PMID- 38504543
OWN - NLM
STAT- MEDLINE
DCOM- 20240321
LR  - 20240416
IS  - 2589-451X (Electronic)
IS  - 0255-2922 (Print)
IS  - 0255-2922 (Linking)
VI  - 44
IP  - 2
DP  - 2024 Apr
TI  - 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.
PG  - 373-380
LID - 10.19852/j.cnki.jtcm.20231110.003 [doi]
AB  - 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.
FAU - Xiyu, L I
AU  - Xiyu LI
AD  - Department of Gynecology, Dongzhimen Hospital, Beijing University of Chinese 
      Medicine, Beijing 100700, China.
FAU - Yanhong, Yang
AU  - Yanhong Y
AD  - Department of Gynecology, Luoyang 1st Hospital of TCM, Luoyang 471099, China.
FAU - Jian, Sun
AU  - Jian S
AD  - Department of Gynecology, Zaozhuang Hospital of TCM, Zaozhuang 277099, China.
FAU - Quanfang, Nie
AU  - Quanfang N
AD  - Department of Gynecology and Obstetrics, Loudi Central Hospital, Loudi 417099, 
      China.
FAU - Lifen, Liu
AU  - Lifen L
AD  - Department of Gynecology and Obstetrics, Yiyang 1st Hospital of TCM, Yiyang 
      413002, China.
FAU - Guifen, L I
AU  - Guifen LI
AD  - Department of Gynecology, Harrison International Peace Hospital, Hengshui 053000, 
      China.
FAU - Junping, Y U
AU  - Junping YU
AD  - Department of Gynecology and Obstetrics, Shanxi Fenyang Hospital, Fenyang 032299, 
      China.
FAU - Zhuangjin, Zhang
AU  - Zhuangjin Z
AD  - Department of Gynecology and Obstetrics, Hengyang Chinese Medicine Hospital, 
      Hengyang 421001, China.
FAU - Yi, X U
AU  - Yi XU
AD  - Scientific Research Institute of Beijing Tongrentang Technology Development Co., 
      Ltd. Beijing 100061, China.
FAU - Ting, Zou
AU  - Ting Z
AD  - 10 Female Reproductive and Health Medicine Research Committee of Chinese 
      Traditional Medicine Association, Beijing 100061, China.
FAU - Yun, Shi
AU  - Yun S
AD  - Department of Gynecology, Dongzhimen Hospital, Beijing University of Chinese 
      Medicine, Beijing 100700, China.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - China
TA  - J Tradit Chin Med
JT  - Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan
JID - 8211546
RN  - 0 (xiaoyao)
RN  - 0 (Drugs, Chinese Herbal)
SB  - IM
MH  - Female
MH  - Humans
MH  - *Spleen
MH  - Depression
MH  - Hot Temperature
MH  - *Premenstrual Syndrome/drug therapy
MH  - Liver
MH  - Double-Blind Method
MH  - *Drugs, Chinese Herbal
PMC - PMC10927397
OTO - NOTNLM
OT  - Jiawei Xiaoyao pill
OT  - double-blind method
OT  - premenstrual syndrome
OT  - randomized controlled trial
EDAT- 2024/03/20 06:45
MHDA- 2024/03/21 12:46
PMCR- 2024/04/15
CRDT- 2024/03/20 02:43
PHST- 2024/03/21 12:46 [medline]
PHST- 2024/03/20 06:45 [pubmed]
PHST- 2024/03/20 02:43 [entrez]
PHST- 2024/04/15 00:00 [pmc-release]
AID - 1710137238698-253859447 [pii]
AID - JTCM-44-2- [pii]
AID - 10.19852/j.cnki.jtcm.20231110.003 [doi]
PST - ppublish
SO  - J Tradit Chin Med. 2024 Apr;44(2):373-380. doi: 
      10.19852/j.cnki.jtcm.20231110.003.