The First Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China.
Clinical Medical College of Acupuncture Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
BMJ Open. 2024 Mar 28;14(3):e081312. doi: 10.1136/bmjopen-2023-081312.
Parkinson's disease (PD) has a significant impact on a substantial number of individuals in China. Notably, 31% of patients with PD also grapple with the additional burden of anxiety. This dual challenge of managing both PD and anxiety underscores the complexity of the condition and the diverse range of symptoms patients may experience. Considering the circumstances, the cost and potential drawbacks associated with traditional antiparkinsonian drugs become increasingly relevant. Acupuncture emerges as a significant non-pharmacological adjunct therapy. Offering a potentially safer and more cost-effective option, acupuncture addresses the pressing need for holistic and complementary treatments that may alleviate both the motor symptoms of PD and the accompanying anxiety.
This is a multicentre, randomised controlled and assessor-blind trial. A total of 210 eligible patients with PD will be randomly assigned (1:1) to Jin's three-needle (JTN) acupuncture group or waitlist (WL) group. Patients in the JTN group will receive acupuncture therapy three times per week for 4 weeks. Patients in the WL group will maintain their original dosage of antiparkinsonian drugs and receive acupuncture therapy after the observation period. The primary outcome measure will be the Unified Parkinson's Disease Rating Scale score. The secondary outcome measures will be the scores of the Hoehn-Yahr Rating Scale, Unified Dyskinesia Rating Scale, Non-Motor Symptoms Scale, 39-item Parkinson's Disease Questionnaire, Parkinson Anxiety Scale, Hamilton Anxiety Scale, Hamilton Depression Scale, Zarit burden interview and the level of cortisol and adrenocorticotropic hormone. The evaluation will be executed at baseline, the end of the treatment and a follow-up period.
The study was approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine (K[2023]014). All patients have to provide written, informed consent. The study will be disseminated through presentations in peer-reviewed international journals and at national and international conferences.
Chinese Clinical Trial Registry; ChiCTR2300074675.
帕金森病（PD）在中国有大量患者，其中 31%的患者还伴有焦虑。这双重挑战凸显了这种疾病的复杂性和患者可能经历的各种症状。考虑到这种情况，传统抗帕金森药物的成本和潜在缺点变得越来越重要。针灸作为一种重要的非药物辅助治疗方法出现了。它提供了一种更安全、更具成本效益的选择，针对的是对整体和补充治疗的迫切需求，这些治疗可能缓解 PD 的运动症状和伴随的焦虑。
这是一项多中心、随机对照和评估者盲法试验。共有 210 名符合条件的 PD 患者将被随机分配（1:1）到金氏三针（JTN）针灸组或候补名单（WL）组。JTN 组患者每周接受 3 次针灸治疗，共 4 周。WL 组患者将保持原有的抗帕金森药物剂量，并在观察期后接受针灸治疗。主要结局指标将是统一帕金森病评定量表评分。次要结局指标将是 Hoehn-Yahr 分级量表评分、统一运动障碍评分量表评分、非运动症状量表评分、39 项帕金森病问卷评分、帕金森焦虑量表评分、汉密尔顿焦虑量表评分、汉密尔顿抑郁量表评分、Zarit 负担访谈评分以及皮质醇和促肾上腺皮质激素水平。评估将在基线、治疗结束时和随访期间进行。
该研究已获得广州中医药大学第一附属医院伦理委员会的批准（K[2023]014）。所有患者都必须提供书面知情同意书。该研究将通过在同行评议的国际期刊上发表和在国内外会议上展示来传播。
中国临床试验注册中心；ChiCTR2300074675。
