NCT01921504

Effect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Kyunghee University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to investigate the effect of acupuncture treatment on functional dyspepsia.

Detailed description

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.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DEVICE	Acupuncture	Acupuncture treatment 1. Acupuncture rationale 1a) Style of acupuncture: body acupuncture (in accordance with meridian theory) 2. Needling details 2a) Number of needle insertions per subject per session: 9-19 2b) Acupoints: Basic points - Large Intestine(LI)4, Stomach(ST)36, Liver(LR)3, Spleen(SP)4, Conception Vessel(CV)12 Optional points - Gallbladder(GB)21, Small Intestine(SI)14, Pericardium(PC)6, External points of Hand and Neck(EX-HN)5, Stomach(ST)34 2c) Depth: 5 \~ 30mm 2d) Response sought: 'Deqi' 2e) Needle stimulation: Manipulation 2f) Retention time: 15 minutes 2g) Needle type: 25 X 30 mm, sterilized stainless steel needle, Dongbang Inc., Korea

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-12-01
• Completion: 2014-02-01
• First posted: 2013-08-13
• Last updated: 2013-08-13

Locations

2 sites across 1 country: South Korea