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Study protocol for a prospective, investigator-initiated clinical trial on the vascular effects of acupuncture in the abdomen and lower limbs for patients with diarrhea-predominant irritable bowel syndrome.

International journal of colorectal disease
April 25, 2025
Seok-Hee Jeon et al. (11 authors)
Journal ArticleClinical Trial ProtocolRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the effects of abdominal acupuncture versus lower limb acupuncture on IBS-D symptom relief and gut microbial diversity.

Results Summary

The study was designed to evaluate differences in symptom relief and microbiota adaptation between local (abdominal) and systemic (lower limb) acupuncture techniques. Preliminary data suggested that IBS-D treatment may need to be personalized, though final results were not yet reported.

Population

36 participants diagnosed with IBS-D via Rome IV criteria.

Effective Dosage

Eight acupuncture sessions distributed over 4 weeks.

Duration

4 weeks

Interactions

None mentioned

Extracted Claims (7)
InterventionDirectionEndpointPopulationDosageImpactClaim #
acupuncture treatments using local and systemic needling techniques
neutral
IBS-D symptom expression and gut microbial diversity features
participants diagnosed with IBS-D via Rome IV criteria
-
investigates the effects
#1
abdominal acupuncture
neutral
symptom relief and microbiota adaptation outcomes
participants diagnosed with IBS-D via Rome IV criteria
-
compare in symptom relief and microbiota adaptation outcomes
#2
lower limb acupuncture
neutral
symptom relief and microbiota adaptation outcomes
participants diagnosed with IBS-D via Rome IV criteria
-
compare in symptom relief and microbiota adaptation outcomes
#3
standard treatment
neutral
-
participants diagnosed with IBS-D via Rome IV criteria
-
provided to participants
#4
acupuncture treatment
neutral
-
participants diagnosed with IBS-D via Rome IV criteria
-
receive eight sessions
#5
abdominal and lower limb acupuncture techniques
neutral
symptom relief and microbiota adaptation outcomes
participants diagnosed with IBS-D via Rome IV criteria
-
compare in symptom relief and microbiota adaptation outcomes
#6
abdominal and lower limb acupuncture treatment
neutral
acupuncture therapy benefit for IBS-D
participants diagnosed with IBS-D via Rome IV criteria
-
adds to our understanding of acupuncture therapy benefit
#7
Abstract

BACKGROUND: Physicians classify irritable bowel syndrome with diarrhea symptoms under the label IBS-D which represents a gastrointestinal disorder that meets specific functional diagnostic criteria. Studies show acupuncture helps manage IBS-D symptoms though researchers do not understand if specific treatment points in the abdomen provide better outcomes than standard acupuncture points in the lower body regions. The study investigates the effects acupuncture treatments using local and systemic needling techniques have on IBS-D symptom expression and gut microbial diversity features. METHODS: The study employs a randomized controlled single-blinded exploratory clinical trial design which includes 36 participants diagnosed with IBS-D via Rome IV criteria. Participants are randomly allocated to one of three groups: abdominal acupuncture, lower limb acupuncture, or standard treatment. Participants who receive acupuncture treatment receive eight sessions which are distributed throughout 4 weeks as clinicians activate specific points connected to gastrointestinal function. Lifestyle education and approved medications with symptom management make up the standard treatment provided to participants. The main outcome measures assess IBS Symptom Severity Scale (IBS-SSS) score changes from baseline at Week 5. Additional evaluation measures in this study comprise stool consistency examination alongside patient global assessments and cold-heat surveys along with EQ-5D-5L quality of life assessment and gut microbiota examination as secondary outcomes. RESULTS: Research has been designed to evaluate how abdominal and lower limb acupuncture techniques compare in symptom relief and microbiota adaptation outcomes. The preliminary data is expected to reveal distinct patterns between local and wide-reaching effects which suggests that IBS-D treatment should be tailored on a personal basis. CONCLUSION: The comparison of abdominal and lower limb acupuncture treatment efficacy adds to our understanding of acupuncture therapy benefit for IBS-D. The results will help guide clinical practice and support the creation of tailored acupuncture treatments.

Medical Subject Headings (MeSH)
HumansIrritable Bowel SyndromeAcupuncture TherapyDiarrheaLower ExtremityProspective StudiesAbdomenTreatment OutcomeQuality of LifeFemaleGastrointestinal MicrobiomeAdultMaleMiddle Aged
Study Links
Quality Scores
SafetyNot Assessed
Efficacy70/10
Quality80/10
Research Impact Scores
APT Score0.05
Weight Score2.60
Normalized Score0.64
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