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Journal of Traditional Chinese Medicine >

2024 , Vol. 44 >Issue 2: 373 - 380

DOI: https://doi.org/10.19852/j.cnki.jtcm.20231110.003

Effectiveness and safety of Jiawei Xiaoyao pill (加味逍遥丸) in the treatment of premenstrual syndrome (liver depression, spleen deficiency, and blood-heat syndrome): a multi-center, randomized, placebo-controlled trial

  • Xiyu LI ,
  • Yanhong YANG ,
  • Jian SUN ,
  • Quanfang NIE ,
  • Lifen LIU ,
  • Guifen LI ,
  • Junping YU ,
  • Zhuangjin ZHANG ,
  • Yi XU ,
  • Ting ZOU ,
  • Yun SHI
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  • 1 Department of Gynecology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
    2 Department of Gynecology, Luoyang 1st Hospital of TCM, Luoyang 471099, China
    3 Department of Gynecology, Zaozhuang Hospital of TCM, Zaozhuang 277099, China
    4 Department of Gynecology and Obstetrics, Loudi Central Hospital, Loudi 417099, China
    5 Department of Gynecology and Obstetrics, Yiyang 1st Hospital of TCM, Yiyang 413002, China
    6 Department of Gynecology, Harrison International Peace Hospital, Hengshui 053000, China
    7 Department of Gynecology and Obstetrics, Shanxi Fenyang Hospital, Fenyang 032299, China
    8 Department of Gynecology and Obstetrics, Hengyang Chinese Medicine Hospital, Hengyang 421001, China
    9 Scientific Research Institute of Beijing Tongrentang Technology Development Co., Ltd. Beijing 100061, China
    10 Female Reproductive and Health Medicine Research Committee of Chinese Traditional Medicine Association, Beijing 100061, China

Received date: 2022-12-11

  Accepted date: 2023-04-27

  Online published: 2023-11-10

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Abstract

OBJECTIVE: To investigate the effectiveness and safety of Jiawei Xiaoyao pill (加味逍遥丸，JXP) in the treatment of symptoms associated with premenstrual syndrome (PMS).

METHODS: A total of 144 regularly menstruating women with PMS were recruited at 8 sites in China from August 2017 to December 2018, and randomized to receive either a JXP or a matching placebo (12 g/d, 6 g twice a day) for 3 menstrual cycles. The primary indicator was the reduced Daily Record of Severity of Problems (DRSP) scores in the luteal phase after 3 months of treatment. The safety outcomes included clinical adverse events (AEs), adverse reactions (ARs), changes in vital signs, and laboratory tests.

RESULTS: JXP surpassed the placebo in reducing DRSP scores (psychological/somatic dysfunction) in the luteal phase over 3 menstrual cycles of treatment (PFAS = 0.002, PPPS = 0.001). Additionally, there were no significant differences in the incidence of AEs, severe AEs, withdrawal due to AEs and ARs between the two groups (all P > 0.05), and no clinically significant adverse medical events related to the test drug observed.

CONCLUSIONS: JXP was superior to the placebo in relieving the symptoms associated with PMS, which signified that JXP may be effective, safe, and well-tolerated as an alternative therapy.

Key words： premenstrual syndrome; randomized controlled trial; double-blind method; Jiawei Xiaoyao pill

Cite this article

Xiyu LI , Yanhong YANG , Jian SUN , Quanfang NIE , Lifen LIU , Guifen LI , Junping YU , Zhuangjin ZHANG , Yi XU , Ting ZOU , Yun SHI . Effectiveness and safety of Jiawei Xiaoyao pill (加味逍遥丸) in the treatment of premenstrual syndrome (liver depression, spleen deficiency, and blood-heat syndrome): a multi-center, randomized, placebo-controlled trial[J]. Journal of Traditional Chinese Medicine, 2024 , 44(2) : 373 -380 . DOI: 10.19852/j.cnki.jtcm.20231110.003

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