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Acupuncture for Irritable Bowel Syndrome



Acupuncture for Irritable Bowel Syndrome

For Condition: Irritable Bowel Syndrome
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 260

Location and Contact Information:

Harvard Medical School *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting Ted  Kaptchuk 617-384-8550


Additional Information:
Study ID Numbers:
  R01AT001414;  KaptchukTJ
Study Start Date: February 2004
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065403

Other Irritable Bowel Syndrome Studies:
1. Brain Imaging and Pain in Irritable Bowel Syndrome

2. Acupuncture for Irritable Bowel Syndrome

3. Genetics of Fibromyalgia

4. Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

5. Treatment of Functional Bowel Disorders

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