BMJ open · 2024
Acupoint catgut embedding advantage in treating gastro-oesophageal reflux disease (ACE-GERD): study protocol for a randomised controlled trial.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Wen Shuting, Zhao Xiying, Lin Xiaofeng, Fu Zhaoli, Qin Shumin, Pan Qimou, Liu Fengbin, He Wenfang, Liu Tianwen
Аннотация
BACKGROUND: Gastro-oesophageal reflux disease (GERD) is a highly prevalent disorder worldwide and developing effective treatment strategies for GERD is a clinical priority. GERD is associated with anxiety and depression. Several approaches have been developed to improve GERD, although effectiveness is limited. Acupoint catgut embedding (ACE) is an established technique in traditional Chinese medicine for the treatment of anxiety and depression. This study will investigate the effects of ACE on anxiety, depression, acid reflux and heartburn in patients with GERD.
METHODS: The ACE-GERD trial is a single-centre, prospective randomised controlled trial. 62 patients will be randomly assigned equally to the experimental and control groups. Patients will be treated with ACE or sham ACE. In the experimental group, absorbable polyglycolic acid sutures will be implanted at the acupoints using sterile disposable injection needles. The sham ACE treatment will exhibit similar surface characteristics but lack absorbable polyglycolic acid sutures. Treatments will be administered every 2 weeks for a period of 10 weeks. The main outcome measure is the Reflux Disease Questionnaire symptom score. Secondary outcomes are the endoscopic assessment, 24-hour pH/impedance monitoring test, oesophageal high-resolution manometer, Gastro-oesophageal Reflux Disease Questionnaire score, Gastro-oesophageal Reflux Disease Health-related Quality of Life, Self-rating Anxiety Scale and Self-rating Depression Scale scores.
DISCUSSION: The ACE-GERD trial aims to evaluate the efficacy of ACE treatment as a therapeutic tool for improving anxiety, depression, acid reflux and heartburn in patients with GERD and to provide the evidence base for future clinical studies.
ETHICS AND DISSEMINATION: The trial has been approved by the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (ethics no. BF2023-113-01). Results will be published in peer-reviewed journals and presented at scientific conferences and meetings.
TRIAL REGISTRATION NUMBER: ChiCTR2300074643.
METHODS: The ACE-GERD trial is a single-centre, prospective randomised controlled trial. 62 patients will be randomly assigned equally to the experimental and control groups. Patients will be treated with ACE or sham ACE. In the experimental group, absorbable polyglycolic acid sutures will be implanted at the acupoints using sterile disposable injection needles. The sham ACE treatment will exhibit similar surface characteristics but lack absorbable polyglycolic acid sutures. Treatments will be administered every 2 weeks for a period of 10 weeks. The main outcome measure is the Reflux Disease Questionnaire symptom score. Secondary outcomes are the endoscopic assessment, 24-hour pH/impedance monitoring test, oesophageal high-resolution manometer, Gastro-oesophageal Reflux Disease Questionnaire score, Gastro-oesophageal Reflux Disease Health-related Quality of Life, Self-rating Anxiety Scale and Self-rating Depression Scale scores.
DISCUSSION: The ACE-GERD trial aims to evaluate the efficacy of ACE treatment as a therapeutic tool for improving anxiety, depression, acid reflux and heartburn in patients with GERD and to provide the evidence base for future clinical studies.
ETHICS AND DISSEMINATION: The trial has been approved by the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (ethics no. BF2023-113-01). Results will be published in peer-reviewed journals and presented at scientific conferences and meetings.
TRIAL REGISTRATION NUMBER: ChiCTR2300074643.