Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Symptom Improvement Rate at Week 4
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Symptom Improvement Rate at Week 4
时间窗: 4 weeks after the start of treatment.
The primary outcome is the percentage of participants experiencing symptom improvement using the 7-point Likert scale for Overall Treatment Effect (OTE). The Overall Treatment Effect (OTE) questionnaire was categorized as "extremely worse than baseline," "worse than baseline," "slightly worse than baseline," "no change," "slightly improved than baseline," "improved than baseline," or "much improved than baseline." Participants will rate their symptom severity compared to baseline, and those reporting "improved than baseline" or "much improved than baseline"will be considered responders. The primary outcome will assess the efficacy of 5 Hz and 100 Hz electroacupuncture compared to sham treatment.
Main Symptom Resolution Rate at Week 4
时间窗: 4 weeks after the start of treatment.
The second primary outcome is the rate of complete resolution of the main symptoms of functional dyspepsia at week 4. For Postprandial Distress Syndrome (PDS), the primary symptoms are postprandial fullness and early satiety; for Epigastric Pain Syndrome (EPS), the main symptoms are epigastric pain and burning. Complete resolution is defined as a score of 0 for the respective main symptoms on a validated symptom severity scale. The severity of each symptom is divided into: no symptoms (0 points), mild (1 point), moderate (2 points), and severe (3 points). The outcome will compare the resolution rates between the 5 Hz, 100 Hz, and sham electroacupuncture groups.
次要结局
- Nepean Dyspepsia Index (NDI) Score Change(Baseline to Week 4)
- Global Overall Symptom (GOS) Score Change(Baseline to Week 4)
- Treatment Expectation Score(Prior to the first treatment (Baseline))
- Blind evaluation(immediately after 1st and 6th treatment sessions)
- Hospital Anxiety and Depression Scale (HADS) Score Change(Baseline to Week 4)
研究者
Yi Liang
Research Fellow
The Third Affiliated hospital of Zhejiang Chinese Medical University