Tacklind James, MacDonald Roderick, Rutks Indy, Wilt Timothy J
Center for Chronic Disease Outcomes Research (111-0), Minneapolis Veterans Affairs Medical Center, One Veterans Drive, Minneapolis, MN 55417, USA.
Cochrane Database Syst Rev. 2009 Apr 15(2):CD001423. doi: 10.1002/14651858.CD001423.pub2.
Benign prostatic hyperplasia (BPH), a nonmalignant enlargement of the prostate, can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto, or dwarf palm plant, Serenoa repens (also known by its botanical name of Sabal serrulatum), is one of several phytotherapeutic agents available for the treatment of BPH.
This systematic review aimed to assess the effects of Serenoa repens in the treatment of LUTS consistent with BPH.
Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, and The Cochrane Library), by checking bibliographies, and by handsearching the relevant literature.
Trials were eligible if they (1) randomized men with symptomatic BPH to receive preparations of Serenoa repens (alone or in combination) for at least four weeks in comparison with placebo or other interventions, and (2) included clinical outcomes such as urologic symptom scales, symptoms, and urodynamic measurements. Eligibility was assessed by at least two independent observers.
Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of Serenoa repens with placebo or other interventions was the change in urologic symptom-scale scores. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for side effects or adverse events was the number of men reporting side effects.
In this update 9 new trials involving 2053 additional men (a 64.8% increase) have been included. For the main comparison - Serenoa repens versus placebo - 3 trials were added with 419 subjects and 3 endpoints (IPSS, peak urine flow, prostate size). Overall, 5222 subjects from 30 randomized trials lasting from 4 to 60 weeks were assessed. Twenty-six trials were double blinded and treatment allocation concealment was adequate in eighteen studies.Serenoa repens was not superior to placebo in improving IPSS urinary symptom scores, (WMD (weighted mean difference) -0.77 points, 95% CI -2.88 to 1.34, P > 0.05; 2 trials), finasteride (MD (mean difference) 0.40 points, 95% CI -0.57 to 1.37, P > 0.05; 1 trial), or tamsulosin (WMD -0.52 points, 95% CI -1.91 to 0.88, P > 0.05; 2 trials).For nocturia, Serenoa repens was significantly better than placebo (WMD -0.78 nocturnal visits, 95% CI -1.34 to -0.22, P < 0.05; 9 trials), but with the caveat of significant heterogeneity (I(2) = 66%). A sensitivity analysis, utilizing higher quality, larger trials (>/= 40 subjects), demonstrated no significant difference (WMD -0.31 nocturnal visits, 95% CI -0.70 to 0.08, P > 0.05; 5 trials) (I(2) = 11%). Serenoa repens was not superior to finasteride (MD -0.05 nocturnal visits, 95% CI -0.49 to 0.39, P > 0.05; 1 trial), or to tamsulosin (per cent improvement) (RR) (risk ratio) 0.91, 95% CI 0.66 to 1.27, P > 0.05; 1 trial).Comparing peak urine flow, Serenoa repens was not superior to placebo at trial endpoint (WMD 1.02 mL/s, 95% CI -0.14 to 2.19, P > 0.05; 10 trials), or by comparing mean change (WMD 0.31 mL/s, 95% CI -0.56 to 1.17, P > 0.05; 2 trials).Comparing prostate size at endpoint, there was no significant difference between Serenoa repens and placebo (MD -1.05 cc, 95% CI -8.84 to 6.75, P > 0.05; 2 trials), or by comparing mean change (MD -1.22 cc, 95% CI -3.91 to 1.47, P > 0.05; 1 trial).
AUTHORS' CONCLUSIONS: Serenoa repens was not more effective than placebo for treatment of urinary symptoms consistent with BPH.
良性前列腺增生（BPH）是前列腺的非恶性肿大，可导致下尿路梗阻性和刺激性症状（LUTS）。使用植物和草药进行药物治疗（植物疗法）来治疗与BPH相关的LUTS很常见。美洲锯叶棕，即矮棕榈植物，锯叶棕（其植物学名也称为沙巴锯叶棕）的浆果提取物，是可用于治疗BPH的几种植物治疗剂之一。
本系统评价旨在评估锯叶棕治疗与BPH相符的LUTS的效果。
通过检索计算机化的综合和专业数据库（MEDLINE、EMBASE和Cochrane图书馆）、检查参考文献以及手工检索相关文献来查找试验。
符合以下条件的试验即为合格：（1）将有症状的BPH男性随机分组，使其接受锯叶棕制剂（单独或联合使用）至少四周，与安慰剂或其他干预措施进行比较；（2）纳入临床结局，如泌尿系统症状量表、症状和尿动力学测量。由至少两名独立观察者评估入选资格。
至少两名独立审阅者使用标准表格提取有关患者、干预措施和结局的信息。比较锯叶棕与安慰剂或其他干预措施有效性的主要结局指标是泌尿系统症状量表评分的变化。次要结局包括夜尿症的变化和尿动力学测量。副作用或不良事件的主要结局指标是报告有副作用的男性人数。
在本次更新中，纳入了9项新试验，涉及另外2053名男性（增加了64.8%）。对于主要比较——锯叶棕与安慰剂——增加了3项试验，共419名受试者和3个终点（国际前列腺症状评分、最大尿流率、前列腺大小）。总体而言，对来自30项持续4至60周的随机试验的5222名受试者进行了评估。26项试验为双盲试验，并在18项研究中充分实施了治疗分配隐藏。在改善国际前列腺症状评分方面，锯叶棕并不优于安慰剂（加权平均差[WMD] -0.77分，95%置信区间[-2.88, 1.34]，P>0.05；2项试验）、非那雄胺（平均差[MD] 0.40分，95%置信区间[-0.57, 1.37]，P>0.05；1项试验）或坦索罗辛（WMD -0.52分，95%置信区间[-1.91, 0.88]，P>0.05；2项试验）。对于夜尿症，锯叶棕显著优于安慰剂（WMD -0.78次夜间排尿，95%置信区间[-1.34, -0.22]，P<0.05；9项试验），但需注意存在显著异质性（I² = 66%）。一项敏感性分析，采用质量更高、样本量更大（≥40名受试者）的试验，结果显示无显著差异（WMD -0.31次夜间排尿，95%置信区间[-0.70, 0.08]，P>0.05；5项试验）（I² = 11%）。锯叶棕并不优于非那雄胺（MD -0.05次夜间排尿，95%置信区间[-0.49, 0.39]，P>0.05；1项试验），也不优于坦索罗辛（改善百分比）（风险比[RR]）0.91，95%置信区间[0.66, 1.27]，P>0.05；1项试验）。比较最大尿流率时，在试验终点锯叶棕并不优于安慰剂（WMD 1.02 mL/s，95%置信区间[-0.14, 2.19]，P>0.05；10项试验），通过比较平均变化（WMD 0.31 mL/s，95%置信区间[-0.56, 1.17]，P>0.05；2项试验）也是如此。比较终点时的前列腺大小，锯叶棕与安慰剂之间无显著差异（MD -1.05 cc，95%置信区间[-8.84, 6.75]，P>0.05；2项试验），通过比较平均变化（MD -1.22 cc，95%置信区间[-3.91, 1.47]，P>0.05；1项试验）也是如此。
锯叶棕在治疗与BPH相符的泌尿系统症状方面并不比安慰剂更有效。
