Acupuncture for Irritable Bowel Syndrome (IBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00093327
Recruitment Status : Completed
First Posted : October 8, 2004
Last Update Posted : August 18, 2006
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Brief Summary:
The purpose of this study is to determine whether acupuncture is effective in reducing the symptoms of irritable bowel syndrome (IBS).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Procedure: Acupuncture Phase 2

Detailed Description:

IBS is a disorder that affects colon functioning. Although it does not cause permanent harm or lead to more serious conditions, IBS can cause a great deal of discomfort and distress. The effectiveness of acupuncture in treating various conditions has been investigated in numerous studies. However, little is known about acupuncture's efficacy in treating IBS. This study will determine whether acupuncture can alleviate the symptoms of IBS, including pain relief with defecation, changes in stools, and changes in the frequency of bowel movements.

Participants in this study will be randomly assigned to receive bi-weekly sessions of either active or placebo acupuncture or no treatment for 6 weeks. Study visits will occur at study start, Week 3, and Week 6 (study completion). At each study visit, blood collection will occur to measure levels of cortisol, a stress hormone associated with IBS. Participants will also complete questionnaires about their IBS symptoms. Selected participants will be interviewed at each visit, in order to determine whether participants' interpretations and understanding of IBS influences their response to treatment. Any subject who does not receive active acupuncture during the trial is eligible for 6 free acupuncture treatments after the study is over.

Study Type : Interventional  (Clinical Trial)
Enrollment : 287 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Acupuncture for Irritable Bowel Syndrome (IBS) Trial
Study Start Date : September 2003
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Irritable bowel syndrome of moderate severity for at least 12 weeks within 1 year prior to study entry
  • Colonoscopy or flexible sigmoidoscopy/air contrast barium enema within 5 years prior to study entry
  • Able to walk
  • Able and willing to cooperate with the study
  • Sufficient knowledge of English to be able to participate in the study

Exclusion Criteria:

  • Medications that affect the gastrointestinal tract or visceral sensation, unless the participant is on a stable dose for at least 1 month prior to study entry and for the duration of the study
  • History of severe or intractable IBS
  • History of acupuncture treatment
  • Score between 37 and 150 on the Functional Bowel Disorder Severity Index (FBDSI)
  • Any concomitant bowel problem that would interfere with the study
  • History of laxative abuse
  • Abdominal surgery, with the exception of uncomplicated removal of the appendix, uterus, or gallbladder more than 6 months prior to study entry
  • History of metabolic or inflammatory disease that may affect bowel movement
  • History of significant psychiatric, neurological, metabolic, hepatic, renal, infectious, hematological, cardiovascular, gastrointestinal, or pulmonary illness. Participants who are stable for more than 1 year with conditions that will not interfere with the study are not excluded.
  • History of drug or alcohol abuse within 2 years prior to study entry
  • Positive for opiates at the initial visit drug screen
  • Abnormal vital signs, physical examination results, or clinical laboratory values, unless these abnormalities are judged to be clinically insignificant
  • Pregnancy or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00093327

United States, Massachusetts
Beth Israel Deaconess Medical Center, General Clinical Research Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Ted Kaptchuk, OMD Beth Israel Deaconess Medical Center Identifier: NCT00093327     History of Changes
Other Study ID Numbers: R01AT001414-01 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2004    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: August 2006

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases