Acupuncture with the Sancai Acupoint Matching Method for Primary Insomnia: A Randomized Controlled Trial

Study Objectives: Primary insomnia (PI) remains a widespread public health concern. This study aims to evaluate the efficacy and safety of the novel Sancai acupoint matching method for PI, and to explore its potential peripheral biochemical mechanisms. Methods and Design: 76 PI patients were randomly assigned to either the real-acupuncture (RA) group or the sham-acupuncture (SA) group, with 38 cases in each group. The RA group received verum acupuncture based on the stated principle over an 8-week treatment period (20 sessions), while the SA group received sham acupuncture. Assessments were conducted at baseline, immediately post-treatment, and at 1, 4- and 12-week follow-ups using the Insomnia Severity Index (ISI) as the primary outcome measure, along with the Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS). Objective sleep parameters were monitored via polysomnography (PSG), and serum levels of 5-hydroxytryptamine (5-HT) and brain-derived neurotrophic factor (BDNF) were measured before and after treatment. Results: Improvements in ISI, PSQI, SAS and SDS scores were superior in the RA group compared to the SA group ( P < 0.05). The objective sleep parameters in the RA group were significantly improved, and the levels of serum 5-HT and BDNF were significantly increased ( P < 0.05). Conclusion: The Sancai acupoint matching method is a safe and effective treatment for primary insomnia, significantly improving patients’ subjective sleep quality, emotional symptoms, and objective sleep parameters, and upregulating peripheral blood levels of 5-HT and BDNF. These findings support the clinical application of this acupuncture protocol and provide a foundation for subsequent mechanistic studies. Clinical Trial Registration: The study was registered at the Chinese Clinical Trial. Registry, registration ID: ChiCTR2300072229, China. Keywords: acupuncture, Sancai acupoint matching method, primary insomnia, randomized controlled trial, 5-HT, BDNF