Alternate Therapies for Benign Prostate Symptoms

描述(由申请人提供)：整个CAMU(泌尿系统症状的补充和替代医学)试验功能齐全，进展顺利。它成功地对369名参与者进行了随机抽样，超过了最初的目标350人；然而，招募花费的时间比最初预计的6个月要长，因此议定书规定的最后一名参与者的治疗期现在延长到目前的资助期之后，该资助期将于2010年3月31日结束。第一个参与者计划于2009年12月完成后续行动，最后一个参与者将于2010年9月完成后续行动。CAMU是一项随机、双盲、双臂试验，有369名参与者，在72周的时间里大致平均分配给Serenoa epens提取物或安慰剂，在连续三个24周的期间内递增剂量，从每天320毫克开始，然后是640毫克，然后是960毫克。节育裤继续进行研究治疗，直到他们达到规定的停止治疗的原因或完成72周的治疗期。继续申请的具体目标是：1.完成CAMU、方案规定的治疗、后续行动和结束活动2.准备最终数据集和3.完成计划的出版物，包括基于最终试验数据集的最终结果和其他论文。 公共卫生相关性：良性前列腺增生症(BPH)是老年男性发病率的常见原因。有烦人症状的男性可能会从一系列传统的医疗方法中进行选择，包括药物治疗、微创疗法或各种手术疗法。对于目前症状并不特别令人困扰的男性来说，药物治疗可能是防止症状恶化的一种有吸引力的方法。

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.