Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia

Yi Liang

Status: Enrolling

Conditions: Functional Dyspepsia

Treatments: Other: 5 Hz electroacupuncture; Other: Sham electroacupuncture; Other: 100 Hz electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06618911

20240903074110247

Details and patient eligibility

About

Brief Summary Template for the Study:

The goal of this clinical trial is to evaluate whether electroacupuncture can treat functional dyspepsia (FD) in adult participants aged 18 to 65 years, including both males and females, who have been diagnosed with functional dyspepsia based on the Rome IV criteria. The main questions it aims to answer are:

• Does 5 Hz electroacupuncture improve symptoms in functional dyspepsia patients?
• Does 100 Hz electroacupuncture improve symptoms in functional dyspepsia patients?
• Are there differences in the efficacy between 5 Hz and 100 Hz electroacupuncture in treating functional dyspepsia and its subtypes (PDS and EPS)?

Researchers will compare the effects of 5 Hz electroacupuncture, 100 Hz electroacupuncture, and sham electroacupuncture to determine which approach provides more significant symptom relief and whether different frequencies have varying impacts on FD subtypes.

Participants will:

• Receive electroacupuncture treatment at specific acupoints (such as Liangmen, Tianshu, Zusanli, and Xiajuxu) for 30-minute sessions, 3 times a week for 4 weeks.
• Be randomly assigned to one of the following groups: 5 Hz electroacupuncture, 100 Hz electroacupuncture, or sham electroacupuncture (control).
• Have their functional dyspepsia symptoms, quality of life, and any adverse effects monitored and evaluated throughout the study.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with functional dyspepsia based on Rome IV diagnostic criteria.
• Aged 18 to 80 years, inclusive, with no gender restrictions.
• Normal endoscopy results within the past year, showing no structural explanation for symptoms.
• No acupuncture treatment in the last month.
• Not participating in any other clinical trials in the past 2 months.
• Able to understand and provide informed consent.

Exclusion criteria

• Presence of serious or malignant diseases (e.g., cirrhosis, heart failure, gastrointestinal tumors) that could explain dyspepsia symptoms.
• Positive for Helicobacter pylori infection based on C-13 urea breath test or gastric biopsy.
• History of gastrointestinal surgery (excluding laparoscopic and other minimally invasive surgeries).
• Recent use (within 2 weeks) of medications affecting dyspepsia, including prokinetics, proton pump inhibitors, antacids, or antidepressants.
• Presence of severe mental or physical conditions, such as dementia or illiteracy, that could interfere with study participation.
• Severe coagulation disorders.
• Substance abuse or alcohol dependence.
• Pregnant or breastfeeding women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups

5 Hz Electroacupuncture Group

Experimental group

Description:

Participants will receive electroacupuncture at a frequency of 5 Hz at four acupoints: Liangmen (ST21) and Tianshu (ST25) (local acupoints), and Zusanli (ST36) and Xiajuxu (ST39) (distal acupoints). Disposable needles will be inserted until the "deqi" sensation is achieved. The needles will be connected to an SDZ-IIB electroacupuncture device set at 5 Hz, with stimulation lasting 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This group aims to evaluate the efficacy of low-frequency electroacupuncture for treating functional dyspepsia.

Treatment:

Other: 5 Hz electroacupuncture

100 Hz Electroacupuncture Group

Experimental group

Description:

Participants will receive electroacupuncture at a frequency of 100 Hz at the same four acupoints: Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Needles will be inserted to induce the "deqi" sensation and connected to an SDZ-IIB device set at 100 Hz, with stimulation lasting 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This group assesses the efficacy of high-frequency electroacupuncture for functional dyspepsia.

Treatment:

Other: 100 Hz electroacupuncture

Sham Electroacupuncture (Control) Group

Sham Comparator group

Description:

Participants will receive sham electroacupuncture at the same acupoints: Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Non-penetrating needles will touch the skin but will not induce "deqi." A sham electroacupuncture device (no actual current) will be used, and treatment will last 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This arm serves as a placebo control to evaluate the true effect of electroacupuncture.

Treatment:

Other: Sham electroacupuncture