Complementary and Alternative Medicine for Urological Symptoms

The Complementary and Alternative Medicine for Urological Symptoms (CAMUS) study was a double-blind, placebo-controlled randomized clinical trial that investigated the efficacy of a widely available phytotherapy, saw palmetto extract, at up to 3 times the standard dose on lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH) in men. Although saw palmetto fruit extract is widely used for treating lower urinary tract symptoms attributed to BPH, a well-design National Institutes of Health supported clinical trial (Avins A et al. JAMA) failed to a benefit of this treatment compared to placebo. The CAMUS study enrolled males with a peak urinary flow rate of at least 4 mL/s and an American Urological Associate Symptom Index (AUASI) score of between 8 and 24 at screening visits. Participants were randomly assigned equally to receive one, two, and then three 320 mg gelcaps daily containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks; or an identical number of placebo gelcaps escalated similarly. The primary outcome was the change in AUASI score from baseline to 72 weeks. Participants were closely monitored for adverse events. The study concluded that saw palmetto extract used at up to 3 times the standard daily dose had no greater effect than placebo on improving lower urinary symptoms or other outcomes related to BPH.泌尿症状辅助与替代疗法（Complementary and Alternative Medicine for Urological Symptoms, CAMUS）研究为一项双盲、安慰剂对照随机临床试验，旨在评估一款广泛应用的植物疗法——锯棕榈提取物（saw palmetto extract），以最高达标准剂量3倍的给药方案，对男性良性前列腺增生（benign prostatic hyperplasia, BPH）所致下尿路症状的治疗效果。尽管锯棕榈果提取物已广泛用于治疗良性前列腺增生引发的下尿路症状，但一项由美国国立卫生研究院（National Institutes of Health, NIH）资助的设计严谨的临床试验（Avins A等人，《美国医学会杂志（JAMA）》）并未发现该疗法相较于安慰剂存在临床获益。CAMUS研究纳入了筛查时最大尿流率≥4 mL/s、美国泌尿学会症状指数（American Urological Association Symptom Index, AUASI）评分介于8至24分的男性受试者。受试者被平均随机分配至两组：试验组每日服用1粒、2粒继而3粒含标准化锯棕榈果提取物的320 mg凝胶胶囊，分别于第24周和第48周进行剂量递增；对照组则服用同等数量、剂量递增方案一致的安慰剂凝胶胶囊。本研究的主要结局指标为从基线至第72周时美国泌尿学会症状指数评分的变化情况。研究人员对受试者的不良事件进行了严密监测。研究结论显示，以最高达标准每日剂量3倍的方案使用锯棕榈提取物，在改善下尿路症状或其他与良性前列腺增生相关的结局方面，并未展现出优于安慰剂的效果。