Alternate Therapies for Benign Prostate Symptoms

描述（由申请人提供）：整个CAMUS（泌尿系统症状的补充和替代医学）试验功能齐全，正在顺利进行。它已经成功地随机分配了369名参与者，超过了最初目标的350名；然而，招募时间比最初预计的6个月要长，因此，协议规定的最后一批参与者的治疗期现在已经超出了目前的资助期，该资助期将于2010年3月31日结束。第一个参与者将于2009年12月完成后续工作，最后一个参与者将于2010年9月完成后续工作。CAMUS是一项随机、双盲、双组试验，共有369名参与者，在72周的时间内，大约平均分配给Serenoa repens提取物或安慰剂，在连续3个24周的时间内，剂量逐渐增加，从每天320毫克开始，然后是640毫克，然后是960毫克。受试者继续接受研究治疗，直到他们符合协议规定的停止治疗的原因或完成72周的治疗期。这个延续应用程序的具体目标是：1。完成CAMUS，协议规定的治疗，随访和关闭活动2。3.准备最终的数据集。完成计划的出版物，包括最终结果和基于最终试验数据集的其他论文。

DESCRIPTION (provided by applicant): The overall CAMUS (Complementary and Alternative Medicine for Urologic Symptoms) trial is fully functional and well underway. It has successfully randomized 369 participants, more than the 350 initially targeted; however, recruitment took longer than the six months initially expected so that the protocol specified treatment period for the last participants now extends beyond the current funding period, which ends March 31, 2010. The first participant is scheduled to complete follow-up in December 2009 and the last in September 2010. CAMUS is a randomized, double-blind, two arm trial with 369 participants, approximately equally allocated to either the Serenoa repens extract or placebo over a 72 weeks period in escalating doses over three consecutive 24 week periods, beginning with 320 mg, then 640 mg and then 960 mg daily. Pariticpants continue on study treatment until they meet a protocol defined reason for treatment discontinuation or complete the 72 weeks treatment period. The specific aims for this continuation application are to: 1. Complete CAMUS, the protocol specified treatment, follow-up and close out activities 2. Prepare the final dataset and 3. Complete planned publications, including final results and other papers based on the final trial dataset. PUBLIC HEALTH RELEVANCE: Benign Prostatic Hyperplasia (BPH) is a common cause of morbidity among older men. Men with bothersome symptoms may choose from a spectrum of traditional medical treatments, including medications, minimally invasive therapies or a variety of surgical therapies. For men with symptoms that are not particularly bothersome at present, medical therapy may be an attractive way to prevent progression of .svmntoms.