Tu Mingqi, Wu Xiaoting, Qu Siying, Jin Junyan, Chen Nisang, Xiong Sangsang, Pei Shuangyi, Li Xinwei, Shi Yan, Hu Hantong, Li Xiaoyu, Fang Jianqiao, Shao Xiaomei
Key Laboratory for Research of Acupuncture Treatment and Transformation of Emotional Diseases, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, The Third Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, China.
The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.
Front Psychiatry. 2023 Jun 9;14:1183127. doi: 10.3389/fpsyt.2023.1183127. eCollection 2023.
Antidepressants still have some side effects in treating major depressive disorder (MDD), and acupuncture therapy is a complementary therapy of research interest for MDD. Acupoints are sensitive sites for disease response and stimulation points for acupuncture treatment. Prior studies suggest that the biological specificity of acupoints is altered in physiological and pathological situations. Therefore, we hypothesize that the biological specificity of acupoints is associated with the diagnosis of MDD and that stimulating acupoints with significant biological specificity can achieve a better therapeutic effect than clinical common acupoints. This study aims to investigate the efficacy and safety of intradermal acupuncture (IA) treatment for MDD based on changes in the biological specificity of acupoints.
The first part of the study will enroll 30 MDD patients and 30 healthy control (HC) participants to assess pain sensitivity and thermal specificity of MDD-related acupoints using a pressure pain threshold gauge (PTG) and infrared thermography (IRT). The potentially superior acupoints for treating MDD will be selected based on the results of PTG and IRT tests and referred to as pressure pain threshold strong response acupoints (PSA) and temperature strong response acupoints (TSA).The second part of the study will enroll 120 eligible MDD patients randomly assigned to waiting list (WL) group, clinical common acupoint (CCA) group, TSA group, and PSA group in a 1:1:1:1 ratio. The change in the Patient Health Questionnaire-9 Items (PHQ-9), the MOS item short-form health survey (SF-36), pressure pain threshold, temperature of acupoints, and adverse effects will be observed. The outcomes of PHQ-9 and SF-36 measures will be assessed before intervention, at 3 and 6 weeks after intervention, and at a 4-week follow-up. The biological specificity of acupoint measures will be assessed before intervention and at 6 weeks after intervention. All adverse effects will be assessed.
This study will evaluate the therapeutic effect and safety of IA for MDD based on changes in the biological specificity of acupoints. It will investigate whether there is a correlation between the biological specificity of MDD-related acupoints and the diagnosis of MDD and whether stimulating strong response acupoints is superior to clinical common acupoints in the treatment of MDD. The study's results may provide insights into the biological mechanisms of acupuncture and its potential as a complementary therapy for MDD.
ClinicalTrials.gov, identifier: NCT05524519.
抗抑郁药在治疗重度抑郁症（MDD）时仍有一些副作用，而针灸疗法是一种针对MDD具有研究价值的辅助疗法。穴位是疾病反应的敏感部位和针灸治疗的刺激点。先前的研究表明，穴位的生物学特异性在生理和病理情况下会发生改变。因此，我们假设穴位的生物学特异性与MDD的诊断相关，并且刺激具有显著生物学特异性的穴位比临床常用穴位能取得更好的治疗效果。本研究旨在基于穴位生物学特异性的变化，探讨皮内针（IA）治疗MDD的疗效和安全性。
研究的第一部分将招募30例MDD患者和30名健康对照（HC）参与者，使用压力痛阈仪（PTG）和红外热成像（IRT）评估与MDD相关穴位的疼痛敏感性和热特异性。将根据PTG和IRT测试结果选择治疗MDD的潜在优势穴位，称为压力痛阈强反应穴位（PSA）和温度强反应穴位（TSA）。研究的第二部分将招募120例符合条件的MDD患者，按1:1:1:1的比例随机分配到等待列表（WL）组、临床常用穴位（CCA）组、TSA组和PSA组。观察患者健康问卷9项（PHQ-9）、医疗结局研究简明健康调查（SF-36）、压力痛阈、穴位温度的变化以及不良反应。将在干预前、干预后3周和6周以及4周随访时评估PHQ-9和SF-36的测量结果。将在干预前和干预后6周评估穴位测量的生物学特异性。评估所有不良反应。
本研究将基于穴位生物学特异性的变化评估IA治疗MDD的疗效和安全性。它将研究与MDD相关穴位的生物学特异性与MDD诊断之间是否存在相关性，以及在MDD治疗中刺激强反应穴位是否优于临床常用穴位。该研究结果可能为针灸的生物学机制及其作为MDD辅助疗法的潜力提供见解。
ClinicalTrials.gov，标识符：NCT05524519。
