Bihlet Asger Reinstrup, Byrjalsen Inger, Andersen Jeppe Ragnar, Simonsen Simone Faurholt, Mundbjerg Kamilla, Helmer Betina, Riis Bente Juel, Karsdal Morten Asser, Christiansen Claus
NBCD A/S, Herlev, Denmark.
Sanos Clinic, Herlev, Denmark.
Front Pharmacol. 2021 Oct 22;12:760629. doi: 10.3389/fphar.2021.760629. eCollection 2021.
Menopause is associated with detrimental changes in turnover of bone and cartilage and a variety of symptoms with negative impact on the quality of life. Naturally occurring isoflavones from , Kudzu root, may possess chondroprotective and symptom-relieving properties, but efficacy and safety of dosing and dose frequencies required for pharmacological action is unclear. This clinical trial evaluates the efficacy on bone and cartilage turnover, menopausal symptoms, and safety of five dose regimens of Kudzu root extract administered either once, twice or three times daily in women with at least mild menopausal symptoms. Fifty postmenopausal women were randomized equally into five different dose regimen groups of Kudzu root extract in a four-week, parallel group, open-label, single-center, exploratory study design. Biomarkers CTX-I and CTX-II reflecting bone and cartilage degradation, respectively, were assessed in blood samples and 24-h urine samples. Change from baseline in the Menopause Rating Scale (MRS) and subscales was evaluated. Safety endpoints were frequency of adverse events, changes in hematology and safety chemistry data, vital signs and electrocardiogram. Fifty women (Age 54.2 years, SD: 2.9) were randomized. After 4 weeks of treatment, biomarkers of bone resorption and cartilage degradation were statistically significantly reduced from baseline levels in the group receiving two capsules three times a day, serum/urine CTX-I (-18.4%, 95% CI: -8.1 to -27.5, = 0.001/-34.2%, 95% CI: -21.6 to -44.7, < 0.0001), urine CTX-II (-17.4% 95% CI: -2.5 to -30.0, = 0.02). The observed effects were consistent across study groups but appeared to favour three times daily dosing. Four weeks of treatment led to statistically significant reductions in the MRS Total Score ( < 0.0001-0.03) in four out of five treatment groups. Kudzu root extract was well tolerated in all dose regimens, and no serious adverse events were reported. The results indicate that Kudzu extract may possess beneficial effects on bone and cartilage health and may be a promising natural alternative to existing treatments for menopausal symptoms. Kudzu root extract was well tolerated for short-term treatment of mild to severe menopausal symptoms in women in all tested doses and dose frequencies.
绝经与骨骼和软骨代谢的有害变化以及对生活质量产生负面影响的各种症状相关。来自葛根的天然异黄酮可能具有软骨保护和缓解症状的特性，但药理作用所需的给药剂量和频率的疗效及安全性尚不清楚。本临床试验评估了每日服用一次、两次或三次的五种葛根提取物剂量方案对至少有轻度绝经症状女性的骨骼和软骨代谢、绝经症状的疗效及安全性。在一项为期四周的平行组、开放标签、单中心探索性研究设计中，50名绝经后女性被平均随机分为五个不同的葛根提取物剂量方案组。分别在血液样本和24小时尿液样本中评估反映骨骼和软骨降解的生物标志物CTX-I和CTX-II。评估绝经评分量表（MRS）及其子量表相对于基线的变化。安全终点包括不良事件的发生率、血液学和安全化学数据的变化、生命体征和心电图。50名女性（年龄54.2岁，标准差：2.9）被随机分组。治疗4周后，每日服用三次两粒胶囊的组中，骨吸收和软骨降解的生物标志物较基线水平有统计学显著降低，血清/尿液CTX-I（-18.4%，95%置信区间：-8.1至-27.5，P = 0.001/-34.2%，95%置信区间：-21.6至-44.7，P < 0.0001），尿液CTX-II（-17.4%，95%置信区间：-2.5至-30.0，P = 0.02）。各研究组观察到的效果一致，但似乎每日三次给药效果更佳。五分之四的治疗组经过四周治疗后，MRS总分有统计学显著降低（P < 0.0001 - 0.03）。所有剂量方案中葛根提取物耐受性良好，未报告严重不良事件。结果表明，葛根提取物可能对骨骼和软骨健康有益，可能是治疗绝经症状的现有疗法的一种有前景的天然替代物。在所有测试剂量和给药频率下，葛根提取物对女性轻度至重度绝经症状的短期治疗耐受性良好。
