Back to resultsEffect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial
Primary Purpose
Functional Dyspepsia
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia focused on measuring Functional Dyspepsia, Acupuncture, Genotype, Ghrelin
Eligibility Criteria
Inclusion Criteria:
- Age of 18 ~ 75, with a elementary-school diploma or higher, should be able to read and write Korean
One who meet Rome III FD criteria* and has been suffering from FD for the last 3 months with symptom onset at least 6 months prior to diagnosis
One or more of the following:
- Bothersome postprandial fullness
- Early satiation
- Epigastric pain
- Epigastric burning
- One who checks more than 4 points on visual analogue scale (VAS) for dyspeptic symptoms
- One who has normal esophagogastroduodenoscopy results within a year and been diagnosed with FD by a specialist consultation
- One who receives no other treatments during the study
- One who voluntarily agrees with study protocol and signs an written informed consent
Exclusion Criteria:
- One who has peptic ulcer or gastroesophageal reflux disease (GERD)
- One who has obvious signs of irritable bowel syndrome (IBS)
- One who has alarm symptoms (weight loss, black or tar stool, dysphagia)
- One who has serious structural disease (disease of heart, lung, liver or kidney) or mental illness
- One who has had surgery related with the gastrointestinal tract (Appendectomy more than 6 months ago is acceptable)
- One who is pregnant or breastfeeding
- One who is taking drugs which might affect gastrointestinal tract (Wash-out period: 2 weeks before participating in the trial)
- One who is HIV-positive
- One who has a problem of malabsorption or maldigestion
- One who has difficulties in attending the trial or receiving treatments (e.g Paralysis, serious mental illness, dementia, drug addiction, busyness, severe disorder in vision or hearing, impossibility of visit, illiterate, etc.)
- One who does not want to sign the informed consents
- One who has clotting disorders or leukopenia, pace-maker, seizure disorders or is taking anticoagulant therapy
Sites / Locations
- Kyung Hee University Oriental Medicine HospitalRecruiting
- Kyung Hee University Hospital at GangdongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acupuncture
No treatment
Arm Description
Participants in this group are given twice-a-week acupuncture treatment for 4 weeks.
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.
Outcomes
Primary Outcome Measures
Proportion 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.
Secondary Outcome Measures
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.
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'.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01921504
First Posted
August 7, 2013
Last Updated
August 9, 2013
Sponsor
Kyunghee University Medical Center
Collaborators
Acupuncture and Meridian Science Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01921504
Brief Title
Effect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial
Official Title
Effect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
Acupuncture and Meridian Science Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
Functional Dyspepsia, Acupuncture, Genotype, Ghrelin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Participants in this group are given twice-a-week acupuncture treatment for 4 weeks.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Other Intervention Name(s)
Acupuncture treatment
Intervention Description
Acupuncture treatment
Acupuncture rationale 1a) Style of acupuncture: body acupuncture (in accordance with meridian theory)
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
Primary Outcome Measure Information:
Title
Proportion of responders
Description
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)
Secondary Outcome Measure Information:
Title
Nepean Dyspepsia Index - Korean version (NDI-K)
Description
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)
Title
EuroQol-5 Dimension (EQ-5D)
Description
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'.
Time Frame
After treatment (4 wks)
Title
Functional Dyspepsia-Related Quality of Life (FD-QoL) Questionnaire
Description
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)
Title
Beck's Depression Inventory (BDI)
Description
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)
Title
The State-Trait Anxiety Inventory (STAI)
Description
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)
Title
Ghrelin hormone measurement (1. Total ghrelin, 2. Deacylated ghrelin)
Description
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)
Title
Genotype analysis by Axiom® exome genotyping arrays
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 18 ~ 75, with a elementary-school diploma or higher, should be able to read and write Korean
One who meet Rome III FD criteria* and has been suffering from FD for the last 3 months with symptom onset at least 6 months prior to diagnosis
One or more of the following:
Bothersome postprandial fullness
Early satiation
Epigastric pain
Epigastric burning
One who checks more than 4 points on visual analogue scale (VAS) for dyspeptic symptoms
One who has normal esophagogastroduodenoscopy results within a year and been diagnosed with FD by a specialist consultation
One who receives no other treatments during the study
One who voluntarily agrees with study protocol and signs an written informed consent
Exclusion Criteria:
One who has peptic ulcer or gastroesophageal reflux disease (GERD)
One who has obvious signs of irritable bowel syndrome (IBS)
One who has alarm symptoms (weight loss, black or tar stool, dysphagia)
One who has serious structural disease (disease of heart, lung, liver or kidney) or mental illness
One who has had surgery related with the gastrointestinal tract (Appendectomy more than 6 months ago is acceptable)
One who is pregnant or breastfeeding
One who is taking drugs which might affect gastrointestinal tract (Wash-out period: 2 weeks before participating in the trial)
One who is HIV-positive
One who has a problem of malabsorption or maldigestion
One who has difficulties in attending the trial or receiving treatments (e.g Paralysis, serious mental illness, dementia, drug addiction, busyness, severe disorder in vision or hearing, impossibility of visit, illiterate, etc.)
One who does not want to sign the informed consents
One who has clotting disorders or leukopenia, pace-maker, seizure disorders or is taking anticoagulant therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae-Woo Park, KMD, PhD
Phone
+82-2-440-6219
Email
pjw2907@khu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Seok-Jae Ko, KMD, Doctor's course
Phone
+82-2-440-6245
Email
kokokoko119@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-woo Park, Doctor's degree
Organizational Affiliation
Kyung Hee University Hospital at Gangdong, Seoul, Repulic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Oriental Medicine Hospital
City
Seoul
State/Province
Dongdaemun-gu
ZIP/Postal Code
130-872
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-sung Kim, KMD, PhD
Phone
+82 2 958 8895
Email
oridoc@khu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jin-sung Kim, KMD, PhD
First Name & Middle Initial & Last Name & Degree
Ga-jin Han, KMD, M.S.
First Name & Middle Initial & Last Name & Degree
Ju-yeon Kim, KMD, M.S.
First Name & Middle Initial & Last Name & Degree
Kyung Kang, KMD, M.S.
First Name & Middle Initial & Last Name & Degree
Seung-won Jang, KMD, B.S.
First Name & Middle Initial & Last Name & Degree
Ji-young Son, KMD, B.S.
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
State/Province
Gangdong-gu
ZIP/Postal Code
130-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Woo Park, KMD, PhD
Phone
+82 2 440 6219
Email
pjw2907@khu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae-Woo Park, KMD, PhD
First Name & Middle Initial & Last Name & Degree
Seok-Jae Ko, KMD, M.S.
First Name & Middle Initial & Last Name & Degree
Hyangsook Lee, KMD, PhD
First Name & Middle Initial & Last Name & Degree
Kwang-ro Ju, MD, PhD
First Name & Middle Initial & Last Name & Degree
Su Kang Kim, PhD
First Name & Middle Initial & Last Name & Degree
Hyunju Chung, PhD
First Name & Middle Initial & Last Name & Degree
Seul-Ki Kim, KMD, B.S.
First Name & Middle Initial & Last Name & Degree
Min-ji Kim, KMD, B.S.
First Name & Middle Initial & Last Name & Degree
Mi-Hee Lee
12. IPD Sharing Statement
Citations:
PubMed Identifier
24655542
Citation
Han G, Ko SJ, Park JW, Kim J, Yeo I, Lee H, Kim SY, Lee H. Acupuncture for functional dyspepsia: study protocol for a two-center, randomized controlled trial. Trials. 2014 Mar 22;15:89. doi: 10.1186/1745-6215-15-89.
Results Reference
derived
Links:
URL
http://amsrc.khu.ac.kr/center/center_03_eng.php
Description
Acupuncture and Meridian Science Research Center (AMSRC)
Learn more about this trial
Effect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial
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