Soy germ extract alleviates menopausal hot flushes: placebo-controlled double-blind trial.

BACKGROUND/OBJECTIVES: A double-blind, placebo-controlled study was performed to assess the potency of a soy germ preparation for the alleviation of menopausal hot flushes. SUBJECTS/METHODS: Caucasian women with at least seven hot flushes daily were treated with soy germ extract (100 mg isoflavone glycosides) daily or with placebo for 12 weeks, followed by 12 weeks of open treatment with soy. Outcome parameters were the number of hot flushes and the evaluation of the Greene Climacteric Scale. RESULTS: A total of 192 women were included. As the hot flush diaries from one study centre were lost, the assessment of hot flushes was based on 136 participants (soy: 54 women; placebo: 82 women). After 12 weeks, 180 women were available for the analysis of Greene Scale and safety (soy and placebo: each 90 women). Hot flushes were reduced by 43.3% (-3.5 hot flushes) with soy and by 30.8% with placebo (-2.6; p < 0.001). After the open treatment phase with soy, both original groups showed a reduction of 68% of hot flushes. A subgroup analysis showed better effects for soy when symptoms were classified as "severe" at baseline. After 12 weeks of double-blind treatment, there was an improvement from baseline values of 71 and 78% with soy with the items "hot flushes" and "sweating", compared with 24% for both items with placebo. Hormonal safety parameters remained uninfluenced. CONCLUSIONS: Soy germ extract with 100 mg of isoflavone glycosides was shown to modestly, but significantly reduce menopausal hot flushes.

The effect of red clover isoflavone supplementation over vasomotor and menopausal symptoms in postmenopausal women.

OBJECTIVE: To evaluate the effect of red clover isoflavone supplementation over vasomotor and overall menopausal symptoms in postmenopausal women. METHODS: One hundred and nine postmenopausal women aged 40 or more were assigned to randomly receive either two daily capsules of the active compound (80 mg red clover isoflavones, Group A) or placebo of equal appearance (Group B) for a 90-day period. After a washout period of 7 days, medication was crossed over and taken for 90 days more. Daily hot flush and night sweat frequency and overall menopausal symptom intensity (Kupperman Index) were measured at baseline, 90, 97 and 187 days. RESULTS: Daily hot flush/night sweat frequency and Kupperman Index values were similar in both studied groups at baseline. All indices significantly decreased after red clover phase in Group A, corresponding, respectively to a 73.5%, 72.2% and 75.4% average decrement. These decrements were significantly higher than those observed for Group B after placebo phase (8.2%, 0.9% and 6.7% respectively). In Group A, after washout and placebo phases all values significantly increased. In Group B, all indices remained similar after placebo and washout phases, however significantly dropping after red clover treatment. These values were also significantly lower than those observed in Group A after placebo phase. No side effects were encountered after treatment with the active compound or placebo. CONCLUSION: Red clover isoflavone supplementation was more effective than placebo in reducing daily vasomotor frequency and overall menopausal intensity in postmenopausal women.

Balancing steroidal hormone cascade in treatment-resistant veteran soldiers with PTSD using a fermented soy product (FSWW08): a pilot study.

UNLABELLED: Abstract Introduction: A clinical study was conducted to determine steroidal hormone cascade in the blood to relate them to mental performance with the Clinician-Administered PTSD scale (CAPS), serum lipid concentrations, and steroidal hormones, particularly cortisol, testosterone, estradiol, dehydroepiandrosterone (DHEA), and pregnenolone, in treatment-resistant male veterans with combat-related chronic posttraumatic stress disorder (PTSD) before and after consumption of a special fermented soy formulation (FSWW08). Admitted veterans in the study were resistant to conventional psychological and pharmacological therapies. METHOD: Ten treatment-resistant soldiers with combat-related PTSD (according to the International Classification of Diseases, 10th Revision code) for ≤1.5 years were enrolled in this study. A specially formulated fermented soy product, FSWW08, was given to the veterans for 3 months and then extended to 6 months. CAPS was used to assess the severity of PTSD. Immunologic cytokines, triglycerides, and 16 steroidal hormones were also determined from the blood of the PTSD patients before, during, and after consumption of the FSWW08. RESULTS: FSWW08 increased blood levels of steroids, such as testosterone, estradiol, and particularly the adrenal hormones cortisol and androstenediol. Decreased steroidal hormones from the upper part of the hormone cascade, such as cholesterol, DHEA, and pregnenolone were experienced. The arteriosclerotic risk was reduced (cholesterol, 280±35 to 205±22 mmol/L, p<0.001; triglycerides, 645±267 to 161±22 mg/dL, p<0.001; very-low-density lipoprotein cholesterol, 312±112 to 151±20 mg/dL, p<0.001; homocysteine in serum (i.s.), 26±4 to 11.8±2.1 µmol/L, p<0.001). High-density lipoprotein cholesterol concentration was significantly lower after consumption of FSWW08 (51±15 to 89±7.8 mg/dL, p<0.001). FSWW08 significantly reduced mental symptoms according to CAPS after 7 days throughout the 6-month study. Insomnia (estradiol increased from 53±24 to 88±41 pg/L), breathing disorders (may be related to increased aldosterone) are hormone dependent and were corrected in those with insomnia. The increase in testosterone and decrease in prolactin was corroborated by an increase in sex drive and improved partner relationships. Common immunity disorders of the veterans, such as increased herpes labialis, flu-like syndromes, and stomach pain were resolved in all veterans and was corroborated by significant improvements in immunologic cytokines: tumor necrosis factor α was reduced (from 13.5±0.4 to 9.0±1.4 pg/mL, p<0.001) and interleukin ß (from 7.0±0.5 to 4.5±1.8 pg/mL) and interferon γ (from 10.4±2.4 to 6.3±1.5 pg/mL, p=0.001) were also detected. PTSD is associated with clinically elevated leukocytes and lymphocytes, which are reduced by FSWW08 as well. CONCLUSION: It is the first time that the normalization of the whole steroidal hormone cascade in the blood could be correlated with improvements in mental and physical parameters (especially metabolic and immunologic disorders) in veterans with combat-related and treatment-resistant PTSD. Studies of FSWW08 in larger cohorts and over longer periods of time, as well as dosing effects, have to be conducted to validate these results.

Effect of Red Clover Isoflavones over Skin, Appendages, and Mucosal Status in Postmenopausal Women.

Objective. Evaluate in postmenopausal women the effect of red clover extract (RCE) isoflavones over subjective status of skin, appendages, and several mucosal sites. Method. Postmenopausal women (n = 109) were randomly assigned to receive either two daily capsules of the active compound (80 mg RCE, Group A) or placebo of equal appearance (Group B) for a 90-day period. After a washout period of 7 days, medication was crossed over and taken for 90 days more. Subjective improvement of skin, appendages, and several mucosal site status was assessed for each studied group at 90 and 187 days using a visual analogue scale (VAS). In addition, libido, tiredness, and urinary, sleep, and mood complaints were also evaluated. Results. Women after RCE intervention (both groups) reported better subjective improvement of scalp hair and skin status, libido, mood, sleep, and tiredness. Improvement of urinary complaints, nail, body hair, and mucosa (oral, nasal, and ocular) status did not differ between treatment phases (intra- and intergroup). Overall satisfaction with treatment was reported higher after RCE intervention (both groups) as compared to placebo. Conclusion. RCE supplementation exerted a subject improvement of scalp hair and skin status as well as libido, mood, sleep, and tiredness in postmenopausal women.

Managing immunity in resistant cancer patients correlates to survival: results and discussion of a pilot study.

Many cancer patients do not die due to impaired organ functions, but as a result of reduced general conditions, such as cachexia, sarcopenia, depression, infections, or stress. Reduced general health may be caused by immune modifying cytokines released from the tumor into the body. Improvement of immunity would not only reduce cancer side effects through inhibiting cytokine release from the tumor into the blood, but also, according to a new hypothesis, modify the cancer stem cells (CSC) in the tumor, which are believed to drive cancer growth and metastasis. We reported previously several investigations with a dietary fermented soy formulation (FSWW08) in cancer patients, where we saw a) strong reduction of cancer symptoms, b) broken resistance to chemotherapy, and c) a strong reduction of chemotherapy's toxic side effects, when taken in combination. This publication reports two new findings from a pilot study with postsurgical, treatment resistant patients conducted over four years. First, neither treatment resistance nor side effects were observed. Second, more patients have survived than expected. The improved health and immunity is detected together with increased CSC differentiation, suggesting lower aggressiveness, which was corroborated by increased gene expressions, particularly of steroidal hormones, MAPkinase, NF-κB, and tumor suppressor factor p53, a typical marker of "stemness" or cell differentiation. Although limited by its small, homogenous sample size, the results of this pilot study illustrate the relationship between CSCs differentiation, and the clinical symptoms of immunity, which influence survival outcomes and raise the clinical potential of measuring CSCs in ovarian, prostate, and breast cancers. The improved survival rates are also seen in larger cohort studies, which show similar gene expression profiles, which were induced by FSWW08 in the treatment resistant cancer patients in this study.

Cancer protection of soy resembles cancer protection during pregnancy.

It has been established that carrying a pregnancy to full-term at an early age can protect against contracting cancer by up to 50% in later life. The trophoblast theory of cancer states that trophoblast and cancer tissue are very similar. New findings suggest that the loss of fetal cells during pregnancy resemble those cells responsible for causing metastasis in cancer. Fetal cells and spreading cancer cells are highly proliferative. They are similar to stem cells, exhibiting no or low hormone receptor expression, and require a hormone receptor independent mechanism for control. Control of membrane stability during pregnancy is of vital importance for a successful pregnancy and is mediated by androstenediol and 2-methoxyestradiol. 2-Methoxyestradiol has no hormone receptor affinity and elicits strong anticancer effects particularly against cancer stem cells and fetal cells, for which currently no treatment has yet been established. There is a discussion whether pregnancy reduces cancer stem cells in the breast. Soy isoflavones are structurally similar to both hormones, and elicit strong anticancer effects and antiangiogenesis via inhibition of NF-κB, even in hormone receptor independent breast cancers seen in epidemiologic studies. The trophoblast theory of cancer could help to explain why soy baby nutrition formulas have no effect on baby physiology, other than the nutritional aspect, although soy elicits many effects on the adult immune system. To survive the immune system of the mother, the immune system of the fetus has to be separated; otherwise, the reduction of the immune system in the mother, a necessary feature for the blastocyst to grow, would immediately reduce the immunity for the fetus and endanger its survival. Similar to a fetus, newly born babies show immune insensitive to Th1 and Th2 cytokines, which are necessary and crucial for regulating the immune system of the mother, thus raising the risk of the baby of developing allergies and neurodermatitis. Gene expression studies in vitro as well as in circulating tumor cells from patients consuming a fermented soy product support the antiangiogenic as well as antiproliferative effects of soy.

Effects of a red clover extract (MF11RCE) on endometrium and sex hormones in postmenopausal women.

OBJECTIVE: To evaluate the effects of a non-prescription red clover extract (MF11 RCE, Melbrosin International, Vienna, Austria) on selected sex hormones and endometrium in postmenopausal women. PATIENTS AND METHODS: One-hundred and nine postmenopausal women with an age > or =40 years were randomly assigned to one of two groups either two capsules of MF11RCE (80mg isoflavone) per day for a 90 day period, or placebo of equal design. After a 7 day washout period, medication was crossed-over for another 90 days. RESULTS: Combined evaluation demonstrated that supplementation with MF11RCE (verum), in contrast to placebo, significantly increased plasma testosterone levels and decreased endometrial thickness. CONCLUSION: MF11RCE exerts a moderate effect on testosterone levels in postmenopausal women, while estradiol levels remained unchanged. The observed reduction of endometrial thickness provides further support for a safe role for isoflavones in terms of endometrial hyperplasia.