Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms

The overall treatment effect (OTE) after 2 weeks of treatment refers to the proportion of patients who showed significant improvement or improvement.

After 8 weeks of treatment, the proportion of patients with overall treatment effect (OTE) showing significant improvement or improvement;

After the patient agreed to participate in this study, the research team immediately provided the patient with an actigraphy device (ActiGraph wGT3X-BT) and gave detailed instructions on how to use it. Patients were required to wear the device continuously for 7 days before treatment, 2 weeks after treatment, and 10 weeks after treatment to assess their sleep status. The device was worn on the non-dominant wrist. While wearing the wrist actigraphy device, patients were also asked to maintain a sleep diary, recording bedtimes and wake-up times for 7 days, or the times when the device was removed (e.g., for bathing). The actigraphy data, including sleep efficiency, total sleep time, wake time after sleep onset, and sleep fragmentation index, were processed and scored using Actiware 6.0 software.

The full unabbreviated title of the scale is Modified Functional Dyspepsia Symptom Diary (FDSD). The score ranges from a minimum of 0 to a maximum of 4 for each symptom item. Higher scores represent more severe symptoms and a worse clinical condition.

Self-Rating Anxiety Scale (SDS)。The full title of the scale is Self-Rating Anxiety Scale (SDS). Its total score ranges from a minimum of 20 to a maximum of 80. A higher total score indicates a more severe level of anxiety, meaning a worse psychological outcome.

Measurement Method of Autonomic Nervous Function Changes

In the Title field, the measurement for assessing autonomic nervous function changes in FD patients with sleep disorders induced by auricular acupoint stimulation is specified as the Hyperarousal Scale (HAS), a validated hyperarousal assessment tool. Collected HAS data (reflecting autonomic nervous function changes) were aggregated using descriptive statistics (mean ± SD).

In the Description field, additional details about the measurement and data summary metric: HAS is a self-reported scale for hyperarousal assessment, closely linked to autonomic nervous function disorders. Before summary, HAS scores were verified for completeness/validity; invalid scores (>10% missing items) were excluded, and valid scores were aggregated by mean ± SD for subsequent statistical analysis.

The Pittsburgh Sleep Quality Index (PSQI)。This scale is a validated instrument used to assess sleep quality over a one-month period. The total score of the PSQI ranges from a minimum of 0 to a maximum of 21. A higher score indicates poorer sleep quality, while a lower score reflects better sleep quality.

• Collection time points: baseline, 2 weeks after treatment. 2. Scan preparation: The subjects lie flat on the MRI examination bed and remain still for 10 minutes. They are instructed to keep their eyes closed quietly, breathe steadily, stay awake, avoid thinking activities, and keep their bodies still. Appropriate stimuli are provided to the patients, after which earplugs are used to reduce noise, and foam head cushions and medical tape are used to fix the head to prevent movement. The patient is then placed into the MRI scanner to begin the fMRI scan. 3. Scanning protocol: (1) Scanner parameters: Equipment and parameters: Using the General Electric 3-Tesla Discovery MR 750 whole-body small-aperture scanner (32-channel parallel receiver coil). The scanning protocol includes: 1) Sagittal 3D T1-weighted images: Repetition time (TR) = 7.4 ms; Echo time (TE) = 3.5 ms; Flip angle (FA) = 12°; Acquisition matrix = 256 × 256; Slice thickness = 1 mm, no gap. Duration: 7 minutes; fMRI paramet

The Gastrointestinal Symptom Rating Scale (GCSI) is a validated instrument for evaluating gastrointestinal symptom severity. Its total score ranges from a minimum of 0 to a maximum of 144. Higher scores reflect more severe gastrointestinal symptoms and a worse clinical condition.

The Short Form Nepean Dyspepsia Index (SF-NDI) is a validated tool for evaluating health-related quality of life in patients with dyspepsia. The total score ranges from a minimum of 0 to a maximum of 50. A higher SF-NDI score represents a worse quality of life and more severe symptom-related impairment.

Self-Rating Depression Scale (SAS)。Total score range: the minimum score is 20, and the maximum score is 80. A higher total score on the SAS reflects more severe depressive symptoms and a poorer mental health status.

Electrocardiographic signals were collected before treatment, after 2 weeks, and after 8 weeks of treatment using a CREDIT heart rate variability analyzer. Data such as high-frequency values, low-frequency values, low-frequency/high-frequency ratios, and the standard deviation of normal heartbeats were analyzed to investigate the mechanism of auricular acupoint stimulation on autonomic nervous function in FD patients with sleep disorders.

The Insomnia Severity Index (ISI) is a validated tool used to assess the severity of insomnia symptoms. The total score ranges from a minimum score of 0 to a maximum score of 28. In this scale, higher scores indicate more severe insomnia symptoms and a worse clinical condition, while lower scores reflect milder or absent sleep disturbances.

Patient safety during treatment was assessed by the Adverse Events Table