Acupuncture for Irritable Bowel Syndrome

This study has been completed.

First Received on July 22, 2003. Last Updated on August 16, 2006 History of Changes

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Collaborator:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00065403

Purpose

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.

Condition	Intervention	Phase
Irritable Bowel Syndrome	Device: Acupuncture	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	260
Study Start Date:	February 2004
Estimated Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065403

Locations

United States, Massachusetts
Harvard Medical School
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Ted Kaptchuk, OMD

Harvard University

More Information

No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00065403 History of Changes
Other Study ID Numbers:	R01 AT001414, KaptchukTJ
Study First Received:	July 22, 2003
Last Updated:	August 16, 2006
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Irritable Bowel Syndrome
Acupuncture

Additional relevant MeSH terms:

Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases

Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 12, 2012