Yang Lian-Sheng, Li Yang-Mei, Zhou Dan-Feng, Zhao Bai-Ming, Zheng Shu-Zhen, Chen Zhen-Hu, Zhang Kun, Lu Li-Ming
Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.
Department of Acupuncture and Moxibustion, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Front Neurol. 2022 Jun 2;13:902170. doi: 10.3389/fneur.2022.902170. eCollection 2022.
Although significant progress has been made in the pharmacologic management of Parkinson's Disease (PD), effective management of movement disorders is still a hurdle for therapeutics targeting PD. Acupuncture is one therapeutic option that could potentially improve the motor function of PD and is widely used as adjuvant therapy. Among the various acupuncture approaches, (QHN) therapy has been found to improve motor-function control for patients with PD. However, evidence regarding its efficacy remains scarce. Therefore, to address this need, this study will determine the effects of QHN therapy on motor function in patients with PD and compare it to placebo effects.
This trial is a multicenter, prospective randomized controlled clinical trial. We randomly allocated 144 participants to two groups of 72 patients. Patients in the treatment group were treated with QHN therapy. The control group had undergone insertion of acupuncture needles at sham acupoints not corresponded to acupuncture points. Participants in the verum treatment group and sham-acupuncture control group received 9 sessions over 6 weeks followed by 8 weeks of follow-up. The primary outcome was the change of motor function from baseline to weeks 6 and 14 measured by the PD Rating Scale-Part III Motor Examination (UPDRS-III). Secondary outcome measures included the change of PD daily quality of life-39 (PDQ-39) and Non-Motor Symptoms Scale for PD (NMSS) from baseline to weeks 6 and 14.
The results of this trial will generate data to improve our general understanding of the efficacy of QHN therapy on motor function in patients with PD and thoroughly compare these responses to the placebo effect.
The trial was registered at the Chinese Clinical Trials Registry (ChiCTR- 2000030871) on 16 March 2020.
尽管帕金森病（PD）的药物治疗已取得显著进展，但针对PD的运动障碍的有效管理仍是治疗的一大障碍。针灸是一种可能改善PD患者运动功能的治疗选择，被广泛用作辅助治疗。在各种针灸方法中，发现齐刺疗法（QHN）可改善PD患者的运动功能控制。然而，关于其疗效的证据仍然稀少。因此，为满足这一需求，本研究将确定QHN疗法对PD患者运动功能的影响，并将其与安慰剂效应进行比较。
本试验是一项多中心、前瞻性随机对照临床试验。我们将144名参与者随机分为两组，每组72名患者。治疗组患者接受QHN疗法治疗。对照组在与穴位不对应的假穴位处插入针灸针。真治疗组和假针灸对照组的参与者在6周内接受9次治疗，随后进行8周的随访。主要结局是通过帕金森病评定量表第三部分运动检查（UPDRS-III）测量从基线到第6周和第14周运动功能的变化。次要结局指标包括从基线到第6周和第14周帕金森病日常生活质量-39（PDQ-39）和帕金森病非运动症状量表（NMSS）的变化。
本试验的结果将生成数据，以提高我们对QHN疗法对PD患者运动功能疗效的总体认识，并将这些反应与安慰剂效应进行全面比较。
该试验于2020年3月16日在中国临床试验注册中心（ChiCTR-2000030871）注册。
