Effect and Mechanism of Auricular Acupressure on Functional Dyspepsia With Insomnia

NCT06466044 | Completed DMC

• 1 other identifier: 2024-KLS-231-05
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Functional dyspepsia refers to a chronic digestive system disease with upper abdominal symptoms originating from the gastroduodenal region, and after clinical examination, including upper gastrointestinal endoscopy, the organic diseases causing the above symptoms are excluded. According to Rome IV standard, functional dyspepsia can be divided into two categories: postprandial discomfort syndrome and epigastric pain syndrome. FD not only seriously affects the quality of life of patients, but also causes a heavy social and economic burden. Therefore, active prevention and treatment of FD, especially PDS, has become an unavoidable problem in clinic. Epidemiological investigation shows that about 30% FD patients have many negative emotions such as insomnia, anxiety and depression, and many anti-negative emotional drugs themselves can cause gastrointestinal side effects, which are considered to be the key reasons for the recurrence of symptoms. In recent years, people have paid more and more attention to the brain-gut axis. Microbial-intestinal-brain axis can also affect brain function by releasing neurotransmitters and inflammatory mediators. In addition, the interaction between bile acids and intestinal microflora may also affect the normal function of the intestine. However, the relationship between specific bile acids, microflora and functional dyspepsia is still uncertain. At present, the effective and safe treatment methods for FD with insomnia are still very limited. In recent years, Auricular Acupressure has obvious advantages in treating FD with insomnia. This study plans to study the clinical efficacy and mechanism of Auricular Acupressure on functional dyspepsia with insomnia. Provide more treatment methods and ideas for clinicians, popularize and apply green diagnosis and treatment methods, bring good news to more patients, and produce remarkable economic and social benefits

Conditions

Functional Dyspepsia; Insomnia

Keywords

Auricular Acupressure; Functional Dyspepsia; insomnia; clinical efficacy; Effect mechanism study

Outcome Measures

Primary Outcomes (1)

• the effective rate at week 2

  The effective rate was based on the proportion of patients whose PSQI score of ≥ 50% at 2 weeks as compared with the baseline PSQI score

  2-week

Secondary Outcomes (13)

• the effective rate at week 8

  8-week after treatment

• short form-Nepean dyspepsia Index

  baseline, 2 weeks, 8 weeks after treatment

• Pittsburgh Sleep Quality Index

  baseline, 2 weeks, 8 weeks after treatment

• Self-rated Anxiety Scale

  baseline, 2 weeks, 8 weeks after treatment

• Self-rated Depression Scale

  baseline, 2 weeks, 8 weeks after treatment

Other Outcomes (3)

• Changes in the composition of the intestinal microbiota.

  baseline,2 weeks after treatment, 8 weeks after treatment

• Changes in Short-chain fatty acid profile composition.

  baseline,2 weeks after treatment, 8 weeks after treatment

• Adverse event table

  baseline,2 weeks after treatment, 8 weeks after treatment

Study Arms (2)

Treatment group

EXPERIMENTAL

Auricular point containing Vaccaria seed was attached to the auricular concha area rich in vagus nerve. Frequency: Press the auricular points three times a day within half an hour after meals, and press the auricular points for about 30 times. Press the auricular concha alternately. The treatment lasted for 2 weeks. Go to the hospital once a week to change the ear patch.

Behavioral: Auricular acupressure in concha area

Control group

SHAM COMPARATOR

Auricular point with Vaccaria seed was attached to the earlobe, which is the place with the least vagal innervation. Frequency: Press the auricular points three times a day within half an hour after meals, and press the auricular points for about 30 times. Press the bilateral earlobes alternately. The treatment lasted for 2 weeks. Go to the hospital to change the ear patch once a week.

Behavioral: Auricular acupressure in earlobe

Interventions

Auricular acupressure in concha area BEHAVIORAL

The method of pressing beans on auricular points is based on the meridian theory and viscera theory in the basic theory of traditional Chinese medicine, combined with the knowledge of modern medical anatomy, and from the perspective of syndrome differentiation and treatment, relevant auricular points are selected, and appropriate stimulation such as kneading, pressing, pinching and pressing is given to the seeds of Vaccaria seed attached to the concha auricularis, so that the auricular points can produce acid, numbness, swelling and pain slowly and continuously. For therapeutic purposes.

Treatment group

Auricular acupressure in earlobe BEHAVIORAL

The auricular point pressing bean method is based on the meridian theory and viscera theory in the basic theory of traditional Chinese medicine, combined with the knowledge of modern medical anatomy, and from the perspective of syndrome differentiation and treatment, the relevant auricular points are selected, and the seeds attached to the ear lobe, which is the least innervated part of vagus nerve, are given appropriate stimulation such as kneading, pressing, pinching and pressing, so that the auricular points produce acid, numbness, swelling and pain slowly and continuously. For therapeutic purposes.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• It meets the diagnostic criteria of functional dyspepsia and insomnia
• Age 18 years or older
• The following drugs were not taken for at least 2 weeks before enrollment: antibiotics (oral, intramuscical and intravenous), microecological preparations (probiotics, prebiotics and Biostime, etc.) and other drugs affecting the gastrointestinal flora, any drugs or health products that improve sleep quality or inhibit neural activity in the brain, drugs related to the treatment of functional dyspepsia or other related treatments
• Agree to participate in the study voluntarily and sign the informed consent

You may not qualify if:

• Secondary insomnia caused by medication or other diseases;
• Patients with comorbid mental disorders, as well as severe diseases of the heart, liver, kidneys and other systems;
• Those who have previously received this treatment method or participated in other clinical trials within 6 months;
• Presence of contraindications for auricular patches, such as skin hypersensitivity or damage to the application site;
• Pregnant and lactating women.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

Location

Related Publications (2)

• Shen MY, Li ZJ, Zhou R, Lou QY, Ying ZK, Liu S, Feng DD, Yang DD, Jiang LX, Wang XL, Wu JX, Li M, Wu JN. Efficacy and Safety of Auricular Acupressure for Insomnia in Patients With Functional Dyspepsia: A Randomized Controlled Trial. Am J Gastroenterol. 2025 Dec 10. doi: 10.14309/ajg.0000000000003880. Online ahead of print.

  PMID: 41369283 DERIVED

• Shen MY, Lou QY, Liu S, Li ZJ, Lin TC, Zhou R, Feng DD, Yang DD, Wu JN. The efficacy and safety of auricular acupoint therapy on treating functional dyspepsia with insomnia: study protocol for a randomized controlled trial. Front Med (Lausanne). 2025 Mar 12;12:1496502. doi: 10.3389/fmed.2025.1496502. eCollection 2025.

  PMID: 40144883 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Wu JianNong, doctor

  The First Affiliated Hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During clinical trials, subjects, evaluators, data managers, and statisticians are unaware of treatment assignments. After randomization and allocation by an independent data manager, it is handed over to the nurse, who will not be involved in the results evaluation or data analysis. Neither the study participants nor the investigators had any effect on randomization and assigned hiding. The participants were told there were two treatment options. Two months after the study, patients were asked to complete a blind assessment and a perceived efficacy assessment, and were asked to guess which treatment they had received to test the success of the blind. All researchers will receive training on the methodological specifications of this study prior to the trial and strictly adhere to the principle of task separation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the two groups affixed the auricular points with Vaccaria seed to the ear, the control group affixed to the ear lobe, and the experimental group affixed to the ear nail area. The ear compression treatment was performed, and the pressure was subject to the patient's gas state (acid, numbness, weight, swelling, etc.). Frequency: 3 times a day, press the ear point within half an hour after a meal, the press frequency is about 30 times, and the bilateral ear lobe is alternately pressed. The treatment lasted for 2 weeks. Go to the hospital once a week to change the ear patch.

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 20, 2024
• Study Start: May 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 20, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)