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Acupuncture for Irritable Bowel Syndrome - Article


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Irritable Bowel Syndrome

Irritable Bowel Syndrome (IBS); Spastic Colon 




Clinical Trial: Acupuncture for Irritable Bowel Syndrome

This study is currently recruiting patients.

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

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 Treatment or Intervention Phase
Irritable Bowel Syndrome
 Device: Acupuncture
Phase I
Phase II

MedlinePlus related topics:  Irritable Bowel Syndrome

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  260

Study start: February 2004;  Expected completion: September 2005

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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

Location and Contact Information

Ted J. Kaptchuk, OMD      617-384-8550    ted_kaptchuk@hms.harvard.edu
Lisa Conboy, PhD      617-384-8565    lisa_conboy@hms.harvard.edu

Massachusetts
      Harvard Medical School, Boston,  Massachusetts,  02115,  United States; Recruiting
Ted Kaptchuk, OMD  617-384-8550    ted_kaptchuk@hms.harvard.edu 
Ted J. Kaptchuk, OMD,  Principal Investigator

More Information

Study ID Numbers:  R01AT001414; KaptchukTJ
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  July 22, 2003
ClinicalTrials.gov Identifier:  NCT00065403
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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December 2, 2009



Page Updated: October 15, 2009
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