Abstract
BackgroundMany 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).MethodsA 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.DiscussionThis 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 registrationChinese Clinical Trial Registry, ChiCTR1800017092 (URL: http://www.chictr.org.cn/showproj.aspx?proj=27173). Registered on July 11, 2018.
Highlights
Many patients with chronic insomnia disorder (CID) have gastrointestinal (GI) symptoms
Acupuncture is a potential therapy for CID
Some researchers have used magnetic resonance imaging (MRI) to study the neural mechanisms by which acupuncture treats certain types of insomnia, such as perimenopausal insomnia [60] and shift work sleep disorder [61]
Summary
Many patients with chronic insomnia disorder (CID) have gastrointestinal (GI) symptoms. 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). Chronic insomnia disorder (CID) is defined as difficulty initiating or maintaining sleep that is associated with daytime consequences and occurs at least three times per week for more than 3 months; CID has a prevalence rate of 5% to 10% [1]. It has recently been suggested that GI function plays a vital role in sleep [10]. These findings provide new insights into the pathological features and treatment of CID associated with GI
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