Efficacy and Safety of Combined Thread Embedding Acupuncture With Auricular Acupuncture for GERD

NCT06157424 | Completed

• 1 other identifier: 703/HDDD-DHYD
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

• The proportion of heartburn resolution

  Heartburn resolution is assessed through patient inquiry during each follow-up examination.

  Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)

Secondary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Acupuncture + Standard treatment

EXPERIMENTAL

Standard treatment plus thread embedding acupuncture and auricular acupuncture

Other: Thread Embedding Acupuncture; Other: Auricular acupuncture; Other: Standard treatment

Standard treatment

ACTIVE COMPARATOR

Standard treatment

Other: Standard treatment

Interventions

Thread Embedding Acupuncture OTHER

Thread Embedding Acupuncture is applied at acupoints including CV-12, CV-13, ST-36, PC-6, BL-17, BL-18, BL-21 on both sides of the body every 2 weeks, totaling 2 sessions over 4 weeks of intervention.

Acupuncture + Standard treatment

Auricular acupuncture OTHER

Auricular acupuncture is administered using adhesive patches with small needles (0.25 x 1.3 mm) placed at acupoints TF4, AH6, CO12, CO4, CO2 once a week, totaling 4 sessions over the 4-week intervention period.

Acupuncture + Standard treatment

Standard treatment OTHER

Standard treatment, continuously administered over the 4-week intervention period, involves standard doses of proton pump inhibitors, additional antacids as needed, and lifestyle modifications.

Acupuncture + Standard treatment; Standard treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University of Medical Center HCMC - Branch no.3, University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (7)

• Maret-Ouda J, Markar SR, Lagergren J. Gastroesophageal Reflux Disease: A Review. JAMA. 2020 Dec 22;324(24):2536-2547. doi: 10.1001/jama.2020.21360.

  PMID: 33351048 BACKGROUND

• Luo Z, Hu X, Chen C, Zhu L, Zhang W, Shen Y, He J. Effect of Catgut Embedment in Du Meridian Acupoint on Mental and Psychological Conditions of Patients with Gastroesophageal Reflux Disease. Evid Based Complement Alternat Med. 2020 Sep 22;2020:5415813. doi: 10.1155/2020/5415813. eCollection 2020.

  PMID: 33029166 BACKGROUND

• Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available.

  PMID: 23419381 BACKGROUND

• Hunt R, Armstrong D, Katelaris P, Afihene M, Bane A, Bhatia S, Chen MH, Choi MG, Melo AC, Fock KM, Ford A, Hongo M, Khan A, Lazebnik L, Lindberg G, Lizarzabal M, Myint T, Moraes-Filho JP, Salis G, Lin JT, Vaidya R, Abdo A, LeMair A; Review Team:. World Gastroenterology Organisation Global Guidelines: GERD Global Perspective on Gastroesophageal Reflux Disease. J Clin Gastroenterol. 2017 Jul;51(6):467-478. doi: 10.1097/MCG.0000000000000854. No abstract available.

  PMID: 28591069 BACKGROUND

• Sun QH, Li TT, Huang MT, Wang MY, Xiao X, Bai XH. [Acupoint selection rules in treating gastroesophageal reflux disease with acupuncture in China based on data mining]. Zhongguo Zhen Jiu. 2020 Dec 12;40(12):1374-8. doi: 10.13703/j.0255-2930.20191107-0003. Chinese.

  PMID: 33415885 BACKGROUND

• Zhu J, Guo Y, Liu S, Su X, Li Y, Yang Y, Hou L, Wang G, Zhang J, Chen JJ, Wang Q, Wei R, Wei W. Acupuncture for the treatment of gastro-oesophageal reflux disease: a systematic review and meta-analysis. Acupunct Med. 2017 Oct;35(5):316-323. doi: 10.1136/acupmed-2016-011205. Epub 2017 Jul 8.

  PMID: 28689187 BACKGROUND

• El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13.

  PMID: 23853213 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: December 6, 2023
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

VN (1)