Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.
Clin Trials. 2009 Dec;6(6):628-36. doi: 10.1177/1740774509352199. Epub 2009 Dec 9.
Benign prostatic hyperplasia (BPH), a common condition among older men, confers its morbidity through potentially bothersome lower urinary tract symptoms. Treatments for BPH include drugs such as alpha-adrenergic receptor blockers and 5-alpha reductase inhibitors, minimally invasive therapies that use heat to damage or destroy prostate tissue, and surgery including transurethral resection of the prostate. Complementary and alternative medicines are gaining popularity in the US. Two phytotherapies commonly used for BPH are extracts of the fruit of Serenoa repens, the Saw palmetto dwarf palm that grows in the Southeastern US, and extracts of the bark of Pygeum africanum, the African plum tree.
The objective of the Complementary and Alternative Medicines for Urological Symptoms (CAMUS) clinical trial is to determine if phytotherapy is superior to placebo in the treatment of BPH.
CAMUS was originally designed as a 3300-participant, four-arm trial of S. repens, P. africanum, an alpha-adrenergic blocking drug, and placebo with time to clinical progression of BPH, a measure of long-term efficacy, as the primary endpoint. Before enrollment started, a randomized, double-blind, placebo-controlled, single institution clinical trial showed that S. repens at the usual dose did not demonstrate any benefit over placebo with respect to symptom relief at 1 year. Consequently, the focus of CAMUS shifted from evaluating long-term efficacy to determining if any short-term (6-18 months) symptom relief could be achieved with increasing doses of S. repens, the phytotherapy most commonly used in the US for BPH.
Results are anticipated in 2011.
Trial design occurs in an environment of continually evolving information. In this case, emerging results from another trial suggested that a study of long-term efficacy was premature, and that an effective dose and preparation of S. repens had to be established before proceeding to a long-term clinical trial.
良性前列腺增生症（BPH）是老年男性常见的病症，其发病率通过潜在令人困扰的下尿路症状表现出来。BPH 的治疗方法包括药物治疗，如α-肾上腺素能受体阻滞剂和 5-α 还原酶抑制剂，以及采用热疗破坏或摧毁前列腺组织的微创疗法，还有包括经尿道前列腺切除术在内的手术治疗。补充和替代医学在美国越来越受欢迎。两种常用于 BPH 的植物疗法是从美国东南部生长的锯棕榈矮棕榈果实中提取的提取物和非洲李树皮的提取物。
泌尿科症状补充和替代药物（CAMUS）临床试验的目的是确定植物疗法是否优于安慰剂治疗 BPH。
CAMUS 最初设计为一项有 3300 名参与者、四个治疗组的试验，其中包括锯棕榈矮棕榈、非洲李树皮、α-肾上腺素能阻滞剂和安慰剂，以 BPH 的临床进展时间作为主要终点，即长期疗效的衡量标准。在开始入组之前，一项随机、双盲、安慰剂对照、单一机构临床试验表明，常规剂量的锯棕榈矮棕榈在缓解症状方面与安慰剂相比没有任何益处，其疗效持续 1 年。因此，CAMUS 的重点从评估长期疗效转向确定使用锯棕榈矮棕榈增加剂量是否可以在 6-18 个月的短期时间内缓解症状，锯棕榈矮棕榈是美国最常用于 BPH 的植物疗法。
预计结果将于 2011 年公布。
试验设计发生在不断变化的信息环境中。在这种情况下，来自另一项试验的结果表明，长期疗效研究为时过早，在进行长期临床试验之前，必须确定锯棕榈矮棕榈的有效剂量和制剂。
