NCT05353933

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-04
• Primary completion: 2022-07-20
• Completion: 2022-07-20
• First posted: 2022-04-29
• Last updated: 2022-07-28

Locations

1 site across 1 country: Vietnam