性和有效性的试验存在许多方法学问题，并且其临床作用的机制（如果有的话）仍然不确定。