Effect and Mechanism of Auricular Acupressure on Functional Dyspepsia With Insomnia

Effect and Mechanism of Auricular Acupressure on Insomnia in Patients With Functional Dyspepsia：a Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia; Insomnia
• Intervention / Treatment: Behavioral: Auricular acupressure in concha area; Behavioral: Auricular acupressure in earlobe

Detailed Description

1. The effective rate. The effective rate was based on the proportion of patients whose PSQI score of ≥ 50% at 2 weeks as compared with the baseline
2. PSQI score. The PSQI is a widely used questionnaire to assess one's sleep quality for the past month, with 7 components for 7 specific features of sleep.
3. sleep quality assessed by actigraphy: Objectively record the clinical sleep changes of the patients before and after treatment by the ActiGraph wGT3X-BT.
4. modified FDSD
5. SF-NDI: Evaluate the functional dyspepsia of patients with functional dyspepsia and insomnia by SF-NDI.
6. SAS, SDS: SAS and SDS were used to evaluate the patients' psychological status.
7. HAS, HRV: Assess the autonomic nervous function of patients before and after treatment by the excessive arousal scale and heart rate variability.
8. To study the therapeutic mechanism of patients before and after treatment by detecting fecal intestinal microecological flora and Short-chain fatty acid spectrum metabonomics.
9. The changes of tongue and pulse before and after treatment were detected by tongue and pulse meter
10. Averse events. Any adverse events, such as unfavorable or unintended signs, symptoms, or diseases, related to the AA treatment or the administration of these comorbidity was reported by patients and professional nurses. Severe adverse events had to be reported to the principal investigator and the data and safety monitoring board within 24 hours after their occurrence.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • First Affiliated Hospital of Zhejiang Chinese Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; 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; 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.
Sham Comparator: Control group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the effective rate at week 8	The effective rate was based on the proportion of patients whose PSQI score of ≥ 50% at 8 weeks as compared with the baseline PSQI score	8-week after treatment
short form-Nepean dyspepsia Index	Clinical functional dyspepsia was assessed by the short form-Nepean dyspepsia Index scale. The short form-Nepean dyspepsia Index scale is scored using a 5-point Likert scale (1-5 points), with the lowest score of 10 points and the highest score of 50 points.	baseline, 2 weeks, 8 weeks after treatment
Pittsburgh Sleep Quality Index	Clinical sleep was assessed by the Pittsburgh Sleep Quality Index. This scale is scored on a scale of 0-3, with a cumulative score of PQSI total score (0-21) and a maximum score of 21. The higher the score, the worse the quality of sleep.	baseline, 2 weeks, 8 weeks after treatment
Self-rated Anxiety Scale	Clinical sleep was assessed by the Self-rated Anxiety Scal.The anxiety self-rating scale is scored on a 4-point scale, with a maximum score of 100 and a minimum score of 20. The higher the score, the more severe the anxiety symptoms. A score below 50 is normal; 50-60 is mild; A score of 70 or more is considered severe.	baseline, 2 weeks, 8 weeks after treatment
Self-rated Depression Scale	Clinical sleep was assessed by the Self-rated Depression Scale. The depression self-rating scale is scored on a 4-point scale, with a maximum score of 100 and a minimum score of 20. The higher the score, the more severe the depressive symptoms. A score of 53-62 is mild depression, 63-72 is moderate depression, and a score above 72 is severe depression.	baseline, 2 weeks, 8 weeks after treatment
Hyperarousal scale	Changes in autonomic nervous function before and after treatment were evaluated on Hyperarousal scale	baseline, 2 weeks, 8 weeks after treatment
Heart rate variability	Changes in autonomic nervous function before and after treatment were evaluated on Hyperarousal scale	baseline, 2 weeks, 8 weeks after treatment
Sleep efficiency	We will collect the sleep efficiency of patients before and after treatment by ActiGraph wGT3X-BT. >85% indicates good sleep quality. 85% or less indicates poor sleep quality.	baseline, 2 weeks, 8 weeks after treatment
Total sleep time.	We will collect the total sleep time of patients before and after treatment by ActiGraph wGT3X-BT. An increase in total sleep time indicates improved sleep quality.	baseline, 2 weeks, 8 weeks after treatment
Wake After Sleep Onset	We will collect the post-sleep awakening time of patients before and after treatment by ActiGraph wGT3X-BT. Increased waking after sleep onset suggests poorer sleep quality.	baseline, 2 weeks, 8 weeks after treatment
Sleep fragmentation index	We will collect the sleep fragmentation index of patients before and after treatment by ActiGraph wGT3X-BT. An increase in the sleep fragmentation index indicates poor sleep quality.	baseline, 2 weeks, 8 weeks after treatment
OTE	To assess patient satisfaction with treatment of functional dyspepsia	baseline, 2 weeks, 8 weeks after treatment
modified FDSD,	The patient was evaluated for symptoms of functional dyspepsia	baseline, 2 weeks, 8 weeks after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the composition of the intestinal microbiota.	Stool samples were collected, and the changes of intestinal microbiota components before and after treatment were explored by analyzing the microbial composition, diversity index, and species composition of intestinal microbiota in feces	baseline,2 weeks after treatment, 8 weeks after treatment
Adverse event table	Patient safety during treatment was assessed by the Adverse Events Table	baseline,2 weeks after treatment, 8 weeks after treatment
Changes in Short-chain fatty acid profile composition.	Blood samples were collected to analyze the changes in the quantity and concentration of short-chain fatty acids in blood, and to explore the changes in the composition of short-chain fatty acids spectrum before and after treatment	baseline,2 weeks after treatment, 8 weeks after treatment

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Investigators: Principal Investigator: Wu JianNong, doctor, The First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Functional Dyspepsia; insomnia; clinical efficacy; Auricular Acupressure; Effect mechanism study
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Signs and Symptoms, Digestive; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Dyspepsia
• Other Study ID Numbers: 2024-KLS-231-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No