Acupuncture for Irritable Bowel Syndrome

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00065403

Enrollment

260

Registered

2003-07-23

Start date

2004-02-29

Completion date

2005-09-30

Last updated

2006-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, Acupuncture

Brief summary

Little is known about acupuncture's efficacy for Irritable Bowel Syndrome (IBS). This trial uses a manualized acupuncture treatment format that closely follows clinical practice and allows flexibility in designing individualized treatments. In addition, a second parallel qualitative study will follow a subgroup of patients throughout the trial to explore the relationships between patients' interpretations and understandings (what anthropologists call meaning) of irritable bowel and their response to treatment. Cortisol levels (an important stress hormone) will also be assessed. This will be a 3-arm trial: Active acupuncture, placebo acupuncture, and wait list.

Interventions

DEVICEAcupuncture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Diagnosis of Irritable Bowel Syndrome based on Rome II criteria, including at least 12 weeks of abdominal discomfort or pain in the last 12 months with at least 2 of the following features: * Relief with defecation * Onset associated with a change in stool frequency * Onset associated with a change in form/appearance of stool

Exclusion criteria

* History of severe or intractable IBS, defined as continuous, unremitting and several abdominal pain greater than 12 hours/day * Previous acupuncture treatment * Concurrent diagnosis of any bowel disturbance that would interfere with the assessment or safety of the study * History of laxative abuse * Previous abdominal surgery (uncomplicated appendectomy, hysterectomy or cholecystectomy at least 6 months prior to entry acceptable) * History of metabolic or inflammatory disease that may affect bowel motility, eg.g., inflammatory bowel disease, diabetes mellitus, sarcoidosis * Other significant illness as determined by Investigator * History of drug or alcohol abuse w/in 2 years; * Insufficient knowledge of English to complete self-assessments to participate in study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026