Master of Science Program in Anti-Aging & Regenerative Medicine, College of Integrative Medicine, Dhurakij Pundit University, Bangkok, Thailand.
Research Center of Nutraceuticals and Natural Products for Health & Anti-Aging, College of Integrative Medicine, Dhurakij Pundit University, Bangkok, Thailand.
J Diet Suppl. 2022;19(2):168-183. doi: 10.1080/19390211.2020.1853648. Epub 2020 Dec 17.
Menopausal symptoms severely reduce the quality of life of post-menopausal women worldwide. Nutraceuticals are widely prescribed as a viable and safer alternative and complementary approach to standard therapies. The aim of this study was to evaluate the clinical efficacy and safety of a nutraceutical in post-menopausal women.
The study was designed as a randomized, double-blinded, placebo-controlled clinical trial. Post-menopausal women aged 45-60 years old were enrolled and randomly assigned to either treatment ( = 50) or placebo group ( = 51). The intervention, a proprietary combination of soy isoflavone, black cohosh, chasteberry and evening primrose oil extracts, and the placebo, were administered to each group for total of 12 weeks. Menopausal symptoms, endocrine profiles, and blood chemistry were evaluated at baseline, 6 weeks, and 12 weeks of the study.
Nutraceutical supplementation demonstrated a statistically significant reduction in hot flushes and sweating ( < 0.0001), sleep problems ( < 0.0005), depressed mood ( = 0.0004) and irritability symptoms ( < 0.0003) compared with the placebo group. There were no significant differences in hormonal levels between the test and placebo groups, however levels of C-reactive protein were significantly decreased. Moreover, serum LDL-C and triglyceride levels were significantly lower than baseline levels in the treatment group at 6- and 12-week timepoints. No adverse effects were reported during the treatment.
These data indicate that a nutraceutical containing a combination of four medicinal herbs effectively and safely improved menopausal symptoms, as well as general health indicators, in post-menopausal women.
更年期症状严重降低了全球绝经后妇女的生活质量。营养保健品被广泛开处方作为标准治疗的可行且更安全的替代和补充方法。本研究旨在评估营养保健品在绝经后妇女中的临床疗效和安全性。
该研究设计为随机、双盲、安慰剂对照临床试验。招募年龄在 45-60 岁的绝经后妇女，并随机分为治疗组（n=50）和安慰剂组（n=51）。干预措施为一种含有大豆异黄酮、黑升麻、圣洁莓和月见草油提取物的专利混合物，以及安慰剂，分别给予两组共 12 周。在研究的基线、6 周和 12 周时评估更年期症状、内分泌谱和血液化学。
营养保健品补充剂在减少热潮红和出汗（<0.0001）、睡眠问题（<0.0005）、抑郁情绪（=0.0004）和易怒症状（<0.0003）方面与安慰剂组相比具有统计学意义。然而，在测试组和安慰剂组之间，激素水平没有显著差异，但 C-反应蛋白水平显著降低。此外，治疗组在 6 周和 12 周时血清 LDL-C 和甘油三酯水平均明显低于基线水平。在治疗期间未报告不良反应。
这些数据表明，含有四种草药组合的营养保健品可有效且安全地改善绝经后妇女的更年期症状以及一般健康指标。
