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Study protocol
Youping Hu
Chengdu University of Traditional Chinese Medicine
Corresponding Author
License:
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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
The study was registered in the Chinese Clinical Trial Registry on July 11, 2018. (ChiCTR1800017092)
Keywords
Chronic insomnia disorder, Gastrointestinal disorder, Multimodal magnetic resonance imaging, Acupuncture
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Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 01 Oct, 2020
No community comments so far
Editorial decision: Minor revision
On 07 Dec, 2020
Review #2 received
Received 04 Dec, 2020
Review #1 received
Received 12 Nov, 2020
Reviewer #3 agreed
On 09 Nov, 2020
Reviewer #2 agreed
On 07 Nov, 2020
Reviewer #1 agreed
On 01 Nov, 2020
Reviewers invited
Invitations sent on 30 Oct, 2020
Editor assigned
On 28 Oct, 2020
Submission checks complete
On 24 Sep, 2020
First submitted
On 19 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Youping Hu
Chengdu University of Traditional Chinese Medicine
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 01 Oct, 2020
No community comments so far
Editorial decision: Minor revision
On 07 Dec, 2020
Review #2 received
Received 04 Dec, 2020
Review #1 received
Received 12 Nov, 2020
Reviewer #3 agreed
On 09 Nov, 2020
Reviewer #2 agreed
On 07 Nov, 2020
Reviewer #1 agreed
On 01 Nov, 2020
Reviewers invited
Invitations sent on 30 Oct, 2020
Editor assigned
On 28 Oct, 2020
Submission checks complete
On 24 Sep, 2020
First submitted
On 19 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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
The study was registered in the Chinese Clinical Trial Registry on July 11, 2018. (ChiCTR1800017092)
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
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