Acupuncture/Moxibustion for Irritable Bowel Syndrome (IBS) (Acu/MoxaIBS)
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.
|Irritable Bowel Syndrome||Other: Standard Acupuncture/Moxibustion (fixed protocol) Other: Individualized Acupuncture/Moxibustion Other: Sham/Placebo Acupuncture/Moxibustion||Phase 2|
|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|
- Patient-rated abdominal pain/discomfort and IBS-Secondary symptom rating: intestinal gas, bloating and stool consistency [ Time Frame: Six months ]
- 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 ]
|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)|
Experimental: Condition 1
Subjects receive Standard Acu/Moxa (fixed protocol)
Other: Standard Acupuncture/Moxibustion (fixed protocol)
Experimental: Condition 2: Individualized Acupuncture/Moxibustion
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
Subjects receive Sham Acupuncture/Placebo Moxibustion (control group)
Other: Sham/Placebo Acupuncture/Moxibustion
Sham/Placebo Acupuncture/Moxibustion Protocol: Not-Active
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945074
|United States, New York|
|New York University, Division of Special Studies in Symptom Management|
|New York, New York, United States, 10010|
|Principal Investigator:||Joyce K Anastasi, PhD, DrNP, FAAN, LAc||New York University|