Combination of Soy Isoflavones, 8-Prenylnaringenin and Melatonin Improves Hot Flashes and Health-Related Quality of Life Outcomes in Postmenopausal Women: Flavie Study.

OBJECTIVES: This study aims to investigate the effects of a combination of soy isoflavones, 8-prenylnaringenin (8-PN), and melatonin in postmenopausal women suffering from moderate-to-severe hot flashes (HFs). METHODS: A multicenter, prospective, open-label study enrolled 44 postmenopausal women suffering from moderate-to-severe HFs (≥ 5 daily or ≥ 35 weekly) to receive 54.4 mg standardized soy isoflavones (including 24.5 mg genistein and 16.3 mg daidzein), 100 µg 8-PN, and 1 mg melatonin once daily for 12 weeks. The primary clinical outcomes included changes in health-related quality of life (HRQoL) scores (Menopause-Specific QoL questionnaire [MENQoL] and Cervantes Scale) and HFs following 4 and 12 weeks of treatment. Other analyses included treatment adherence, acceptability, tolerability, and safety. RESULTS: All of the four domains of MENQoL questionnaire significantly improved at 4 weeks (P < 0.05) and 12 weeks (P < 0.001), affecting significantly the vasomotor, psychosocial, and physical spheres (41.2%, 26.3%, and 25.0%; 12 weeks improvements, respectively). Similarly, in the menopause (39.3%) and psychic (51.7%) domains (both P < 0.05 at 12 weeks), the global score of the Cervantes Scale significantly increased at 4 weeks (18.6%) and 12 weeks (35.4%). Accordingly, moderate-to-severe HFs significantly decreased at 4 weeks compared to baseline (41.7% reduction) and further reduced at 12 weeks (76.5%), including the total number of episodes. CONCLUSIONS: Food supplements containing soy isoflavones, 8-PN, and melatonin showed an early and progressive benefit for reducing clinically significant HFs and for improving HRQoL across all domains, favorably affecting postmenopausal women's overall well-being.

Improvements in Health-Related Quality of Life, Cardio-Metabolic Health, and Fitness in Postmenopausal Women After an Exercise Plus Health Promotion Intervention: A Randomized Controlled Trial.

BACKGROUND: This study explored multidimensional outcomes that were derived from the adherence to regular exercise among previously sedentary postmenopausal 45 to 64 years old women who engaged in a ~20-week exercise program. METHODS: A randomized controlled trial with between-group (intervention and control women) and within-subject measures (baseline, postintervention, and 3-month and 12-month follow-ups) was conducted. HRQoL and several indicators of cardio-metabolic status and fitness were assessed. RESULTS: After the intervention, the participants experienced a positive change in their short and long-term physical and mental health, with significant enhancements in several HRQoL dimensions, particularly mental well-being (23.3% of change) and menopause-related health and subdomains (17.0% of change) (P < .01). Improvements were maintained or continued (eg, mental well-being) overtime. These outcomes were accompanied by significant improvements in cardio-metabolic status and fitness, including weight, BMI, cardio-respiratory fitness and flexibility (up to 16.2% of change, P < .05). After the intervention, the intervention group exhibited better HRQoL than the control group at each of the measurement phases. Between-group differences were also observed for some indicators of cardiovascular health and flexibility. CONCLUSIONS: Our findings add evidence on the association of positive outcomes on HRQoL with improvements in cardio-metabolic health and fitness status after the adoption of an active lifestyle.

Effects of a six-week Pilates intervention on balance and fear of falling in women aged over 65 with chronic low-back pain: A randomized controlled trial.

OBJECTIVE: The purpose of our study was to evaluate the effects of six weeks of Pilates regarding functional balance, fear of falling and pain in community living women older than 65 years old with chronic low-back pain. STUDY DESIGN: A single blind controlled randomized trial of six weeks of Pilates in addition to physiotherapy treatment (n=50) vs. physiotherapy treatment alone (n=47) was conducted on 97 community living women (71.14 ± 3.30 years) with chronic low-back pain (CLBP). MAIN OUTCOME MEASURES: Main outcome measures were fear of falling (FoF), assessed by the Falls Efficacy Scale-international; functional mobility and balance, measured with the Timed up and Go Test; and pain, evaluated using the numeric rating scale. RESULTS: Only the Pilates group showed improvement in FoF (ES; d=.68) and functional mobility and balance (ES; d=1.12) after treatment, and also had better results in pain (ES; d=1.46) than the physiotherapy-only group. CONCLUSIONS: Six weeks of Pilates exercises may be effective in fall prevention through the improvement of FoF, functional balance, and pain in Spanish women over 65 years old with CLBP.

Validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 in Spanish postmenopausal women.

OBJECTIVE: The Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) is a reliable and validated questionnaire that assesses quality of life in osteoporotic women. Our objective was to analyze the reliability and validity of the Spanish version of QUALEFFO-31 and its ability to discriminate between women with osteoporosis and women without osteoporosis in a Spanish postmenopausal population. METHODS: One hundred eighteen women (aged 50-65 y) completed the Spanish version of QUALEFFO-31. Bone mineral density was measured by dual-energy x-ray densitometry. Internal consistency and test-retest reliability were analyzed. Concurrent validity of QUALEFFO-31 was evaluated using Spearman's rank correlation coefficient with the 36-item Short-Form Health Survey (SF-36). To determined responsiveness, we analyzed mean differences between osteoporotic and nonosteoporotic women and performed receiver operating characteristic curve analysis. RESULTS: The Spanish version of QUALEFFO-31 has shown excellent test-retest reliability with a high intraclass correlation coefficient for all its domains, especially for the total score (0.988; P < 0.001), and good internal consistency with optimal Cronbach α values in all scales (0.70-0.90). In concurrent validity analysis, QUALEFFO-31 total score showed a high and negative correlation with several scales of the SF-36 (P < 0.001). In responsiveness analysis, significant differences in the pain (P = 0.002) and QUALEFFO-31 total score (P = 0.004) scales were found between osteoporotic and nonosteoporotic women. No differences in areas under the receiver operating characteristic curve were found between the QUALEFFO-31 and the SF-36 scales. CONCLUSIONS: The Spanish version of QUALEFFO-31 has good internal consistency, concurrent validity, and test-retest reliability, with satisfactory general psychometric properties, and is a valid tool for discriminating between osteoporotic and nonosteoporotic postmenopausal women aged 50 to 65 years.