Protocol- vs. Patient-Oriented TCM Practices: A RCT for IBS Symptom Management
试验速览
- 阶段
- 2 期
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Patient-rated abdominal pain/discomfort and IBS-Secondary symptom rating: intestinal gas, bloating and stool consistency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Condition 1
Condition 1:
Subjects receive Standard Acu/Moxa (fixed protocol)
干预措施: Standard Acupuncture/Moxibustion (fixed protocol) (Other)
Condition 2: Individualized Acupuncture/Moxibustion
Condition 2:
Subjects receive Individualized Acupuncture/Moxibustion (patient-oriented, based on traditional Chinese medicine diagnosis).
干预措施: Individualized Acupuncture/Moxibustion (Other)
Condition 3: Control
Condition 3:
Subjects receive Sham Acupuncture/Placebo Moxibustion (control group)
干预措施: Sham/Placebo Acupuncture/Moxibustion (Other)
结局指标
主要结局
Patient-rated abdominal pain/discomfort and IBS-Secondary symptom rating: intestinal gas, bloating and stool consistency
时间窗: Six months
次要结局
- Quality of life (IBS-QOL & SF-36)(Six months)
- Psychological distress (SCL-90)(Six months)
- Global improvement (CGIS)(Six months)
研究者
Joyce K. Anastasi
Principal Investigator
New York University