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Published on: July 5, 2024
Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation: A Multicenter, Randomized
Tangyi Liu1, Zeyu Wang1, Yunling Li2
1State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Air Force Medical University, Xi'an, China.
Transcutaneous auricular vagal nerve stimulation (taVNS) showed no significant benefit for chronic constipation in adults. This 4-week study found similar response rates between taVNS and sham treatments, indicating limited efficacy.
Area of Science:
- Gastroenterology
- Neurology
- Medical Devices
Background:
- Chronic constipation affects a significant portion of the adult population, impacting quality of life.
- Current treatment options for chronic constipation have limitations and variable efficacy.
- Transcutaneous auricular vagal nerve stimulation (taVNS) is an emerging neuromodulation technique with potential therapeutic applications.
Purpose of the Study:
- To evaluate the efficacy and safety of transcutaneous auricular vagal nerve stimulation (taVNS) as a treatment for adult patients diagnosed with chronic constipation.
- To compare the effectiveness of active taVNS against a sham procedure in improving bowel function and related symptoms.
Main Methods:
- A randomized controlled trial design was employed, enrolling adult patients meeting Rome IV criteria for chronic constipation.
- Participants were assigned to either active taVNS or sham-taVNS, receiving 30-minute sessions twice daily for four weeks.
- Primary outcome was the response rate, defined by complete spontaneous bowel movements and reduced rescue medication use; secondary outcomes included symptom scores and adverse events.
Main Results:
- The study was terminated early due to a lack of efficacy observed during interim analysis.
- After four weeks, response rates were comparable between the taVNS group (17%) and the sham-taVNS group (19%), with no statistically significant difference.
- No serious adverse events were reported, suggesting a favorable safety profile for taVNS in this population.
Conclusions:
- Four weeks of 25 Hz taVNS did not demonstrate effectiveness in treating adult chronic constipation.
- The findings do not support the use of taVNS as a therapeutic intervention for this condition based on the study's parameters.
- Further research may be needed to explore different taVNS parameters or patient populations, but current evidence is unsupportive.
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