Suggested citation: M Tijhuis, E Doets, V van der Velpen and M Vonk Noordegraaf-Schouten, 2015; Preparatory work to support the risk assessment for peri-and postmenopausal women taking food supplements containing isolated isoflavones.
ABSTRACTThe aim of this review was to identify the scientific data from January 2009 till December 2013 on effects of isolated isoflavones from food supplements on reproductive organs (breast, uterus) and thyroid of menopausal women. A search in PubMed, Web of Science, CAB Abstracts and Embase (search date: February 7 th 2014), resulted in 2,497 unique hits. Based on title and abstract, 177 articles were eligible for full text selection. Of these, 95 were human studies (objective 1), 68 were animal studies (objective 2) and 14 contained data on both. Hand search yielded no additional articles. After full text screening, for objective 1, 14 articles met our inclusion criteria for data extraction; for objective 2, 17 met our inclusion criteria for data-extraction and 7 were included for mapping purposes; from articles with data for objective 1 and 2 combined, all 14 were excluded. All included studies were intervention studies. A grey literature search resulted in 1 relevant risk assessment published by a national body. Uterus was the most studied target organ for both objectives; the most prevalent outcomes were endometrial thickness for objective 1 and uterine weight for objective 2. Under objective 2, no studies evaluating thyroid were identified. Studies under objective 1 did not report adverse effects related to isoflavone supplementation, studies under 2 were less consistent. Many methodological issues exist, such as the scarcity of long-term human data and studies aimed at detecting adverse effects; and issues of metabolic differences between species and dose translation from animals to humans.