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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

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Abstract

Objective

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).

Methods

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

Results

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).

Conclusions

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.

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Authors and Affiliations

  1. Department of Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100032, China

    Ai-jun Sun, Ya-ping Wang, Ting-ping Zheng, Shou-qing Lin & Ying Zhang

  2. Department of Obstetrics and Gynecology, Beijing Shijitan Hospital, Beijing, 100038, China

    Bei Gu, Wen-pei Bai & Yang Wei

  3. Department of Gynecology, Obstetrics and Gynecology, Hospital of Fudan University, Shanghai, 200011, China

    Shao-fen Zhang

Authors
  1. Ai-jun Sun
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  2. Ya-ping Wang
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  3. Bei Gu
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  4. Ting-ping Zheng
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  5. Shou-qing Lin
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  6. Wen-pei Bai
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  7. Yang Wei
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  8. Shao-fen Zhang
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  9. Ying Zhang
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Corresponding author

Correspondence to Shou-qing Lin.

Additional information

Supported by the “Tenth-Five” National Medical Science and Technique Foundation, China (No. 2004BA720A08)

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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

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  • DOI: https://doi.org/10.1007/s11655-016-2266-y

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