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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wu JianNong, doctor | The First Affiliated Hospital of Zhejiang Chinese Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Zhejiang Chinese Medical University | Hangzhou | Zhejiang | 310006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41369283 | Derived | 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. | |
| 40144883 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2024 | May 27, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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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.
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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.
|
| 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. |
|
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 |
| 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 |
| Adverse event table | Patient safety during treatment was assessed by the Adverse Events Table | baseline,2 weeks after treatment, 8 weeks after treatment |
| 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. |
| D001523 |
| Mental Disorders |