Acupuncture for Irritable Bowel Syndrome
2 other identifiers
interventional
260
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2003
CompletedFirst Posted
Study publicly available on registry
July 23, 2003
CompletedStudy Start
First participant enrolled
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedAugust 18, 2006
August 1, 2006
July 22, 2003
August 16, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Harvard Medical School
Boston, Massachusetts, 02115, United States
Related Publications (1)
Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, Kirsch I, Schyner RN, Nam BH, Nguyen LT, Park M, Rivers AL, McManus C, Kokkotou E, Drossman DA, Goldman P, Lembo AJ. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008 May 3;336(7651):999-1003. doi: 10.1136/bmj.39524.439618.25. Epub 2008 Apr 3.
PMID: 18390493DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ted Kaptchuk, OMD
Harvard Medical School (HMS and HSDM)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
July 22, 2003
First Posted
July 23, 2003
Study Start
February 1, 2004
Study Completion
September 1, 2005
Last Updated
August 18, 2006
Record last verified: 2006-08