Evaluating Efficacy and Safety of Combined Thread Embedding and Auricular Acupuncture in Gastroesophageal Reflux Disease With Liver Qi Invading Stomach Pattern: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- The proportion of heartburn resolution
研究概览
简要总结
Gastroesophageal reflux disease (GERD) is increasingly prevalent today. Proton-pump inhibitors (PPIs) are the primary treatment, yet their effectiveness remains limited. Various acupuncture methods have shown promise in treating GERD. Among these, thread embedding acupuncture (TEA) and auricular acupuncture (AA) offer the advantage of prolonged treatment per intervention, significantly reducing healthcare visits for procedures, particularly beneficial for conditions requiring extended therapy. This has led to the widespread application of TEA and AA in GERD treatment. However, evidence supporting their effectiveness remains inconclusive. In this study, we aim to assess the efficacy and safety of combining TEA with AA for treating GERD. According to traditional medicine, treatment should be pattern-based. Thus, we will focus on patients exhibiting the Liver Qi Invading Stomach pattern, as reports indicate its prevalence among GERD patients.
详细描述
Patients with GERD diagnosed through the GerdQ score and presenting the traditional medicine pattern of Liver Qi invading Stomach, meeting the inclusion and not the exclusion criteria, will be included in the study. Upon randomization, participants will be allocated into two groups: the control and intervention groups.
The study spans four weeks. Both groups will receive standard GERD treatment following current guidelines, which include PPIs, additional antacids as required, and lifestyle modifications. The intervention group will receive an additional combination of thread embedding acupuncture therapy (TEA) every other week and auricular acupuncture (AA) weekly.
Patients will undergo weekly follow-up examinations. Symptom assessment, quality of life evaluations using specific questionnaires, and antacid medication usage will be monitored weekly. Adverse effects (AE) related to the treatment will be documented throughout the trial.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged from 18 to 60 Years
- •GerdQ score of eight or higher
- •Having heartburn and/or regurgitation on two days per week or more
- •Diagnosis of GERD with Liver Qi Invading Stomach Pattern
排除标准
- •Any prior endoscopy-confirmed structural diseases
- •Uncontrolled inflammatory bowel disease, chronic or genetic conditions, alcohol or drug abuse history
- •Alarming symptoms indicating gastric cancer, complicated ulcers, or serious illnesses
- •History of esophageal or gastrointestinal surgery
- •Current use of medications impacting GERD treatment or assessment
- •Recent (within two weeks) Western Medicine or Traditional Medicine treatment for GERD
- •History of hypersensitivity reactions to any components involved in the intervention
- •Pregnancy or breastfeeding
- •Current participation in any other clinical trials
研究组 & 干预措施
Acupuncture + Standard treatment
Standard treatment plus thread embedding acupuncture and auricular acupuncture
干预措施: Thread Embedding Acupuncture (Other)
Acupuncture + Standard treatment
Standard treatment plus thread embedding acupuncture and auricular acupuncture
干预措施: Auricular acupuncture (Other)
Acupuncture + Standard treatment
Standard treatment plus thread embedding acupuncture and auricular acupuncture
干预措施: Standard treatment (Other)
Standard treatment
Standard treatment
干预措施: Standard treatment (Other)
结局指标
主要结局
The proportion of heartburn resolution
时间窗: Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
Heartburn resolution is assessed through patient inquiry during each follow-up examination.
次要结局
- Chang in the Frequency Scale for the Symptoms of GERD (FSSG) score(Day 0 and after every two week during 4-week treatment (day 0, day 14, day 28))
- Chang in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score(Day 0 and after every two week during 4-week treatment (day 0, day 14, day 28))
- Chang in the Gastroesophageal Reflux disease Questionnaire (GerdQ) score(Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28))
- The proportion of side effects of thread embedding acupuncture and auricular acupuncture(Up to 4 weeks)
- The proportion of regurgitation resolution(Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28))
- Changes in the number of antacid packets used(Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28))
研究者
Bui Pham Minh Man
Investigator
University of Medicine and Pharmacy at Ho Chi Minh City