Effect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial|
- Proportion of responders [ Time Frame: Once in treatment period (4 wks) ] [ Designated as safety issue: No ]
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.
- Nepean Dyspepsia Index - Korean version (NDI-K) [ Time Frame: After treatment (4 wks) ] [ Designated as safety issue: No ]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.
- EuroQol-5 Dimension (EQ-5D) [ Time Frame: After treatment (4 wks) ] [ Designated as safety issue: No ]
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'.
- Functional Dyspepsia-Related Quality of Life (FD-QoL) Questionnaire [ Time Frame: After treatment (4 wks) ] [ Designated as safety issue: No ]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.
- Beck's Depression Inventory (BDI) [ Time Frame: After treatment (4 wks) ] [ Designated as safety issue: No ]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.
- The State-Trait Anxiety Inventory (STAI) [ Time Frame: After treatment (4 wks) ] [ Designated as safety issue: No ]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.
- Ghrelin hormone measurement (1. Total ghrelin, 2. Deacylated ghrelin) [ Time Frame: After treatment (4 wks) ] [ Designated as safety issue: No ]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.
- Genotype analysis by Axiom® exome genotyping arrays [ Time Frame: First visit (0 wk) ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Participants in this group are given twice-a-week acupuncture treatment for 4 weeks.
Other Name: Acupuncture treatment
No Intervention: No treatment
The participants in this group are supposed to wait without any intervention for first 4 weeks. Then they receive the identical acupuncture treatments as in the treatment group for the following 4 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01921504
|Korea, Republic of|
|Kyung Hee University Oriental Medicine Hospital|
|Seoul, Dongdaemun-gu, Korea, Republic of, 130-872|
|Kyung Hee University Hospital at Gangdong|
|Seoul, Gangdong-gu, Korea, Republic of, 130-701|
|Principal Investigator:||Jae-woo Park, Doctor's degree||Kyung Hee University Hospital at Gangdong, Seoul, Repulic of Korea|