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

Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia: a Three-armed Randomized Controlled Trial

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

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.

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.