Dyspepsia Clinical Trial
Official title:
Effect and Mechanism of Acupuncture on Patients With Functional Dyspepsia: a Protocol for a Randomized, Assessor-blind, Sham-controlled Trial
The aim of the study is to investigate the effect of acupuncture on functional dyspepsia compared with sham control. The study aims to clarify the mechanism of acupuncture by assessing functional magnetic resonance imaging and metabolomics.
Functional dyspepsia (FD) is a functional gastrointestinal disorder without any structural
lesion. Due to the lack of satisfactory effect of conventional treatments, many FD patients
turn to alternative treatments such as acupuncture. Acupuncture, one of the most sought
therapeutic modalities in traditional Korean Medicine, has been commonly used for treating
gastrointestinal disorders.
However, the effect and mechanism of acupuncture on FD has not been rigorously evaluated. In
the present study, we will investigate whether 10 sessions of acupuncture over 4 weeks, in
comparison with sham acupuncture, improve symptoms of FD and activate regions of brain area.
We will also perform metabolomics study to find the mechanism of acupuncture to FD. Outcome
measures include proportion of responder, Korean version of Nepean Dyspepsia Index,
Functional Dyspepsia-Related Quality of Life, Ways of Coping Question, Coping Strategy
Questionnaire, Perception of bodily sensation, The State-Trait Anxiety Inventory, Center for
Epidemiologic Studies Depression Scale, functional magnetic resonance imaging and metabolomic
study.
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