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Vaginal health of postmenopausal women on nutraceutical containing equol.
Caruso, S, Cianci, S, Fava, V, Rapisarda, AMC, Cutello, S, Cianci, A
Menopause (New York, N.Y.). 2018;(4):430-435
Abstract
OBJECTIVE The aim of the study was to evaluate the effects of nutraceuticals containing equol on vaginal health of postmenopausal women with vulvovaginal symptoms and dyspareunia. METHODS One hundred twenty-six natural postmenopausal women on +1b +1c (2 and 3-6 y after the final menstrual period, respectively) of the Stages of Reproductive Aging Workshop were enrolled in a nonrandomized trial. Of these, 72 women accepted to use nutraceutical (group A). The remaining 54 women refused the treatment and participated as the control group (group B). Group A was prescribed one tablet daily to take orally, for 8 months. All assessments were made at baseline and at 4 and 8 months. Determination of vaginal maturation index (VMI), evaluation of vaginal pH, and assessment of vaginal atrophy symptoms by the vaginal health index (VHI) were carried out. Dyspareunia score was also measured. RESULTS Group A had a significant increase in VMI (68 ± 5 vs 58 ± 8) and improvement of vaginal pH (4.1 ± 1.3 vs 5.1 ± 1.7) compared with baseline, mainly after 8 months of treatment (P < 0.001). Group A had an improvement of VHI after 4 (13 ± 3, P < 0.01) and 8 (16 ± 2, P < 0.001) months of nutraceutical intake. Dyspareunia reduced after 8 months (5.1 ± 1.3 vs 3.8 ± 1.2, P < 0.001) but not after 4 months (4.7 ± 1.1, P = 0.06) of treatment. Group B showed no changes from baseline evaluation (P = 0.22). CONCLUSIONS Nutraceuticals containing equol could be effective in modulating postmenopausal symptoms, particularly vaginal symptoms, and could be well accepted by the women who usually do not wish to use hormone therapy or cannot use it for medical reasons.
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The effects of flaxseed on menopausal symptoms and quality of life.
Cetisli, NE, Saruhan, A, Kivcak, B
Holistic nursing practice. 2015;(3):151-7
Abstract
The purpose of this study was to analyze the effects of flaxseed on menopausal symptoms and quality of life throughout the menopausal period. The empirical research was conducted in an obstetrics and gynecology outpatient department of a university hospital and involved 140 menopausal women who were divided into 4 groups. The menopausal symptoms decreased and the quality of life increased among the women who used flaxseed for 3 months.
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Effects of a phyto complex on well-being of climacteric women.
Quattrocchi, T, Micali, E, Gentile, A, La Ferrera, EG, Barbaro, L, Ciarcià, S, Corrado, F, Di Costa, M, Fazio, R, Licenziato, R, et al
The journal of obstetrics and gynaecology research. 2015;(7):1093-8
Abstract
AIM: The aim of this study was to assess the effects of a phyto complex on menopausal symptoms. MATERIAL AND METHODS A total of 151 women aged 42-67 years were enrolled. They were in spontaneous or surgical menopause by at least 12 months, reporting symptoms referable to the climacteric syndrome. Two validated and standardized tests were given to the whole sample at the entrance of the study (T0) and after 6 months of treatment (T6): the Greene Climacteric Scale (GCS) and the Beck Depression Inventory (BDI). Interim evaluations were carried out at 1-3 months (T1 and T3) on five symptoms selected from the GCS. The phyto complex was given to each enrolled woman, from the T0 to T6 time-points, for a total of 180 days. RESULTS At the T0 time-point, the average scores were: GCS, 28.98 (standard deviation [SD] ± 10.71); BDI, 14.48 (SD ± 6.5). At the T1 time-point, five parameters of the GCS were assessed with a reduction of 36.25% in symptoms (5.69, SD ± 3.53). At the T6 time-point the assessment was completed: average GCS results were 11.54 (SD ± 8.01) with a 60.17% improvement; and average BDI results were 6.11 (SD ± 4.6) with a 58.91% improvement in the depressive symptoms. CONCLUSIONS The phyto complex under consideration is an effective tool to counter, in a quick and long-lasting manner, the most common and nagging symptoms of the climacteric syndrome, such as hot flushes, insomnia and depression.
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Estrogen receptor and PI3K/Akt signaling pathway involvement in S-(-)equol-induced activation of Nrf2/ARE in endothelial cells.
Zhang, T, Liang, X, Shi, L, Wang, L, Chen, J, Kang, C, Zhu, J, Mi, M
PloS one. 2013;(11):e79075
Abstract
S-(-)equol, a natural product of the isoflavone daidzein, has been reported to offer cytoprotective effects with respect to the cardiovascular system, but how this occurs is unclear. Interestingly, S-(-)equol is produced by the human gut, suggesting a role in physiological processes. We report that treatment of human umbilical vein endothelial cells and EA.hy926 cells with S-(-)equol induces ARE-luciferase reporter gene activity that is dose and time dependent. S-(-)equol (10-250 nM) increases nuclear factor-erythroid 2-related factor 2 (Nrf2) as well as gene products of Nrf2 target genes heme oxygenase-1 (HO-1) and NAD(P)H (nicotinamide-adenine-dinucleotide-phosphate) quinone oxidoreductase 1 (NQO1). Endothelial cells transfected with an HA-Nrf2 expression plasmid had elevated HA-Nrf2, HO-1, and NQO1 in response to S-(-)equol exposure. S-(-)equol treatment affected Nrf2 mRNA only slightly but significantly increased HO-1 and NQO1 mRNA. The pretreatment of cells with specific ER inhibitors or PI3K/Akt (ICI182,780 and LY294002) increased Nrf2, HO-1, and NQO1 protein, impaired nuclear translocation of HA-Nrf2, and decreased ARE-luciferase activity. Identical experiments were conducted with daidzein, which had effects similar to S-(-)equol. In addition, DPN treatment (an ERβ agonist) induced the ARE-luciferase reporter gene, promoting Nrf2 nuclear translocation. Cell pretreatment with an ERβ antagonist (PHTPP) impaired S-(-)equol-induced Nrf2 activation. Pre-incubation of cells followed by co-treatment with S-(-)equol significantly improved cell survival in response to H2O2 or tBHP and reduced apoptotic and TUNEL-positively-stained cells. Notably, the ability of S-(-)equol to protect against H2O2-induced cell apoptosis was attenuated in cells transfected with an siRNA against Nrf2. Thus, beneficial effects of S-(-)equol with respect to cytoprotective antioxidant gene activation may represent a novel strategy to prevent and treat cardiovascular diseases.
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Eviendep® reduces number and size of duodenal polyps in familial adenomatous polyposis patients with ileal pouch-anal anastomosis.
Calabrese, C, Praticò, C, Calafiore, A, Coscia, M, Gentilini, L, Poggioli, G, Gionchetti, P, Campieri, M, Rizzello, F
World journal of gastroenterology. 2013;(34):5671-7
Abstract
AIM: To evaluate if 3 mo oral supplementation with Eviendep® was able to reduce the number of duodenal polyps in familial adenomatous polyposis (FAP) patients with ileal pouch-anal anastomosis (IPAA). METHODS Eleven FAP patients with IPAA and duodenal polyps were enrolled. They underwent upper gastrointestinal (GI) endoscopy at the baseline and after 3 mo of treatment. Each patient received 5 mg Eviendep twice a day, at breakfast and dinner time, for 3 mo. Two endoscopists evaluated in a blinded manner the number and size of duodenal polyps. Upper GI endoscopies with biopsies were performed at the baseline (T0) with the assessment of the Spigelman score. Polyps > 10 mm were removed during endoscopy and at the end of the procedure a new Spigelman score was determined (T1). The procedure was repeated 3 mo after the baseline (T2). Four photograms were examined for each patient, at T1 and T2. The examined area was divided into 3 segments: duodenal bulb, second and third portion duodenum. Biopsy specimens were taken from all polyps > 10 mm and from all suspicious ones, defined by the presence of a central depression, irregular surface, or irregular vascular pattern. Histology was classified according to the updated Vienna criteria. RESULTS At baseline the mean number of duodenal detected polyps was 27.7 and mean sizes were 15.8 mm; the mean Spigelman score was 7.1. After polypectomy the mean number of duodenal detected polyps was 25.7 and mean sizes were 7.6 mm; the mean Spigelman score was 6.4. After 3 mo of Eviendep bid, all patients showed a reduction of number and size of duodenal polyps. The mean number of duodenal polyps was 8 (P = 0.021) and mean size was 4.4 mm; the mean Spigelman score was 6.6. Interrater agreement was measured. Lesions > 1 cm found a very good degree of concordance (kappa 0.851) and a good concordance was as well encountered for smaller lesions (kappa 0.641). CONCLUSION Our study demonstrated that short-term (90 d) supplementation with Eviendep® in FAP patients with IPAA and with recurrent adenomas in the duodenal mucosa, resulted effective in reducing polyps number of 32% and size of 51%.
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Reduction in Ki-67 in benign breast tissue of high-risk women with the lignan secoisolariciresinol diglycoside.
Fabian, CJ, Kimler, BF, Zalles, CM, Klemp, JR, Petroff, BK, Khan, QJ, Sharma, P, Setchell, KD, Zhao, X, Phillips, TA, et al
Cancer prevention research (Philadelphia, Pa.). 2010;(10):1342-50
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Abstract
Preclinical and correlative studies suggest reduced breast cancer with higher lignan intake or blood levels. We conducted a pilot study of modulation of risk biomarkers for breast cancer in premenopausal women after administration of the plant lignan secoisolariciresinol given as the diglycoside (SDG). Eligibility criteria included regular menstrual cycles, no oral contraceptives, a >3-fold increase in 5-year risk, and baseline Ki-67 of ≥2% in areas of hyperplasia in breast tissue sampled by random periareolar fine-needle aspiration (RPFNA) during the follicular phase of the menstrual cycle. SDG (50 mg/d) was given for 12 months, followed by repeat RPFNA. The primary end point was change in Ki-67. Secondary end points included change in cytomorphology, mammographic breast density, serum bioavailable estradiol and testosterone insulin-like growth factor-I and IGF-binding protein-3, and plasma lignan levels. Forty-five of 49 eligible women completed the study with excellent compliance (median = 96%) and few serious side effects (4% grade 3). Median plasma enterolactone increased ∼9-fold, and total lignans increased 16-fold. Thirty-six (80%) of the 45 evaluable subjects showed a decrease in Ki-67, from a median of 4% (range, 2-16.8%) to 2% (range, 0-15.2%; P < 0.001, Wilcoxon signed rank test). A decrease from baseline in the proportion of women with atypical cytology (P = 0.035) was also observed. Based on favorable risk biomarker modulation and lack of adverse events, we are initiating a randomized trial of SDG versus placebo in premenopausal women.
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Genistein supplements might not induce clitoral modifications in postmenopausal women: a prospective, pilot study.
Battaglia, C, Cianciosi, A, Mancini, F, Fabbri, R, Busacchi, P, Nappi, RE, Venturoli, S
The journal of sexual medicine. 2009;(11):3132-8
Abstract
INTRODUCTION Vaginal dryness, low sexual desire, and low sexual arousability are critical issues for many postmenopausal women. Hormone therapy seems to improve vaginal lubrication and dyspareunia. AIM: To evaluate, in postmenopausal women who refused hormonal therapy, the role of genistein in the treatment of vasomotor symptoms and its capacity to induce clitoral volumetric and vascular modifications independently from sexual stimulation. METHODS Twenty-nine postmenopausal women who refused hormonal therapy were submitted to oral daily treatment with genistein 45 mg (Group I; N = 15); or no treatment (Group II; N = 14). The Group II patients served as controls. The patients were not randomly assigned to the two groups. The patients were studied before and after 3 months. MAIN OUTCOMES MEASURES Endometrial and clitoral ultrasonographic analysis; color Doppler evaluation of the dorsal clitoral artery; evaluation of hormonal plasma concentrations; administration of the two-factor Italian McCoy Female Sexuality Questionnaire; compilation of a monthly diary reporting the number of hot flashes. The ultrasound, color Doppler and psychometric tests were performed by examiners blinded to the participant's group assignment. RESULTS In the genistein-treated patients the vasomotor symptoms ameliorated at the end of the study. The use of genistein did not influence any other parameter. CONCLUSIONS Postmenopausal women submitted to a 3-months treatment with genistein showed an improvement of vasomotor symptoms. However, isoflavones seem to not induce any modification in the clitoral structures.
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Is there a role for soy isoflavones in the therapeutic approach to polycystic ovary syndrome? Results from a pilot study.
Romualdi, D, Costantini, B, Campagna, G, Lanzone, A, Guido, M
Fertility and sterility. 2008;(5):1826-33
Abstract
OBJECTIVE To evaluate the effect of the soy isoflavone genistein on the metabolic and hormonal disturbances of polycystic ovary syndrome (PCOS), we studied a group of obese, hyperinsulinemic, and dyslipidemic women presenting this syndrome during 6 months of phytoestrogen administration. DESIGN Pilot prospective study. SETTING Operative division of endocrinological gynecology in a university hospital. PATIENT(S): Twelve Caucasian obese, hyperinsulinemic, and dyslipidemic women with PCOS. INTERVENTION(S): Patients received 36 mg/d of genistein for 6 months. Ultrasonographic pelvic exams, hormonal and lipid features, oral glucose tolerance test, and euglycemic hyperinsulinemic clamp were performed at baseline and after 3 and 6 months of treatment. MAIN OUTCOME MEASURE(S): Basal hormonal assays, lipid profile, and glycoinsulinemic assessment. RESULT(S): Phytoestrogens supplementation significantly improved total cholesterol levels, reducing low-density lipoprotein (LDL) cholesterol and resulting in a significant decrease in the LDL-high-density lipoprotein ratio (LDL-HDL). Triglycerides showed a trend toward decrease, whereas no changes were detected in very low-density lipoprotein cholesterol plasma levels. Genistein treatment did not significantly affect anthropometric features, the hormonal milieu, and menstrual cyclicity. No significant changes occurred in glycoinsulinemic metabolism. CONCLUSION(S): The possible advantages derived from the therapeutic use of phytoestrogens in PCOS are limited to improvement of the lipidic assessment.
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The prenylflavonoid isoxanthohumol from hops (Humulus lupulus L.) is activated into the potent phytoestrogen 8-prenylnaringenin in vitro and in the human intestine.
Possemiers, S, Bolca, S, Grootaert, C, Heyerick, A, Decroos, K, Dhooge, W, De Keukeleire, D, Rabot, S, Verstraete, W, Van de Wiele, T
The Journal of nutrition. 2006;(7):1862-7
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Abstract
Hops, an essential beer ingredient, are a source of prenylflavonoids, including 8-prenylnaringenin (8-PN), one of the most potent phytoestrogens. Because 8-PN concentrations in beers are generally low, its health effects after moderate beer consumption were considered negligible. However, human intestinal microbiota may activate up to 4 mg/L isoxanthohumol (IX) in beer into 8-PN. Depending on interindividual differences in the intestinal transformation potential, this conversion could easily increase the 8-PN exposure 10-fold upon beer consumption. Here, we present a further investigation of the process both in vitro and in vivo. In vitro experiments with the dynamic SHIME model showed that hop prenylflavonoids pass unaltered through the stomach and small intestine and that activation of IX into 8-PN (up to 80% conversion) occurs only in the distal colon. In vitro incubations of 51 fecal samples from female volunteers with IX enabled us to separate the fecal microbiota into high (8 of 51), moderate (11 of 51) and slow (32 of 51) 8-PN producers, clearly illustrating an interindividual variability. Three women, selected from the respective groups, received a daily dose of 5.59 mg IX for 4 d. Intestinal IX activation and urinary 8-PN excretion were correlated (R(2) = 0.6417, P < 0.01). These data show that intestinal conversion of IX upon moderate beer consumption can lead to 8-PN exposure values that might fall within the range of human biological activity.
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Method of defining equol-producer status and its frequency among vegetarians.
Setchell, KD, Cole, SJ
The Journal of nutrition. 2006;(8):2188-93
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Abstract
7-Hydroxy-3-(4'-hydroxyphenyl)-chroman (S-equol) is a specific end-metabolite formed in the biotransformation of the dietary soy isoflavones daidzin and daidzein by intestinal bacteria. The frequency of equol production varies among individuals and populations, and it is suggested that the efficacy of soy foods differs depending on the ability of an individual to produce equol. To develop a standardized approach to define equol-producer status that can be universally adopted to differentiate these 2 distinct populations, we measured isoflavones in serum and urine collected from a cohort of 41 healthy adults, comprising 29 vegetarians and 12 nonvegetarians, after consuming 2 x 250 mL/d soy milk on 3 consecutive days. Serum and urinary daidzein and S-equol concentrations were analyzed by MS. Serum S-equol and daidzein concentrations ranged from 10.3-139 nmol/L (2.5-33.6 microg/L) and 16-1401 nmol/L (4.0-356 microg/L), respectively, whereas in urine the corresponding concentrations ranged from 16-12,574 nmol/L (4-3043 microg/L) and 539-26,834 nmol/L (137-6816 microg/L), respectively. The log10-transformed urinary S-equol:daidzein ratio provided a clearer distinction of equol-producer status than the absolute serum or urinary S-equol concentrations because it is independent of isoflavone intake and minimizes interindividual variation in isoflavone pharmacokinetics or differences in analytical methodologies. A threshold value for the log10-transformed urinary S-equol:daidzein ratio of -1.75 provided a demarcation to define equol-producer status. The frequency of equol producers in the vegetarians was 59%, similar to the reported frequency in Japanese adults consuming soy, and much higher than for nonvegetarian adults (25%), suggesting that dietary components other than soy influence S-equol synthesis by intestinal bacteria.