Myers S P, Vigar V
NatMed-Research Unit, Division of Research, Southern Cross University, Military Rd., Lismore, NSW 2480, Australia.
NatMed-Research Unit, Division of Research, Southern Cross University, Military Rd., Lismore, NSW 2480, Australia.
Phytomedicine. 2017 Jan 15;24:141-147. doi: 10.1016/j.phymed.2016.12.003. Epub 2016 Dec 12.
To critically assess the evidence for a specific standardised extract of Trifolium pratense isoflavones (Promensil) at a dosage of 80mg/day in the treatment of menopausal hot flushes.
Systematic literature searches were performed in Medline, Scopus, CINAHL Plus, Cochrane, AMED and InforRMIT and citations obtained from 1996 to March 2016. Reference lists were checked; corresponding authors contacted and the grey literature searched for additional publications.
Studies were selected according to predefined inclusion and exclusion criteria. All randomised clinical trials of a specific standardised extract of Trifolium pratense isoflavones (Promensil) used as a mono-component at 80mg/day and measuring vasomotor symptoms were included. The data extraction and quality assessment were performed independently by one reviewer and validated by a second with any disagreements being settled by discussion. Weighted mean differences and 95% confidence intervals were calculated for continuous data using the fixed-effects model.
Twenty potentially relevant papers were identified, with only five studies meeting the inclusion criteria. The meta-analysis demonstrated a statistical and clinically relevant reduction in hot flush frequency in the active treatment group compared to placebo. Weighted mean difference 3.63 hot flushes per day: [95% CI 2.70-4.56]; p˂0.00001). Due to a lack of homogeneity a priori defined sub-group analyses were performed demonstrating a substantive difference between cross-over and parallel-arm clinical trial designs.
There is evidence for a statistical and clinically significant benefit for using a specific standardised extract of red clover isoflavones (Promensil) at 80mg/day for treating hot flushes in menopausal women across the 3 studies included in the meta-analysis. The preparation was safe over the short-term duration of the studies (3 months).
严格评估红车轴草异黄酮标准化提取物（普丽普莱）80毫克/天的剂量用于治疗更年期潮热的证据。
在医学文献数据库（Medline）、Scopus、护理学与健康领域数据库（CINAHL Plus）、考克兰系统评价数据库、联合和补充医学数据库（AMED）以及墨尔本皇家理工大学信息数据库（InforRMIT）中进行了系统的文献检索，并获取了1996年至2016年3月期间的文献引用。检查了参考文献列表；联系了通讯作者，并搜索了灰色文献以查找其他出版物。
根据预先定义的纳入和排除标准选择研究。纳入所有将红车轴草异黄酮标准化提取物（普丽普莱）作为单一成分、以80毫克/天的剂量使用并测量血管舒缩症状的随机临床试验。数据提取和质量评估由一名审阅者独立进行，并由第二名审阅者进行验证，任何分歧都通过讨论解决。使用固定效应模型计算连续数据的加权平均差和95%置信区间。
共识别出20篇可能相关的论文，只有5项研究符合纳入标准。荟萃分析表明，与安慰剂相比，活性治疗组的潮热频率在统计学和临床上均有显著降低。加权平均差为每天3.63次潮热：[95%置信区间2.70 - 4.56]；p<0.00001）。由于缺乏同质性，进行了预先定义的亚组分析，结果显示交叉试验和平行组临床试验设计之间存在实质性差异。
在纳入荟萃分析的3项研究中，有证据表明，使用红车轴草异黄酮标准化提取物（普丽普莱）80毫克/天治疗更年期妇女潮热在统计学和临床上具有显著益处。在研究的短期（3个月）期间，该制剂是安全的。
