MacDonald R, Ishani A, Rutks I, Wilt T J
The DVA Coordinating Center of the Cochrane Collaborative Review Group in Prostatic Diseases and Urologic Malignancies. Minneapolis VA Center for Chronic Diseases Outcomes Research, Minneapolis 55417, USA.
BJU Int. 2000 May;85(7):836-41. doi: 10.1046/j.1464-410x.2000.00365.x.
To systematically review the evidence for the clinical effects and safety of the rye-grass pollen extract (Cernilton) in men with symptomatic benign prostatic hyperplasia (BPH).
Trials were identified by searching Medline, specialized databases (EMBASE, Cochrane Library, Phytodok), bibliographies, and contacting relevant trialists and manufacturers. Randomized or controlled clinical trials were included if: men with symptomatic BPH were treated with Cernilton; a control group received either placebo or pharmacological therapy; the treatment duration was >/= 30 days; and clinical outcomes were reported.
In all, 444 men were enrolled in two placebo-controlled and two comparative trials lasting 12-24 weeks. Three studies used a double-blind method although the concealment of treatment allocation was unclear in all. Cernilton improved 'self-rated urinary symptoms' (the proportion reporting satisfactory or improving symptoms) vs placebo and another plant product, Tadenan. The weighted mean (95% confidence interval) risk ratio (RR) for self-rated improvement vs placebo was 2.40 (1. 21-4.75) and the weighted RR vs Tadenan was 1.42 (1.21-4.75). Cernilton reduced nocturia compared with placebo or Paraprost (a mixture of amino acids); against placebo, the weighted RR was 2.05 (1.41-3.00), and against Paraprost the weighted mean difference for nocturia was - 0.40 times per evening (- 0.73 to 0.07). Cernilton did not improve urinary flow rates, residual volume or prostate size compared with placebo or the comparative study agents. Adverse events were rare and mild; the withdrawal rate for Cernilton was 4. 8%, compared with 2.7% for placebo and 5.2% for Paraprost.
The Cernilton trials analysed were limited by their short duration, limited number of enrolees, omissions in reported outcomes, and the unknown quality of the preparations used. The comparative trials had no confirmed active control. The available evidence suggests that Cernilton is well tolerated and modestly improves overall urological symptoms, including nocturia. Additional randomized placebo and active-controlled trials are needed to evaluate the long-term clinical effectiveness and safety of Cernilton.
系统评价黑麦草花粉提取物（舍尼通）对有症状的良性前列腺增生（BPH）男性患者的临床疗效和安全性证据。
通过检索Medline、专业数据库（EMBASE、Cochrane图书馆、Phytodok）、参考文献，并联系相关试验人员和制造商来确定试验。纳入随机或对照临床试验的条件为：有症状的BPH男性患者接受舍尼通治疗；对照组接受安慰剂或药物治疗；治疗持续时间≥30天；报告了临床结局。
共有444名男性参与了两项安慰剂对照试验和两项持续12 - 24周的比较试验。三项研究采用了双盲法，尽管所有研究中治疗分配的隐匿情况均不明确。与安慰剂和另一种植物产品达尿通相比，舍尼通改善了“自我评估的尿路症状”（报告症状满意或改善的比例）。与安慰剂相比，自我评估改善的加权平均（95%置信区间）风险比（RR）为2.40（1.21 - 4.75），与达尿通相比的加权RR为1.42（1.21 - 4.75）。与安慰剂或保前列（一种氨基酸混合物）相比，舍尼通减少了夜尿症；与安慰剂相比，加权RR为2.05（1.41 - 3.00），与保前列相比，夜尿症的加权平均差异为每晚 - 0.40次（ - 0.73至0.07）。与安慰剂或比较研究药物相比，舍尼通未改善尿流率、残余尿量或前列腺大小。不良事件罕见且轻微；舍尼通的撤药率为4.8%，安慰剂为2.7%，保前列为5.2%。
所分析的舍尼通试验存在局限性，包括持续时间短、受试者数量有限、报告结局存在遗漏以及所用制剂质量未知。比较试验没有经证实的活性对照。现有证据表明舍尼通耐受性良好，并适度改善了包括夜尿症在内的总体泌尿系统症状。需要更多的随机安慰剂和活性对照试验来评估舍尼通的长期临床有效性和安全性。
