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Effect of Acupuncture on Symptoms of Diarrhea and Pain in 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: NCT00219505
Recruitment Status : Terminated (no eligible subjects identified during recruitment)
First Posted : September 22, 2005
Last Update Posted : November 24, 2017
American College of Gastroenterology
Information provided by (Responsible Party):
Penn State University

Brief Summary:
Acupuncture has been used for centuries in China in the treatment of diarrhea. Our hypothesis is that acupuncture is effective in the treatment of abdominal pain and diarrhea in patients with diarrhea-predominant IBS

Condition or disease Intervention/treatment
Irritable Bowel Syndrome Procedure: acupuncture

Detailed Description:
Patients will complete a diary to determine if they qualify for the study. Patients will be randomized to receive either acupuncture or sham acupuncture (needle insertion 1 cm away from acupuncture site). Patients will be blinded to whether they are receiving acupuncture or sham acupuncture. The acupuncturist is blinded as to the patient response. The patients will undergo venupuncture to draw blood to determine sertotonin and beta-endorphin levels. They will receive treatment in 12 sessions over 4 weeks. They will maintain a diary during this time period to document level of pain and frequency of bowel movements. Blood will be drawn at week 2 and 4 and, 6 weeks after cessation of treatment, subjects will again record abdominal symptoms and frequency of bowel movements for 2 weeks. Blood will be drawn for hormone levels at 8 weeks after completion of study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Effect of Acupuncture on Symptoms of Diarrhea and Pain in Diarrhea Predominant Irritable Bowel Syndrome (IBS) and Effect on Plasma Beta-endorphin and Serotonin Levels.
Study Start Date : August 2001
Estimated Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Frequency of bowel movement

Secondary Outcome Measures :
  1. Abdominal pain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • frequence of bowel movement of at least 3/day
  • global disease severity of at least 3

Exclusion Criteria:

  • taking medications which will influence frequency of bowel movement
  • patient taking anticoagulants or suffering from coagulopathy
  • pregancy

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): NCT00219505

United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
American College of Gastroenterology
Principal Investigator: Ann Ouyangm, MD Penn State College of Medicine and Penn State Milton S. Hershey Medical Center

Responsible Party: Penn State University Identifier: NCT00219505     History of Changes
Other Study ID Numbers: 2000-343
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by Penn State University:
Diarrhea-predominant irritable bowel syndrome
abdominal pain

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