The efficacy and mechanism of action of the Umei decoction in insomnia: A randomized active-controlled clinical trial

• The study evaluates Umei decoction’s role in insomnia, blending Chinese medicine with modern healthcare. • The study focuses on comparing the efficacy of traditional and innovative insomnia treatments. • The study uses PSQI, ISI, and DBAS for comprehensive treatment outcome assessment. • The study reveals that Umei decoction impacts neurotransmitter and stress response pathways. • The study highlights Umei decoction’s potential effectiveness in insomnia treatment. Insomnia, affecting the quality of life of millions globally, necessitates urgent and effective treatment strategies. This study conducted a randomized controlled trial to compare traditional and novel treatment methods in a cohort of 60 insomnia patients. Sleep quality and symptoms were assessed using the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS). Additionally, transcranial Doppler (TCD) technology was employed to measure cerebral hemodynamic parameters. We divided the patients into two groups for insomnia treatment: (1) Control group: oral administration of zopiclone tablets; (2) Treatment group: oral administration of WuMei Decoction. The findings revealed that novel treatment approaches significantly improved sleep quality, disturbances, daytime functionality, and cerebral hemodynamic indicators. Furthermore, identifying 220 potential target genes through systems biology approaches offers new insights into the molecular mechanisms of insomnia and opportunities for drug development.