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Acupuncture/Moxibustion for Irritable Bowel Syndrome (IBS) (Acu/MoxaIBS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00945074
First Posted: July 23, 2009
Last Update Posted: September 22, 2016
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.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Joyce K. Anastasi, New York University
  Purpose

The objective of this study is to test the efficacy of a symptom management treatment strategy, namely, Acupuncture/Moxibustion (Acu/Moxa) to improve the symptoms associated with Irritable Bowel Syndrome (IBS) in persons between the ages of 18 to 70 years.

IBS has been defined as abdominal pain or discomfort in the mid or lower gastrointestinal (GI) tract, associated with defecation or a change in bowel patterns and with features of disordered defecation. Current therapies include dietary modification, psychotherapy and pharmacological therapies. Traditional eastern approaches offer a therapeutic approach to symptom management that is subtle, holistic and holds promise as an intervention for IBS.

This study will enroll 171 men and women experiencing IBS with diarrhea (IBS-D) defined by the ROME III criteria. Subjects will be randomized (by chance) to one of three experimental intervention conditions: Condition 1,subjects receive Standard Acu/Moxa; Condition 2, subjects receive Individualized Acu/Moxa and Condition 3, subjects receive Sham Acupuncture/Placebo Moxibustion(control group).

Subjects will attend a screening/intake session followed by two treatment sessions per week for 4 weeks, one treatment session per week for 4 weeks, and 2 non-treatment follow-up sessions at weeks 12 and 24. All subjects will be assessed by a diagnostic acupuncturist (blinded to treatment assignments), receive interventions appropriate to their condition assignment by treating acupuncturists, be administered the same instruments, and submit their symptom diaries for data entry and analysis. All subjects will complete a prospective symptom diary for the duration of the study.


Condition Intervention Phase
Irritable Bowel Syndrome Other: Standard Acupuncture/Moxibustion (fixed protocol) Other: Individualized Acupuncture/Moxibustion Other: Sham/Placebo Acupuncture/Moxibustion Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Protocol- vs. Patient-Oriented TCM Practices: A RCT for IBS Symptom Management

Resource links provided by NLM:


Further study details as provided by Joyce K. Anastasi, New York University:

Primary Outcome Measures:
  • Patient-rated abdominal pain/discomfort and IBS-Secondary symptom rating: intestinal gas, bloating and stool consistency [ Time Frame: Six months ]

Secondary Outcome Measures:
  • Global improvement (CGIS) [ Time Frame: Six months ]
  • Quality of life (IBS-QOL & SF-36) [ Time Frame: Six months ]
  • Psychological distress (SCL-90) [ Time Frame: Six months ]

Estimated Enrollment: 171
Study Start Date: July 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Condition 1

Condition 1:

Subjects receive Standard Acu/Moxa (fixed protocol)

Other: Standard Acupuncture/Moxibustion (fixed protocol)
Acupuncture/Moxibustion
Experimental: Condition 2: Individualized Acupuncture/Moxibustion

Condition 2:

Subjects receive Individualized Acupuncture/Moxibustion (patient-oriented, based on traditional Chinese medicine diagnosis).

Other: Individualized Acupuncture/Moxibustion
Individualized Tailored Acupuncture/Moxibustion Protocol based on TCM Diagnosis
Sham Comparator: Condition 3: Control

Condition 3:

Subjects receive Sham Acupuncture/Placebo Moxibustion (control group)

Other: Sham/Placebo Acupuncture/Moxibustion
Sham/Placebo Acupuncture/Moxibustion Protocol: Not-Active

  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 18 to 70 years of age who have a prior diagnosis of IBS (6 months or greater)
  • Verification/documentation of subject's diagnosis of IBS (ROME III criteria).
  • Subjects must be experiencing recurrent abdominal pain/discomfort with two or more of the following, as described in the Rome III criteria: (1) Improvement with defecation; and/or (2) Onset associated with a change in frequency of stool; and/or (3) Onset associated with a change in form (appearance) of stool.
  • Four-week prospective daily symptom diary must show: IBS with diarrhea IBS-D), defined by ROME III
  • Subjects agree to complete symptom diaries and return completed diaries at all sessions.
  • Women of childbearing age must agree to use an acceptable method of contraception.
  • Subjects may be on antidepressants(on stable regimen for at least 6 months)

Exclusion Criteria:

  • Individuals who have IBS-Mixed, IBS-Unspecified or IBS-Constipation
  • Individuals who have a history of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology (eg., colon cancer, colitis, Crohn's, celiac, endometriosis, prostate cancer) or lactose intolerance
  • Individuals experiencing alarm symptoms according to Rome III
  • Abdominal surgery, with the exception of uncomplicated removal of the appendix, uterus, or gallbladder more than 6 months prior to study entry.
  • Individuals who are currently taking the following medications more than 3 days a week: antibiotics, narcotics, cholestyramine, colchicine, iron supplements, antispasmotics, benzodiazepines
  • Individuals currently receiving other types of complementary therapies such as herbs, massage, reiki etc.;Individuals receiving behavioral therapies for IBS; Individuals receiving physical therapy for pelvic pain
  • Pregnant women.
  • Individuals with an acute medical condition, i.e., pneumonia and/or conditions that requiring acute medical attention.
  • Individuals with asthma or smoke allergy
  • Individuals receiving acupuncture currently and less than 6 months prior to enrollment and/or history of receiving moxibustion
  • Individuals with plans for travel, lifestyle change, or other activity that would preclude attending the planned study sessions or recording daily dietary information.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00945074


Locations
United States, New York
New York University, Division of Special Studies in Symptom Management
New York, New York, United States, 10010
Sponsors and Collaborators
New York University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Joyce K Anastasi, PhD, DrNP, FAAN, LAc New York University
  More Information

Responsible Party: Joyce K. Anastasi, Principal Investigator, New York University
ClinicalTrials.gov Identifier: NCT00945074     History of Changes
Other Study ID Numbers: 7833948
R01NR010730 ( U.S. NIH Grant/Contract )
First Submitted: July 21, 2009
First Posted: July 23, 2009
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Joyce K. Anastasi, New York University:
Acupuncture
Moxibustion
Traditional Chinese Medicine
Complementary Medicine
Irritable Bowel Syndrome
IBS

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