Clinical trial NCT01921504: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Dyspepsia
Keywords: Functional Dyspepsia
Acupuncture
Genotype
Ghrelin
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Acupuncture and Meridian Science Research Center
First posted: 2013-08-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

    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

Primary outcomes:
measure: Proportion of responders
timeFrame: Once in treatment period (4 wks)
Secondary outcomes:
measure: Nepean Dyspepsia Index - Korean version (NDI-K)
timeFrame: After treatment (4 wks)
measure: EuroQol-5 Dimension (EQ-5D)
timeFrame: After treatment (4 wks)
measure: Functional Dyspepsia-Related Quality of Life (FD-QoL) Questionnaire
timeFrame: After treatment (4 wks)
measure: Beck's Depression Inventory (BDI)
timeFrame: After treatment (4 wks)
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: After treatment (4 wks)
measure: Ghrelin hormone measurement (1. Total ghrelin, 2. Deacylated ghrelin)
timeFrame: After treatment (4 wks)
measure: Genotype analysis by Axiom® exome genotyping arrays
timeFrame: First visit (0 wk)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Oriental Medicine Hospital
state: Dongdaemun-gu
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
state: Gangdong-gu
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong, Seoul, Repulic of Korea
name: Jae-woo Park, Doctor's degree
role: PRINCIPAL_INVESTIGATOR
References:
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.