Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, Beijing, China.
Department of Obstetrics and Gynecology, Obstetrics & Gynecology Hospital of Fudan University, Shanghai, China.
Climacteric. 2021 Jun;24(3):246-252. doi: 10.1080/13697137.2020.1820476. Epub 2020 Oct 5.
This study aimed to investigate the safety and efficacy of Xiangshao granules for treating emotional disorders in perimenopausal and postmenopausal women.
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 ( = 150) or Xiangshao granules ( = 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.
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 ( < 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.
Xiangshao granules can relieve symptoms of depression and anxiety significantly and safely.
本研究旨在探讨香芍颗粒治疗围绝经期及绝经后妇女情志异常的安全性和有效性。
本研究为双盲、随机、安慰剂对照、多中心临床试验,纳入 300 例年龄 40-60 岁的围绝经期及绝经后中国女性。患者接受安慰剂(n=150)或香芍颗粒(n=150)治疗 8 周。结局指标包括汉密尔顿抑郁量表(HAMD)和汉密尔顿焦虑量表(HAMA)评分,于基线、4 周和 8 周进行评估。主要疗效变量为 8 周时 HAMD 和 HAMA 评分的变化。
治疗 8 周后,香芍组 HAMD 评分从 15.0 分降至 7.9 分,安慰剂组从 16.3 分降至 10.0 分,HAMA 评分分别从 16.0 分降至 8.5 分和从 17.1 分降至 10.9 分,两组患者抑郁和焦虑症状均有明显改善(均 P<0.05)。香芍组的临床治愈率明显更高。两组不良反应发生率无显著差异。
香芍颗粒可显著且安全地缓解抑郁和焦虑症状。