Curative Effect and Autonomic Nerve Function of Patients With Primary Insomnia of Liver Depression and Spleen Deficiency Type Based on the Acupoint Selection of Meridian Theory: Protocol for a Randomized Controlled Trial
Bibliographic record
Abstract
Background: 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. Objective: 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. Methods: 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. Results: 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 As of December 2025, a total of 40 participants have been enrolled, of whom 4 have withdrawn.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. Conclusions: 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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.015 | 0.011 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.009 | 0.004 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.005 | 0.003 |
| Insufficient payload (model declined to judge) | 0.026 | 0.003 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".