■抗抑郁药在治疗重度抑郁症(MDD)方面仍然有一些副作用,针灸疗法是MDD研究兴趣的补充疗法。穴位是疾病反应的敏感部位,是针刺治疗的刺激点。先前的研究表明,在生理和病理情况下,穴位的生物学特异性会发生变化。因此,我们假设穴位的生物学特异性与MDD的诊断有关,具有显著生物学特异性的刺激穴位可以获得比临床常见穴位更好的治疗效果。本研究旨在根据穴位生物学特异性的变化,探讨皮内针刺(IA)治疗MDD的有效性和安全性。
■研究的第一部分将招募30名MDD患者和30名健康对照(HC)参与者,以使用压力疼痛阈值计(PTG)和红外热成像(IRT)评估与MDD相关的穴位的疼痛敏感性和热特异性。用于治疗MDD的潜在优势穴位将基于PTG和IRT测试的结果来选择,并且被称为压力疼痛阈值强反应穴位(PSA)和温度强反应穴位(TSA)。研究的第二部分将招募120名符合条件的MDD患者,随机分配到等待名单(WL)组,临床共同穴位(CCA)组,TSA集团,和PSA组以1:1:1:1的比例。患者健康问卷-9项目(PHQ-9)的变化,MOS项目简式健康调查(SF-36),压力痛阈值,穴位温度,和不利影响将被观察到。PHQ-9和SF-36措施的结果将在干预前进行评估,在干预后3周和6周,在4周的随访中。将在干预前和干预后6周评估穴位测量的生物学特异性。将评估所有不良反应。
■这项研究将根据穴位生物学特异性的变化来评估IA对MDD的治疗效果和安全性。它将研究MDD相关穴位的生物学特异性与MDD的诊断之间是否存在相关性,以及刺激强反应穴位在MDD的治疗中是否优于临床常见穴位。该研究的结果可能为针灸的生物学机制及其作为MDD补充疗法的潜力提供了见解。
■ClinicalTrials.gov,标识符:NCT05524519。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: ClinicalTrials.gov, identifier: NCT05524519.