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

GERD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06157424
• Other study ID #: 703/HDDD-DHYD
• Status: Completed
• Phase: N/A
• Start date: December 6, 2023
• Est. completion date: March 18, 2024

Study information

• Verified date: March 2024
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 18, 2024
• Est. primary completion date: March 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• GERD

Intervention

Other:
• Thread Embedding Acupuncture
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.
• Auricular acupuncture
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.
• Standard treatment
Standard treatment, continuously administered over the 4-week intervention period, involves standard doses of proton pump inhibitors, additional antacids as needed, and lifestyle modifications.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. Erratum In: Am J Gastroenterol. 2013 Oct;108(10):1672. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The proportion of regurgitation resolution	Regurgitation 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	Chang in the Gastroesophageal Reflux disease Questionnaire (GerdQ) score	As per GerdQ, patients were prompted to recall their symptoms and utilization of over-the-counter medications in the past week. It employs a four-point Likert scale (0-3) for scoring, resulting in a total GerdQ score range from 0 to 18. A higher score signifies a more severe condition.	Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
Secondary	Chang in the Frequency Scale for the Symptoms of GERD (FSSG) score	The FSSG questionnaire consists of twelve questions categorized into two domains: reflux symptoms and dysmotility symptoms. Using a 5-point Likert scale (0-4), the FSSG yields a total score range of 0 to 48. A higher score suggests a more severe or significant disease.	Day 0 and after every two week during 4-week treatment (day 0, day 14, day 28)
Secondary	Chang in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score	The GERD-HRQL questionnaire consists of 16 questions utilizing a numerical Likert-type response. Patients assess symptom severity on an ordinal scale ranging from 0 to 5. The total score range for GERD-HRQL spans from 0 to 80, incorporating evaluations for heartburn, regurgitation, and other related aspects. A higher score reflects a more severe disease.	Day 0 and after every two week during 4-week treatment (day 0, day 14, day 28)
Secondary	Changes in the number of antacid packets used	The number of antacid packets used per week will be recorded during each follow-up visit.	Day 0 and after every week during 4-week treatment (day 0, day 7, day 14, day 21, day 28)
Secondary	The proportion of side effects of thread embedding acupuncture and auricular acupuncture		Up to 4 weeks