A Multi-center, Randomized, Controlled and Open Clinical Trial of Heyan Kuntai Capsule (和颜坤泰胶囊) and Hormone Therapy in Perimenopausal Women

Ai-jun Sun; Ya-ping Wang; Bei Gu; Ting-ping Zheng; Shou-qing Lin; Wen-pei Bai; Yang Wei; Shao-fen Zhang; Ying Zhang

doi:10.1007/s11655-016-2266-y

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A Multi-center, Randomized, Controlled and Open Clinical Trial of Heyan Kuntai Capsule (和颜坤泰胶囊) and Hormone Therapy in Perimenopausal Women

OriginalPaper | Updated：2021-08-27

- A Multi-center, Randomized, Controlled and Open Clinical Trial of Heyan Kuntai Capsule (和颜坤泰胶囊) and Hormone Therapy in Perimenopausal Women
- A Multi-center, Randomized, Controlled and Open Clinical Trial of Heyan Kuntai Capsule (和颜坤泰胶囊) and Hormone Therapy in Perimenopausal Women
- 中国结合医学杂志（英文版） 2018年24卷第7期页码：487-493
- Affiliations：
  
  1. Department of Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,China
  2. Department of Obstetrics and Gynecology, Beijing Shijitan Hospital,Beijing,China
  3. Department of Gynecology, Obstetrics and Gynecology, Hospital of Fudan University,Shanghai,China
- Author bio：
- Funds：
  
  Supported by the “Tenth-Five” National Medical Science and Technique Foundation, China (No. 2004BA720A08)
- DOI：10.1007/s11655-016-2266-y
  中图分类号：
- 纸质出版日期：2018，
  
  网络出版日期：2016-9-20，
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Sun, Aj., Wang, Yp., Gu, B. et al. A Multi-center, Randomized, Controlled and Open Clinical Trial of Heyan Kuntai Capsule (和颜坤泰胶囊) and Hormone Therapy in Perimenopausal Women., Chin. J. Integr. Med. 24, 487–493 (2018). https://doi.org/10.1007/s11655-016-2266-y

Ai-jun Sun, Ya-ping Wang, Bei Gu, et al. A Multi-center, Randomized, Controlled and Open Clinical Trial of Heyan Kuntai Capsule (和颜坤泰胶囊) and Hormone Therapy in Perimenopausal Women[J]. Chinese Journal of Integrative Medicine, 2018,24(7):487-493.
Sun, Aj., Wang, Yp., Gu, B. et al. A Multi-center, Randomized, Controlled and Open Clinical Trial of Heyan Kuntai Capsule (和颜坤泰胶囊) and Hormone Therapy in Perimenopausal Women., Chin. J. Integr. Med. 24, 487–493 (2018). https://doi.org/10.1007/s11655-016-2266-y DOI：

Ai-jun Sun, Ya-ping Wang, Bei Gu, et al. A Multi-center, Randomized, Controlled and Open Clinical Trial of Heyan Kuntai Capsule (和颜坤泰胶囊) and Hormone Therapy in Perimenopausal Women[J]. Chinese Journal of Integrative Medicine, 2018,24(7):487-493. DOI： 10.1007/s11655-016-2266-y.

摘要

To evaluate the efficacy and safety of Heyan Kuntai Capsule (和颜坤泰胶囊

HYKT) and hormone therapy (HT) on perimenopausal syndromes (PMSs). From 2005 to 2008

390 women with PMSs were recruited from 4 clinic centers. The inclusion criteria included ages 40 to 60 years

estradiol (E2) below 30 ng/L

and follicle stimulating hormone (FSH) above 40 IU/L

etc. The patients were randomly assigned to HYKT group or HT group by random number table method

administrated HYKT or conjugated estrogen with/without medroxyprogesterone acetate tablets for 12 months. During treatment

the patients were interviewed quarterly

Kupperman Menopausal Index (KMI) scores

hot flush scores

insomnia scores

Menopause-Specific Quality of Life (MENQOL) scores and adverse effects were used for evaluating drug efficacy and safety respectively. The last interview was made at the end of 12-month treatment After treatment

KMI scores of HYKT group and HT group were both significantly decreased compared with baseline (P <0.01) and there was no significant difference between groups (P >0.05)

except that KMI of HYKT group was higher after 3-month treatment (P <0.05). After treatment

hot flush and insomnia scores were both improved significantly in two groups (P <0.01); and HT had a better performance than HYKT in improving hot flush (P <0.05). MENQOL were significantly improved in both groups after treatment (P <0.01); but there was no significant difference between two groups (P >0.05). The incidence of adverse event in the HYKT group was much lower than that in the HT group (P <0.01). HYKT could effectively relieve PMSs and improve patients quality of life without severe adverse reactions. Although HYKT exerted curative effects more slowly than hormone

it possessed better safety profile than hormone.

Abstract

To evaluate the efficacy and safety of Heyan Kuntai Capsule (和颜坤泰胶囊

HYKT) and hormone therapy (HT) on perimenopausal syndromes (PMSs). From 2005 to 2008

390 women with PMSs were recruited from 4 clinic centers. The inclusion criteria included ages 40 to 60 years

estradiol (E2) below 30 ng/L

and follicle stimulating hormone (FSH) above 40 IU/L

etc. The patients were randomly assigned to HYKT group or HT group by random number table method

administrated HYKT or conjugated estrogen with/without medroxyprogesterone acetate tablets for 12 months. During treatment

the patients were interviewed quarterly

Kupperman Menopausal Index (KMI) scores

hot flush scores

insomnia scores

KMI scores of HYKT group and HT group were both significantly decreased compared with baseline (P <0.01) and there was no significant difference between groups (P >0.05)

except that KMI of HYKT group was higher after 3-month treatment (P <0.05). After treatment

it possessed better safety profile than hormone.

关键词

perimenopausal syndromesHeyan Kuntai Capsulehormone therapyKupperman Menopausal IndexMenopause-Specific Quality of LifeChinese Medicine

Keywords

perimenopausal syndromesHeyan Kuntai Capsulehormone therapyKupperman Menopausal IndexMenopause-Specific Quality of LifeChinese Medicine

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