Wilt T J, MacDonald R, Ishani A
The VA Coordinating Center of the Cochrane Collaborative Review Group in Prostatic Diseases and Urologic Malignancies, 13/Minneapolis, VA, USA.
BJU Int. 1999 Jun;83(9):976-83. doi: 10.1046/j.1464-410x.1999.00026.x.
To conduct a systematic review of the evidence for the efficacy of beta-sitosterol in men with symptomatic benign prostatic hyperplasia (BPH).
Studies were identified through Medlinetrade mark (1966-98), EMBASEtrade mark, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with study authors and pharmaceutical companies. Randomized trials were included if: men had symptomatic BPH; plant extract preparations contained beta-sitosterols; a control group received placebo or a pharmacological therapy; and treatment duration was >/=30 days. Study characteristics, demographic information, enrolment criteria and outcomes were extracted.
Four trials comprising a total of 519 men met the inclusion criteria. All were double-blind and lasted 4-26 weeks. Three studies used nonglucosidic beta-sitosterols and one used a preparation that contained only beta-sitosterol-beta-d-glucoside. Compared with placebo, beta-sitosterol improved urinary symptom scores and flow measures. For the two studies reporting the International Prostate Symptom Score (IPSS), the weighted mean difference (WMD) against placebo was -4.9 IPSS points (95% confidence interval, CI,-6.3 to-3.5). The WMD for peak urinary flow rate was 3.91 mL/s (95% CI 0.91 to 6.90, four studies) and for residual volume the WMD was -28.62 mL (95% CI-41.42 to-15.83, four studies). beta-sitosterol did not reduce prostate size. The trial using pure beta-sitosterol-beta-d-glucoside (WA184) showed no improvement in urinary flow measures. Withdrawal rates for men assigned to beta-sitosterol and placebo were 7.8% and 8.0% (not significant), respectively.
beta-sitosterol improves urological symptoms and flow measures. However, the existing studies are limited by short treatment duration and lack of standardized beta-sitosterol preparations. Their long-term effectiveness, safety and ability to prevent the complications of BPH are unknown.
对β-谷甾醇治疗有症状的良性前列腺增生（BPH）男性患者疗效的证据进行系统评价。
通过医学索引数据库（1966 - 1998年）、EMBASE数据库、植物药文献数据库、Cochrane图书馆、已识别试验和综述文章的参考文献，以及与研究作者和制药公司联系来识别研究。纳入的随机试验需满足以下条件：男性患有有症状的BPH；植物提取物制剂含有β-谷甾醇；对照组接受安慰剂或药物治疗；治疗持续时间≥30天。提取研究特征、人口统计学信息、纳入标准和结局。
四项试验共纳入519名男性，符合纳入标准。所有试验均为双盲试验，持续4 - 26周。三项研究使用非糖苷化β-谷甾醇，一项研究使用仅含β-谷甾醇-β-D-葡萄糖苷的制剂。与安慰剂相比，β-谷甾醇改善了尿路症状评分和尿流指标。对于两项报告国际前列腺症状评分（IPSS）的研究，与安慰剂相比的加权平均差（WMD）为 -4.9 IPSS分（95%置信区间，CI，-6.3至 -3.5）。最大尿流率的WMD为3.91 mL/s（95% CI 0.91至6.90，四项研究），残余尿量的WMD为 -28.62 mL（95% CI -41.42至 -15.83，四项研究）。β-谷甾醇未缩小前列腺体积。使用纯β-谷甾醇-β-D-葡萄糖苷的试验（WA184）在尿流指标方面未显示改善。分配到β-谷甾醇组和安慰剂组的男性退出率分别为7.8%和8.0%（无显著差异）。
β-谷甾醇改善了泌尿系统症状和尿流指标。然而，现有研究受治疗持续时间短和缺乏标准化β-谷甾醇制剂的限制。其长期有效性、安全性以及预防BPH并发症的能力尚不清楚。
