Clinical trial NCT06466044: Effect and Mechanism of Auricular Acupressure on Functional Dyspepsia With Insomnia
Official title: Effect and Mechanism of Auricular Acupressure on Insomnia in Patients With Functional Dyspepsia：a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Dyspepsia
Insomnia
Keywords: Auricular Acupressure
Functional Dyspepsia
insomnia
clinical efficacy
Effect mechanism study
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the effective rate at week 2
timeFrame: 2-week
Secondary outcomes:
measure: the effective rate at week 8
timeFrame: 8-week after treatment
measure: short form-Nepean dyspepsia Index
timeFrame: baseline, 2 weeks, 8 weeks after treatment
measure: Pittsburgh Sleep Quality Index
timeFrame: baseline, 2 weeks, 8 weeks after treatment
measure: Self-rated Anxiety Scale
timeFrame: baseline, 2 weeks, 8 weeks after treatment
measure: Self-rated Depression Scale
timeFrame: baseline, 2 weeks, 8 weeks after treatment
measure: Hyperarousal scale
timeFrame: baseline, 2 weeks, 8 weeks after treatment
measure: Heart rate variability
timeFrame: baseline, 2 weeks, 8 weeks after treatment
measure: Sleep efficiency
timeFrame: baseline, 2 weeks, 8 weeks after treatment
measure: Total sleep time.
timeFrame: baseline, 2 weeks, 8 weeks after treatment
measure: Wake After Sleep Onset
timeFrame: baseline, 2 weeks, 8 weeks after treatment
measure: Sleep fragmentation index
timeFrame: baseline, 2 weeks, 8 weeks after treatment
measure: OTE
timeFrame: baseline, 2 weeks, 8 weeks after treatment
measure: modified FDSD,
timeFrame: baseline, 2 weeks, 8 weeks after treatment
Other outcomes:
measure: Changes in the composition of the intestinal microbiota.
timeFrame: baseline,2 weeks after treatment, 8 weeks after treatment
measure: Changes in Short-chain fatty acid profile composition.
timeFrame: baseline,2 weeks after treatment, 8 weeks after treatment
measure: Adverse event table
timeFrame: baseline,2 weeks after treatment, 8 weeks after treatment
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Wu JianNong, doctor
role: PRINCIPAL_INVESTIGATOR
References: