| Super Aspirin Study OutcomesSoy Isoflavone Supplement Reduces Menopausal Symptoms Reference: Han K, Soares J, Haider M, et al. Benefits of soy isoflavone therapeutic regimen on menopausal symptoms. Obstet Gynecol 2002;99:389-94. Design: Randomized, double-blind, placebo-controlled clinical trial. Participants: 80 menopausal women ages 45-55 years who had been experiencing symptoms of menopause for at least 12 months. Study Medication and Dosage: Subjects consumed one capsule t.i.d. of soy isoflavones (Eugenbio Co. Ltd, Seoul, South Korea), providing a total of 100 mg of soy isoflavones per day, or placebo. Each capsule contained 50.3 mg soy protein and 33.3 mg isoflavones, providing 23.3 mg of genistein, 6.2 mg of daizein, and 3.8 mg of gycitein. Duration: Four months Outcome Measures: The Kupperman index was used to assess changes in menopausal symptoms at baseline and after 4 months of treatment. The Kupperman index is a numerical conversion index and covers 11 menopausal symptoms-hot flashes (vasomotor), paresthesia, insomnia, nervousness, melancholia, vertigo, weakness, arthralgia or myalgia, headache, palpitations, and formication. Cardiovascular risk factors were also assessed by evaluating plasma lipids, body mass index (BMI), blood pressure and glucose levels. To examine the effects of the isoflavones on hormone levels, follicle-stimulating hormone (FSH), luteinizing hormone (LH) and 17 ?-estradiol were measured. Transvaginal sonography was performed to quantify endometrial thickness. Key Findings: A significant decrease in menopausal symptoms was observed in the soy isoflavone group compared to placebo (p < 0.01). There were no differences in blood pressure, blood glucose, or BMI in the isoflavone group compared to baseline measures and placebo. Total cholesterol (p < .001) and low-density lipoproteins (LDL) (p < .001) decreased significantly in the soy isoflavone group compared to placebo, while high-density lipoproteins (HDL) and triglycerides increased in both groups compared to baseline measures. No difference in FSH and LH levels were observed between the placebo and the soy isoflavone group. An increase in estrogen levels was observed in the soy isoflavone group but not in the placebo group. Despite this increase in estrogen levels in the soy isoflavone group, there was no measured increase in endometrial thickness. Practice Implications: This Brazilian clinical trial demonstrates that supplementation with 100 mg/day of soy isoflavones effectively alleviates vasomotor symptoms, such as hot flashes, associated with menopause. It should be noted that other trials using 50-200 mg/day of soy isoflavones have been negative. Interestingly, although soy isoflavone supplementation increased 17b-estradiol, the rise was not sufficient to increase endometrial thickness. While preliminary, the trial also suggests potential cardiovascular benefits with soy isoflavone supplementation. |
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