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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
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
Kyung Hee University Oriental Medicine Hospital
Seoul, Dongdaemun-gu, South Korea
RECRUITINGKyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, South Korea
RECRUITINGProportion of responders
The proportion of patients who answer "Yes" to more than half of adequate relief questions in the treatment period. Patients are expected to report their response to the acupuncture treatment by answering the following question at each visit: "After the last visit, have you had adequate relief of your stomach pain or discomfort?" Questions will be asked at each visit during treatment period (Twice a week for 4 wks, total 8 times - 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 wks). Responders are defined as patients reporting adequate relief for at least 50% of the study period (more than 4 times of "Yes" to adequate relief question out of total 8 questions). The proportion of responder will be compared statistically between experimental group and no intervention group.
Time frame: Once in treatment period (4 wks)
Nepean Dyspepsia Index - Korean version (NDI-K)
The Nepean Dyspepsia Index is a reliable and valid measure of quality of life in FD. The Nepean Dyspepsia Index originally contains 42 items designed to measure impairment of a subject's ability to engage in relevant aspects of their life because of dyspepsia. It was subsequently shortened to 25 items, yielding 5 sub-scales. NDI-K, validated in 2004 by Choi at al., made up of 2 sections which are about symptom-based questions and quality of life. In this trial, symptom-based questions, i.e. questions about period, severity and distressful degree of 15 symptoms, will be evaluated.
Time frame: After treatment (4 wks)
EuroQol-5 Dimension (EQ-5D)
EQ-5D is a standardized instrument as a measure of health outcome. EQ-5D consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). First page is made up of 5 questions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has 3 levels: no problem, some problems, major problems. Second page consists of EQ VAS and its explanation. EQ VAS records the respondent's self-rated health on a vertical visual analogue scale where each endpoint is labelled either 'Best imaginable health state' and 'Worst imaginable health state'.
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Time frame: After treatment (4 wks)
Functional Dyspepsia-Related Quality of Life (FD-QoL) Questionnaire
The FD-QOL scale is a 21-item Likert-type questionnaire that can easily be completed within 5 min. Short administration time and high comprehensibility supports the feasibility of measuring health-related quality of life.
Time frame: After treatment (4 wks)
Beck's Depression Inventory (BDI)
The Beck Depression Inventory (BDI), created by Dr. Aaron T. Beck, is a 21-question multiple-choice self-report inventory and one of the most widely used instruments for measuring the severity of depression.
Time frame: After treatment (4 wks)
The State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety (anxiety triggered by a specific event), and trait anxiety (anxiety derived from personal characteristic). Higher scores are positively correlated with higher levels of anxiety.
Time frame: After treatment (4 wks)
Ghrelin hormone measurement (1. Total ghrelin, 2. Deacylated ghrelin)
Ghrelin is a gut-derived peptide found in the stomach. It is known to play a role in the regulation of gastric motility and appetite.
Time frame: After treatment (4 wks)
Genotype analysis by Axiom® exome genotyping arrays
Genome-wide association study (GWAS)examines genetic variants in different individuals to see if any variant is associated with a trait. In this study, the GWAS is planned to elucidate any associations between genetic difference and response to acupuncture treatment in FD patients.
Time frame: First visit (0 wk)