Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia

Official title

Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia: A Multicenter Clinical Trial Study

Overview

Functional dyspepsia (FD) is a common disorder that causes stomach discomfort, such as fullness or pain after eating, without any visible structural disease. Acupuncture is often used to manage these symptoms. This study aims to evaluate the safety and effectiveness of electroacupuncture-a form of acupuncture that uses gentle electrical stimulation-for treating functional dyspepsia. Specifically, the trial will compare the benefits of applying electroacupuncture to points on the abdomen (local points) versus points on the arms and legs (distal points), alongside a control group receiving a sham (inactive) treatment. The goal is to determine the most effective acupuncture strategy for improving patients' digestive symptoms and overall quality of life.

Detailed description

Functional dyspepsia (FD) significantly impairs patients' quality of life and is often accompanied by psychological distress. While traditional acupuncture is widely used in the treatment of FD, electroacupuncture has been suggested to enhance therapeutic effects by providing continuous, standardized electrical stimulation to specific acupoints. However, the comparative effectiveness of targeting local abdominal acupoints versus distal limb acupoints remains unclear.

This multicenter randomized controlled trial is designed to investigate the physiological and clinical effects of electroacupuncture on FD. Following informed consent, participants are randomly assigned in a 1:1:1 ratio to one of three parallel arms:

Local Electroacupuncture Group: Electrical stimulation applied to selected abdominal acupoints.

Distal Electroacupuncture Group: Electrical stimulation applied to selected limb acupoints.

Control Group: Acupuncture with a sham electroacupuncture device that delivers no electrical current.

The intervention phase consists of treatments administered twice weekly for 3 weeks (totaling 6 sessions). All procedures are standardized and performed by licensed acupuncturists with a minimum of three years of clinical experience. Active groups utilize a standard electroacupuncture device to deliver the current, while the sham group is designed to maintain blinding without providing active electrical stimulation. Following the intervention phase, participants enter a 12-week follow-up period to assess the sustainability of the therapeutic effects.

By comparing local and distal stimulation strategies, this research intends to elucidate the optimal clinical application of electroacupuncture and provide evidence-based guidance for the management of functional dyspepsia.

Interventions

• Other Electroacupuncture (Local Acupoints)
  Participants assigned to this intervention will receive electroacupuncture at local abdominal acupoints, including bilateral Shangwan (CV13), Zhongwan (CV12), Xiawan (CV10), Liangmen (ST21), and Tianshu (ST25). Sterile disposable acupuncture needles (0.30 × 40 mm) will be inserted vertically by licensed acupuncturists with at least three years of clinical experience to a depth of approximately 20-30 mm to elicit the Deqi sensation (such as soreness, numbness, distension, or heaviness). Two pairs
• Other Electroacupuncture (Distal Acupoints)
  Participants in this group will receive electroacupuncture at distal limb acupoints, including bilateral Zusanli (ST36), Shangjuxu (ST37), Xiajuxu (ST39), and Yinlingquan (SP9). Sterile disposable acupuncture needles (0.30 × 40 mm) will be inserted by trained acupuncturists to achieve the Deqi sensation. Electrical stimulation will be applied by connecting bilateral Zusanli (ST36) and Xiajuxu (ST39) to an SDZ-V electroacupuncture device. The stimulation frequency will be set at 5 Hz, and the cur
• Other Sham Electroacupuncture (Control)
  Participants in the control group will receive acupuncture at the same acupoints as the electroacupuncture groups using identical needling procedures to achieve the Deqi sensation. However, the needles will be connected to a specially designed sham electroacupuncture device that appears identical to the active SDZ-V electroacupuncture device but does not deliver electrical stimulation. Each treatment session will last 30 minutes and will be administered twice weekly for 3 weeks (6 sessions in to

Primary outcome measures

• Overall Treatment Effect (OTE) Response Rate at Week 3 [Time frame: Week 3]
• Main Symptom Elimination Rate at Week 3 [Time frame: Week 3]

Secondary outcome measures (7)

• Global Overall Symptom (GOS) Score [Time frame: Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15]
• Nepean Dyspepsia Index (NDI) Score [Time frame: Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15]
• Hospital Anxiety and Depression Scale (HADS) Score [Time frame: Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15]
• Expectation of Electroacupuncture Treatment [Time frame: Baseline (Week 0)]
• Blinding Assessment [Time frame: Baseline (after Session 1) and Week 3 (after Session 6)]
• Treatment Adherence [Time frame: Week 0, Week 3, and Week 15]
• Safety Outcomes (Adverse Events) [Time frame: From baseline to Week 15]

Eligibility criteria

Inclusion criteria

• Participants who meet the Rome IV diagnostic criteria for functional dyspepsia (FD).
• Age 18 to 80 years, male or female.
• Chinese patients with a normal upper gastrointestinal endoscopy within the past 1 year, or judged by a gastroenterologist with more than 3 years of clinical experience to have no structural disease that explains the symptoms.
• Willing and able to provide written informed consent and comply with study procedures.

Exclusion criteria

• Functional dyspepsia symptoms caused by severe or malignant diseases (e.g., liver cirrhosis, heart failure, or gastrointestinal tumors).
• Helicobacter pylori infection, defined as a positive urea breath test or positive Hp test on endoscopy.
• History of gastrointestinal surgery (except minimally invasive procedures such as laparoscopy).
• Presence of a permanent or temporary cardiac pacemaker or use of external/temporary pacing support.
• Use of medications that may affect dyspepsia symptoms within 2 weeks prior to enrollment, including antisecretory drugs, antacids, prokinetic agents, digestive enzymes, nonsteroidal anti-inflammatory drugs, antidepressants, or traditional Chinese medicine for FD.
• Conditions that may make participation difficult, such as severe mental or physical illness, dementia, or illiteracy.
• Severe coagulation disorders.
• Acupuncture treatment for gastrointestinal diseases within the past 1 month.
• Participation in another clinical trial within the past 2 months.
• Drug abuse or alcohol abuse.
• Pregnant or breastfeeding women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 4 centers

• Hangzhou First People's Hospital — Hangzhou
• Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine — Hangzhou
• The First Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou
• The Third Affiliated Hospital of Zhejiang Chinese Medicinal University — Hangzhou

Identifiers

NCT: NCT07496580 · 20260305031650208

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗