The safety evaluation of the complex non-hormonal correction of climacteric disorders was carried out among 120 women with the metabolic syndrome during the period of peri- and post-menopause. Three equal groups of 40 patients were formed. In the main group a non-pharmacological complex was applied (diet therapy, psychotherapy, physical therapy, exercise therapy) and the intake of the extract of dry red clover (Trifoliumpratense), standardized to 40% of the Isoflavones in a dose of 160 mg (1 capsule) oral per day was prescribed. In the first control group only non-pharmacological methods were used. The women of the second control group took the extract of dry red clover only. The degree of severity of the climacteric syndrome was measured by the Kupperman index. Before and six months after treatment in all groups the thickness of endometrium was estimated by trans-vaginal sonogra-phy, cytologic examination of PAP-tests and breast examinations. After six months of treatment the Kupperman index has significantly declined in the first group – to 4,3±2,2, i.e. more by five times (<0,05 in comparison to the index registered before treatment). Only one case of individual intolerance was registered – in the first group on the second day of the intake of the extract of the dry red clover. As a result this patient was excluded from the research. No initiations of proliferation processes in the endometrium, mammary glands and no oncogenic influence on the epithelium of uterine cervix have been registered in any of experimental groups. Thus, the optimal effective and safe treatment for climacteric disorders among women with the metabolic syndrome showed to be a comprehensive treatment approach with the use of phyto-estrogen and non-pharmacological correction incorporated.
climacteric syndrome, metabolic syndrome, substitute hormonal therapy, non-hormonal therapy, safety of treatment
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