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Intervention Review
Serenoa repens for benign prostatic hyperplasia
Editorial Group: Cochrane Prostatic Diseases and Urologic Cancers Group
Published Online: 14 APR 2010
Assessed as up-to-date: 27 JAN 2012
DOI: 10.1002/14651858.CD001423.pub2
Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Database Title
Additional Information
How to Cite
Tacklind J, MacDonald R, Rutks I, Stanke JU, Wilt TJ. Serenoa repens for benign prostatic hyperplasia. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD001423. DOI: 10.1002/14651858.CD001423.pub2.
Publication History
- Publication Status: Edited (no change to conclusions)
- Published Online: 14 APR 2010
This is not the most recent version of the article.View current version (12 Dec 2012)
Abstract
Background
Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate, which 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 (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH.
Objectives
This systematic review aimed to assess the effects and harms of Serenoa repens in the treatment of men with LUTS consistent with BPH.
Search methods
We searched for trials in general and in specialized databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE®, EMBASE, CINAHL®, Web of Science, SCOPUS, BIOSIS Previews®, LILACS, ClinicalTrials.gov, Controlled-Trials.com, World Health Organization (WHO), and Google Scholar. We also handsearched systematic reviews, references, and clinical practice guidelines. There were no language restrictions.
Selection criteria
Trials were eligible if they randomized men with symptomatic BPH to receive preparations of SR (alone or in combination) for at least four weeks in comparison with placebo or other interventions, and included clinical outcomes, such as urologic symptom scales, symptoms, and urodynamic measurements. Eligibility was assessed by at least two independent observers (JT, RM).
Data collection and analysis
One review author (JT) extracted Information on patients, interventions, and outcomes which was then checked by another review author (RM). The main outcome measure for comparing the effectiveness of SR with active or inert controls was change in urologic symptom-scale scores, with validated scores taking precedence over non validated ones. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for harms was the number of men reporting side effects.
Main results
In a meta-analysis of two high quality long-term trials (n = 582), Serenoa repens therapy was not superior to placebo in reducing LUTS based on the AUA (mean difference (MD) 0.25 points, 95% confidence interval (CI) -0.58 to 1.07). A 72 week trial with high quality evidence, using the American Urological Association Symptom Score Index, reported that SR was not superior to placebo at double and triple doses. In the same trial the proportions of clinical responders (≥ three-point improvement) were nearly identical (42.6% and 44.2% for SR and placebo, respectively), and not significant (RR 0.96, 95% CI 0.76 to 1.22).
This update, which did not change our previous conclusions, included two new trials with 444 additional men, an 8.5% (5666/5222) increase from our 2009 updated review, and a 28.8% (1988/1544) increase for our main comparison, SR monotherapy versus placebo control (17 trials). Overall, 5666 men were assessed from 32 randomized, controlled trials, with trial lengths from four to 72 weeks. Twenty-seven trials were double blinded and treatment allocation concealment was adequate in 14.
In a trial of high quality evidence (N = 369), versus placebo, SR did not significantly decrease nightly urination on the AUA Nocturia scale (range zero to five) at 72 weeks follow-up (one-sided P = 0.19).
The three high quality, moderate-to-long term trials found peak urine flow was not improved with Serenoa repens compared with placebo (MD 0.40 mL/s, 95% CI -0.30 to 1.09).
Comparing prostate size (mean change from baseline), one high quality 12-month trial (N = 225) reported no significant difference between SR and placebo (MD -1.22 cc, 95% CI -3.91 to 1.47).
Authors' conclusions
Serenoa repens, at double and triple doses, did not improve urinary flow measures or prostate size in men with lower urinary tract symptoms consistent with BPH.
Plain language summary
Serenoa repens for benign prostatic hyperplasia
Benign prostatic hyperplasia (BPH) is the nonmalignant enlargement of the prostate gland that is caused by an increase in volume of epithelial (top layer of tissue that line cavities and surfaces of the body) and stromal (connective tissue) cells. This increase in cells can, over time, create fairly large, discrete nodules in the periurethral region of the prostate, and in turn can restrict the urethral canal causing partial or complete blockage.
The use of plants and herbs (phytotherapy) for the treatment of lower urinary tract symptoms associated with BPH is common and has been growing steadily in most Western countries. The extract of the berry of the American saw palmetto, or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH.
The update of this review included 32 randomized controlled trials involving 5666 men.
Compared with placebo, Serenoa repens, at double and triple the usual dose, provides no improvement for nocturia, peak urine flow, and symptom scores for men with benign prostatic hyperplasia.
摘要
背景
Serenoa repens治療良性前列腺肥大
良性前列腺肥大，並不是惡性的增生，但是可以導致阻塞性或刺激性的下泌尿道症狀。用植物和草本藥物(天然草本療法)用於治療良性前列腺肥大併有下泌尿道症狀，一直有穩定的成長。Serenoa repens(另一個植物名為Sabal serrulatum)是美洲saw palmetto與dwarf palm植物的萃取物，它是許多可用來治療良性前列腺肥大的天然草本療法藥物之一。
目標
系統性的回顧以評估Serenoa repens用於治療良性前列腺肥大併有下泌尿道症狀的效果。
搜尋策略
經由檢查書目和相關文獻，在電腦的一般和專業資料庫(MEDLINE, EMBASE, Cochrane Library, Phytodok)中搜尋適合的臨床試驗。
選擇標準
試驗的篩選條件包括(1)隨機分配良性前列腺肥大的男性患者接受Serenoa repens治療 (單獨或併用)，並分別與接受安慰劑治療，或其他治療良性前列腺肥大藥物做比較、(2)包括臨床結果，例如泌尿症狀評估表、泌尿道症狀或尿路動力學檢查。符合資格與否，至少由兩位獨立的審查員評估而定。
資料收集與分析
關於病人的資料，介入處置和臨床結果，是經過至少兩個獨立審查員使用同一種標準格式來收集。主要的結果是比較Serenoa repens與安慰劑或其他BPH藥物的有效性。次要結果評估包括夜尿次數和尿路動態學的改變。副作用的評估是比較報告副作用的人數。
主要結論
在本次更新中，新加入了3個臨床試驗，包括230位男性受試者 (7.8%)。總共有21個隨機分組試驗，為期4到48週，包括3,139位受試者。其中，18個試驗為雙盲，但只有11個其治療分組的盲性隱藏較完整。相對於安慰劑，Serenoa repens在排尿症狀及分數，及尿流速方面都有改善。排尿症狀分數的加權平均差異 (WMD) 為 −1.41 (範圍0−19) (95% CI為 −2.52， −0.30，一個研究)。而自我評估改善程度的危險對比值 (RR) 為1.76 (95% CI = 1.21，2.54，6個研究)。夜尿次數的WMD為每晚 −0.76次 (95% CI = −1.22， −0.32，10個研究)。最大尿流速的WMD為1.86 ml/sec (95% CI = 0.60，3.12，9個研究)。Serenoa repens和finasteride有相似的排尿症狀改善程度 (WMD = 0.37 IPSS分數 (範圍0 – 35)，95% CI = −0.45，1.19，2個研究) 及最大尿流率 (WMD = −0.74 ml/sec，95% CI = −1.66，0.18，2個研究)。Serenoa repens造成的不良反應是輕微且不多見的。安慰劑，Serenoa repens及finasteride各組的退出試驗比例分別為7%，9%及11%。
作者結論
本研究指出Serenoa repens可以造成排尿症狀及尿流速微幅至中等程度的改善。Serenoa repens和finasteride在排尿症狀及尿流速方面有相似的改善程度，而且有較少的不良反應。其長期效果，安全性及預防BPH併發症的效果仍未知，本次資料更新和我們先前的文獻回顧結果一致。
翻譯人
本摘要由臺灣大學附設醫院賴明志翻譯。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。
總結
Serenoa repens是一種植物配方，可提供BPH病人微幅至中度的排尿症狀及尿流速的改善。一個增生的前列腺腺體，良性前列腺肥大(BPH)，可干擾排尿，增加排尿次數和引發急尿感，或導致膀胱排空尿液出問題。手術和藥物常常被用來嘗試治療前列腺增生症。然而，使用植物藥，試圖緩解前列腺增生症狀也很常見。Serenoa repens 是一種極為流行的植物藥用於治療良性前列腺肥大。這次的回顧性研究發現，Serenoa repens有很好的耐受性，可提供排尿症狀及尿流速微幅至中等程度的改善，其程度和finasteride可造成者類似。仍需觀察Serenoa repens的長期效果。