vasomotor symptoms, psychoemotional symptoms, urogenital symptoms
Conditions
Interventions
The three treatment groups consisted of 20 participants in each group and followed during 16 weeks. The participants were randomized according to the following therapies:
Phytoestrogen group (n=20):
drug
dietary supplement
HP3.073.433.101
E02.190.755
Sponsors
UNICAMP
UNICAMP
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria consisted of postmenopausal women between 40 and 60 years of age who had had their last menstrual period more than 12 months previously, had follicle-stimulating hormone (FSH) levels higher than 30mIU/mL and estradiol levels lower than 20 pg/ml, who were having more than 8 hot flashes in 24 hours, had not been using any form of hormonal treatment during the previous six months and were not currently using any lipid-lowering drugs, antidiabetic drugs, soybean derived products or herbal supplements.
Exclusion criteria
Exclusion criteria: The exclusion criteria consisted of: previous hysterectomy, chronic gastrointestinal disorder, any contraindication to hormone therapy or patients participating in another clinical trial. Finally, women were excluded if they had a known allergy or hypersensitivity to soy or cow milk or were not willing to cease consumption of soy products for the 16 weeks of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At the screening visit, women completed a standardized questionnaire designed to obtain information on their demographic characteristics including age, ethnicity, education level and social status. Women were also queried about their reproductive history, age at menopause, time since menopause, use of medication, history of cigarette smoking and frequency of alcohol consumption. In all three groups, data were collected at baseline and after sixteen weeks of use of the respective medication. To examine the effects of the regime on endogenous hormone levels, follicle-stimulating hormone (FSH) and 17beta estradiol were measured. The Menopause Rating Scale (MRS) was used to evaluate menopausal symptoms at baseline and after 16 weeks of treatment. The MRS is composed of 11 items assessing menopausal symptoms and is divided into three subscales [13]: § Somatic symptoms: hot flashes, heart discomfort, sleeping problems and muscle and joint problems (items 1-3 and 11, respectively). § Psychological symptoms: depressive mood, irritability, anxiety, physical and mental exhaustion (items 4-7, respectively). § Urogenital symptoms: sexual problems, bladder problems and vaginal dryness (items 8-10, respectively). Each item is graded by the subject, scores ranging from zero (absent) to four (1=mild; 2=moderate; 3=severe; 4=very severe). The total score for each subscale is the sum of each item graded within that subscale. Total MRS score is composed of the sum of the scores obtained for each subscale. Transvaginal sonography was performed to evaluate endometrial thickness.It will be considered the comparision of the endometrial thickness of baseline and after 16 weeks of treatment. The vaginal trofism will be evaluated by vaginal smears. The maturation index was scored under a light microscope by a single cytopathologist blinded to the study group at the baseline and after treatment. The Maturation Value (MV) was calculated by the following way: Superficial cells wer | — |
Secondary
| Measure | Time frame |
|---|---|
| Analize the metabolic effects. . Blood was drawn for measurement of total lipid levels, lipoprotein levels and glucose analysis after women had fasted for 12 hours overnight. Plasma glucose was measured by a glucose oxidase assay. Plasma total cholesterol and triglyceride levels were measured using enzymatic techniques. Lipoproteins were determined according to the Lipid Research Clinics (LRC) method run by the National Institute of Health using commercial kits (Roche). The inter-run coefficients of variation were 1.5% (TGs), 0.8% (TC) and 1.3% (HDLc). LDL cholesterol was calculated using the Friedwald Equation: LDL cholesterol = total cholesterol – HDL cholesterol – (triglycerides/5). The Castelli I index was calculated as the ratio between total cholesterol and HDL cholesterol. Castelli II index was calculated as the ratio between LDL cholesterol and HDL cholesterol. Analize the safety profile.Side effects were analyzed according to the occurrence or exacerbation of an adverse event during the treatment period. ;Quality of life was measured by the abbreviated version of the World Health Organization’s Quality of Life instrument (WHOQOL-BREF), 1998, at baseline (T1) and at 16 weeks of treatment (T2). | — |
Countries
Brazil
Contacts
Public ContactAARÃO;Adriana PINTO-NETO;Pedro
UNICAMP;UNICAMP
Outcome results
None listed