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Take care when using dietary supplements with isolated isoflavones
Dietary supplements are becoming increasingly popular. Some of them are classified as rogue by health experts, others are recommended. For example, dietary supplementation with isolated isoflavones is recommended for the relief of menopausal symptoms. Women should strictly observe dose and duration guidelines when taking the medicine.
Not all dietary supplements are recommended
Dietary supplements are becoming increasingly popular. Some of these, according to experts, are very useful, but some have serious deficiencies that can lead to health problems. It has recently been reported that nutritional supplements in the US are responsible for 23,000 medical emergencies per year. In Germany, too, such funds are widespread. Some may cause problems if used incorrectly. In a recent communication, the Federal Institute for Risk Assessment (BfR) points out that dosage levels and duration of use should be adhered to when taking dietary supplements with isolated isoflavones during and after the menopause.
For the relief of menopausal symptoms
According to the BfR, in Germany, some dietary supplements, some of them dietetic foods, are being advertised with isolated or enriched isoflavones to alleviate the symptoms of women with menopausal symptoms. Isoflavones are herbal ingredients found in, for example, soya and red clover. In the body, they may have a (weak) estrogenic effect, which is why they are also called phytoestrogens. Older studies have concluded that a diet rich in phytoestrogens in women serves to prevent postmenopausal breast cancer. Health claims for isoflavones claimed by the European Food Safety Authority (EFSA) have so far been rejected. The BfR had already evaluated dietary supplements with isolated isoflavones in health in 2007. At that time, it was found that necessary long-term studies that could prove the safety of preparations containing isoflavones were not available.
For dietary supplements with isolated isoflavones, the instructions for use should be followed carefully. (Image: Unclesam / fotolia.com) Final assessment of safety is now available
It also states that due to the lack of data, dosages in preparations enriched with isolated isoflavones, which could still be considered safe, could not be reliably established. It has also been found that women taking postmenopausal and long-term postoperative care should not be considered at risk of prolonged intake of dietary supplements with higher levels of isolated isoflavones, as they are at an increased risk for estrogen-dependent tumors or diseases anyway. In 2009, a request was made to EFSA after a final assessment of the safety of isolated isoflavones was not possible in the context of an expert meeting at BfR. EFSA has now completed its evaluation and published an opinion. In the current communication, the BfR explains the scientific state of play.
Conclusions from the current EFSA opinion
EFSA's Scientific Panel has assessed the health risks posed to postmenopausal and postmenopausal women by dietary supplements containing isolated isoflavones. In particular, it was examined whether there is a link between the intake of isoflavones in food supplements and the occurrence of undesirable effects on possible target organs such as the female breast, the uterus and the thyroid gland. EFSA stated in its report that there is no evidence of adverse effects of isolated isoflavones on the three target organs studied. In addition, EFSA concludes that the isoflavone doses used in human studies and the duration of use for which no adverse effect was present for any of the three target organs was used as a guide to a sufficiently safe use for women can serve the menopause.
Orientation values refer to the healthy general population
EFSA's guidance will include soy-based preparations with dosages of isoflavones / extracts of up to 100 mg per day for up to ten months and red clover-based products with dosages of up to 43.5 mg isoflavones per day Day called for a duration of up to three months. According to the European Authority, the limited data available for women in the period around the menopause makes no statement. The experts also emphasized that, due to the overall insufficient data, the above-mentioned benchmarks only apply to the healthy general population. People diagnosed with estrogen-dependent cancers of the mammary gland or uterus in the past, or those who currently have the disease, are considered a special risk group that could not be included in the report.
Do not exceed the period of receipt
In its opinion, EFSA also noted a number of uncertainties in the risk assessment undertaken and identified further research needs, in particular to clarify the safety of long-term use of preparations with isolated isoflavones in humans. The BfR agrees with EFSA's assessment that the dosage and duration of administration used in human studies, under which adverse effects on at least the target organs studied were not observed, could serve as a guide to a sufficiently safe use of isolated isoflavones in dietary supplements in women without to look at existing estrogen-dependent diseases in the postmenopausal period. The BfR recommends not to exceed the EFSA guidelines for the dosage and duration of dietary supplements with isolated isoflavones for postmenopausal women.
If necessary seek medical advice
In the light of the inadequate data available for perimenopausal women mentioned by EFSA, the BfR believes that, if applied during the menopausal phase, these benchmarks should not be exceeded until further notice. The BfR points out that the data currently available for a final assessment of possible health risks at higher doses and / or prolonged use of isolated isoflavones, ie. H. under conditions of use (dosage and duration of use) in excess of the stated guide values are generally insufficient. Due to the lack of data, the intake of dietary supplements with isolated isoflavones is not recommended for individuals with a previously diagnosed estrogen-dependent (cancer) disease of the mammary gland or the uterus as a history and for those with a current diagnosis. In conclusion, the BfR writes: "Since in individual cases the presence of estrogen-dependent diseases may not be known, it may be necessary to seek medical advice before taking isoflavone-containing preparations." (Ad)