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.

Study Overview

• Status: Unknown
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Device: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jae-Woo Park, KMD, PhD; Phone Number: +82-2-440-6219; Email: pjw2907@khu.ac.kr
• Study Contact Backup: Name: Seok-Jae Ko, KMD, Doctor's course; Phone Number: +82-2-440-6245; Email: kokokoko119@hanmail.net

Study Locations

• Korea, Republic of
  • Dongdaemun-gu
    • Seoul, Dongdaemun-gu, Korea, Republic of, 130-872
      • Recruiting
      • Kyung Hee University Oriental Medicine Hospital
      • Contact: Jin-sung Kim, KMD, PhD; Phone Number: +82 2 958 8895; Email: oridoc@khu.ac.kr
      • Principal Investigator: Jin-sung Kim, KMD, PhD
      • Sub-Investigator: Ga-jin Han, KMD, M.S.
      • Sub-Investigator: Ju-yeon Kim, KMD, M.S.
      • Sub-Investigator: Kyung Kang, KMD, M.S.
      • Sub-Investigator: Seung-won Jang, KMD, B.S.
      • Sub-Investigator: Ji-young Son, KMD, B.S.
  • Gangdong-gu
    • Seoul, Gangdong-gu, Korea, Republic of, 130-701
      • Recruiting
      • Kyung Hee University Hospital at Gangdong
      • Contact: Jae-Woo Park, KMD, PhD; Phone Number: +82 2 440 6219; Email: pjw2907@khu.ac.kr
      • Principal Investigator: Jae-Woo Park, KMD, PhD
      • Sub-Investigator: Seok-Jae Ko, KMD, M.S.
      • Sub-Investigator: Hyangsook Lee, KMD, PhD
      • Sub-Investigator: Kwang-ro Ju, MD, PhD
      • Sub-Investigator: Su Kang Kim, PhD
      • Sub-Investigator: Hyunju Chung, PhD
      • Sub-Investigator: Seul-Ki Kim, KMD, B.S.
      • Sub-Investigator: Min-ji Kim, KMD, B.S.
      • Sub-Investigator: Mi-Hee Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

    1. Bothersome postprandial fullness
    2. Early satiation
    3. Epigastric pain
    4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; Participants in this group are given twice-a-week acupuncture treatment for 4 weeks.	Device: Acupuncture; 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; Other Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Once in treatment period (4 wks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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'.	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.	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.	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.	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.	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.	First visit (0 wk)

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Collaborators: Acupuncture and Meridian Science Research Center
• Investigators: Principal Investigator: Jae-woo Park, Doctor's degree, Kyung Hee University Hospital at Gangdong, Seoul, Repulic of Korea

Publications and helpful links

General Publications

• 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.

Helpful Links

• Acupuncture and Meridian Science Research Center (AMSRC)

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 9, 2013
• First Posted (Estimate): August 13, 2013

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 9, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Functional Dyspepsia; Acupuncture; Genotype; Ghrelin
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: KHNMC-OH-IRB 2013-006