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，正在进行中。它成功地随机化了369名参与者，超过了最初的350名目标;然而，招募时间超过了最初预期的六个月，因此方案规定的最后一名参与者的治疗期现在超过了目前的资助期，该资助期于2010年3月31日结束。第一名参与者计划于2009年12月完成随访，最后一名参与者计划于2010年9月完成随访。CAMUS是一项随机、双盲、两组试验，共有369名参与者，在72周的时间内大致平均分配至Serenoa repens提取物或安慰剂组，在连续三个24周的时间内以递增剂量进行，从每天320 mg开始，然后640 mg，然后960 mg。参与者继续接受研究治疗，直到他们符合方案规定的治疗中止原因或完成72周治疗期。本延续申请的具体目的是：1.完成CAMUS、方案规定的治疗、随访和关闭活动2。准备最终数据集和3.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。 公共卫生相关性：良性前列腺增生（BPH）是老年男性发病的常见原因。有令人烦恼的症状的男性可以选择一系列传统的医学治疗，包括药物，微创治疗或各种手术治疗。对于目前症状并不特别令人烦恼的男性，药物治疗可能是预防症状进展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.