Combination of Soy Isoflavones, 8-Prenylnaringenin and Melatonin Improves Hot Flashes and Health-Related Quality of Life Outcomes in Postmenopausal Women: Flavie Study.
| Autor: | Estrugo CP; Department of Obstetrics and Gynecology, Dr. Puchol's Clinic, Valencia, Spain., Rodríguez MT; Department of Obstetrics and Gynecology, The Casanovas Centre, Barcelona, Spain., de Guevara NM; Department of Obstetrics and Gynecology, Faculty of Medicine, University of Granada, Granada, Spain., Gómez JG; Department of Obstetrics and Gynecology, Hospital San Rafael, Madrid, Spain., Ridocci F; RyD Maternity Clinic, Valencia, Spain., Moro-Martín MT; Department of Obstetrics and Gynecology, Tocogyn Clinic, Alcalá de Henares, Spain., Guinot M; Department of Obstetrics and Gynecology, Dra. Guinot's Surgery, Barcelona, Spain., Saz-Leal P; Medical Affairs, Italfarmaco (ITF) Research Pharma Sociedad de Responsabilidad Limitada Unipersonal (SLU), Madrid, Spain. p.saz@italfarmacogroup.com., Nieto Magro C; Medical Affairs, Italfarmaco (ITF) Research Pharma Sociedad de Responsabilidad Limitada Unipersonal (SLU), Madrid, Spain. |
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| Jazyk: | angličtina |
| Zdroj: | Journal of menopausal medicine [J Menopausal Med] 2023 Aug; Vol. 29 (2), pp. 73-83. |
| DOI: | 10.6118/jmm.22034 |
| Abstrakt: | 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. Competing Interests: PS-L and CNM are employees of ITalfarmaco Research Pharma SLU. NM-LG receives honoraria or consulting fees from Italfarmaco Research Pharma SLU, Astellas or Shionogi. (Copyright © by The Korean Society of Menopause.) |
| Databáze: | MEDLINE |
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