The Effect of Electroacupuncture on Microcirculation in Patients With Hypertension and Cognitive Impairment: Protocol for a Multicenter Randomized Controlled Trial (Preprint)
Bibliographic record
Abstract
BACKGROUND Hypertension is a significant risk factor for cardiovascular diseases and is associated with an increased risk of mild cognitive impairment (MCI). The lack of effective treatment for these conditions underscores the urgent need for novel therapeutic approaches. Previous studies have indicated that microcirculation serves as the pathological basis for the comorbidity of hypertension and cognitive dysfunction. Our initial clinical studies have indicated that acupuncture could be a safe and effective treatment for managing hypertension and MCI. Whether acupuncture can enhance hypertension and cognitive impairment by modulating microcirculation, and the precise mechanisms involved, warrants further exploration. OBJECTIVE The objective of the trial is to evaluate the clinical efficacy of electroacupuncture on MCI of patients with hypertension and to explore whether it can improve hypertension and cognitive impairment by regulating microcirculation. METHODS In this multicenter, large-scale, single-blind, randomized controlled trial, we will recruit 252 patients with hypertension and cognitive impairment from 3 hospitals and randomly assign them to 3 groups in a 1:1:1 ratio: the electroacupuncture group, the sham electroacupuncture (SEA) group, and the waiting list group. The electroacupuncture group and SEA group will receive either electroacupuncture or SEA for 12 weeks, while the waiting list group will not receive acupuncture treatment for the first 12 weeks. The primary outcome will be the changes in overall cognitive function, as measured by the Montreal Cognitive Assessment. The secondary outcomes include blood pressure status, subdomain cognitive function, mental status, sleep quality, hemodynamics, and microcirculation indicators. RESULTS The study protocol has been approved by the institutional review board of the First Affiliated Hospital of Tianjin University of traditional Chinese medicine. This study was registered on April 26, 2024, with the Chinese Clinical Trial Registry. Data collection began in May 2024 and ended in April 2025. Currently, data from this trial are in the collection phase, and no data analysis has been performed. As of January 1, 2025, we have collected data from 65 patients. The results of this trial are expected to be submitted for publication in July 2026. CONCLUSIONS This clinical trial aims to compare the efficacy of electroacupuncture versus SEA or waiting list control in the treatment of hypertension with cognitive impairment and to explore its impact on microcirculation through hemodynamic and microcirculatory indices. The results of this trial will contribute to clarifying the microcirculatory mechanisms of electroacupuncture in the treatment of hypertension with cognitive impairment, providing a solid foundation for further research on electroacupuncture therapy. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR2400083501; https://www.chictr.org.cn/showproj.html?proj=220722 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/70876
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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 | 0.025 | 0.025 |
| Meta-epidemiology (narrow) | 0.005 | 0.003 |
| Meta-epidemiology (broad) | 0.010 | 0.006 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.007 | 0.006 |
| Insufficient payload (model declined to judge) | 0.055 | 0.009 |
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".