Presentation (CTI)

OBJECTIVES: The aim of this study is to examine the safety and effectiveness of Xiangshao granules as a potential treatment for anxiety symptoms in women during the perimenopausal and postmenopausal stages.
METHODS: This multicenter, double-blind, randomized, placebo-controlled trial was conducted from December 2021 to June 2023 at 18 centers in China, enrolling 360 women aged 40-65 years with menopausal anxiety. Participants were randomly assigned to receive Xiangshao granules (high-dose group, n=180) or placebo (very-low-dose group, n=180) for eight weeks. The primary outcome was the change in Self-Rating Anxiety Scale (SAS) scores; secondary outcomes included the Self-Rating Depression Scale (SDS), Kupperman Index, and Gastrointestinal Symptom Score (GIS).
RESULTS: After eight weeks, SAS scores declined significantly inthe high-dose group (57.2 to 44.7) compared with the placebo group (56.6 to 47.2; p=0.0086), yielding a higher clinical improvement rate (69.8% vs. 56.9%; p=0.0151). Although no significant between-group differences were observed for SDS, Kupperman Index, or GIS, all showed improvements from baseline, and adverse event rates were comparable. Transcriptomic analysis revealed modifications in the dopaminergic synapse pathway following Xiangshao treatment; network pharmacology identified FOS, ATF2, and CREB1 as key dopaminergic pathway-related targets, and metabolomic data corroborated these findings. Collectively, Xiangshao granules safely and effectively alleviate menopausal anxiety, potentially by modulating dopaminergic signaling.
CONCLUSIONS: Xiangshao granules demonstrated significant efficacy and safety in reducing anxiety symptoms in menopausal women. Multi-omics analysis further suggested that their therapeutic effect may involve modulation of the dopaminergic synaptic pathway. These findings contribute novel insights into the treatment of menopausal anxiety and provide a scientific basis for future clinical and mechanistic studies.