Acupuncture for Irritable Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Keywords

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Irritable Bowel Syndrome Acupuncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Acupuncture

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ted Kaptchuk, OMD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Locations

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Harvard Medical School

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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. doi: 10.1136/bmj.39524.439618.25. Epub 2008 Apr 3.

Reference Type DERIVED

PMID: 18390493 (View on PubMed)

Other Identifiers

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KaptchukTJ

Identifier Type: -

Identifier Source: secondary_id

R01AT001414

Identifier Type: NIH

Identifier Source: org_study_id

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