Acupuncture for Functional Dyspepsia: a Functional Magnetic Resonance Imaging (fMRI) Study

Chengdu University of Traditional Chinese Medicine

Status: Completed

Conditions: Functional Dyspepsia

Treatments: Other: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02996604

15QNJJ0008

81473602 (Other Grant/Funding Number)

Details and patient eligibility

About

He-Mu-point combination（ST36 and CV12） is one of the most commonly used acupoints combination with synergistic effect for functional dyspepsia(FD). The investigators design the trial to identify the efficacy and explore the central integrated mechanism of puncturing at He-Mu-point combination on FD with functional magnetic resonance imaging (fMRI).

Full description

105 participants with functional dyspepsia will be allocated into three groups: Low-He point group, Mu point group and He-Mu-point combination group.Every participant will receive 20 sessions of manual acupuncture treatment during 4 weeks. Clinical evaluations will be assessed three times, as measured after randomization, 10 and 20 sessions of treatment.The fMRI scans will be conducted twice, after randomization and treatment completion.

Enrollment: 105 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. right handed，age between 18 and 45 years old, college degree or above;
2. match the Rome III criteria on FD;
3. no local organic disease by gastroscope examination;
4. before entering the study, without taking any prokinetic agents at least 15days and participating in other clinical study;
5. signing an informed consent in writing by the participant or the immediate family member.

Exclusion criteria

1. consciousness, cannot express subjective symptoms and psychiatric participants;
2. participants with advanced cancer or other serious wasting diseases, easy to be infected and bleeding;
3. complicating with severe cardiovascular, hepatic,nephritic,digestive, hematopoietic system diseases;
4. impregnate or lactation female;
5. severe depression and anxiety symptoms;
6. female with serious dysmenorrhea;
7. obvious headache, migraine, history of head injury.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups

Low-He point(ST36)

Experimental group

Description:

Zusanli (ST36, the Low-He point of stomach) is the most important point for gastrointestinal disorder, including functional dyspepsia. Everyone in the group will be punctured at unilateral Zusanli.

Treatment:

Other: acupuncture

Mu point(CV12)

Experimental group

Description:

Zhongwan (CV12, the Mu point of stomach) is also good at regulating gastric function. Everyone in the group will be punctured at Zhongwan.

Treatment:

Other: acupuncture

He-Mu-point combination(ST36 and CV12)

Active Comparator group

Description:

In traditional Chinese acupuncture theory，synergistic effect can be produced by acupoints combination and the He-Mu-point combination is a classical acupoints combination formula for gastrointestinal diseases. Everyone in the group will be punctured at unilateral Zusanli and Zhongwan.

Treatment:

Other: acupuncture