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
  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 1
Phase 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Ted Kaptchuk, OMD Harvard Medical School
  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):
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:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014