Wirkungen von Phytoöstrogenen und Mikronährstoffen auf menopausale Symptome - eine Beobachtungsstudie

Purpose: The objective of this prospective 6-months open observational study was to investigate the influence of soy-isoflavones and selected micronutrients on typical symptoms in peri- and postmenopausal women. Patients and Methods: 29 peri- (regular or unregular bleedings 12 mo.) women with menopausal symptoms measured by Menopause Rating Scale (MRS) II received an oral supplement containing 50 mg soy-isoflavones, 240 mg calcium, 60 mg magnesium, 90 mg vitamin C and 30 mg vitamin E, α-Linolenic acid 630 mg (Salus Novasoy® capsules of the concern Salushaus, Bruckmuhl). The following data were collected at baseline and after 4, 12 and 26 weeks: MRS II, date of the last menstruation, FSH, LH, DHEAS, testosterone, estradiol, estrone, progesterone, prolactin, TSH, ALT, AST, triglycerides, cholesterol, HDL, homocystein und lipoprotein (a), haemogram, weight, blood pressure, tolerability by scale from 1-4 (very good - bad), side effects by numeration; endometrial sonography and vaginal smear were performed at baseline and in week 12 and 26. Data were analyzed by Wilcoxon rank sum tests. Results: Data of 24 study participants between 42 and 61 years (median 52 years) over 6 months were analyzed. At the beginning the median of MRS II scores was 15 (range 3-29). Significant reduction of menopausal symptoms in the MRS-score after 26 weeks treatment in 16 of 24 patients was observed (reduction of 3,5 points at week 26 [p = 0.004]). Triglycerides and cholesterol were reduced in week 12 (p = 0.001 and p = 0.02, respectively). Significant increase of testosterone (p = 0.006) in week 26. No change of other parameters, no effect on the vaginal or endometrial mucosa was observed. Good or very good tolerability was reported by all 24 patients. Minor, possibly treatment-related temporary side effects were noted in six patients. Conclusion: Peri- and postmenopausal women seeking an alternative solution to Hormone Replacement Therapy could possibly benefit from treatment with soy-isoflavones in regard to menopausal symptoms and lipids. Randomized, double blind, placebocontrolled trials are warranted to further characterize effect profile, long-term preventive potential and side-effects of phytoestrogens in relation to climacteric symptomes, bone turnover, cardio-vascular system, breast and endometrium.