Objective: To evaluate the long-term effects of a combination of isoflavones, agnus castus and magnolia extracts (combined isoflavone compound [CIC]) on climacteric symptoms and cardiometabolic risk in symptomatic postmenopausal women. Methods: This interventional, prospective study evaluated climacteric symptoms, mood and sleep disorders using the 21-item Greene Climacteric Scale (GCS) and 7-item Insomnia Severity Index (ISI) questionnaires; and cardiovascular, metabolic and thrombotic risk markers at baseline (T0) and after 12 months of CIC treatment (T1). Results: In healthy postmenopausal women (N = 71), 12-month CIC treatment significantly reduced patient-reported vasomotor symptoms (100% vs. 17%), mood disorders (67% vs. 25%) and sleep disorders (89% vs. 19%%) (all p <.001) compared with baseline; and significantly improved GCS psychological, somatic, and vasomotor domain scores and ISI sleep disturbance scores (all p <.05). CIC significantly reduced systolic (p =.022) and diastolic blood pressure (p <.001), and heart rate (p <.001); glucose concentrations (p =.018), HOMA index (p =.013), and ALT (p =.035), homocysteine (p =.005) and NT-proBNP (p =.003) levels. Conclusions: Long-term CIC therapy improved vasomotor symptoms, mood disorders, sleep disorders, hemodynamic measurements and cardiometabolic risk markers in healthy postmenopausal women. ClinicalTrials.gov Identifier: NCT03699150.
Long-term effects of a combination of isoflavones, agnus castus and magnolia extracts on climacteric symptoms and cardiometabolic risk profile in postmenopausal women
Franchini M;Fortunato L;Guiducci L
2022
Abstract
Objective: To evaluate the long-term effects of a combination of isoflavones, agnus castus and magnolia extracts (combined isoflavone compound [CIC]) on climacteric symptoms and cardiometabolic risk in symptomatic postmenopausal women. Methods: This interventional, prospective study evaluated climacteric symptoms, mood and sleep disorders using the 21-item Greene Climacteric Scale (GCS) and 7-item Insomnia Severity Index (ISI) questionnaires; and cardiovascular, metabolic and thrombotic risk markers at baseline (T0) and after 12 months of CIC treatment (T1). Results: In healthy postmenopausal women (N = 71), 12-month CIC treatment significantly reduced patient-reported vasomotor symptoms (100% vs. 17%), mood disorders (67% vs. 25%) and sleep disorders (89% vs. 19%%) (all p <.001) compared with baseline; and significantly improved GCS psychological, somatic, and vasomotor domain scores and ISI sleep disturbance scores (all p <.05). CIC significantly reduced systolic (p =.022) and diastolic blood pressure (p <.001), and heart rate (p <.001); glucose concentrations (p =.018), HOMA index (p =.013), and ALT (p =.035), homocysteine (p =.005) and NT-proBNP (p =.003) levels. Conclusions: Long-term CIC therapy improved vasomotor symptoms, mood disorders, sleep disorders, hemodynamic measurements and cardiometabolic risk markers in healthy postmenopausal women. ClinicalTrials.gov Identifier: NCT03699150.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.