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The Therapeutic Efficacy of Gold Needle "Regulating Spirit" Acupuncture for Amnestic Mild Cognitive Impairment:
Xin Wang1, Yilin Tao2, Qianqian Li1
1Department of Psychosomatic Medicine, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
Background:
Amnestic mild cognitive impairment (aMCI), the predominant subtype of mild cognitive impairment, carries the highest risk of progression to Alzheimer disease among all mild cognitive impairment subtypes. Currently, clinical practice lacks an established, authoritative treatment method for this condition. Prior clinical evidence indicates acupuncture may enhance cognitive function in individuals with mild cognitive impairment. Further clinical evidence suggests Gold Needle therapy demonstrates significant therapeutic effects for challenging and refractory conditions; however, a critical gap exists: no clinical trials currently ascertain whether Gold Needle therapy surpasses conventional acupuncture in treating aMCI. This trial aims to rigorously evaluate the therapeutic efficacy and safety of the Gold Needle "Regulating Spirit" method for clinical symptoms in patients with aMCI, alongside investigating its underlying imaging and biochemical mechanisms.
Objective:
This proposed study aims to identify imaging and laboratory biomarkers for the early diagnosis of aMCI, thereby providing a theoretical foundation for clinical practice.
Methods:
This randomized controlled trial will recruit 90 patients diagnosed with aMCI from the Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University, alongside 20 healthy volunteers. The 90 patients with aMCI will be randomly allocated to 1 of 3 groups: the Gold Needle "Regulating Spirit" group uses gold-based needles, the general acupuncture "Regulating Spirit" group, or a sham acupuncture control group. The Gold Needle "Regulate Spirit" group uses gold-based needles, the general acupuncture "Regulate Spirit" group uses standard needles, and the sham acupuncture group administers Park needles. Participants will undergo 3 sessions per week of their assigned acupuncture or placebo treatment over a continuous 12-week period.
Results:
This study was initiated on September 1, 2023. As of October 30, 2025, 110 eligible participants had been enrolled, and data collection had been completed in full. Data analysis is currently underway, and the preliminary results are expected to be available by June 2025. We hypothesize that, compared with the filiform needle-based mind-regulating acupuncture group, the golden needle-based mind-regulating acupuncture group will demonstrate superior efficacy in improving cognitive impairment. This superiority will be reflected in multiple key outcome measures, including Montreal Cognitive Assessment and Mini-Mental State Examination scores, plasma biomarkers, and functional magnetic resonance imaging findings.
Conclusions:
We anticipate that by the end of the trial, we will be able to definitively ascertain whether the gold acupuncture needle technique for "regulating spirit" offers a significant advantage in treating aMCI, and further investigate the nature of this therapeutic benefit, to offer a more efficacious intervention for the clinical management of aMCI and the prevention of Alzheimer disease.
Insights
Gold Needle acupuncture shows promise for treating amnestic mild cognitive impairment (aMCI), potentially improving cognitive function and offering a new intervention for Alzheimer disease prevention.
Area of Science:
- Neurology
- Integrative Medicine
- Biomarker Research
Background:
- Amnestic mild cognitive impairment (aMCI) is a precursor to Alzheimer disease, lacking definitive treatments.
- Acupuncture may improve cognitive function in aMCI patients.
- Gold Needle therapy shows potential for refractory conditions, but its efficacy against standard acupuncture for aMCI is unproven.
Purpose of the Study:
- To evaluate the efficacy and safety of Gold Needle "Regulating Spirit" therapy for aMCI.
- To identify imaging and laboratory biomarkers for early aMCI diagnosis.
- To compare Gold Needle therapy with conventional acupuncture and sham treatment for aMCI.
Main Methods:
- A randomized controlled trial involving 90 aMCI patients and 20 healthy volunteers.
- Three groups: Gold Needle, general acupuncture, and sham acupuncture, each receiving 3 weekly sessions for 12 weeks.
- Assessment of cognitive function, plasma biomarkers, and functional MRI.
Main Results:
- Preliminary results are expected by June 2025.
- Hypothesis: Gold Needle therapy will outperform standard acupuncture in improving cognitive scores (MoCA, MMSE), plasma biomarkers, and fMRI findings.
- Study initiated September 1, 2023, with 110 participants enrolled by October 30, 2025.
Conclusions:
- To determine if Gold Needle "Regulating Spirit" therapy is superior to conventional acupuncture for aMCI.
- To investigate the therapeutic mechanisms, including imaging and biochemical changes.
- To provide a more effective intervention for aMCI management and Alzheimer disease prevention.
