Wei Peng1, Xiaojuan Hong1, Yaru Huangfu1, Zhao Sun2, Wei Shen2, Fen Feng3, Liang Gong4, Zhifu Shen5, Baojun Guo6, Leixiao Zhang1, Yanan Wang1, Ying Zhao1, Tianmin Zhu7, Youping Hu8, Siyi Yu9. 1. Acupuncture & Tuina College, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan, China. 2. Hainan Medical University, Haikou, 571199, Hainan, China. 3. Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610072, Sichuan, China. 4. Chengdu Second People's Hospital, Chengdu, 610017, Sichuan, China. 5. North Sichuan Medical College, Nanchong, 637100, Sichuan, China. 6. Henan Provincial People's Hospital, Zhengzhou, 450003, Henan, China. 7. Rehabilitation and Health Preservation College, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan, China. 8. Acupuncture & Tuina College, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan, China. hypcdutcm@yeah.net. 9. Acupuncture & Tuina College, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan, China. cdutcmysy@gmail.com.
Abstract
BACKGROUND: Many patients with chronic insomnia disorder (CID) have gastrointestinal (GI) symptoms. First-line insomnia medications do not treat GI problems. Acupuncture has a comprehensive regulative action on both CID and GI disorder and is receiving increasing attention. Recent studies indicate that both CID and GI diseases may cause abnormal brain activity. However, the neurological mechanism underlying the effect of acupuncture on such diseases is still unclear. The aim of this study is to explore the pathological mechanisms of CID with GI discomfort, as well as the main response characteristics of acupuncture treatment from multiple perspectives using multimodal magnetic resonance imaging (MRI). METHODS: A total of 60 participants with CID and GI disorders will be randomly divided into two groups (real acupuncture group and sham acupuncture group; ratio of 1:1). Patients will receive 20 sessions (five sessions per week) of real acupuncture treatment or sham acupuncture treatment. The primary outcome is the aggregate score on the Pittsburgh Sleep Quality Index. Secondary outcomes are scores on the Gastrointestinal Symptom Rating Scale, Self-Rating Anxiety Scale, and Self-Rating Depression Scale. Multimodal MRI scans and clinical assessments will be performed both at baseline and post-treatment. Another 30 age-, sex-, and education-matched healthy subjects will be recruited as controls and will receive MRI scans and clinical evaluations. DISCUSSION: This study aims to provide scientific evidence for the mechanism of acupuncture in treating CID with GI disorder using multimodal MRI imaging data on brain structure, function, and metabolism. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1800017092 (URL: http://www.chictr.org.cn/showproj.aspx?proj=27173 ). Registered on July 11, 2018.
RCT Entities:
BACKGROUND: Many patients with chronic insomnia disorder (CID) have gastrointestinal (GI) symptoms. First-line insomnia medications do not treat GI problems. Acupuncture has a comprehensive regulative action on both CID and GI disorder and is receiving increasing attention. Recent studies indicate that both CID and GI diseases may cause abnormal brain activity. However, the neurological mechanism underlying the effect of acupuncture on such diseases is still unclear. The aim of this study is to explore the pathological mechanisms of CID with GI discomfort, as well as the main response characteristics of acupuncture treatment from multiple perspectives using multimodal magnetic resonance imaging (MRI). METHODS: A total of 60 participants with CID and GI disorders will be randomly divided into two groups (real acupuncture group and sham acupuncture group; ratio of 1:1). Patients will receive 20 sessions (five sessions per week) of real acupuncture treatment or sham acupuncture treatment. The primary outcome is the aggregate score on the Pittsburgh Sleep Quality Index. Secondary outcomes are scores on the Gastrointestinal Symptom Rating Scale, Self-Rating Anxiety Scale, and Self-Rating Depression Scale. Multimodal MRI scans and clinical assessments will be performed both at baseline and post-treatment. Another 30 age-, sex-, and education-matched healthy subjects will be recruited as controls and will receive MRI scans and clinical evaluations. DISCUSSION: This study aims to provide scientific evidence for the mechanism of acupuncture in treating CID with GI disorder using multimodal MRI imaging data on brain structure, function, and metabolism. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1800017092 (URL: http://www.chictr.org.cn/showproj.aspx?proj=27173 ). Registered on July 11, 2018.
Authors: James K Walsh; Catherine Coulouvrat; Goeran Hajak; Matthew D Lakoma; Maria Petukhova; Thomas Roth; Nancy A Sampson; Victoria Shahly; Alicia Shillington; Judith J Stephenson; Ronald C Kessler Journal: Sleep Date: 2011-08-01 Impact factor: 5.849
Authors: Michael J Sateia; Daniel J Buysse; Andrew D Krystal; David N Neubauer; Jonathan L Heald Journal: J Clin Sleep Med Date: 2017-02-15 Impact factor: 4.062
Authors: Seung Young Kim; Rok Seon Choung; Seung Ku Lee; Jung Wan Choe; Sung Woo Jung; Jong Jin Hyun; Ja Seol Koo; Sang Woo Lee; Chol Shin Journal: J Neurogastroenterol Motil Date: 2018-04-30 Impact factor: 4.924