Abstract
BackgroundThis 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.Methods and resultsFifty-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.ConclusionShort-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.Trial registrationNCT04381026; ClinicalTrial.gov (retrospectively registered).
Highlights
Menopause is a natural biological process related to the end of a womans reproductive life and is associated with physical symptoms such as vascular dysfunction, psychological symptoms including mood changes, irritability, anxiety, or depression, and metabolic effects such as weight gain and slowed metabolism [1]
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
The oral gavage of 50mg/kg of an ethanolic extract of Aframomum melegueta resulted in a statistically significant attenuation of alpha1 spectral power, which lasted two hours after recording in the frontal cortex and hippocampus (Fig 2C). This result was confirmed with a higher dose of 100.0 mg/kg Aframomum melegueta extract, which resulted in a significant attenuation of alpha1 spectral power in the cortex, hippocampus, and striatum during the first hour and in the cortex and hippocampus during the second hour
Summary
Menopause is a natural biological process related to the end of a womans reproductive life and is associated with physical symptoms such as vascular dysfunction (hot flashes, palpitations, and night sweats), psychological symptoms including mood changes, irritability, anxiety, or depression, and metabolic effects such as weight gain and slowed metabolism [1]. The socalled perimenopause, estrogen levels are reduced and a high percentage of women experience a variety of symptoms—such as hot flashes, night sweats, or palpitations, as well as insomnia, anxiety, or depression—that affect their Quality of Life. The prevalence of such symptoms ranges from 74% in of women in Europe, 36–50% in North America, 45–69% in Latin America, and 22–63% in Asia [4]. 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.
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