NCT06466044

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Dyspepsia
• Insomnia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-05-15
• Primary completion: 2024-12-31
• Completion: 2025-02-20
• First posted: 2024-06-20
• Last updated: 2025-07-01

Locations

1 site across 1 country: China