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.
J Tradit Chin Med
; 44(2): 373-380, 2024 Apr.
Article
en En
| MEDLINE
| ID: mdl-38504543
ABSTRACT
OBJECTIVE:
To investigate the effectiveness and safety of Jiawei Xiaoyao pill (ï¼JXP) 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.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Medicinas Tradicionales:
Medicinas_tradicionales_de_asia
/
Medicina_china
Métodos Terapéuticos y Terapias MTCI:
Terapias_biologicas
Asunto principal:
Bazo
/
Síndrome Premenstrual
/
Medicamentos Herbarios Chinos
Idioma:
En
Revista:
J Tradit Chin Med
Año:
2024
Tipo del documento:
Article
País de afiliación:
China