Coon Joanna Thompson, Pittler Max H, Ernst Edzard
Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, 25 Victoria Park Road, Exeter EX2 4NT, UK.
Phytomedicine. 2007 Feb;14(2-3):153-9. doi: 10.1016/j.phymed.2006.12.009. Epub 2007 Jan 18.
To critically assess the evidence of supplements containing Trifolium pratense (red clover) isoflavones in the reduction of hot flush frequency in menopausal women.
Systematic literature searches were performed in (Medline (1951 - April 2006), Embase (1974 - April 2006), CINAHL (1982 - April 2006), Amed (1985 - April 2006) and The Cochrane Library (Issue 2, 2006). Reference lists located were checked for further relevant publications. Experts in the field and manufacturers of identified products were contacted for unpublished material. No language restrictions were imposed.
Studies were selected according to predefined inclusion and exclusion criteria. All randomized clinical trials of monopreparations containing T. pratense isoflavones for treating hot flushes were included. Study selection, data extraction and validation were performed by at least two reviewers with disagreements being settled by discussion. Weighted means and 95% confidence intervals were calculated and sensitivity analyses were performed.
Seventeen potentially relevant articles were retrieved for further evaluation. Five were suitable for inclusion in the meta-analysis. The meta-analysis indicates a reduction in hot flush frequency in the active treatment group (40-82 mg daily) compared with the placebo group (weighted mean difference -1.5 hot flushes daily; 95% CI -2.94 to 0.03; p=0.05).
There is evidence of a marginally significant effect of T. pratense isoflavones for treating hot flushes in menopausal women. Whether the size of this effect can be considered clinically relevant is unclear. Whereas there is no apparent evidence of adverse events during short-term use, there are no available data on the safety of long-term administration.
严格评估含有红车轴草异黄酮的补充剂在降低绝经后女性潮热频率方面的证据。
在以下数据库进行了系统的文献检索：（医学期刊数据库（1951年 - 2006年4月）、荷兰医学文摘数据库（1974年 - 2006年4月）、护理学与健康领域数据库（1982年 - 2006年4月）、澳大利亚医学文献数据库（1985年 - 2006年4月）以及考克兰图书馆（2006年第2期）。对所找到的参考文献列表进行检查以获取更多相关出版物。联系了该领域的专家和已识别产品的制造商以获取未发表的资料。未设语言限制。
根据预先确定的纳入和排除标准选择研究。纳入所有含红车轴草异黄酮单一制剂治疗潮热的随机临床试验。研究选择、数据提取和验证由至少两名审阅者进行，如有分歧通过讨论解决。计算加权均值和95%置信区间，并进行敏感性分析。
检索到17篇可能相关的文章以供进一步评估。其中5篇适合纳入荟萃分析。荟萃分析表明，与安慰剂组相比，活性治疗组（每日40 - 82毫克）的潮热频率有所降低（加权平均差为每日 -1.5次潮热；95%置信区间为 -2.94至0.03；p = 0.05）。
有证据表明红车轴草异黄酮在治疗绝经后女性潮热方面有略微显著的效果。尚不清楚这种效果的大小是否具有临床相关性。虽然短期使用期间没有明显的不良事件证据，但尚无关于长期给药安全性的可用数据。
