Evaluation of the Menopause-Specific Quality of Life Questionnaire: a factor-analytic approach.
Menopause. 2012 Feb;19(2):211-5
Authors: Van Dole KB, Devellis RF, Brown RD, Jonsson Funk ML, Gaynes BN, Williams RE
Abstract
OBJECTIVE: Despite being used in multiple studies, the Menopause-Specific Quality of Life Questionnaire (MENQOL) has not been assessed with factor analysis, a common method of item reduction in quality of life tools.
METHODS: The Menopause Epidemiology Study is a cross-sectional population-based study of women 40 to 65 years old in the United States chosen from a source population selected by random digit dialing and probability sampling. We focused on 2,703 postmenopausal women for our analyses. Before analysis and to prevent model overfitting, we split our sample into two equal groups using a uniform random sample. Using parallel analysis for factor extraction, we performed confirmatory factor analysis on the MENQOL to examine the current factor structure and to evaluate the efficiency of the items in the existing tool. Reliability coefficients (Cronbach α) were calculated for each of the domains.
RESULTS: With few exceptions, the items from the original MENQOL factored into the domains under which they were originally placed. Using this method, five items did not add significant statistical value to the scoring of the domains: difficulty sleeping; poor memory; accomplishing less than I used to; changes in appearance, texture, or tone of my skin; and feeling tired. Reliability coefficients for the four original domains were acceptable: vasomotor, 0.87; psychosocial, 0.85; physical, 0.88; and sexual, 0.77.
CONCLUSIONS: Results from factor analysis indicate that although the MENQOL was developed more than 15 years ago, the strength of the items is still highly valuable today in the assessment of women’s menopause-related quality of life.
OBJECTIVE: The aim of this study was to determine the efficacy, safety, and lowest practical dose of a transdermal estradiol gel in the treatment of symptomatic postmenopausal women. METHODS: Healthy postmenopausal women with seven or more moderate to severe hot flushes per day or 50 to 60 or more per week were randomized to transdermal gel containing 1.5 mg (n = 73) or 0.75 mg (n = 75) estradiol (EstroGel 0.06%) or placebo (n = 73) in a phase 3 study, or to 0.375 mg (n = 119) or 0.27 mg (n = 118) estradiol (0.03% gel) or placebo (n = 114) in a phase 4 study. RESULTS: The frequency of moderate to severe hot flushes and severity of all hot flushes significantly decreased versus placebo at weeks 4 and 12 with 1.5, 0.75, and 0.375 mg estradiol. Overall participant responder rates were generally lower in the phase 4 study than those in the phase 3 study with the approved 0.75-mg estradiol dose. Vaginal maturation index (VMI) shifts from baseline to week 12 were significant (P < 0.001) with 0.75 and 1.5 mg estradiol versus placebo; VMI improved (P < 0.001), superficial cells increased (P = 0.005), and parabasal cells decreased (P = 0.002) with 0.375 mg estradiol vs placebo but not with 0.27 mg estradiol. The most frequently reported treatment-emergent adverse events, although not necessarily treatment related, were headache, infection, breast pain, and nausea (phase 3 study) and insomnia and headache (phase 4 study). No serious adverse events were related to treatment; no deaths occurred. CONCLUSION: A transdermal gel with 0.75 mg estradiol was the lowest practical dose that effectively reduced the frequency and severity of moderate to severe hot flushes, improved VMI, and was well tolerated.
PMID: 22282101 [PubMed - as supplied by publisher]
Using bazedoxifene plus conjugated estrogens for treating postmenopausal women: a comprehensive review.
Menopause. 2012 Jan 24;
Authors: Taylor HS, Ohleth K
Abstract
ABSTRACT: The objective of this article was to review clinical outcomes reported with the tissue selective estrogen complex containing bazedoxifene (BZA) and conjugated estrogens (CE) in postmenopausal women. PubMed was searched from inception to June 2011 using the key words bazedoxifene and conjugated estrogens. We reviewed six published articles reporting the clinical efficacy and safety outcomes of three different level I evidence, multicenter, blind, randomized, placebo-controlled studies. BZA/CE reduced hot flush frequency and severity, prevented loss of bone mass, and treated vulvar-vaginal atrophy and its symptoms without endometrial stimulation and provided amenorrhea and breast tenderness rates similar to those with placebo. Overall safety was not different from that observed with placebo, and no unexpected findings were reported. The tissue selective estrogen complex composed of BZA/CE is a new progestin-free therapy that alleviates hot flushes and prevents the loss of bone mass in postmenopausal women with endometrial hyperplasia and amenorrhea rates comparable with those of placebo.
PMID: 22278343 [PubMed - as supplied by publisher]
Soy germ isoflavones improve menopausal symptoms but have no effect on blood lipids in early postmenopausal Chinese women: a randomized placebo-controlled trial.
Menopause. 2012 Jan 24;
Authors: Ye YB, Wang ZL, Zhuo SY, Lu W, Liao HF, Verbruggen MA, Fang S, Mai HY, Chen YM, Su YX
Abstract
OBJECTIVE: Estrogen therapy is, to date, the most effective treatment of menopausal syndrome and also has a favorable effect on lipid profiles. Because of its potential adverse effects, however, a more acceptable alternative therapy needs to be identified. This study examines the effect of soy germ isoflavones on menopausal symptoms and serum lipids. METHODS: Ninety early postmenopausal Chinese women, aged 45 to 60 years, were randomly assigned to three treatment groups (30 each) receiving daily doses of 0 (placebo), 84, and 126 mg of soy germ isoflavones. Hot flush frequency, Kupperman scores, serum 17β-estradiol, follicle-stimulating hormone, luteinizing hormone, and serum lipids, including triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, apolipoprotein A-I, and apolipoprotein B100, were assessed at baseline and at 12 and 24 weeks after treatment. RESULTS: Both the frequency of hot flushes and the Kupperman index score decreased in all three treatment groups during the intervention period, but the percentage decreases in both were significantly greater in the two isoflavone groups (44.3 ± 19.1 and 57.8 ± 37.4 [84 mg isoflavones]; 48.5 ± 27.2 and 56.7 ± 26.7 [126 mg isoflavones]) than in the placebo group (27.8 ± 15.5 and 34.6 ± 46.2; p < 0.01). There was no significant difference in the changes in estradiol, follicle-stimulating hormone, and luteinizing hormone among the three treatment groups during the study, and no significant differences were observed in the lipid components. CONCLUSIONS: A daily supplement of 84 or 126 mg soy germ isoflavones may improve menopausal symptoms, although neither dose was found to affect lipid profiles in early postmenopausal Chinese women after 24 weeks of treatment. The favorable effects are unlikely to be associated with female hormones.
PMID: 22278344 [PubMed - as supplied by publisher]
Age and sex effects on the association between body composition and bone mineral density in healthy Chinese men and women.
Menopause. 2012 Jan 13;
Authors: Cheng Q, Zhu YX, Zhang MX, Li LH, Du PY, Zhu MH
Abstract
OBJECTIVE:: Many studies have examined the relationships between body composition and bone mineral density (BMD), but little attention has been given to how these relationships vary by age and sex. The aim of this study was to investigate the distributions of lean mass (LM), fat mass (FM), and BMD and the correlation between body composition and BMD in Chinese men and women of different ages. METHODS:: In total, the body compositions of 1,475 men and 1,534 women aged 20 to 96 years were analyzed. Using dual-energy x-ray absorptiometry, we measured the BMD of the spine, femur, and total body and the LM, FM, and percentage of body fat (Fat %). The population was divided into groups based on age and sex: young, premenopausal, and postmenopausal women and young, middle-aged, and older men. The correlations between BMD and variables of body composition were investigated using the Pearson correlation test and multiple regression analysis. RESULTS:: The peak BMD values of the spine, femur, and total body are observed in women aged 30 to 39, 20 to 29, and 30 to 39 years, respectively, and in men aged 20 to 29 years at all sites. The peak LM, FM, and Fat % values were observed at age 40 to 49, 60 to 69, and 70 to 79 years in women, respectively, and at 40 to 49, 70 to 79, and 70 to 79 years in men, respectively. A statistically significant correlation was observed between LM and BMD of all sites (r = 0.253-0.591, P < 0.01) in all groups. However, FM was significantly correlated to BMD only in postmenopausal women and older men (r = 0.089-0.336, P < 0.01). Fat % negatively correlated to BMD in young people (r = -0.169 to -0.366, P < 0.05). When stepwise regression models were analyzed, LM remained the strongest predictor of total body, spine, and femur BMD (standardized coefficients = 0.264-0.637, P < 0.001) in Chinese men and women of different ages. CONCLUSIONS:: We believe that LM is the strongest predictor of BMD at all ages for Chinese men and women, even though positive correlations between FM and BMD existed in old people.
PMID: 22251870 [PubMed - as supplied by publisher]
