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南非醉茄(Withania Somnifera)根提取物对围绝经期女性更年期症状的影响:一项随机、双盲、安慰剂对照研究。

Effect of an ashwagandha (Withania Somnifera) root extract on climacteric symptoms in women during perimenopause: A randomized, double-blind, placebo-controlled study.

作者信息

Gopal Sriram, Ajgaonkar Ashutosh, Kanchi Padmaja, Kaundinya Aditi, Thakare Vaishali, Chauhan Sanjaya, Langade Deepak

机构信息

Department of Obstetrics and Gynaecology, D Y Patil University School of Medicine, Navi Mumbai, India.

Department of Obstetrics and Gyanecology, Vedanta Hospital, Thane, India.

出版信息

J Obstet Gynaecol Res. 2021 Dec;47(12):4414-4425. doi: 10.1111/jog.15030. Epub 2021 Sep 22.

Abstract

BACKGROUND

Perimenopause is the period during which many physiological changes mark the transition into the final menstrual period of a woman and these changes are associated with climacteric symptoms.

OBJECTIVES

This study aimed to assess the efficacy and tolerability of an Ashwagandha root extract on the climacteric symptoms, quality of life (QoL), and hormonal parameters in perimenopausal women.

MATERIALS AND METHODS

In this 8-week, randomized, double-blind, placebo-controlled study, 100 women with climacteric symptoms were randomly allocated to take either a placebo or 300 mg of an Ashwagandha root extract twice daily. Outcomes were measured using the menopause rating scale (MRS), menopause-specific QoL (MENQoL), hot flash score, and hormonal changes in estradiol, follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone.

RESULTS

Among 100 participants enrolled, 91 participants completed the study. In comparison with the placebo, ashwagandha supplementation was associated with a statistically significant reduction in total MRS score (p < 0.0001), reflected by significant reductions in the psychological (p = 0.0003), somato-vegetative (p = 0.0152), and urogenital (p < 0.0001) domains. Ashwagandha intake demonstrated a statistically significant reduction in total MENQoL scores (p < 0.0001) and was also associated with a statistically significant increase in serum estradiol (p < 0.0001) and a significant reduction in serum FSH (p < 0.0001) and serum LH (p < 0.05) compared with the placebo. There was no significant between the group differences in the serum testosterone level.

CONCLUSION

These findings suggest that ashwagandha root extract can be a safe and effective option to relieve mild to moderate climacteric symptoms during perimenopause in women.

摘要

背景

围绝经期是许多生理变化标志着女性进入最后月经期的时期,这些变化与更年期症状相关。

目的

本研究旨在评估南非醉茄根提取物对围绝经期女性更年期症状、生活质量(QoL)和激素参数的疗效及耐受性。

材料与方法

在这项为期8周的随机、双盲、安慰剂对照研究中,100名有更年期症状的女性被随机分配,每天两次服用安慰剂或300毫克南非醉茄根提取物。使用更年期评定量表(MRS)、更年期特异性生活质量量表(MENQoL)、潮热评分以及雌二醇、促卵泡激素(FSH)、促黄体生成素(LH)和睾酮的激素变化来测量结果。

结果

在纳入的100名参与者中,91名完成了研究。与安慰剂相比,补充南非醉茄与总MRS评分在统计学上显著降低相关(p < 0.0001),这体现在心理(p = 0.0003)、躯体 - 植物神经(p = 0.0152)和泌尿生殖(p < 0.0001)领域的显著降低。与安慰剂相比,服用南非醉茄在总MENQoL评分上有统计学显著降低(p < 0.0001),还与血清雌二醇在统计学上显著升高(p < 0.0001)以及血清FSH(p < 0.0001)和血清LH(p < 0.05)在统计学上显著降低相关。两组血清睾酮水平之间无显著差异。

结论

这些发现表明,南非醉茄根提取物可能是缓解女性围绝经期轻度至中度更年期症状的安全有效选择。

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