Influence of a new botanical combination on quality of life in menopausal Spanish women: Results of a randomized, placebo-controlled pilot study.

<h4>Background</h4>This study was designed to evaluate the beneficial effects of a botanical extract combination containing soy isoflavone extract (100mg), Aframomum melegueta seed dry extract (50 mg), and Punica granatum skin dry extract (100mg) on health-related Quality of Life in heal...

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Autores principales:	Laura López-Ríos, Miguel A Barber, Julia Wiebe, Rubén P Machín, Tanausú Vega-Morales, Ricardo Chirino
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/64401edd928b428bb34fd31691196673
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spelling	oai:doaj.org-article:64401edd928b428bb34fd316911966732021-12-02T20:06:41ZInfluence of a new botanical combination on quality of life in menopausal Spanish women: Results of a randomized, placebo-controlled pilot study.1932-620310.1371/journal.pone.0255015https://doaj.org/article/64401edd928b428bb34fd316911966732021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0255015https://doaj.org/toc/1932-6203<h4>Background</h4>This study was designed to evaluate the beneficial effects of a botanical extract combination containing soy isoflavone extract (100mg), Aframomum melegueta seed dry extract (50 mg), and Punica granatum skin dry extract (100mg) on health-related Quality of Life in healthy Spanish menopausal women with hot flashes, anxiety, and depressive symptoms using the validated Cervantes Scale.<h4>Methods and results</h4>Fifty-seven outpatient women (45-65 years) with menstrual problems associated with climacteric syndrome were enrolled from April 2018 to April 2019 in the context of a prospective, placebo-controlled, double-blind study. Women were randomized to receive treatment with either the botanical combination (250 mg daily divided into two doses) or placebo for eight weeks. At the beginning and end of the study, health-related Quality of Life was assessed using the Cervantes Scale. Subjects treated with the botanical extract, compared to subjects in the placebo group, showed a significant improvement in the Global health-related Quality of Life score (38% [11.3-50.0]% vs. 18.8% [0-37.7]%; P = 0.04) on the Cervantes Scale and, specifically, in the menopause and health domain (13.6% [0-45.4]% vs. 40.7% [20.6-61.0]%; P = 0.05). By contrast, there were no significant changes in the psychic, sexuality, and couple relationship related domains of the Cervantes Scale. Patients who concluded the study did not report substantial side effects.<h4>Conclusion</h4>Short-term intake of the botanical combination improved the Global Quality of Life of climateric women, according to the Cervantes Scale. Since this is a pilot trial, results should be analysed with caution.<h4>Trial registration</h4>NCT04381026; ClinicalTrial.gov (retrospectively registered).Laura López-RíosMiguel A BarberJulia WiebeRubén P MachínTanausú Vega-MoralesRicardo ChirinoPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 7, p e0255015 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Laura López-Ríos Miguel A Barber Julia Wiebe Rubén P Machín Tanausú Vega-Morales Ricardo Chirino Influence of a new botanical combination on quality of life in menopausal Spanish women: Results of a randomized, placebo-controlled pilot study.
description	<h4>Background</h4>This study was designed to evaluate the beneficial effects of a botanical extract combination containing soy isoflavone extract (100mg), Aframomum melegueta seed dry extract (50 mg), and Punica granatum skin dry extract (100mg) on health-related Quality of Life in healthy Spanish menopausal women with hot flashes, anxiety, and depressive symptoms using the validated Cervantes Scale.<h4>Methods and results</h4>Fifty-seven outpatient women (45-65 years) with menstrual problems associated with climacteric syndrome were enrolled from April 2018 to April 2019 in the context of a prospective, placebo-controlled, double-blind study. Women were randomized to receive treatment with either the botanical combination (250 mg daily divided into two doses) or placebo for eight weeks. At the beginning and end of the study, health-related Quality of Life was assessed using the Cervantes Scale. Subjects treated with the botanical extract, compared to subjects in the placebo group, showed a significant improvement in the Global health-related Quality of Life score (38% [11.3-50.0]% vs. 18.8% [0-37.7]%; P = 0.04) on the Cervantes Scale and, specifically, in the menopause and health domain (13.6% [0-45.4]% vs. 40.7% [20.6-61.0]%; P = 0.05). By contrast, there were no significant changes in the psychic, sexuality, and couple relationship related domains of the Cervantes Scale. Patients who concluded the study did not report substantial side effects.<h4>Conclusion</h4>Short-term intake of the botanical combination improved the Global Quality of Life of climateric women, according to the Cervantes Scale. Since this is a pilot trial, results should be analysed with caution.<h4>Trial registration</h4>NCT04381026; ClinicalTrial.gov (retrospectively registered).
format	article
author	Laura López-Ríos Miguel A Barber Julia Wiebe Rubén P Machín Tanausú Vega-Morales Ricardo Chirino
author_facet	Laura López-Ríos Miguel A Barber Julia Wiebe Rubén P Machín Tanausú Vega-Morales Ricardo Chirino
author_sort	Laura López-Ríos
title	Influence of a new botanical combination on quality of life in menopausal Spanish women: Results of a randomized, placebo-controlled pilot study.
title_short	Influence of a new botanical combination on quality of life in menopausal Spanish women: Results of a randomized, placebo-controlled pilot study.
title_full	Influence of a new botanical combination on quality of life in menopausal Spanish women: Results of a randomized, placebo-controlled pilot study.
title_fullStr	Influence of a new botanical combination on quality of life in menopausal Spanish women: Results of a randomized, placebo-controlled pilot study.
title_full_unstemmed	Influence of a new botanical combination on quality of life in menopausal Spanish women: Results of a randomized, placebo-controlled pilot study.
title_sort	influence of a new botanical combination on quality of life in menopausal spanish women: results of a randomized, placebo-controlled pilot study.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/64401edd928b428bb34fd31691196673
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Influence of a new botanical combination on quality of life in menopausal Spanish women: Results of a randomized, placebo-controlled pilot study.

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