Complementary and Alternative Medicine for Urological Symptoms (CAMUS)

泌尿系统症状的补充和替代医学 (CAMUS)

基本信息

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
项目类别：
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

项目摘要

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.