“Gengnian Ningxin Granules” for the treatment of perimenopausal syndrome:a randomized, double-blind, placebo-controlled clinical trial

NI Shuang; LI Ji; ZHANG Li; DAI Yi-ting; WU Rui-xin; HAN Xiao-li

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“Gengnian Ningxin Granules” for the treatment of perimenopausal syndrome:a randomized, double-blind, placebo-controlled clinical trial

更新时间：2022-08-31

- “Gengnian Ningxin Granules” for the treatment of perimenopausal syndrome:a randomized, double-blind, placebo-controlled clinical trial
- Shanghai Journal of Traditional Chinese Medicine Vol. 49, Issue 3, Pages: 35-37(2015)
- 作者机构：
  
  1. 上海中医药大学附属龙华医院妇科,上海,200032
- 作者简介：
- 基金信息：
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NI Shuang, LI Ji, ZHANG Li, et al. “Gengnian Ningxin Granules” for the treatment of perimenopausal syndrome:a randomized, double-blind, placebo-controlled clinical trial. [J]. Shanghai Journal of Traditional Chinese Medicine 49(3):35-37(2015)
DOI：

NI Shuang, LI Ji, ZHANG Li, et al. “Gengnian Ningxin Granules” for the treatment of perimenopausal syndrome:a randomized, double-blind, placebo-controlled clinical trial. [J]. Shanghai Journal of Traditional Chinese Medicine 49(3):35-37(2015) DOI：

摘要

目的：观察更年宁心颗粒治疗围绝经期综合征的临床疗效。方法：将60例围绝经期综合征患者随机分为治疗组与对照组,每组30例。治疗组予更年宁心颗粒治疗,对照组予更年宁心颗粒安慰剂。两组疗程均为2个月,观察改良Kupperman评分(KI)、烘热汗出次数及性激素水平(FSH、LH、E,2,)的变化情况。结果：①试验期间无脱落病例,60例受试者均完成试验研究。②治疗前后组内比较,两组KI评分的差异均有统计学意义(P＜0.05)；组间治疗后比较,KI评分差异有统计学意义(P＜0.05)。③治疗前后组内比较,两组烘热汗出次数的差异均有统计学意义(P＜0.05)；组间治疗后比较,烘热汗出次数差异有统计学意义(P＜0.05)。④治疗前后组内比较,两组性激素水平(FSH、LH、E,2,)差异均无统计学意义(P＞0.05)；组间治疗后比较,FSH、LH、E,2,水平差异无统计学意义(P＞0.05)。结论：更年宁心颗粒治疗围绝经期综合征可显著改善患者烘热汗出等临床症状,但其作用机制并非通过提高雌激素水平。

Abstract

Objective: To observe the clinical efficacy of “Gengnian Ningxin Granules” in treating perimenopausal syndrome. Methods Sixty cases with perimenopausal syndrome were randomized into treatment group and control group, with 30 cases in each group. Treatment group was treated with “Gengnian Ningxin Granules”, and the control group was treated with placebo, with the course of 2 months. The modified Kupperman index, hot flashes times and levels of sex hormones (FSH, LH, E,2,) were observed. Results: ① Non-shedding case during the period of the clinical trial. All the 60 cases completed the study. ② In both groups, there was significant difference in KI score between before and after the treatment (P＜0.05); after treatment, there was significant difference in KI score between the two groups (P＜0.05). ③ In both groups, there was significant difference in hot flashes times between before and after the treatment (P＜0.05); after treatment, there was significant difference between the two groups (P＜0.05). ④ In both groups, no significant difference was found in the levels of sex hormones (E,2, FSH, LH) between before and after the treatment (P＞0.05); after treatment, no significant difference was found in the levels of E,2, FSH and LH between the two groups (P＞0.05). Conclusion: “Gengnian Ningxin Granules” is effective to improve the clinical symptoms in patients with perimenopausal syndrome. Its mechanism may be not association with the improvement of estrogen level.

关键词

围绝经期综合征更年宁心颗粒清心平肝法安慰剂

Keywords

perimenopausal syndrome“Gengnian Ningxin Granules”clearing heart and soothing liver methodplacebo

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