Effect and Mechanism of Auricular Acupressure on Functional Dyspepsia With Insomnia

Not Applicable

Recruiting

• Conditions: Functional Dyspepsia; Insomnia
• Interventions: Behavioral: Ear point pressure bean method in ear concha area; Behavioral: Ear point pressure bean method in earlobe

• Registration Number: NCT06466044
• Lead Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

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

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-05-14
• Study Start: 2024-05-15
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-20
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-20
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Ear point pressure bean method in ear concha area	Auricular point containing Vaccaria seed was attached to the auricular concha area rich in vagus nerve. According to the degree of pressure, the patient's gaseous state (acid, numbness, heaviness, swelling, etc.) shall prevail. ). Frequency: Press the auricular points three times a day within half an hour after meals for about 1-2 minutes, 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.
Control group	Ear point pressure bean method in earlobe	Auricular point with Vaccaria seed was attached to the earlobe, which is the place with the least vagal innervation. Ear pressure therapy depends on the patient's gas state (acid, numbness, heaviness, bloating, etc.). ). Frequency: Press the auricular points three times a day within half an hour after meals for about 1-2 minutes, 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.

Primary Outcome Measures

Name	Time	Method
the effective rate at week 2	2-week	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

Secondary Outcome Measures

Name	Time	Method
the effective rate at week 8	8-week after treatment	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
short form-Nepean dyspepsia Index	baseline, 2 weeks, 8 weeks after treatment	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.
Pittsburgh Sleep Quality Index	baseline, 2 weeks, 8 weeks after treatment	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.
Self-rated Anxiety Scale	baseline, 2 weeks, 8 weeks after treatment	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.
Self-rated Depression Scale	baseline, 2 weeks, 8 weeks after treatment	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.
Hyperarousal scale	baseline, 2 weeks, 8 weeks after treatment	Changes in autonomic nervous function before and after treatment were evaluated on Hyperarousal scale
Heart rate variability	baseline, 2 weeks, 8 weeks after treatment	Changes in autonomic nervous function before and after treatment were evaluated on Hyperarousal scale
Sleep efficiency	baseline, 2 weeks, 8 weeks after treatment	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.
Total sleep time.	baseline, 2 weeks, 8 weeks after treatment	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.
Wake After Sleep Onset	baseline, 2 weeks, 8 weeks after treatment	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.
Sleep fragmentation index	baseline, 2 weeks, 8 weeks after treatment	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.
OTE	baseline, 2 weeks, 8 weeks after treatment	To assess patient satisfaction with treatment of functional dyspepsia
modified FDSD,	baseline, 2 weeks, 8 weeks after treatment	The patient was evaluated for symptoms of functional dyspepsia

Trial Locations

Locations (1)

First Affiliated Hospital of Zhejiang Chinese Medical University; 🇨🇳 Hangzhou, Zhejiang, China