Phytoestrogen Supplementation in Postmenopausal Women
Phytoestrogen Supplementation in Postmenopausal Women
The goal of the study was to assess the impact of soy and red clover derived phytoestrogens
 on serum lipids in postmenopausal women. Both soya and red clover have high phytoestrogen
 content. Phytoestrogens, a class of estrogenic molecules produced by plants bind to the
 estrogen receptor and are capable of producing estrogenic effects. Therefore, our hypothesis
 was that they can reduce the levels of serum lipids.

 Materials and Methods: Researchers investigated total cholesterol, cholesterol fractions and
 triglycerides in blood, before treatment and in six months periods, throughout 18 months. The
 study involved 74 healthy postmenopausal women, divided into three groups. The first group of
 23 patients received red clover derived isoflavones, the second one with 26 patients got soy
 derived phytoestrogens, while the third, control group with 25 patients, was without
 medications.
A classic clinical sample was constructed. A total of 117 consecutive postmenopausal women
 who came to us in four months periods due to the postmenopausal symptoms (hot flushes, sleep
 disturbances, mood swings and vaginal dryness) were enlisted for the research. Out of them 74
 fulfilled the inclusion criteria and were randomized. Randomization process was simple manual
 and was done in the way that every woman with the odd randomization number received soya
 while those with the even randomization number received red clover derived isoflavones.
 However, during the study neither the doctors nor the patients knew what the randomization
 was and what the medication was. Women in the control group did not receive any medications
 and were only used for comparison. Examinees for this group were randomly selected from
 healthy postmenopausal women who had regular colposcopic check-ups during the same period.
 Out of 186 such women, 111 fulfilled the inclusion criteria, and every third was recruited
 for the study. In such way patients have been randomly divided in three groups (soya - S, red
 clover - RC, control - C) consisting of 37 women each. However, 6 women had to be excluded
 from soya and 5 from red clover group, as they did not take treatment on regular basis.
 Moreover, 7 women from soya, 6 from red clover and 9 from control group were excluded as a
 result of developing health problems (hypertension in 11 cases and uterine bleeding in 8
 cases and H-SIL in 3 cases). One woman from soya group wanted to start taking hormone
 replacement therapy. Three women decided to drop out from the control group. So, finally 23
 women from soya group, 26 from red clover and 25 from control group had undergone the study
 to the end.

 Women were taking one capsule per day of either soya or red clover derived phytoestrogens,
 early in the morning, before meal. The soya daily dose contained 2 isoflavones: genistein
 (39mg) and daidzein (1mg), while the red clover capsule consisted of 4 isoflavones: biokain A
 (23mg), daidzein (1mg), formononetin (15mg) and genistein (1mg). Each patient was keeping
 self-reported daily diary of the therapy administration, symptoms and adverse reactions.

 Researchers investigated total cholesterol, cholesterol fractions (LDL, HDL) and
 triglycerides, in cubital vein blood of patients, as well as body height and weight for each
 subject (out of which Body Mass Index - BMI was calculated by the standard formula). Data
 were recorded at the study beginning and 6, 12 and 18 months after the treatment
 commencement. Standard tests for lipid level evaluation were carried out on Olympus AU 400
 automatic analyzer with referral rates for triglycerides from 0,61 to 2,10 mmol/l, total
 cholesterol 3,63 - 6,46 mmol/l, HDL 0,75 - 1,99 mmol/l, LDL 1,60 - 4,78 mmol/l.
Inclusion Criteria:

 -  healthy postmenopausal women, not taking any medications (anti-osteoporotic,
 lipid-lowering, anti-hypertensive and hormone based) that could influence the study
 results, last menstrual cycle of the investigated women was at least 12 months before
 entering the study.

 Exclusion Criteria:

 -  unfulfilled inclusion criteria at any time of the study, allergies or severe adverse
 reactions on the administered drugs, changing of the regular dietary habits, the study
 protocol interruption and the wish of the patient to withdraw from the study.