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

Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City (Other)
Overall Status
Completed
CT.gov ID
NCT05353933
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
2.5
Actual Duration (Months)
26.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Thread embedding acupuncture
  • Drug: Pantoprazole 40mg
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Thread Embedding Acupuncture Combined With PPI in Treating GERD
Actual Study Start Date :
May 4, 2022
Actual Primary Completion Date :
Jul 20, 2022
Actual Study Completion Date :
Jul 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Thread embedding acupuncture
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.

Drug: Pantoprazole 40mg
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.
Active Comparator: PPI

Oral pantoprazole 40 mg capsules (Pantostad 40 CAP) once daily for 4 weeks.

Drug: Pantoprazole 40mg
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.

Outcome Measures

Primary Outcome Measures

  1. Change in the Gastroesophageal reflux disease questionnaire score (GerdQ) after each week of treatment. [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.

  2. Change in the proportion of GERD typical symptoms absence after each week of treatment. [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.

Secondary Outcome Measures

  1. 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).]

    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.

  2. 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).]

    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.

  3. The proportion of thread embedding acupuncture side effects. [Up to 4 weeks.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Medical Center HCMC - Branch no.3 Ho Chi Minh Vietnam 700000

Sponsors and Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bui Pham Minh Man, Principal Investigator, University of Medicine and Pharmacy at Ho Chi Minh City
ClinicalTrials.gov Identifier:
NCT05353933
Other Study ID Numbers:
  • 606/HDDD-DHYD
First Posted:
Apr 29, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophagitis, Peptic
Pantoprazole

Study Results

No Results Posted as of Jul 28, 2022