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Vaginal, endometrial, and reproductive hormone findings: randomized, placebo-controlled trial of black cohosh, multibotanical herbs, and dietary soy for vasomotor symptoms: the Herbal Alternatives for Menopause (HALT) Study.
Reed, SD, Newton, KM, LaCroix, AZ, Grothaus, LC, Grieco, VS, Ehrlich, K
Menopause (New York, N.Y.). 2008;(1):51-8
Abstract
OBJECTIVE To evaluate vaginal, endometrial, and reproductive hormone effects of three herbal regimens compared with placebo and hormone therapy (HT). DESIGN This was a 1-year, randomized, double-blind, placebo-controlled trial of 351 women, ages 45 to 55, with two or more vasomotor symptoms per day. Women were randomly assigned to (1) black cohosh, (2) a multibotanical containing black cohosh, (3) the same multibotanical plus dietary soy counseling, (4) HT, or (5) placebo. Women were ineligible if they had used HT in the previous 3 months or menopausal herbal therapies in the previous month. Data on vaginal cytology and dryness were collected (at baseline and 3 and 12 mo). Daily menstrual diaries were maintained by 313 women with a uterus, and abnormal bleeding was evaluated. Serum estradiol, follicle-stimulating hormone, luteinizing hormone, and steroid hormone-binding globulin were assessed (baseline and 12 mo) among 133 postmenopausal women. Gynecologic outcomes of the five groups were compared. RESULTS The five groups did not vary in baseline vaginal cytology profiles, vaginal dryness, menstrual cyclicity, or hormone profiles. The HT group had a lower percentage of parabasal cells and vaginal dryness than the placebo group at 3 and 12 months (P < 0.05). Abnormal bleeding occurred in 53 of 313 (16.9%) women. There were no differences in frequency of abnormal bleeding between any of the herbal and placebo groups, whereas women in the HT group had a greater risk than those in the placebo group (P < 0.001). Among postmenopausal women, HT significantly decreased follicle-stimulating hormone and increased estradiol; none of the herbal interventions showed significant effects on any outcomes at any time point. CONCLUSION Black cohosh, used alone or as part of a multibotanical product with or without soy dietary changes, had no effects on vaginal epithelium, endometrium, or reproductive hormones.
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Daidzein-rich isoflavone aglycones are potentially effective in reducing hot flashes in menopausal women.
Khaodhiar, L, Ricciotti, HA, Li, L, Pan, W, Schickel, M, Zhou, J, Blackburn, GL
Menopause (New York, N.Y.). 2008;(1):125-32
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Abstract
OBJECTIVE The aim of this study was to determine the effect of DRIs on hot flash symptoms in menopausal women. DESIGN This was a randomized, double-blind, placebo-controlled trial of menopausal women, aged 38 to 60 years, who experienced 4 to 14 hot flashes per day. After a 1-week run-in period, a total of 190 menopausal women were randomized to receive a placebo or 40 or 60 mg/day of a DRI for 12 weeks. The primary outcome was the mean changes from baseline to week 12 in the frequency of hot flashes recorded in the participant diary. The secondary outcomes included changes in quality of life and hormonal profiles. RESULTS A total of 147 women (77%) completed the study. It was found that 40 and 60 mg of DRI improved hot flash frequency and severity equally. At 8 weeks hot flash frequency was reduced by 43% in the 40-mg DRI group and by 41% in the 60-mg DRI group, compared with 32% in the placebo group (P = not significant vs placebo). The corresponding numbers for 12 weeks were 52%, 51%, and 39%, respectively (P = 0.07 and 0.09 vs placebo). When comparing the two treatment groups with the placebo group, there were significant reductions in mean daily hot flash frequency. The supplement (either 40 or 60 mg) reduced hot flash frequency by 43% at 8 weeks (P = 0.1) and 52% at 12 weeks (P = 0.048) but did not cause any significant changes in endogenous sex hormones or thyroid hormones. Menopausal quality of life improved in all three groups, although there were no statistically significant differences between groups. CONCLUSIONS DRI supplementation may be an effective and acceptable alternative to hormone treatment for menopausal hot flashes.
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[The role of thrombin activatable fibrinolysis inhibitor in disturbances of fibrinolytic system in obesity].
Kołacz, E, Lewandowski, K, Zawilska, K
Polskie Archiwum Medycyny Wewnetrznej. 2005;(5):424-30
Abstract
The aim of the study was to evaluate fibrinolysis in obese women. Study group consisted of 45 obese women (mean age 36,8 +/- 16,6 years, mean BMI 35,7 +/- 4,9), who were allocated to two subgroups: premenopausal (mean age 32,3 +/- 9,9 years, mean BMI 36,9 +/- 5,6) and postmenopausal (mean age 64,8+/-10,1 years, mean BMI 33,3 +/- 2,55). Control group consisted of 45 women (mean age 35,3 +/- 13,9 years) with normal BMI (21,8 +/- 3,09). Global fibrinolytic activity was diminished only in obese women after menopause. Final analysis revealed significant increase of TAFI antigen and activity in the plasma of obese women. The existence of significant correlation in multifactor regression analysis between TAFI plasma content and euglobulin clot lysis time (ECLT) and global fibrinolytic capacity (GFC) as well confirmed negative influence of this inhibitor on fibrinolytic capacity in obese women. The increase of TAFI antigen and activity in the plasma was independent of age, BMI, glucose, cholesterol, triglicerides, insulin and leptin concentration in the plasma. The results of ECLT and GFC may be also influenced by PAI-1 activity particularly in women before menopause, which was significantly elevated in our group of patients. This increase as not dependent with TAFI antigen concentration. In conclusion, the observed increase TAFI antigen and activity in the plasma of obese women may influence the thrombotic risk in this group of patients, especially after menopause.
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A psycho-educational program for improving women's attitudes and coping with menopause symptoms.
Rotem, M, Kushnir, T, Levine, R, Ehrenfeld, M
Journal of obstetric, gynecologic, and neonatal nursing : JOGNN. 2005;(2):233-40
Abstract
OBJECTIVE To examine the impact of participation in a psycho-educational program on women's attitudes toward menopause, the perceived severity of their symptoms, and the association between the two. DESIGN Quasi-experimental. Data were gathered at baseline and 3 months after termination of the program. SETTING Two health maintenance organization clinics. PARTICIPANTS Eighty-two healthy 40- to 60-year-old women who chose to participate in the study. Thirty-six women participated in the program, and 46 women comprised the control group. INTERVENTION Program participants met for 10 weekly sessions to receive information from a professional team on subjects related to menopause and to share and discuss their experiences. MAIN OUTCOME MEASURES Attitudes toward menopause and severity of menopause symptoms. RESULTS The more negative the attitudes, the higher was the severity of symptoms. Participants reported significant improvements in attitudes and reductions in symptom severity compared to their own baseline scores and compared with the control group. CONCLUSIONS Participation in a program that combines delivery of information and processing of experiences on the cognitive, emotional, and social levels may improve women's attitudes toward menopause and ease the perceived severity of their symptoms, thereby increasing quality of life.
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Usefulness of HMG-CoA reductase inhibitor in Japanese hyperlipidemic women within seven years of menopause.
Ohta, H, Masuda, A, Fuyuki, T, Sugimoto, I, Suda, Y, Makita, K, Takamatsu, K, Horiguchi, F, Nozawa, S
Hormone research. 2000;(3):120-4
Abstract
OBJECTIVE To assess the therapeutic value of treatment with an HMG-CoA reductase inhibitor in women with hypoestrogenic hyperlipidemia caused by menopause. DESIGN Fifty-six women with total cholesterol (TC) levels of 220 mg/dl or more who were within 7 years of menopause were randomly assigned to receive an HMG-CoA reductase inhibitor (pravastatin 10 mg/day; treated group, 26 patients) or no medical treatment (nontreated group, 30 patients) in this 6-month nonblinded prospective trial. RESULTS In the treated group, the mean (SD) TC levels decreased significantly from 254.5+/-22.3 mg/dl at baseline to 204.7+/-22.2 mg/dl (19.6%), and the mean low-density lipoprotein cholesterol (LDL-C) level decreased significantly from 146.7+/-30.5 to 104.3+/-22.5 mg/dl (28.9%); the mean arteriosclerotic index decreased significantly from 2.98 to 2.08 (30.2%). There were no significant changes in either triglyceride levels or high-density lipoprotein cholesterol (HDL-C) levels. In the nontreated group, there were no significant changes in the TC, HDL-C, LDL-C, or triglyceride levels; there was also no change in the arteriosclerotic index. After 6 months, the TC level, LDL-C level, and arteriosclerotic index were significantly lower in the treated group compared with the nontreated group (p<0.01). CONCLUSIONS The results indicate that the HMG-CoA reductase inhibitor lowered TC and LDL-C levels and was useful in the treatment of hypoestrogenic hyperlipidemia for periods of at least 6 months.