The study was conducted by Jian-Nong Wu from the Department of Intensive Care Unit, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China, along with colleagues. The researchers aimed to evaluate the clinical effectiveness and safety of auricular acupressure for insomnia in FD patients, an area where high-quality evidence has been limited.
In this trial, adults diagnosed with both functional dyspepsia and insomnia were randomly assigned to receive either active auricular acupressure or sham auricular acupressure. The active treatment targeted specific points in the ear concha region, while the sham intervention involved stimulation of the earlobe, an area not traditionally linked to therapeutic effects. Treatments were administered three times daily, on alternate days, over two weeks.
The primary outcome was improvement in sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI). A clinical response was defined as at least a 50% reduction in PSQI scores at the end of two weeks. Additional outcomes included sustained response at eight weeks, objective sleep parameters measured by actigraphy, changes in FD symptoms, quality of life, mental health measures, and autonomic nervous system function.
The key findings were as follows:
- The study enrolled 82 participants, with 41 patients assigned to the auricular acupressure group and 41 to the sham group.
- After two weeks of treatment, more than half of the patients receiving auricular acupressure showed significant improvement in sleep quality, compared with fewer than one-third in the sham group.
- The difference in response rates between the two groups was both statistically significant and clinically meaningful.
- Improvements in sleep quality in the auricular acupressure group were maintained throughout the eight-week post-treatment follow-up period.
- Secondary analyses indicated improvements in sleep-related parameters and overall well-being among patients with functional dyspepsia.
- Auricular acupressure was well tolerated, with only mild adverse events reported.
- The frequency and severity of adverse events were similar in both the active and sham groups, with no serious treatment-related complications observed.
The authors noted key limitations, including the small sample size, exclusion of standard medications, and possible placebo effects due to cultural familiarity with traditional Chinese medicine.
Despite these constraints, the study suggests that auricular acupressure is a safe and effective short-term, non-pharmacological option for improving insomnia in patients with functional dyspepsia. The researchers call for larger, multicenter trials with longer follow-up to better define its clinical role and mechanisms.
Reference:
Shen, Meng-Yuan MD1,*; Li, Ze-Jiong MMed1,*; Zhou, Rong MMed1; Lou, Qin-Yi MMed1; Ying, Zhe-Kai MMed1; Liu, Shan MD1; Feng, Dan-Dan MMed2; Yang, Dong-Dong MD1; Jiang, Ling-Xia MMed3; Wang, Xiao-Le MMed4; Wu, Jian-Xiong MD5; Li, Meng MD6; Wu, Jian-Nong MD2. Efficacy and Safety of Auricular Acupressure for Insomnia in Patients With Functional Dyspepsia: A Randomized Controlled Trial. The American Journal of Gastroenterology ():10.14309/ajg.0000000000003880, December 10, 2025. | DOI: 10.14309/ajg.0000000000003880
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