Complementary and Alternative Medicine for Urological Symptoms (CAMUS)

泌尿系统症状的补充和替代医学 (CAMUS)

• 批准号: 7988841
• 负责人: Andrew L Avins
• 金额: $ 12.59万
• 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 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7988841
• 关键词: Address; Adherence; Age-Years; American; Benefits and Risks; Benign Prostatic Hypertrophy; Blood Chemical Analysis; California; Chronic Prostatitis; Clinical; Clinical Trials; Commit; Committee Members; Complementary and alternative medicine; Complete Blood Count; Conflict (Psychology); Data; Data Collection; Data Set; Dose; Double-Blind Method; Enrollment; Europe; Functional disorder; Funding; Incontinence; Intervention; Measurement; Measures; Nocturia; Paper; Participant; Patient observation; Pharmaceutical Preparations; Phytotherapy; Placebo Control; Placebos; Principal Investigator; Procedures; Process; Prostate-Specific Antigen; Protocols documentation; Publications; Quality of life; Randomized Clinical Trials; Residual volume; Sabal serrulata; Saw Palmetto Berry Extract; Saw palmetto extract; Site; Sleep; Specific qualifier value; Symptoms; Techniques; Time; Uncertainty; United States National Institutes of Health; Urine; Visit; Work; arm; base; clinical research site; dietary supplements; eligible participant; experience; follow-up; indexing; lower urinary tract symptoms; men; older men; pill; primary outcome; public health relevance; trial comparing; urologic

DESCRIPTION (provided by applicant): Benign prostatic hyperplasia (BPH) is a common problem for older men. Several treatment options exist for BPH, including watchful waiting, prescription medications, and invasive procedures. Despite the availability of these conventional approaches, millions of men in the U.S. have chosen to use complementary and alternative medicine (CAM) to treat their symptoms. Most common among CAM approaches is the use of non-prescription extracts of the saw palmetto berry. Saw palmetto has been used for centuries by native cultures to address lower urinary tract symptoms (LUTS) and this herbal therapy is used commonly in Europe, often as first-line therapy. Several prior studies suggested that saw palmetto may have specific efficacy in reducing bothersome LUTS, but more recent data have raised some doubts about this assertion. The CAMUS study is a two-arm, double-blind, placebo-controlled randomized clinical trial comparing three escalating doses of a saw palmetto extract to an identical-appearing placebo. Beginning in mid-2008, 369 participants have been enrolled at 11 participating clinical centers and are being followed for 18 months for a primary outcome of change in the American Urological Association Symptom Index (AUASI) scores. Eligible participants are men at least 45 years of age who have an AUASI score between 8 and 24, a peak urine flow of at least 4 ml/sec, a prostate-specific antigen <10 ng/dl, and no prior invasive BPH intervention. This proposal is for the continuation of the Kaiser Permanente, Northern California (KPNC) CAMUS site. Forty participants are enrolled at KPNC and all remain in the study. Adherence has been excellent: we have experienced no missed study visits and pill adherence has ranged from 79-90%. The site PI, Dr. Andrew Avins, is an active Steering Committee member and chairs the Protocol Adherence Committee. Plans for the final year of the KPNC clinical site consist of continuing to follow all participants and working to maintain their outstanding adherence to date. We will employ all feasible techniques to encourage participant adherence and maintain high-quality data collection. All participants will be closed out during this fund year, a process that will require substantial effort in repeating all baseline measurements, arranging for final follow-up, and verifying all study data and regulatory compliance issues. The KPNC site is committed to continuing to provide outstanding data for the final year of the CAMUS study and continuing its active participation in this pivotal clinical trial. PUBLIC HEALTH RELEVANCE: Millions of men in the U.S. take saw palmetto extracts for their symptoms of BPH. Whether saw palmetto is safe and effective for these men is unclear as existing data are conflicting. The Kaiser Permanente, Northern California site of the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) clinical trial is helping to better define the risks and benefits of saw palmetto by contributing to the most definitive data to date on the clinical value of this widely used dietary supplement.

描述（由申请人提供）：良性前列腺增生（BPH）是老年男性的常见问题。 BPH存在几种治疗选择，包括注意等待，处方药和侵入性程序。尽管有这些常规方法的可用性，但美国数以百万计的男性选择使用补充和替代医学（CAM）来治疗其症状。在CAM方法中最常见的是使用锯棕榈浆果的非处方提取物。锯棕榈已经被天然培养物用于几个世纪以解决较低的尿路症状（LUTS），这种草药疗法通常在欧洲使用，通常是一线治疗。几项先前的研究表明，SAW Palmetto可能在减少麻烦的LUTS方面具有特定的功效，但是最近的数据引起了人们对此断言的一些疑问。 CAMUS研究是一项两臂，双盲，安慰剂对照的随机临床试验，将三种不断升级的锯棕榈提取物与相同的同意安慰剂进行了比较。从2008年中期开始，已有369名参与者参加了11个参与临床中心，并遵循18个月的时间，以进行美国泌尿外科协会症状指数（AUASI）评分的主要结果。符合条件的参与者是至少45岁的男性，其AUASI得分在8到24之间，尿液流量至少为4 mL/sec，前列腺特异性抗原<10 ng/dl，没有先前的浸润性BPH干预。 该建议是为了继续北加州北加州（KPNC）CAMUS网站的延续。 40名参与者参加了KPNC，所有参与者都保留在研究中。依从性非常出色：我们没有经历过未错过的学习访问，药丸依从性的范围为79-90％。站点PI Andrew Avins博士是一名活跃的指导委员会成员，并担任协议依从委员会的主席。 KPNC临床场地最后一年的计划包括继续跟随所有参与者并努力保持其迄今为止的出色依从性。我们将采用所有可行技术来鼓励参与者遵守并保持高质量的数据收集。所有参与者将在本年度中关闭，这一过程将需要大量精力重复所有基线测量，安排最终随访以及验证所有研究数据和法规合规性问题。 KPNC站点致力于继续为CAMUS研究的最后一年提供出色的数据，并继续积极参与这项关键的临床试验。 公共卫生相关性：美国数以百万计的男性以BPH的症状为帕尔梅托提取物。对于这些人而言，Saw Palmetto是否安全有效，因为现有数据矛盾。 Kaiser Permanente，北加州的北加州互补和泌尿外科症状替代药物（CAMUS）临床试验正在帮助更好地定义SAW Palmetto的风险和好处，从而促成迄今为止最明确的数据，以迄今为止这种广泛使用的饮食补充剂的临床价值。