Efficacy and Safety of Auricular Acupressure for Insomnia in Patients With Functional Dyspepsia: A Randomized Controlled Trial

Abstract

INTRODUCTION:

Insomnia is a prevalent and debilitating disorder often experienced by patients with functional dyspepsia (FD). Auricular acupressure (AA) has gained attention for its potential in treating both FD and insomnia. However, its clinical efficacy and safety remain unclear because of a lack of high-quality randomized controlled trials.

METHODS:

Patients with FD and insomnia were enrolled and randomly divided into AA group or sham AA (SAA) group. Patients in the AA group were treated in the ear concha region, and patients in the SAA group were treated in the earlobe region. Treatment was given 3 times a day, 1 day apart, for 2 weeks. The primary outcome was the response rate, defined as a reduction of at least 50% in the Pittsburgh Sleep Quality Index score at week 2; minimal clinically important improvement was defined as a 4-point reduction, and minimal clinically important difference was defined as a 3-point reduction. Secondary outcomes included the response rate at 8 weeks, sleep parameters measured by actigraphy, FD symptoms, quality of life, mental health status, and autonomic functions.

RESULTS:

Eighty-two participants were randomized into the AA group (41 participants) or the SAA group (41 participants). The response rate at week 2 was 53.7% in the AA group compared with 29.3% in the SAA group (95% confidence interval −35.6 to −13.2, P < 0.001). The efficacy of AA was sustained during the 8-week posttreatment follow-up. Adverse events were all mild and comparable between the 2 groups (P = 0.53).

DISCUSSION:

Among patients with FD and insomnia, a 2-week treatment of AA is more effective than SAA in improving the response rate, with benefits maintained over an 8-week follow-up period.

INTRODUCTION

Insomnia, characterized by difficulty falling asleep, maintaining sleep, and subsequent daytime impairments, is a prevalent condition that significantly affects health. It is increasingly common and often comorbid with other medical conditions (1,2). In patients with functional dyspepsia (FD), insomnia is particularly widespread, affecting 30%–50% of these individuals (3). Patients with FD are at a higher risk for insomnia compared with healthy individuals, and those with both FD and insomnia tend to experience more severe symptoms, higher rates of depression and anxiety, and increased healthcare utilization (4,5).

Currently, the treatment for patients with co-occurring FD and insomnia often involves acid suppression and gastrointestinal motility agents as the primary regimen, supplemented by anxiolytics and antidepressants (6–8). However, these treatments are limited by their long-term side effects and uncertain clinical efficacy. Although some nonpharmacological therapies, such as exercise and music therapy, show promise, their clinical effectiveness and safety still require validation through large-scale studies (9–11). Given the shortcomings of existing therapies for insomnia in FD, there is an increasing interest in exploring alternative approaches that are effective, feasible, and associated with fewer adverse effects.

Auricular acupressure (AA), a traditional therapy rooted in Chinese medicine, has gained attention for its potential benefits. AA works by stimulating the central nervous system through vagal afferent nerves in the auricle of the ear. AA modulates the brain-gut axis through vagus nerve activation, reducing visceral hypersensitivity, normalizing intestinal motility, improving sleep, and alleviating anxiety and other negative emotions (12–14).

Owing to its ease of application and management, AA has become increasingly popular. However, many of the treatment protocols used in clinical studies are based on the personal experience of investigators, lacking standardization and reproducibility. This makes it difficult to draw definitive conclusions from current research. Therefore, this study aims to evaluate the efficacy and safety of AA in treating FD with insomnia through a rigorously standardized randomized controlled trial while also exploring its underlying mechanisms.

METHODS

Study design

This prospective, randomized, sham-controlled trial was conducted from May 2024 to January 2025 at the Zhejiang Provincial Hospital of Traditional Chinese Medicine (TCM), China. The study was approved by the Institutional Review Board and Ethics Committee of the Zhejiang Provincial Hospital of TCM and was monitored by an independent study steering committee, data monitoring committee, and ethics committee. All participants provided written informed consent before enrollment. The study adhered to the Consolidated Standards of Reporting Trials and the Standards for Reporting Interventions in Clinical Trials of Acupuncture guidelines for trial design and reporting (15). The trial was registered with ClinicalTrials.gov (NCT06466044). The trial was conducted in accordance with the trial registration protocol with no major deviations.

Participants

The study population consisted of adults who met the following inclusion criteria: (i) individuals aged 18 years or older; (ii) Pittsburgh Sleep Quality Index (PSQI) score was greater than 7 (16); (iii) those fulfilling the diagnosis of insomnia and diagnosis of FD based on the Rome IV criteria (17,18); (iv) those had not taken any of the followings for at least 2 weeks before enrollment: antibiotics (oral, intramuscular, or intravenous); dietary supplements that affect the gastrointestinal microbiota (such as probiotics, prebiotics, or synthetic bacteria); any drugs or health supplements that improve sleep quality or inhibit brain nerve activity; and no FD-related drugs or therapies; and (v) those who were willing to sign an informed consent form. The exclusion criteria included (i) secondary insomnia caused by medication or other diseases; (ii) patients with comorbid mental disorders, as well as severe diseases of the heart, liver, kidneys and other systems; (iii) those who have previously received this treatment method or participated in other clinical trials within 6 months; (iv) presence of contraindications for auricular patches; and (v) pregnant and lactating women.

Randomization and blinding

Randomization was performed using a centralized network randomization system with a block size of 4, assigning patients in a 1:1 ratio to either the AA or sham AA (SAA) group. The randomization sequence was embedded into the system. Patients, outcome assessors, and statisticians were blinded to group allocation throughout the trial. After randomization and concealed assignment by an independent data manager, results were handed to a professional nurse for implementation. Neither the data manager nor the nurse participated in outcome assessment. Participants were informed of the 2 treatment options, and after 2 months, they completed a blinded assessment to guess which treatment they had received to evaluate the success of blinding.

Procedures

On enrollment, research assistants helped participants complete baseline assessments, including the PSQI, wear a wrist actigraph (Actigraph model wGT3X-BT) on the nondominant wrist for 24 hours over 7 days, and complete a sleep diary (19). The actigraph objectively measured sleep parameters, including sleep efficiency (SE), wake time after sleep onset, sleep latency, and total sleep time using the Cole-Kripke algorithm (Actilife, version 6.11.7). The primary assessment tools include (i) the PSQI, assessing sleep quality over the past month across 7 dimensions, with total scores ranging from 0 to 21. The higher the score, the worse the sleep quality. (ii) The modified Functional Dyspepsia Symptom Diary (FDSD), evaluating the severity of dyspepsia symptoms (5 symptoms rated on a scale of 0–10). Higher scores indicate more severe symptoms (11). (iii) The short-form Nepean Dyspepsia Index (SF-NDI), measuring quality-of-life impact from dyspepsia (10 items scored from 1 to 5). Higher scores correspond to lower quality of life (20). (iv) The Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS), quantifying anxiety/depression symptoms experienced in the past week (critical thresholds: SAS ≥50, SDS ≥53). Higher total scores reflect more severe symptoms (21,22). (v) The Hyperarousal Scale (HAS), assessing cognitive and emotional hyperarousal states in response to stimuli (26 items scored from 0 to 3), where a total score exceeding 32 indicates a hyperarousal state (23). (vi) Heart Rate Variability (HRV) is an assessment of autonomic nervous system function using time-domain metrics, such as standard deviation of normal-to-normal intervals (SDNN), root mean square of successive differences (RMSSD), and percentage of successive normal-to-normal intervals that differ by more than 50 ms (PNN50), as well as frequency-domain metrics, such as high frequency (HF). HF is expressed as a standardized value (HF/[HF + LF]), and a higher value indicates stronger vagus nerve activity (24). These measures were assessed at baseline, 2-week posttreatment, and 8-week posttreatment are shown in Figure 1 of supplementary 1 (http://links.lww.com/AJG/D837). Adverse events were monitored and recorded at each assessment point.

Interventions

AA was a home-based, hospital-supported therapy. Participants received a 30-minute training session on how to independently perform AA and complete an AA record form. After skin cleaning, a professional nurse placed seeds of Vaccaria segetalis on bilateral auricular acupoints and secured them with tape. Participants were instructed to manually stimulate each acupoint 3 times a day (morning, afternoon, and evening) for 30 seconds per point, alternating between the right and left ear pavilion, until the ear became red or sensitive to pressure (25). Each treatment session was separated by 1 day. An AA record form was completed after each compression. Treatment adherence was considered high if 80% of the scheduled treatment sessions (17 treatments) were completed. Participants also received intensive treatments once a week, each lasting 20–25 minutes in a reserved room, for a total of 2 weeks. Before the patients were enrolled, nurses with at least 10 years of experience in AA were trained using a standardized procedure and passed both theoretical and practical examinations to ensure the consistency of the treatment. Throughout the study, participants were alerted through phone calls from the study team for treatment schedules and study-related arrangements.

The treatment in the AA group targeted the auricular concha area, where vagus nerve distribution is abundant, based on TCM principles (11,26). In the SAA group, seeds of Vaccaria segetalis were adhered to the earlobe, an area with minimal vagal innervation, as a sham treatment (11,27). The specific operation details of the intervention are shown in Figure 2 of supplementary 1 (http://links.lww.com/AJG/D837).

Outcomes

Assessments were conducted at baseline, and weeks 2 and 8.

Primary outcome.

The primary outcome was the response rate at week 2, defined as the proportion of participants whose PSQI score decreased by ≥ 50% from baseline (13). Based on previous literature, a change score of 4 points (vs baseline) in the PSQI was defined as the minimal clinically important improvement (MCII), and a difference score of 3 points (vs SAA group) was considered to be the minimal clinically important difference (MCID) (28–30).

Secondary outcomes.

Secondary outcomes included the response rate at week 8, objective sleep parameters (measured by actigraphy), FD symptoms and quality of life (measured using the modified FDSD and SF-NDI), emotional distress (assessed using SAS and SDS), autonomic function (evaluated through HAS and HRV), and adverse events. The 2-week outcome provided an early measure of symptomatic relief, while the 8-week follow-up assessed the durability of the treatment effect.

Statistical analysis

Sample size calculations were based on preliminary data from a small sample. Assuming a 50% response rate in the AA group and a 20% response rate in the SAA group, with α = 0.05 and 80% power, a minimum of 36 participants per group was required. To account for a 10% dropout rate, a total of 80 participants was necessary. Sample size estimation was performed using PASS V2023.

Statistical analyses followed the intention-to-treat (ITT) principle, including all randomized participants. Missing data were handled through multiple imputation. Generalized estimating equation (GEE) analyses were used to evaluate outcomes, with covariates such as sex, marital status, education, age, and baseline score included in adjusted models. The robustness of results was assessed using Per-Protocol, modified ITT, and Complete Case analyses. Subgroup analysis based on sex, age, and Helicobacter pylori status was conducted by adding interaction terms (sex × group, age × group, H. pylori × group) to the GEE models. Sensitivity analyses, including pattern mixture models, Last Observation Carried Forward, Expectation-Maximization Lag, and Mean-value sensitivity analyses, were performed to assess the impact of missing data assumptions. For HRV, normalized values were used, HF was calculated as HF/(HF + LF) (31,32). Safety analyses were conducted on the safety data set, which included all participants who received at least 1 AA session. The Bang Blinding Index and James test were used to assess the success of blinding. All the data in this study were analyzed through R project for Statistical Computing (R, version 4.4.2) and SAS (version 9.4), with significance level indicated by 2-sided P < 0.05.

RESULTS

Patient characteristics

A total of 183 consecutive patients were screened. Of these, 101 patients were excluded for various reasons, resulting in 82 patients who were enrolled and randomly assigned to either the AA group (n = 41) or the SAA group (n = 41). The participant flow is shown in Figure 1. Among them, the AA group had a mean [SD] age of 39.1 [10.5] years; there were 26 women (63.4%), while the SAA group had a mean [SD] age of 39.4 [11.1] years; there were 28 women (68.3%). Among all participants, 77 completed the 2-week intervention and 74 completed the 8-week follow-up. Baseline characteristics were similar between the 2 groups. According to the AA record form, the average number of treatments was 20 in the SAA group and 19 in the AA group, both exceeding 80% of the scheduled treatment duration (17 sessions).

Figure 1.

Study flow diagram. AA, auricular acupressure; SAA, sham auricular acupressure.

Primary outcome

As given in Table 1, the ITT analysis revealed a response rate of 53.7% at the end of the 2-week AA treatment compared with 29.3% in the SAA group, with a statistically significant difference between the 2 groups (difference −24.4 percentage points [95% confidence interval (CI) −35.6 to −13.2]; P < 0.001). This finding was consistent with the adjusted GEE model (P < 0.001). Similar results were observed across different analysis sets (Table 1 of supplementary 1, http://links.lww.com/AJG/D837). In addition, the AA group exhibited significantly greater, clinically meaningful reductions in the PSQI total score than the SAA group (the changes of PSQI compared with baseline, AA: −6.6 points [95% CI −7.4 to −5.8], SAA: −2.5 points [95% CI −3.4 to −1.6]; MCII = 4), and PSQI was meaningfully and significantly lower in the AA compared with the SAA group (difference −4.2 points [95% CI −5.7 to −2.7]; P < 0.001; MCID = 3). Among the 7 subscales of PSQI, the AA group showed significantly greater improvements compared with the SAA group in the following subitems: sleep quality (difference 0.6 points [95% CI 0.2–1.0]; P < 0.001), sleep latency (difference 0.8 points [95% CI 0.4–1.1]; P < 0.001), and sleep duration (difference 1.2 points [95% CI 0.7–1.7]; P < 0.001). There were no significant differences in the use of sleep medications or daytime functional impairments (P = 0.128, 0.064). The changes in the 7 components of the PSQI are also given in Table 2 of supplementary 1 (http://links.lww.com/AJG/D837). The trends in response rate and changes in PSQI scores for both groups are presented in Figure 2. Notably, differences between the 2 groups emerged by week 2 and continued to improve through week 8. Similar results were observed in sensitivity analyses (Table 3 of supplementary 1, http://links.lww.com/AJG/D837).

Table 1.

Primary and secondary outcomes in the intention-to-treat population^a

Figure 2.

Response rate based on PSQI (a) and the change of PSQI (b) at each assessment time point. ***P < 0.001. AA, auricular acupressure; PSQI, Pittsburgh Sleep Quality Index; SAA, sham auricular acupressure.

Secondary outcomes

Table 1 summarizes the secondary outcomes. At week 8, the ITT analysis showed that the response rate in the AA group was significantly higher than in the SAA group (48.8% vs 22.0%, P < 0.001). In addition, the AA group exhibited significantly greater, clinically meaningful reductions in PSQI total score than the SAA group (the changes of PSQI compared with baseline, AA: −5.8 points [95% CI −6.7 to −4.9], SAA: −2.1 points [95% CI −2.9 to −1.3]; MCII = 4), and PSQI was meaningfully and significantly lower in the AA compared with SAA group (difference −3.8 points [95% CI −5.6 to −2.0]; P < 0.001; MCID = 3). The 7 subscales of PSQI showed similar trends at week 8 as at week 2. Objective sleep parameters recorded by actigraphy also showed statistically significant improvement in the AA group compared with the SAA group (ActiGraph Sleep Report of supplementary 1, http://links.lww.com/AJG/D837). However, no significant differences were observed between the groups in total sleep time and SE at week 8 (P = 0.468, 0.310). The mean change in the modified FDSD scores from baseline was significantly greater in the AA group compared with the SAA group, with differences of 11.4 (95% CI 7.2–15.6; P < 0.001) at week 2 and 10.3 (95% CI 7.0–13.3; P < 0.001) at week 8, respectively. Specific changes in dyspepsia symptoms at 2 and 8 weeks are given in Table 4 of supplementary 1 (http://links.lww.com/AJG/D837). Similar trends were observed in SF-NDI scores at 2 and 8 weeks, with intergroup differences of 5.3 (95% CI 0.5–10.1; P = 0.018) and 4.6 (95% CI 0.4–8.8; P = 0.033), respectively.

For negative emotions, patients in the AA group had a 7.9-point (95% CI 0.6–15.2) lower SAS score than those in the SAA group at week 8 (P = 0.025), whereas no significant difference was identified at week 2 (difference 5.3 [95% CI −2.0 to 12.6]; P = 0.65). The reduction in the SDS scores from baseline was also significantly higher in the AA group at week 8, compared with the SAA group (difference 10.5 [95% CI 1.0–20.0]; P = 0.025), whereas no significant difference was identified at week 2 between the 2 groups (difference 7.7 [95% CI −1.80 to 17.2]; P = 0.248). Adjusted GEE analyses for all secondary outcomes showed similar results (Table 5 of supplementary 1, http://links.lww.com/AJG/D837).

Mechanisms of AA involving autonomic functions

The mean change from baseline in HAS scores was significantly lower in the AA group compared with the SAA group, with between-group differences of 6.5 (95% CI 2.9–10.1; P < 0.001) at week 2 and 5.3 (95% CI 1.3–9.3; P = 0.002) at week 8. After 2 weeks of treatment, vagal nerve activity (HF component) in the AA group was significantly higher than in the SAA group, with differences of −0.4 (95% CI −0.6 to −0.2; P < 0.001) at week 2 and −0.4 (95% CI −0.5 to −0.3; P = 0.005) at week 8. Similar trends were observed for SDNN, RMSSD, and PNN50, indicating improvements in autonomic function in the AA group (Table 1).

Post hoc analysis

In the trial, 8 participants had a history of AA treatment before participating (Table 2). After excluding patients with previous AA experiences, the results indicated that the response rate difference between the AA group and the SAA group remained statistically significant (2 weeks: AA group: 46.3% vs SAA group: 24.4%, P < 0.001; 8 weeks: AA group: 41.5% vs SAA group: 17.1%, P < 0.001). This finding was consistent with the overall sample results, suggesting that a history of AA treatment did not have a significant impact on the core conclusions (Table 6 of supplementary 1, http://links.lww.com/AJG/D837).

Table 2.

Baseline characteristics of the intention-to-treat population^a

Subgroup analysis

Subgroup analyses of the primary outcome indicated a consistent benefit of AA over SAA across most subgroups (Figure 3 of supplementary 1, http://links.lww.com/AJG/D837). Among women, those receiving AA had a higher response rate (20/27) than those receiving SAA (11/27) (P = 0.015), whereas men showed a nonsignificant trend (11/14 vs 6/14, P = 0.061). Subgroup analysis further revealed AA's superiority in participants aged 40 years or older (P = 0.015) and H. pylori-negative patients (P = 0.012), but not in those older than 40 years (P = 0.073) and H. pylori-positive/unknown subgroups (P = 0.102, 0.309). There were no significant interactions in any of the subgroups (P > 0.10 for all comparisons).

Safety

Adverse events occurred in 6 of 41 patients (14.6%) in the AA group and 3 of 39 patients (7.7%) in the SAA group (P = 0.53). All adverse events were mild and localized, with 9 instances of local pain occurring after the first treatment. Other adverse reactions included skin redness and skin irritation. These events were self-limiting and resolved without medical intervention (Figure 3).

Figure 3.

Adverse events. AA, auricular acupressure; SAA, sham auricular acupressure.

Blinding quality

The results showed that 2 patients (4.9%) in the SAA group correctly guessed their treatment assignment, while 3 patients (7.3%) in the AA group also guessed correctly. This indicated that the blind method was successful. For details, see Blinding Assessment in supplementary 1 (http://links.lww.com/AJG/D837).

DISCUSSION

To our knowledge, this is the first study to demonstrate that AA is more effective than SAA in alleviating insomnia symptoms associated with FD over a 2-week treatment period. This study provides valuable evidence regarding the optimal dosing of AA protocols for FD-related insomnia. Notably, at the 8-week follow-up, the beneficial effects of AA persisted, indicating that the improvements were not short-lived and had statistical and clinical significance. Our findings show that AA significantly improved both subjective and objective sleep quality, alleviated dyspeptic symptoms, enhanced overall quality of life, and reduced negative emotions. No serious adverse events were reported throughout the trial. These results suggest that AA may be a safe and effective for patients experiencing FD with insomnia.

Previous studies on treatment for FD with insomnia have typically used longer durations of treatment (11,28,33). However, longer treatments present challenges for patients in time commitment and transportation. Based on clinical experience and literature review, we designed a 2-week treatment regimen for the first time. Our results showed that after AA treatment, the decrease in PSQI exceeded the MCID (3 points) and MCII (4 points), demonstrating improved sleep quality. However, no notable impact was observed on sleeping medication use or daytime dysfunction. Further analysis revealed that neither daytime dysfunction nor sleeping medication use was severe enough to account for any significant differences between the group posttreatment. Objective sleep parameters showed improvements, but there were no effects on SE at 8 weeks. This may be attributed to the longer durations typically required to observe objective improvements in SE. In addition, AA demonstrated a positive effect in women, participants younger than 40 years, and those without current H. pylori infection. However, owing to the limited sample size, these findings are exploratory and should be interpreted with caution. Future studies with larger samples and prospective designs (e.g., sex-stratified randomization) are needed to verify these findings.

AA also showed advantages in improving FD symptoms and quality of life. Although AA seemed to improve anxiety and depression, there was no statistically significant difference at 2 weeks. Further analysis revealed that the SAA group had a significant reduction in both the SAS and SDS scores at 2 weeks, with reductions of approximately 11 points and 4 points, respectively, by 8 weeks. This suggests a placebo effect in the SAA group in the short term, which diminished over time, while the treatment effect in the AA group was sustained. There are 2 primary explanations for this observation. First, since all participants were Chinese, anxiety and depression are inherently subjective symptoms, making them particularly susceptible to the placebo effect when treated with traditional Chinese therapies. Second, although blinding was successful, a small percentage of patients in the SAA group correctly guessed their treatment allocation, which may have heightened their treatment expectations and thus increased the placebo response.

AA has significant advantages over existing treatments for FD and insomnia. First, AA is convenient and easy to manage. Unlike other alternative therapies, AA does not depend on specific venues or equipment, enhancing patient compliance and clinical efficacy, particularly in resource-limited settings (34). This is supported by the AA record form, which showed a high number of scheduled treatments, indicating good patient acceptance. Second, AA provides a low-cost, patient-friendly treatment option that compares favorably with western medications. Previous systematic reviews of AA-associated adverse events have found most to be transient and mild (35). In our study, adverse events were mild and self-limiting. Finally, AA has the potential to achieve multiple therapeutic goals. It may improve both sleep quality and gastrointestinal function by stimulating the vagus nerve.

The brain-gut axis has received increasing attention in recent years as a key link between the emotional and cognitive centers of the brain and peripheral intestinal functions. This bidirectional communication between the central and enteric nervous systems plays a significant role in conditions such as FD (36). Previous studies have indicated that delayed proximal gastric emptying in patients with FD may be related to reduced vagus nerve activity (37). Stimulation of the auricular vagus nerve can modulate functional connectivity within the cerebral cortex and the default mode network in patients suffering from insomnia by influencing the nucleus of the solitary tract-limbic nucleus pathway (35). In our study, AA reduced hyperarousal states while simultaneously increasing vagal activity. Furthermore, the microbiome serves as a functional and anatomical foundation for gastrointestinal tract-brain interactions (38,39). Through the microbial-gut-brain axis, gut microbiota modulates brain function through neurotransmitter (e.g., serotonin) and inflammatory mediator release. These substances influence mood, cognition, and behavior, subsequently regulating gastrointestinal function (40,41). Future studies will use gene sequencing, microbial profiling, and multimodal magnetic resonance imaging to elucidate the specific mechanisms by which AA treats patients with FD accompanied by insomnia from a microbial-gut-brain axis perspective.

Our study has several limitations. First, prokinetic agents and antidepressants were not used in this study. It remains unclear whether AA has a synergistic effect when combined with these drugs for treating FD with insomnia, which warrants further investigation. Second, the small sample size of the subgroup limits the generalizability of our subgroup analysis results. Larger sample sizes are needed to confirm the specific effects of AA on different populations. Finally, this study did not assess participants' familiarity with AA or other techniques in TCM. Given that all participants were Chinese and thus generally more receptive to TCM culture, a potential placebo effect might have occurred, possibly leading to an underestimation of AA's true efficacy. Future studies will use a personalized sham control design, incorporate validated tools for assessing placebo effects, and use functional imaging techniques to examine the specificity of acupoints. In addition, participants from diverse cultural backgrounds will be included, and the impact of prior familiarity with TCM on treatment outcomes will be analyzed through stratified methods. These improvements aim to enhance the rigor of the sham group and minimize cultural bias.

In conclusion, a 2-week AA treatment seems to be an effective and safe alternative therapy for treating insomnia in patients with FD. Further research should focus on longer follow-up periods and delve deeper into the specific mechanisms underlying AA's effects.

CONFLICTS OF INTEREST

Guarantor of the article: Jian-Nong Wu, MD.

Specific author contributions: J.-N.W. and M.L.: conceptualization, investigation, resources, data curation, writing—review and editing, visualization. M.-Y.S. and L.-X.J.: conceptualization, investigation, methodology, software, writing—original draft. Z.-J.L.: writing—review and editing, visualization, supervision. Z.-K.Y.: methodology, software, supervision. Q.-Y.L.: writing—review and editing, visualization. S.L. and J.-X.W.: formal analysis, software, methodology. D.-D.F., D.-D.Y., and R.Z.: visualization, supervision. X.-L.W.: methodology, visualization.

Financial support: This work was supported by the National Natural Science Foundation of China (grant numbers 82174178) and the Zhejiang Provincial Administration of Traditional Chinese Medicine major project (grant number GZY-ZJ-KJ-23015).

Potential competing interests: None to report.

Ethics committee and clinical trials: The study protocol was approved by the Ethics Committee of the Zhejiang Provincial Hospital of Traditional Chinese Medicine and is registered on ClinicalTrials.gov (NCT06466044).

Data availability statement: All individual participant data collected during the study after deidentification are available to scientific researchers on reasonable request through the first or last author, from immediately after publication until 10 years later. All data will be kept for 10 years. The study protocol was published in Frontiers in Medicine (DOI:10.3389/fmed.2025.1496502), the details in the supplementary 2 (http://links.lww.com/AJG/D838).

Study Highlights.

WHAT IS KNOWN

• ✓ Auricular acupressure (AA) has been recommended for the management of functional dyspepsia and insomnia, but the evidence for their effectiveness is inconsistent. The aim was to determine the effect of AA on patients with functional dyspepsia and insomnia.

WHAT IS NEW HERE

• ✓ AA achieved higher response rates and maintained the benefits over an 8-week follow-up period.

• ✓ AA effectively improved indigestion symptoms, quality of life, anxiety, and depression during treatment.

• ✓ AA suppressed the patient's hyperarousal state and increased vagal nerve activity.

• ✓ Adverse events were all mild and comparable.

Supplementary Material

acg-121-2313-s001.docx ^{(9.2MB, docx)}

acg-121-2313-s002.docx ^{(3.7MB, docx)}

ABBREVIATIONS:

AA

auricular acupressure

BMI

body mass index

CI

confidence interval

FD

functional dyspepsia

FDSD

Functional Dyspepsia Symptom Diary

GEE

generalized estimating equation

H. pylori

Helicobacter pylori

HAS

Hyperarousal Scale

HF

high frequency

HRV

heart rate variability

ITT

intention-to-treat

MCID

minimal clinically important difference

MCII

minimal clinically important improvement

PNN50

percentage of successive normal-to-normal intervals that differ by more than 50 ms

PSQI

Pittsburgh Sleep Quality Index

RMSSD

root mean square of successive differences

SAA

sham auricular acupressure

SAS

Self-Rating Anxiety Scale

SDNN

standard deviation of normal-to-normal intervals

SDS

Self-Rating Depression Scale

SE

sleep efficiency

SF-NDI

Short-Form Nepean Dyspepsia Index

SL

sleep latency

TCM

Traditional Chinese Medicine

TST

total sleep time

WASO

wake after sleep onset