Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Functional Dyspepsia

Treatments: Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04548011

GAMHospital20200906

Details and patient eligibility

About

The objective of this trial is to assess acupuncture of different treatment frequency on improving quality of life in patients with functional dyspepsia.

Full description

The effect of treatment frequency of acupuncture on the functional dyspepsia is unclear. In this study, 60 participants with FD will be recruited and randomly allocated (using a 1:1:1 allocation ratio) into three times a week group, once a week group and waiting for treatment group. Participants will receive acupuncture treatment at bilateral Zhongwan（CV12）, Tianshu（ST25）, Neiguan（PC6）, Liangqiu（ST34）, Yanglinquan（GB34）, Zusanli（ST36）and Taichong（LR3) of different treatment frequency for 4 weeks. This trial is designed to analyze the acupuncture of different treatment frequency on improving quality of life in patients with FD and to provide evidence for the establishment of acupuncture treatment quantization standard of FD.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of FD as defined by the Roman IV Functional Dyspepsia Diagnostic criteria

   One or more of the following:

   1. Bothersome postprandial fullness
   2. Bothersome early satiation
   3. Bothersome epigastric pain
   4. Bothersome epigastric burning AND No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms Epigastric Pain Syndrome (EPS) criteria: fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.

   Postprandial Distress Syndrome Diagnostic (PDS) criteria: must include one or both of the following at least 3 days per week:

2. Age 18-75 years.

3. Signed informed consent and volunteered to participate in the trial.

Exclusion criteria

Candidate participants with any of the following items will be excluded from this trial.

1. Gastrointestinal motility drugs taken within the past 15 days; Acupuncture treatments within the past 30 days; participating in other ongoing clinical trials
2. Severe heart, lung, liver, brain or kidney damage.
3. Would-be mothers, pregnant or lactation;
4. Progressive malignant tumor or other severe consumptive diseases, easy to be complicated with bleeding and infection;
5. Cognitive impairment such as unable to express subjective symptoms of discomfort or give informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Three times a week group

Experimental group

Description:

Twenty participants in three times a week group will receive acupuncture treatment 3 times per week (every other day) for 4 weeks, 12 sessions totally. The acupuncture operation as above. Participants will not be not allowed to take any other medication or accept any treatment for FD. should not be accepted during the study. In case of unbearable symptoms, the assistant researchers will detailly document.

Treatment:

Other: Acupuncture

Once a week group

Experimental group

Description:

Twenty participants in once a week group will receive acupuncture treatment 1 time per week for 4 weeks (Weekly fixed day), 4 sessions totally. Other inventions will be same as the Three times a week group.

Treatment:

Other: Acupuncture

Waiting for treatment group

No Intervention group

Description:

After the health education（such as dietary adjustment for FD patients）, the participants will be followed up for 4 weeks. At the end of the follow-up, the patients could be given free acupuncture treatment (the invention will be similar with that of the Three times a week group) for 4 weeks at will.