Effect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial

Kyung Hee University

Status: Unknown

Conditions: Functional Dyspepsia

Treatments: Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01921504

KHNMC-OH-IRB 2013-006

Details and patient eligibility

About

The aim of the study is to investigate the effect of acupuncture treatment on functional dyspepsia.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Acupuncture

Experimental group

Description:

Participants in this group are given twice-a-week acupuncture treatment for 4 weeks.

Treatment:

Device: Acupuncture

No treatment

No Intervention group

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.