Efficacy and Safety of Thread Embedding Acupuncture Combined With PPI in Treating GERD
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
- 1
- 主要终点
- Change in the proportion of GERD typical symptoms absence after each week of treatment.
研究概览
简要总结
Gastroesophageal reflux disease is a very common disease nowadays. Proton-pump inhibitors (PPIs) are the first-line treatment for this disease. However, the effectiveness of treatment with PPIs is still limited. Acupuncture has been shown to be effective in treating this condition. Another treatment method is thread embedding acupuncture therapy, which is a method of burying threads into acupoints to create a more lasting stimulation than traditional acupuncture.
This study will evaluate the efficacy and safety of the combination of thread embedding acupuncture and standard dose pantoprazole compared with standard dose pantoprazole as monotherapy in adults.
详细描述
Patients with GERD diagnosed based on the GerdQ score who meet the inclusion criteria and do not meet the exclusion criteria will be included in the study. After randomization, patients will be divided into 2 groups: control group and intervention group. In both groups, patients will be treated for GERD according to current guidelines including PPIs, additional antacids as needed, and lifestyle changes. The intervention group will include additional thread embedding acupuncture therapy (TEA) twice on day 0 and day 14th. Intervention duration is 4 weeks.
The objectives of the study are to evaluate the improvement of GERD symptoms by using the evaluation score including Gastroesophageal reflux disease questionnaire (GerdQ) and Frequency Scale for the Symptoms of GERD (FSSG); the evaluation score of Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) will be used to evaluate the improvement of quality of life; and evaluate the safety of TEA in the treatment of GERD.
All scales will be evaluated before and after the intervention. For the GerdQ score, patients will be assessed weekly, every 2 weeks for FSSG and GERD-HRQL during the 4-week intervention. For TEA's side effects, it will be assessed regularly during the 4-week intervention.
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)
盲法说明
The investigator who examine GERD-related symptoms and outcome assessor will be blinded.
However, the investigator who examine the side effects of thread embedding acupuncture will not be blinded.
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
- •Male or female 18-60 years of age.
- •Patients with total scores ≥ 8 on the Gastroesophageal Reflux Disease Questionnaire (GerdQ) and scores ≥ 2 for each symptom including heartburn and/or regurgitation.
- •Ability to read, understand and provide informed consent.
- •Currently not receiving any intervention to treat GERD.
排除标准
- •Have any current symptoms related to a structural disease that has been confirmed by endoscopy (e.g., gastrointestinal cancer, eosinophilic esophagitis, candida esophagitis, peptic ulcers, Zollinger-Ellison syndrome, pyloric stenosis, etc.).
- •With known inflammatory bowel disease or other serious disease (hepatic, renal, respiratory, or cardiac disease) or rare genetic diseases (such as fructose intolerance, glucose-galactose malabsorption, saccharose-isomaltose deficiency), severe concomitant diseases, or a history of alcohol or drug abuse.
- •Have severe dysphagia, hematemesis, weight loss, or hematochezia.
- •A history of oesophageal and/or gastrointestinal surgery.
- •Current use of drugs affecting treatment and evaluation of GERD including systemic glucocorticoids, nonsteroidal anti-inflammatory, calcium channel blockers, anticholinergics, bisphosphonates, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, tetracycline, HIV protease inhibitors, rifampin, potassium supplements, iron, quinidine, zidovudine, anticholinergic agents, alpha-adrenergic antagonists, β2-adrenergic agonists, benzodiazepines, barbiturates, dopamine, estrogens, progesterone, narcotic analgesics, nitrates, prostaglandins, theophylline.
- •Are being treated with proton-pump inhibitors within the last 14 days, H2-receptor antagonists, or prokinetics within the last 10 days, intake of alginates or antacids within the last 3 days or using any traditional medicine to treat GERD within the last 2 weeks.
- •A history of hypersensitivity reaction with PPIs (including their components), catgut or acupuncture or thread embedding acupuncture treatment.
- •Are pregnant or breastfeeding.
- •Are taking part in any other clinical trials.
研究组 & 干预措施
TEA + PPI
Thread embedding acupuncture (TEA) every 2 weeks in 4 weeks (twice). Combined with oral pantoprazole 40 mg capsules (Pantostad 40 CAP) once daily for 4 weeks.
干预措施: Thread embedding acupuncture (Other)
TEA + PPI
Thread embedding acupuncture (TEA) every 2 weeks in 4 weeks (twice). Combined with oral pantoprazole 40 mg capsules (Pantostad 40 CAP) once daily for 4 weeks.
干预措施: Pantoprazole 40mg (Drug)
PPI
Oral pantoprazole 40 mg capsules (Pantostad 40 CAP) once daily for 4 weeks.
干预措施: Pantoprazole 40mg (Drug)
结局指标
主要结局
Change in the proportion of GERD typical symptoms absence after each week of treatment.
时间窗: Assessments at day 0 and after every week during 4-week treatment (day 7th, day 14th, day 21st, day 28th).
Based on the GerdQ score, when the answers for questions 1 and 2 are zero, the disappearance of typical symptoms including heartburn and regurgitation respectively will be determined.
Change in the Gastroesophageal reflux disease questionnaire score (GerdQ) after each week of treatment.
时间窗: Assessments at day 0 and after every week during 4-week treatment (day 7th, day 14th, day 21st, day 28th).
According to GerdQ, patients were asked to reflect on their symptoms and use of over-the-counter medications over the preceding week. It uses a four graded Likert scale (0-3) to score giving a total GerdQ score range of 0-18. High score indicates serious disease.
次要结局
- Change in the health related quality of life after every two weeks of treatment.(Assessments at day 0 and every two weeks during 4-week treatment (day 14th, day 28th).)
- Change in the GERD symptoms frequency after every two weeks of treatment.(Assessments day 0 and every two weeks during 4-week treatment (day 14th, day 28th).)
- The proportion of thread embedding acupuncture side effects.(Up to 4 weeks.)
研究者
Bui Pham Minh Man
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City