Department of Research, Development and Innovation, Nektium Pharma SL, Agüimes, Las Palmas, Spain.
Gynecological Division, Baren Clinic, Las Palmas de Gran Canaria, Las Palmas, Spain.
PLoS One. 2021 Jul 21;16(7):e0255015. doi: 10.1371/journal.pone.0255015. eCollection 2021.
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.
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.
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.
NCT04381026; ClinicalTrial.gov (retrospectively registered).
本研究旨在评估一种植物提取物组合（包含 100mg 大豆异黄酮提取物、50mg Aframomum melegueta 种子干提取物和 100mg Punica granatum 皮干提取物）对有热潮红、焦虑和抑郁症状的健康西班牙绝经后女性健康相关生活质量的有益影响，使用经验证的 Cervantes 量表。
2018 年 4 月至 2019 年 4 月，在一项前瞻性、安慰剂对照、双盲研究中，从 57 名有月经问题的门诊女性（45-65 岁）中招募了与更年期综合征相关的有月经问题的女性。女性随机分为接受植物组合（每天 250mg，分为两剂）或安慰剂治疗 8 周。在研究开始和结束时，使用 Cervantes 量表评估健康相关生活质量。与安慰剂组相比，接受植物提取物治疗的受试者在全球健康相关生活质量评分方面有显著改善（38%[11.3-50.0]%对 18.8%[0-37.7]%；P=0.04），并且在更年期和健康领域有显著改善（13.6%[0-45.4]%对 40.7%[20.6-61.0]%；P=0.05）。相比之下，Cervantes 量表的精神、性和夫妻关系相关领域没有显著变化。完成研究的患者没有报告严重的副作用。
短期摄入植物组合改善了根据 Cervantes 量表的更年期女性的整体生活质量。由于这是一项初步试验，结果应谨慎分析。
NCT04381026；ClinicalTrials.gov（回顾性注册）。
