Li Kunshan, Xu Shifen, Wang Ruiping, Zou Xuan, Liu Huirong, Fan Chunhai, Li Jing, Li Guona, Wu Yiwen, Ma Xiaopeng, Chen Yiyi, Hu Chenfang, Liu Xiru, Yuan Canxing, Ye Qing, Dai Ming, Wu Luyi, Wang Zhaoqin, Wu Huangan
Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.
EClinicalMedicine. 2023 Jan 13;56:101814. doi: 10.1016/j.eclinm.2022.101814. eCollection 2023 Feb.
Motor disturbances and non-motor disturbances such as constipation are the main factors affecting the quality of life in patients with Parkinson's disease (PD). We investigated the efficacy and safety of electroacupuncture combined with conventional pharmacological treatment on motor dysfunction and constipation in PD.
In this multi-centre randomised controlled trial, we enrolled 166 eligible participants between September 19, 2018 and September 25, 2019 in four hospitals in China. Participants were randomly assigned (1:1) to the electroacupuncture (EA) group and the waitlist control group. Each participant in both groups received the conventional pharmacological treatment, EA group received 3 sessions of electroacupuncture per week for 12 weeks. The primary outcome was the change in the Unified Parkinson's Disease Rating Scale (UPDRS) score from baseline to week 12. The secondary outcomes included the evaluation of functional disability in motor symptoms and constipation, the adherence and adverse events were also recorded. Registered with Chictr.org.cn, ChiCTR1800019517.
At week 12, the change in the UPDRS score of the EA group was significantly higher than that of the control group, with a difference of -9.1 points (95% CI, -11.8 to -6.4), and this difference continued into weeks 16 and 24. From baseline to week 12, the 39-item Parkinson Disease Question (PDQ-39) decreased by 10 points (interquartile range, IQR -26.0 to 0.0) in the EA group and 2.5 points (IQR: -11.0 to 4.0) in the control group, the difference was statistically significant. The time and steps for the 20-m walk at week 12, as well as the changes from baseline in the EA group, were comparable with that in the control group. But the EA group had a greater decrease than the control group from baseline in the times for 20-m walks at weeks 16 and 24. From week 4 to week 24, the median values of spontaneous bowel movements (SBMs) per week in the EA group were higher than that in the control group, the differences were all statistically significant. The incidence of EA-related adverse events during treatment was low, and they are mild and transient.
The findings of our study suggested that compared with conventional pharmacological treatment, conventional pharmacological treatment combined with electroacupuncture significantly enhances motor function and increased bowel movements in patients with PD, electroacupuncture is a safe and effective treatment for PD.
Shanghai "Science and Technology Innovation Action Plan" Clinical Medicine Field Project (18401970700), Shanghai Special Project on Aging and Women's and Children's Health Research (020YJZX0134), Shanghai Clinical Research Centre for Acupuncture and Moxibustion (20MC1920500).
运动障碍以及便秘等非运动障碍是影响帕金森病(PD)患者生活质量的主要因素。我们研究了电针联合传统药物治疗对PD患者运动功能障碍和便秘的疗效及安全性。
在这项多中心随机对照试验中,2018年9月19日至2019年9月25日期间,我们在中国的四家医院招募了166名符合条件的参与者。参与者被随机分配(1:1)至电针(EA)组和等待名单对照组。两组的每位参与者均接受传统药物治疗,EA组每周接受3次电针治疗,共12周。主要结局是从基线到第12周统一帕金森病评定量表(UPDRS)评分的变化。次要结局包括对运动症状和便秘的功能障碍评估,还记录了依从性和不良事件。在中国临床试验注册中心(Chictr.org.cn)注册,注册号为ChiCTR1800019517。
在第12周时,EA组的UPDRS评分变化显著高于对照组,差值为-9.1分(95%CI,-11.8至-6.4),且这种差异持续至第16周和第24周。从基线到第12周,EA组帕金森病39项问卷(PDQ-39)下降了10分(四分位间距,IQR -26.0至0.0),对照组下降了2.5分(IQR:-11.0至4.0),差异具有统计学意义。第12周时20米步行的时间和步数,以及EA组相对于基线的变化,与对照组相当。但在第16周和第24周时,EA组20米步行时间相对于基线的下降幅度大于对照组。从第4周至第24周,EA组每周自发排便(SBM)的中位数高于对照组,差异均具有统计学意义。治疗期间与电针相关的不良事件发生率较低,且症状轻微且短暂。
我们的研究结果表明,与传统药物治疗相比,传统药物治疗联合电针可显著增强PD患者的运动功能并增加排便次数,电针是一种治疗PD安全有效的方法。
上海市“科技创新行动计划”临床医学领域项目(18401970700)、上海市老年与妇幼健康研究专项(020YJZX0134)、上海市针灸临床研究中心(20MC1920500)。