TY - JOUR
T1 - The impact of combined nutraceutical supplementation on quality of life and metabolic changes during the menopausal transition: a pilot randomized trial
AU - Villa, Paola
AU - Amar, Inbal D.
AU - Bottoni, Carolina
AU - Cipolla, Clelia
AU - Dinoi, Giorgia
AU - Moruzzi, Maria C.
AU - Scambia, Giovanni
AU - Lanzone, Antonio
PY - 2017
Y1 - 2017
N2 - Purpose: The aim of this study was to assess the efficacy of a combined nutraceutical supplement on symptoms and early metabolic alterations during the menopausal transition. This pilot randomized study was conducted at the service for menopause disorders of the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy. Methods: Ninety women in menopausal transition who attended our service with menopausal symptoms were enrolled in the study. Sixty patients, randomly assigned to the treatment group, were prescribed one daily tablet of a combined nutraceutical compound with phytoestrogen substances, vitamins, micronutrients and passion flower herbal medicine for 6 months. Thirty patients did not receive any treatment and comprised the control group. The intensity of perimenopausal symptoms was assessed by the modified Kuppermann Index (KI) at enrollment and at 3 and 6 months of treatment. At baseline and at the end of the study, patients underwent a clinical evaluation, a pelvic ultrasound and analysis of blood samples. Results: In the nutraceutical supplemented group, a significant reduction in menopausal symptoms was demonstrated according to the KI after 3 and 6 months of supplementation (p < 0.01). The within-group analysis of different KI parameters in the treated group showed a significant improvement in hot flushes (p < 0.001), insomnia (p < 0.01), fatigue (p < 0.01) and irritability (p < 0.01). Metabolic parameters did not change significantly in the nutraceutical supplemented group. In the control group, total cholesterol level showed a significant increase (p < 0.05). Conclusions: Combined nutraceutical supplementation provides an effective and safe solution for early symptoms occurring during menopausal transition.
AB - Purpose: The aim of this study was to assess the efficacy of a combined nutraceutical supplement on symptoms and early metabolic alterations during the menopausal transition. This pilot randomized study was conducted at the service for menopause disorders of the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy. Methods: Ninety women in menopausal transition who attended our service with menopausal symptoms were enrolled in the study. Sixty patients, randomly assigned to the treatment group, were prescribed one daily tablet of a combined nutraceutical compound with phytoestrogen substances, vitamins, micronutrients and passion flower herbal medicine for 6 months. Thirty patients did not receive any treatment and comprised the control group. The intensity of perimenopausal symptoms was assessed by the modified Kuppermann Index (KI) at enrollment and at 3 and 6 months of treatment. At baseline and at the end of the study, patients underwent a clinical evaluation, a pelvic ultrasound and analysis of blood samples. Results: In the nutraceutical supplemented group, a significant reduction in menopausal symptoms was demonstrated according to the KI after 3 and 6 months of supplementation (p < 0.01). The within-group analysis of different KI parameters in the treated group showed a significant improvement in hot flushes (p < 0.001), insomnia (p < 0.01), fatigue (p < 0.01) and irritability (p < 0.01). Metabolic parameters did not change significantly in the nutraceutical supplemented group. In the control group, total cholesterol level showed a significant increase (p < 0.05). Conclusions: Combined nutraceutical supplementation provides an effective and safe solution for early symptoms occurring during menopausal transition.
KW - Hot flushes
KW - Menopause
KW - Nutraceuticals
KW - Obstetrics and Gynecology
KW - Phytoestrogens
KW - Soy isoflavones
KW - Hot flushes
KW - Menopause
KW - Nutraceuticals
KW - Obstetrics and Gynecology
KW - Phytoestrogens
KW - Soy isoflavones
UR - https://publicatt.unicatt.it/handle/10807/111921
UR - https://www.scopus.com/inward/citedby.uri?partnerID=HzOxMe3b&scp=85028767342&origin=inward
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85028767342&origin=inward
U2 - 10.1007/s00404-017-4491-9
DO - 10.1007/s00404-017-4491-9
M3 - Article
SN - 0932-0067
VL - 296
SP - 791
EP - 801
JO - Archives of Gynecology and Obstetrics
JF - Archives of Gynecology and Obstetrics
IS - 4
ER -