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Randomized Controlled Trial
. 2024 Apr;44(2):373-380.
doi: 10.19852/j.cnki.jtcm.20231110.003.

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

L I Xiyu  1 , Yang Yanhong  2 , Sun Jian  3 , Nie Quanfang  4 , Liu Lifen  5 , L I Guifen  6 , Y U Junping  7 , Zhang Zhuangjin  8 , X U Yi  9 , Zou Ting  10 , Shi Yun  1
Affiliations
Randomized Controlled Trial

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

L I Xiyu et al. J Tradit Chin Med. 2024 Apr.

Abstract

Objective: To investigate the effectiveness and safety of Jiawei Xiaoyao pill (，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.

Keywords: Jiawei Xiaoyao pill; double-blind method; premenstrual syndrome; randomized controlled trial.

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Figures

Figure 1
Figure 1. Flowchart of the study participants
JXP: Jiawei Xiaoyao pill; FAS: full analysis set; PPS: per protocol set; SS: safety analysis set.
See this image and copyright information in PMC

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