Acupuncture for Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00065403
First received: July 22, 2003
Last updated: August 16, 2006
Last verified: August 2006

July 22, 2003
August 16, 2006
February 2004
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Complete list of historical versions of study NCT00065403 on ClinicalTrials.gov Archive Site
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Acupuncture for Irritable Bowel Syndrome
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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.

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Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Irritable Bowel Syndrome
Device: Acupuncture
Not Provided
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. Epub 2008 Apr 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
September 2005
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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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00065403
R01 AT001414, KaptchukTJ
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National Center for Complementary and Alternative Medicine (NCCAM)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Ted Kaptchuk, OMD Harvard Medical School
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP