Efficacy and Safety of Thread Embedding Acupuncture in Treating Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Thread Embedding Acupuncture Combined With PPI in Treating GERD

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Other: Thread embedding acupuncture
* Drug: Pantoprazole 40mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEA + PPI<br>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. | Other: Thread embedding acupuncture<br>* Thread embedding acupuncture (TEA) that use chromic catgut thread with 3/0 size with 1 centimeter long for each acupoint (TRUSTIGUT® (C), CPT Sutures Co., Ltd, Ho Chi Minh, Vietnam). Every 2 weeks in 4 weeks (twice), 13 acupoints will be embedded including Xiawan (CV-10), Zhongwan (CV-12), Shangwan (CV-13) and Zusanli (ST-36), Neiguan (PC-6), Geshu (BL-17), Ganshu (BL-18), Pishu (BL-20) in both sides of the body.<br>Drug: Pantoprazole 40mg<br>* Oral pantoprazole 40 mg capsules (Pantostad 40 CAP, Stellapharm J.V. Co., Ltd, Binh Duong, Vietnam) thirty minutes to one hour before the first meal once daily for 4 weeks.<br>|
| Active Comparator: PPI<br>Oral pantoprazole 40 mg capsules (Pantostad 40 CAP) once daily for 4 weeks. | Drug: Pantoprazole 40mg<br>* Oral pantoprazole 40 mg capsules (Pantostad 40 CAP, Stellapharm J.V. Co., Ltd, Binh Duong, Vietnam) thirty minutes to one hour before the first meal once daily for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Gastroesophageal reflux disease questionnaire score (GerdQ) after each week of treatment. | 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. | Assessments at day 0 and after every week during 4-week treatment (day 7th, day 14th, day 21st, day 28th). | 
| Change in the proportion of GERD typical symptoms absence after each week of treatment. | 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. | Assessments at day 0 and after every week during 4-week treatment (day 7th, day 14th, day 21st, day 28th). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the GERD symptoms frequency after every two weeks of treatment. | GERD symptoms frequency will be assessed by the Frequency Scale for the Symptoms of GERD (FSSG). The FSSG questionnaire comprises twelve questions in two domains, the reflux symptom domain and dysmotility symptom domain. The FSSG uses a 5-point Likert scale (0-4). Total FSSG score range of 0-48. High score indicates serious disease. | Assessments day 0 and every two weeks during 4-week treatment (day 14th, day 28th). | 
| Change in the health related quality of life after every two weeks of treatment. | Health related quality of life will be assessed by the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) instrument. The GERD-HRQL with 16 questions uses a numerical Likert-type response, whereby each patient assesses the severity of symptoms on an ordinal scale (0-5). The GERD-HRQL has a possible range of 0-80, with the heartburn, regurgitation and other arms. High score indicates serious disease. | Assessments at day 0 and every two weeks during 4-week treatment (day 14th, day 28th). | 
| The proportion of thread embedding acupuncture side effects. | TEA side effects include: post-treatment discomfort, post-treatment body temperature rising, local hematoma or subcutaneous hemorrhage, local swelling, local induration, local pain, local redness, infection, abscess, pruritus, anaphylaxis. | Up to 4 weeks. |