A consensus view of soyabean phyto-oestrogens in clinical interventions in post-menopausal women is presented that is based on data from the EU-funded project Phytohealth. The phytooestrogens, primarily genistein and daidzein, were given as soyabean-protein isolates, wholesoyabean foods or extracts, supplements or pure compounds. A comprehensive literature search was conducted with well-defined inclusion or exclusion criteria. For areas for which substantial research exists only placebo-controlled double-blind randomised controlled trials (RCT) conducted on healthy post-menopausal women were included. For emerging areas all available human studies in post-menopausal women were reviewed. In order to make cross comparisons between studies the doses of isoflavones were calculated as aglycone equivalents. There is a suggestion, but no conclusive evidence, that isoflavones from the sources studied so far have a beneficial effect on bone health. The consumption of whole-soyabean foods and soyabeanprotein isolates has some beneficial effects on lipid markers of cardiovascular risk. The consumption of isolated isoflavones does not affect blood lipid levels or blood pressure, although it may improve endothelial function. For menopausal symptoms there is currently limited evidence that soyabean-protein isolates, soyabean foods or red-clover (Trifolium pratense L.) extract are effective but soyabean isoflavone extracts may be effective in reducing hot flushes. There are too few RCT studies to reach conclusions on the effects of isoflavones on breast cancer, colon cancer, diabetes or cognitive function. The health benefits of soyabean phytooestrogens in healthy post-menopausal women are subtle and even some well-designed studies do not show protective effects. Future studies should focus on high-risk post-menopausal women, especially in the areas of diabetes, CVD, breast cancer and bone health. The current interest in soyabean and its phyto-oestrogen component in relation to human health has resulted in a substantial number of publications on the potential clinical efficacy of these compounds to improve health in menopausal women. However, although numerous reviews have been presented, to date a consensus on the potential importance of these compounds for menopausal health following a critical grading of the studies and their results has not been conducted. The focus of the current review is specifically to grade the evidence from clinical studies addressing the effects of intervention of soyabean isoflavones (for chemical structures of the aglycones, seeAbbreviations: RCT, randomised controlled trial; SPI, soyabean-protein isolate.
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