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.
异黄酮、西洋牡荆和木兰联合提取物对绝经后妇女更年期症状和心脏代谢风险的长期影响 摘要
目的:评价异黄酮、西洋牡荆和木兰联合提取物(复方异黄酮(CIC))对绝经后妇女的更年期症状及心脏代谢风险的长期影响。 方法:这项前瞻性干预研究在基线(T0)和CIC治疗 12 个月(T1)时, 采用21项Greene更年期量表(GCS)和7项失眠严重程度指数(ISI)问卷评估更年期症状、情绪和睡眠障碍, 并监测心血管、代谢和血栓形成的风险标志物。 结果:在健康的绝经后妇女(N=71)中, 与基线比较, 12个月的CIC治疗显著减少了患者自报告的血管舒缩症状(100%降至17%)、情绪障碍(67%降至25%)和睡眠障碍(89%降至19%)(p均<0.001)。并显著改善了GCS心理、躯体和血管舒缩区评分以及ISI睡眠障碍评分(p均<0.05)。CIC显著降低了收缩压(p=0.022)、舒张压(p<0.001)和心率(p<0.001), 并降低血糖(p=0.018)、HOMA指数(p=0.013)、谷丙转氨酶(p=0.035)、同型半胱氨酸(p=0.005)和氨基末端脑钠肽前体(p=0.003)水平。 结论: CIC的长期治疗可改善健康绝经后妇女的血管舒缩症状、情绪障碍、睡眠障碍、血流动力学测值以及心脏代谢的风险标志物。
Disclosure statement
No potential conflict of interest was reported by the author(s).