Functional Dyspepsia Clinical Trial
Official title:
Effect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial
The aim of the study is to investigate the effect of acupuncture treatment on functional dyspepsia.
Functional dyspepsia (FD) is a functional gastrointestinal disorder without any structural
lesion. FD is claimed to affect 25% of the population in South Korea. Although conventional
approaches based on current evidence such as proton pump inhibitor and prokinetic agents
have been used, many FD patients turn to traditional Korean Medicine treatment largely due
to the lack of satisfactory effect of these treatments.
Acupuncture treatment, one of the most sought therapeutic modalities in traditional Korean
Medicine, has been commonly used for gastrointestinal disorders in Korea. However, the
effect of acupuncture on FD has not been rigorously evaluated. In the present study, we will
investigate whether 8 sessions of acupuncture treatment over 4 weeks, in comparison with no
acupuncture treatment, i.e. waitlist-control, improve symptoms of FD. Outcome measures
include proportion of responder, Korean version of Nepean Dyspepsia Index, EuroQol-5
Dimension, Functional Dyspepsia-Related Quality of Life, Beck's Depression Inventory,
State-Trait Anxiety Inventory and ghrelin hormone. Genome-wide association study (GWAS) will
be also conducted to elucidate any possible difference in genotype between responders and
non-responders to acupuncture treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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