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STUDY PROTOCOL article
Front. Med.
Sec. Gastroenterology
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1496502
This article is part of the Research Topic Age-Related Endocrine Metabolic Disorders, Sleep Disorders, and Diseases Associated with Shortened and Abnormal Telomeres View all articles
The efficacy and safety of auricular acupoint therapy on treating functional dyspepsia with insomnia: study protocol for a randomized controlled trial
Provisionally accepted
Mengyuan Shen 1
Qin-Yi Lou 1
Shan Liu 1
Ze-Jiong Li 1
Tian-chen Lin 1 Rong Zhou 1 Dan- Dan Feng 1
Dong-Dong Yang 1
Jian-Nong Wu 2*- 1 The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), hangzhou, China
- 2 Department of Intensive Care Unit, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, Jiangsu Province, China
Background: Functional dyspepsia (FD) is a prevalent health issue currently lacking optimal treatment options, with its global incidence rate increasing in recent years. Clinical studies have recently focused on the application of auriculotherapy in functional gastrointestinal disorders that are accompanied by negative emotions. However, few randomized controlled trials have investigated the use of auriculotherapy for FD patients with insomnia, leaving the therapeutic efficacy and safety largely undefined. This study aims to evaluate the clinical efficacy and safety of auriculotherapy in treating FD patients with insomnia.This study is a single-center, randomized controlled clinical trial involving 80 patients with FD and insomnia. Using a central randomization system, the subjects are randomly assigned to the auricular acupressure group or the sham auricular acupressure group at a 1:1 ratio, with the auricular acupressure group targeting the concha region and the sham auricular acupressure group targeting the earlobe region. The primary outcome is the response rate at 2 weeks, and the secondary outcomes include the response rate at 8 weeks, sleep data assessed by actigraphy, modified Functional Dyspepsia Symptom Diary, short form-Nepean Dyspepsia Index, Self-rated Anxiety Scale, Self-rated Depression Scale, High Arousal Scale, and Heart Rate Variability. Efficacy results will be evaluated at baseline and at 2 and 8 weeks after treatment. Adverse events will be monitored throughout the study observation period.The results of this trial are anticipated to validate the efficacy and safety of auriculotherapy in improving symptoms of FD and insomnia, as well as in reducing negative emotional states.
Keywords: functional dyspepsia, insomnia, auricular acupoint therapy, randomized controlled trial, efficacy
Received: 14 Sep 2024; Accepted: 28 Feb 2025.
Copyright: © 2025 Shen, Lou, Liu, Li, Lin, Zhou, Feng, Yang and Wu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Jian-Nong Wu, Department of Intensive Care Unit, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, Jiangsu Province, China
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