Efficacy and Safety of Thread Embedding Acupuncture in Treating Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional

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.
    

Intervention name(s): Thread embedding acupuncture; Pantoprazole 40mg
Intervention type(s): Other; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment