Abstract
Background and Aims
Sacral nerve stimulation (SNS) showed anti-inflammatory properties in animal models
of inflammatory bowel disease. We aimed to evaluate the effectiveness and safety of
SNS in patients with ulcerative colitis (UC).
Materials and Methods
Twenty-six patients with mild and moderate disease were randomized into two groups:
SNS (delivered at S3 and S4 sacral foramina) and sham-SNS (delivered 8–10 mm away
from sacral foramina), with the therapy applied once daily for one hour, for two weeks.
We evaluated the Mayo score and several exploratory biomarkers, including C-reactive
protein in the plasma, pro-inflammatory cytokines and norepinephrine in the serum,
assessment of autonomic activity, and diversity and abundance of fecal microbiota
species.
Results
After two weeks, 73% of the subjects in the SNS group achieved clinical response,
compared with 27% in the sham-SNS group. Levels of C-reactive protein, pro-inflammatory
cytokines in the serum, and autonomic activity were significantly improved toward
a healthy profile in the SNS group but not in the sham-SNS group. Absolute abundance
of fecal microbiota species and one of the metabolic pathways were changed in the
SNS group but not in the sham-SNS group. Significant correlations were observed between
pro-inflammatory cytokines and norepinephrine in the serum on the one side and fecal
microbiota phyla on the other side.
Conclusions
Patients with mild and moderate UC were responsive to a two-week SNS therapy. After
performing further studies to evaluate its efficacy and safety, temporary SNS delivered
through acupuncture needles may become a useful screening tool for identifying SNS
therapy responders before considering long-term implantation of the implantable pulse
generator and SNS leads for performing long-term SNS therapy.
Keywords
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Article info
Publication history
Published online: April 11, 2023
Accepted:
January 3,
2023
Received in revised form:
December 24,
2022
Received:
February 11,
2022
Publication stage
In Press Corrected ProofFootnotes
Source(s) of financial support: This work was supported by the grants from Jiangsu Science and Technology Department (BE2018612 and BE2022673), Jiangsu Provincial Medical Youth Talent Project for Invigorating Health Care through Science, Technology and Education (SQWR-201701 and QNRC2016130), and Nanjing Medical Science and Technique Development Foundation (YKK19096).
Conflict of Interest: Victor Pikov is an employee at Medipace Inc, which has an interest in the field of sacral nerve stimulation to treat inflammatory bowel disease. Min Ni and Victor Pikov are listed as inventors on a patent application for the use of sacral nerve stimulation in inflammatory bowel disease. The remaining authors report no conflict of interest.
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© 2023 Published by Elsevier Inc. on behalf of the International Neuromodulation Society.
