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Efficacy of electroacupuncture for the treatment of constipation in Parkinson’s disease: study protocol for a multicentre randomised controlled trial
  1. Kunshan Li1,
  2. Zhaoqin Wang1,
  3. Yiyi Chen2,
  4. Lirong Shen3,
  5. Zhongqiu Li1,
  6. Yiwen Wu4,
  7. Canxing Yuan5,
  8. Yan Huang6,
  9. Luyi Wu1,
  10. Chunhui Bao6,
  11. Wei Zhang7,
  12. Shifen Xu8,
  13. Huangan Wu2
  1. 1Shanghai University of Traditional Chinese Medicine, Shanghai, China
  2. 2Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
  3. 3Shanghai Pudong New Area Hospital of Chinese Medicine, Shanghai, China
  4. 4Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  5. 5Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
  6. 6Key Laboratory of Acupuncture and Immunological Effects, Shanghai University of Traditional Chinese Medicine, Shanghai, China
  7. 7Departement of Biostatistics, School of Public Health, Fudan University, Shanghai, China
  8. 8Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
  1. Correspondence to Professor Huangan Wu; wuhuangan{at}126.com; Dr Shifen Xu; xu_teacher2006{at}126.com

Abstract

Introduction 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.

Methods and analysis 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).

Ethics and dissemination 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.

Trial registration number ChiCTR1900021053

  • constipation
  • parkinson's disease
  • acupuncture
  • randomised controlled trial

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Footnotes

  • KL and ZW contributed equally.

  • Contributors KL and ZW are joint first authors. KL participated in the design of this study and drafted the manuscript. LW, CB and YH revised and edited this manuscript. WZ was responsible for the statistical plan and design. YC and ZL participated in the implementation of the project. ZW, LS, YW and CY will help recruit participants. SX contributed to the design of this study and critical revisions of the manuscript. HW conceived this research and is the research manager. All authors have read and approved this final manuscript.

  • Funding This work was supported by the Shanghai Science and Technology Committee (grant number: 18401970700), the National Key Basic Research Programme of China (grant number: 2015CB554501) and the Shanghai Municipal Commission of Health and Family Planning (grant number: 2018Y0143).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval This study protocol has been approved by four local ethics committees including those at: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (Approval No. 2018–121), Longhua Hospital (Approval No. 2019LCSY034), Shanghai Municipal Hospital of Traditional Chinese Medicine (Approval No. 2019SHL-KY-07–02), and Shuguang Hospital (Approval No. 2019-676-31-01). This study conforms to the Declaration of Helsinki principles.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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