Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
BMJ Open. 2019 Nov 27;9(11):e029841. doi: 10.1136/bmjopen-2019-029841.
Constipation is one of the most common non-motor symptoms in Parkinson's disease (PD). Acupuncture can have a positive on chronic functional constipation and PD, but its efficacy for the treatment of constipation in PD has not yet been confirmed by high-quality clinical trials. Therefore, this study aims to evaluate the efficacy and safety of electroacupuncture (EA) in the treatment of constipation in PD.
This study is a multicentre randomised controlled trial. A total of 124 qualified patients with PD and constipation will be randomly divided into the intervention group (62 participants will receive 12 weeks of EA +usual care) or the waitlist control group (62 participants will receive 12 weeks of usual care). EA will be performed three times per week from weeks 1-8, two times per week during weeks 9 and 10, and once a week during weeks 11 and 12. The primary outcome is the change in mean weekly spontaneous bowel movements from baseline to weeks 8 and 9. The secondary outcomes are the changes from baseline in mean weekly bowel movements, mean weekly stool consistency, and mean weekly straining. Other secondary outcomes include the weekly doses of defecation drugs, Visual Analogue Scale for subjective improvements in stool symptoms, Unified Parkinson's Disease Rating Scale, and the time and number of steps required to walk 20 m. Outcomes will be assessed at baseline, week 4, 8, 12 (intervention period); as well as at week 16, 24 (follow-up period).
Ethical approval has been obtained from four local ethics committees. The results of the study will be published in peer-reviewed journals and will be disseminated through national and international conferences.
ChiCTR1900021053.
便秘是帕金森病（PD）最常见的非运动症状之一。针灸对慢性功能性便秘和 PD 有积极作用，但针灸治疗 PD 便秘的疗效尚未通过高质量的临床试验得到证实。因此，本研究旨在评估电针对 PD 便秘的疗效和安全性。
这是一项多中心随机对照试验。共纳入 124 名符合条件的 PD 伴便秘患者，将随机分为干预组（62 名患者接受 12 周电针+常规护理）或等待对照组（62 名患者接受 12 周常规护理）。电针治疗每周 3 次，持续 8 周，第 9 周和第 10 周每周 2 次，第 11 周和第 12 周每周 1 次。主要结局为从基线到第 8 周和第 9 周平均每周自发性排便次数的变化。次要结局为从基线到每周排便次数、每周粪便稠度和每周排便费力的变化。其他次要结局包括每周排便药物剂量、粪便症状主观改善的视觉模拟量表、统一帕金森病评定量表以及行走 20 米所需的时间和步数。结局将在基线、第 4 周、第 8 周、第 12 周（干预期）以及第 16 周、第 24 周（随访期）进行评估。
该研究已获得 4 个当地伦理委员会的批准。研究结果将发表在同行评议的期刊上，并通过国内和国际会议进行传播。
ChiCTR1900021053。
