Wilt T J, Ishani A, Stark G, MacDonald R, Lau J, Mulrow C
Department of Veterans Affairs Coordinating Center of the Cochrane Collaborative Review Group in Prostatic Diseases and Urologic Malignancies, Minneapolis Veterans Affairs Medical Center, Minn 55417, USA.
JAMA. 1998 Nov 11;280(18):1604-9. doi: 10.1001/jama.280.18.1604.
To conduct a systematic review and, where possible, quantitative meta-analysis of the existing evidence regarding the therapeutic efficacy and safety of the saw palmetto plant extract, Serenoa repens, in men with symptomatic benign prostatic hyperplasia (BPH).
Studies were identified through the search of MEDLINE (1966-1997), EMBASE, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with relevant authors and drug companies.
Randomized trials were included if participants had symptomatic BPH, the intervention was a preparation of S repens alone or in combination with other phytotherapeutic agents, a control group received placebo or other pharmacological therapies for BPH, and the treatment duration was at least 30 days.
Two investigators for each article (T.J.W., A.I., G.S., and R.M.) independently extracted key data on design features, subject characteristics, therapy allocation, and outcomes of the studies.
A total of 18 randomized controlled trials involving 2939 men met inclusion criteria and were analyzed. Many studies did not report results in a method that permitted meta-analysis. Treatment allocation concealment was adequate in 9 studies; 16 were double-blinded. The mean study duration was 9 weeks (range, 4-48 weeks). As compared with men receiving placebo, men treated with S repens had decreased urinary tract symptom scores (weighted mean difference [WMD], -1.41 points [scale range, 0-19] [95% confidence interval (CI), -2.52 to -0.30] [n = 1 study]), nocturia (WMD, -0.76 times per evening [95% CI, -1.22 to -0.32] [n = 10 studies]), and improvement in self-rating of urinary tract symptoms; risk ratio for improvement (1.72 [95% CI, 1.21-2.44] [n = 6 studies]), and peak urine flow (WMD, 1.93 mL/s [95% CI, 0.72-3.14] [n = 8 studies]). Compared with men receiving finasteride, men treated with S repens had similar improvements in urinary tract symptom scores (WMD, 0.37 International Prostate Symptom Score points [scale range, 0-35] [95% CI, -0.45 to 1.19] [n = 2 studies]) and peak urine flow (WMD, -0.74 mL/s [95% CI, -1.66 to 0.18] [n = 2 studies]). Adverse effects due to S repens were mild and infrequent; erectile dysfunction was more frequent with finasteride (4.9%) than with S repens (1.1%; P<.001). Withdrawal rates in men assigned to placebo, S repens, or finasteride were 7%, 9%, and 11%, respectively.
The existing literature on S repens for treatment of BPH is limited in terms of the short duration of studies and variability in study design, use of phytotherapeutic preparations, and reports of outcomes. However, the evidence suggests that S repens improves urologic symptoms and flow measures. Compared with finasteride, S repens produces similar improvement in urinary tract symptoms and urinary flow and was associated with fewer adverse treatment events. Further research is needed using standardized preparations of S repens to determine its long-term effectiveness and ability to prevent BPH complications.
对现有的关于锯叶棕提取物（Serenoa repens）治疗有症状的良性前列腺增生（BPH）男性患者的疗效和安全性的证据进行系统评价，并在可能的情况下进行定量荟萃分析。
通过检索MEDLINE（1966 - 1997年）、EMBASE、Phytodok、Cochrane图书馆、已识别试验和综述文章的参考文献，并与相关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：参与者患有有症状的BPH；干预措施为单独使用锯叶棕制剂或与其他植物治疗剂联合使用；对照组接受安慰剂或其他治疗BPH的药物治疗；治疗持续时间至少30天。
每篇文章由两名研究人员（T.J.W.、A.I.、G.S.和R.M.）独立提取关于研究设计特征、受试者特征、治疗分配和研究结果的关键数据。
共有18项涉及2939名男性的随机对照试验符合纳入标准并进行了分析。许多研究未以允许进行荟萃分析的方法报告结果。9项研究的治疗分配隐藏充分；16项为双盲研究。平均研究持续时间为9周（范围4 - 48周）。与接受安慰剂的男性相比，接受锯叶棕治疗的男性尿路症状评分降低（加权平均差[WMD]，-1.41分[量表范围0 - 19][95%置信区间（CI），-2.52至-0.30][n = 1项研究]），夜尿次数减少（WMD，每晚-0.76次[95% CI，-1.22至-0.32][n = 10项研究]），尿路症状自评改善；改善的风险比为1.72[95% CI，1.21 - 2.44][n = 6项研究]，以及最大尿流率增加（WMD，1.93 mL/s[95% CI，0.72至3.14][n = 8项研究]）。与接受非那雄胺的男性相比，接受锯叶棕治疗的男性在尿路症状评分（WMD，0.37国际前列腺症状评分分[量表范围0 - 35][95% CI，-0.45至1.19][n = 2项研究]）和最大尿流率（WMD，-0.74 mL/s[95% CI，-1.66至0.18][n = 2项研究]）方面有相似的改善。锯叶棕引起的不良反应轻微且不常见；非那雄胺导致勃起功能障碍的发生率（4.9%）高于锯叶棕（1.1%；P <.001）。分配到安慰剂、锯叶棕或非那雄胺组的男性的退出率分别为7%、9%和11%。
关于锯叶棕治疗BPH的现有文献在研究持续时间短、研究设计的变异性、植物治疗制剂的使用以及结果报告方面存在局限性。然而，证据表明锯叶棕可改善泌尿系统症状和流量指标。与非那雄胺相比，锯叶棕在尿路症状和尿流方面产生相似的改善，且治疗相关不良事件较少。需要使用标准化的锯叶棕制剂进行进一步研究，以确定其长期有效性和预防BPH并发症的能力。
