Curative Effect and Autonomic Nerve Function of Patients With Primary Insomnia of Liver Depression and Spleen...

Primary insomnia often corresponds to the syndrome of liver depression and spleen deficiency in traditional Chinese medicine. This study evaluates a new acupuncture protocol derived from the "Jing Bie" theory. Tianrong (TE16) and Tianyou (SI17) were selected to regulate the Shaoyang meridian, soothe the liver, regulate qi (the basic life energy or life force to maintain the physiological function of the body according to traditional Chinese medicine), strengthen the spleen, and tranquilize the mind, so as to restore sleep.

The objective of this study is to evaluate the clinical efficacy of this regimen and to explore its effects on autonomic nervous system function and central nervous system chemistry.

This is a single-blind randomized controlled trial. A total of 96 patients with primary insomnia (liver depression and spleen deficiency pattern) will be recruited and randomly assigned to the treatment group or the control group. At the same time, 48 healthy volunteers will be recruited as the healthy control group.

This study was funded in November 2023. Recruitment and data collection began in January 2024 and are currently underway. As of December 2025, a total of 40 participants have been enrolled, of whom 4 have withdrawn. Recruitment is projected to conclude by December 2026. Data analysis will be performed after the completion of recruitment. The results are expected to be published in summer 2027.

This study integrates a traditional Chinese medicine framework with modern physiological measurements. The aim is to provide evidence for targeted acupuncture strategies by linking clinical improvement to autonomic nervous system balance and neurochemical changes and to elucidate potential mechanisms to provide a nondrug treatment option for insomnia.