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.

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.

SUBMITTER: Xiyu LI 

PROVIDER: S-EPMC10927397 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature