Saw palmetto for benign prostatic hyperplasia

Saw palmetto for benign prostatic hyperplasia
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DOI:
10.1056/nejmoa053085
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发表时间:
2006-02-09
影响因子:
158.5
通讯作者:
Avins, AL
Avins, AL
中科院分区:
医学1区
文献类型:
--
作者:
Bent, S;Kane, C;Avins, AL

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背景:锯棕榈是使用超过200万人在美国治疗良性前列腺增生,通常被推荐作为一种替代药物批准的食品和药物管理局。方法:在这个双盲试验中,我们随机分配225名男性年龄在49岁以上,谁有中度至重度症状的良性前列腺增生一年的治疗锯棕榈提取物(160毫克,每天两次)或安慰剂。主要结果指标是美国泌尿外科协会症状指数(AUASI)评分和最大尿流率的变化。次要结果测量包括前列腺大小的变化、排尿后残余尿量、生活质量、实验室检查值和报告的不良反应率。结果:锯棕榈和安慰剂组之间AUASI评分的变化无显著差异(平均差异,0.04点; 95%置信区间,-0.93至1.01),最大尿流率(平均差异为0.43 ml/min; 95%可信区间为-0.52至1.38)、前列腺大小、排尿后残留量、生活质量或血清前列腺特异性抗原水平。副作用的发生率在两个groups.CONCLUSIONS相似:在这项研究中,看到棕榈没有改善良性前列腺增生的症状或客观措施。
BACKGROUND:Saw palmetto is used by over 2 million men in the United States for the treatment of benign prostatic hyperplasia and is commonly recommended as an alternative to drugs approved by the Food and Drug Administration.METHODS:In this double-blind trial, we randomly assigned 225 men over the age of 49 years who had moderate-to-severe symptoms of benign prostatic hyperplasia to one year of treatment with saw palmetto extract (160 mg twice a day) or placebo. The primary outcome measures were changes in the scores on the American Urological Association Symptom Index (AUASI) and the maximal urinary flow rate. Secondary outcome measures included changes in prostate size, residual urinary volume after voiding, quality of life, laboratory values, and the rate of reported adverse effects.RESULTS:There was no significant difference between the saw palmetto and placebo groups in the change in AUASI scores (mean difference, 0.04 point; 95 percent confidence interval, -0.93 to 1.01), maximal urinary flow rate (mean difference, 0.43 ml per minute; 95 percent confidence interval, -0.52 to 1.38), prostate size, residual volume after voiding, quality of life, or serum prostate-specific antigen levels during the one-year study. The incidence of side effects was similar in the two groups.CONCLUSIONS:In this study, saw palmetto did not improve symptoms or objective measures of benign prostatic hyperplasia.