Xiangshao granules can relieve emotional symptoms in menopausal women: a randomized controlled trial

Abstract

Objective

This study aimed to investigate the safety and efficacy of Xiangshao granules for treating emotional disorders in perimenopausal and postmenopausal women.

Methods

The current investigation was a double-blind, randomized, placebo-controlled, multicenter trial that included 300 perimenopausal and postmenopausal Chinese women aged 40–60 years. Participants received either a placebo (n = 150) or Xiangshao granules (n = 150) for 8 weeks. Outcome measures included Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) scores, which were assessed at baseline, 4 weeks, and 8 weeks. The primary efficacy variables were changes in HAMD and HAMA scores after 8 weeks.

Results

After 8 weeks, the mean HAMD scores decreased from 15.0 to 7.9 in the Xiangshao group and from 16.3 to 10.0 in the placebo group, and the respective mean reductions in HAMA scores were from 16.0 to 8.5 and from 17.1 to 10.9. Clinical improvements in symptoms of both depression and anxiety after 8 weeks differed significantly in the two groups (p < 0.05). The cure rate was significantly higher in the Xiangshao group. There were no significant differences in the rates of adverse events in the two groups.

Conclusions

Xiangshao granules can relieve symptoms of depression and anxiety significantly and safely.

摘要

目的：本研究旨在观察香芍颗粒治疗围绝经期和绝经后妇女情绪障碍的安全性和有效性。

方法：本研究是一项双盲、随机、安慰剂对照的多中心试验, 纳入年龄在40-60岁的围绝经期和绝经后中国妇女300名。参加者接受安慰剂（n = 150）或香芍颗粒（n = 150）治疗, 为期8周。应用汉密尔顿抑郁量表(HAMD)和汉密尔顿焦虑量表(HAMA)评分, 分别在基线、4周和8周进行评估。主要疗效变量为治疗8周后HAMD和HAMA评分的变化。

结果：8周后, 香芍颗粒组和安慰剂组的HAMD平均分分别从15.0分降至7.9分和16.3分降至10.0分, HAMA平均分分别从16.0分降至8.5分和17.1分降至10.9分。在8周后, 两组抑郁和焦虑症状的临床改善均有显著差异（p <0.05）。香芍颗粒组的治愈率明显高于对照组。两组不良事件发生率无显著差异。

结论：香芍颗粒可以安全有效的缓解焦虑抑郁症状。

Keywords:

• Anxiety symptoms
• depressive symptoms
• menopause
• traditional Chinese medicine
• Xiangshao granules

Acknowledgements

The authors are deeply grateful to all participants involved in this study and all of the doctors and researchers who participated in the study.

Potential conflict of interest

All authors confirm that there are no conflicts of interest associated with the article.

Additional information

Funding

This study was supported by the National Key Research and Development Program [grant number 2018YFC1002105; 2018YFC1004801]; National Natural Science Foundation of China Project [grant number 81871141]; CAMS Innovation Fund for Medical Sciences (CIFMS) [grant number 2017-I2M-1-002; 2016-I2M-1-008].