ABSTRACT
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.
ABSTRACT
OBJECTIVE: This study assessed changes in anxiety during different phases of childbirth in a sample of women demanding epidural anesthesia. DESIGN: Prospective, longitudinal case series. SAMPLE: A total of 133 women who demanded epidural anesthesia for childbirth answered the questionnaires. METHODS: Anxiety state was measured using the State Trait Anxiety Inventory (STAI) questionnaire. The STAI-S (anxiety state) was administered in three phases during childbirth: Phase 1 was before applying epidural anesthesia, Phase 2 was 45 min after the application of epidural anesthesia and Phase 3 was at less than 24 h after delivery. Data were collected in two general hospitals: a third-level public hospital and a well-recognized private hospital. MAIN OUTCOME MEASURES: STAI scores. RESULTS: Anxiety state decreases significantly after applying the epidural anesthesia (Phase 2) compared to before anesthesia (Phase 1), and it remains low levels 24 h after childbirth (Phase 3). There were statistically significant differences in STAI scores between the different phases administrated (Phases 1 and 2: p < 0.001; effect size, d = 1.40; Phases 1 and 3: p < 0.001; effect size, d = 1.39). In Phase 3, women with cesarean section birth had significant differences in STAI scores relative to those with spontaneous birth (p = 0.037; d = 0.44). The type of health-care setting (public or private), the educational level and the numbers of previous births does not affect the level of anxiety state in women in any of the three phases. CONCLUSIONS: Women's anxiety decreases significantly after applying epidural anesthesia, and it remains low 24 h after delivery. Anxiety against childbirth was not influenced by the health system used by women, by the condition of primiparous or multiparous, or by the educational level. Women who received an epidural anesthesia with a cesarean section reported higher rates of anxiety state after birth.
