关键词: CCS, Chronic constipation severity scale Constipation EA, Electroacupuncture Electroacupuncture ITT, Intention-to-treat LED, Levodopa equivalent dose MMSE, Mini-Mental State Examination Motor dysfunction PAC-QOL, Patient assessment of constipation quality of life PD, Parkinson's disease PDQ-39, 39-item Parkinson Disease Question Parkinson's disease SBMs, Spontaneous bowel movements UPDRS, Unified Parkinson’s Disease Rating Scale VAS, Visual Analogue Scale

来  源:   DOI:10.1016/j.eclinm.2022.101814   PDF(Pubmed)

Abstract:
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
摘要:
UNASSIGNED:运动障碍和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。探讨电针结合常规药物治疗对PD运动功能障碍和便秘的疗效和安全性。
未经评估: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,我们在中国4家医院纳入了166名符合条件的参与者.参与者被随机分配(1:1)到电针(EA)组和等待名单对照组。两组均接受常规药物治疗,EA组每周接受3次电针,持续12周。主要结果是统一帕金森病评定量表(UPDRS)评分从基线到第12周的变化。次要结果包括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Chictr.org注册。cn,ChiCTR1800019517。
UNASSIGNED:在第12周,EA组的UPDRS评分变化显着高于对照组,差异为-9.1点(95%CI,-11.8至-6.4),这种差异持续到第16周和第24周。从基线到第12周,39项帕金森病问题(PDQ-39)减少了10分(四分位数范围,EA组中的IQR-26.0至0.0)和对照组中的2.5点(IQR:-11.0至4.0),差异有统计学意义。第12周20米步行的时间和步数,以及EA组的基线变化,与对照组相当。但是EA组在第16周和第24周的20米步行时间比对照组的基线下降更大。从第4周到第24周,EA组每周自发排便(SBMs)的中位数高于对照组,差异均有统计学意义。治疗期间EA相关不良事件发生率较低,它们是温和和短暂的。
UNASSIGNED:我们的研究结果表明,与常规药物治疗相比,常规药物治疗联合电针治疗可显著提高PD患者的运动功能,增加排便,电针治疗PD是一种安全有效的治疗方法。
UNASSIGNED:上海“科技创新行动计划”临床医学领域项目(18401970700),上海市老龄化与妇女儿童健康研究专项(020YJZX0134),上海市针灸临床研究中心(20MC1920500).
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