Phytotherapy of Prostateic Symptoms (POPW)

描述（由申请人提供）：NIDDK与国家补充和替代医学中心（NCCAM）和膳食补充剂办公室（CDS）合作，资助了11个临床中心和一个协调站点，从2002年到2009年，为期7年，研究植物疗法治疗良性前列腺增生（BPH）。科罗拉多大学丹佛分校（UCD）被选为该研究的11个临床中心之一，该研究被称为泌尿系统症状的补充和替代医学（CAMUS）试验。CAMUS研究小组设计了一项双盲、安慰剂对照、18个月的临床试验，采用单常规剂量（320毫克/天）、双常规剂量（640毫克/天）和三常规剂量（960毫克/天）的锯棕榈（Serenoa repens）治疗，以确定Serenoa repens在减少与BPH相关的下尿路症状方面的有效性和安全性。总共有369名男性，远远超过了方案中规定的350人，被随机分配到研究中，目前正在11个临床中心接受治疗和随访。UCD将30名男性随机分为两组，一组服用Serenoa repens，另一组服用安慰剂。在随机抽取的30名男性中，有29人正在接受积极治疗和随访。我们预计所有人都将按照方案完成18个月的随访，然而，方案规定的最后一批随机参与者的治疗期将超出目前的资助期，即2010年3月31日结束。该提案旨在为2010年7月1日至2011年6月30日期间继续提供资金，以允许CAMUS临床试验完成其活动。这段时间需要资金，以便参与者有时间完成协议规定的完整治疗期，并使临床中心能够参与数据清理、最终数据分析和发表活动。

DESCRIPTION (provided by applicant): The NIDDK in collaboration with the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplement (CDS) funded 11 clinical centers and a coordinating site for seven years from 2002 -2009 to investigate phytotherapy for benign prostatic hyperplasia (BPH). University of Colorado Denver (UCD) was selected as one of the 11 clinical centers for this study, known as the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) trial. The CAMUS study team designed a double-blind, placebo-controlled, eighteen-month clinical trial of treatment with single usual dose (320 mg/day), double usual dose (640 mg/day) and triple usual dose (960 mg/day) of saw palmetto (Serenoa repens) to determine the efficacy and safety of Serenoa repens at reducing the lower urinary tract symptoms associated with BPH. A total of 369 men, substantially more than the 350 specified in the protocol, have been randomized into the study and are currently being treated and followed at the 11 clinical centers. UCD randomized 30 men to either Serenoa repens or placebo. Of the 30 men who were randomized, 29 are in active treatment and follow-up. We anticipate that all will complete 18 months of follow-up as per protocol, however, the protocol-specified treatment period for the last participants randomized extends beyond the current funding period, which ends March 31, 2010. This proposal is for continued funding for the period July 1, 2010 to June 30, 2011 to allow the CAMUS clinical trial to complete its activities. Funding for this period is needed so that participants will have time to complete the full protocol-specified treatment period, and so that clinical centers can participate in data clean-up, final data analyses, and publication activities. PUBLIC HEALTH RELEVANCE: This Study is being conducted because, despite worldwide use of phytotherapies, the effectiveness and side effects of these over-the-counter dietary supplements for men with benign prostatic hyperplasia are unclear. If Saw palmetto, one of the most commonly used supplements, is effective at reducing lower urinary tract symptoms, it might be preferred by many men because of its "natural therapy" appeal, and its lower cost, relative to prescription medications for BPH.