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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Shanghai University of Traditional Chinese Medicine | OTHER |
| Shanghai Jiao Tong University School of Medicine | OTHER |
| Indiana University |
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The purpose of this study is to observe the efficacy and safety of acupuncture and moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and peripheral immunity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture-moxibustion group | Experimental | Receiving acupuncture and moxibustion treatment. |
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| Sham acupuncture-moxibustion group | Sham Comparator | Receiving sham acupuncture and sham moxibustion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture and moxibustion | Device | Acupuncture acupoints: CV12, bilateral ST36, ST37, SP6, SP9, SP4, LR3 and LI3. Disposable acupuncture auxiliary device and 0.30*40mm or 0.30*25mm acupuncture needles (hwato, suzhou medical supplies factory co., LTD.) were used. The needles were directly inserted 20-30mm into the skin and elicited a de-qi sensation. The needle was kept for 30 min. Moxibustion acupoints: bilateral ST25 and ST36. Using mild-warm moxibustion, The surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint. Moxibustion and acupuncture were performed at the same time, once every other day, three times a week, a total of 12 weeks of treatment. After the treatment, subjects were followed up in the weeks 24, 36 and 48. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with clinical remission | Defined as Crohn's disease activity Index (CDAI) < 150 and decrease > 70 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with clinical remission | Defined as CDAI < 150 and decrease > 70 | Week 24, 36 and 48 |
| The proportion of patients with clinical response | Defined as CDAI decrease > 70 |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal microbiota | Fecal microbiota structure and diversity | Week 12 |
| Plasma inflammatory cytokine levels | IFN-γ, TNF-a, IL-1β IL-17,IL-23 etc. |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huangan Wu, MD,PhD | Shanghai University of TCM | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Institute of Acupuncture, Moxibustion and Meridian | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35198926 | Derived | Bao C, Wu L, Wang D, Chen L, Jin X, Shi Y, Li G, Zhang J, Zeng X, Chen J, Liu H, Wu H. Acupuncture improves the symptoms, intestinal microbiota, and inflammation of patients with mild to moderate Crohn's disease: A randomized controlled trial. EClinicalMedicine. 2022 Feb 12;45:101300. doi: 10.1016/j.eclinm.2022.101300. eCollection 2022 Mar. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D009071 | Moxibustion |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| OTHER |
| Changhai Hospital | OTHER |
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| Sham acupuncture and moxibustion | Device | The acupoints used are same to the experimental group. Same disposable acupuncture auxiliary device and 0.35 * 40mm acupuncture needle (flat and blunt needle tip, Hwato, Suzhou Medical Supplies Factory Co., Ltd.) was selected. When the needle was pricked to the acupoint, it did not penetrating into the skin. The subject only felt slight pain and do not have the de-qi sensation. Sham moxibustion : by using the same moxa stick, The surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint. Sham acupuncture and sham moxibustion were performed at the same time. They were treated once every other day, three times a week, a total of 12 weeks. After the treatment, subjects were followed up in the weeks 24, 36 and 48. |
|
| Week 12, 24, 36 and 48 |
| the mean change of CDAI from baseline | Difference in the mean change of CDAI from baseline between groups | Week 12, 24, 36 and 48 |
| Laboratory tests for disease activity | C-reaction protein, mg/L | Week 12, 24, 36 and 48 |
| Laboratory tests for disease activity | Erythrocyte sedimentation rate, mm/h | Week 12, 24, 36 and 48 |
| Laboratory tests for disease activity | blood platelet level, L | Week 12, 24, 36 and 48 |
| Quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ) | QOL assessment for Crohn's disease | Week 12 and 24 |
| Psychological factors on the Hospital anxiety and depression scale (HADS) | Anxiety and depression assessment for CD | Week 12 and 24 |
| The mean change of Crohn's disease endoscopic index of severity (CDEIS) | Intestinal inflammation performance | Week 48 |
| Fecal calprotectin tests for disease activity | Intestinal inflammation assessment | Week 12 |
| Histological scores for pathogenic manifestations | Hematoxylin-eosin staining and Histological scores | Week 48 |
| The proportion of clinical recurrences | Defined as CDAI > 150 and increased by ≥70 points or need to adjust drug to control active disease | Week 24，36 and 48 |
| Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0) | Eg. acupuncture related bleeding, hematoma, fainting needle, etc; moxibustion related burns, blistering, etc | Week 12, 24，36 and 48 |
| Subgroup analysis of the main outcome measure | Compare using chi square test with stratified method or Fisher's exact test, and Gender, BMI, CDAI score at baseline, concomitant medicine, Montreal classification, biologic use history, and surgical history were used as stratification factors. | Week 12 |
| Week 12 |
| Intestinal barrier function | Plasma Diamine oxidase，lipopolysaccharide, D-lactate level | Week 12 |
| Brain functional changes | Using fMRI (resting-state fMRI) | Week 12 |
| Brain structural changes | brain gray matter, white matter changes | Week 12 |
| Correlation analysis of the change of CRP level and intestinal flora and plasma inflammatory levels at the end of acupuncture treatment | To explore the relationship between CRP and intestinal flora and inflammation influenced by acupuncture | Week 12 |
| Correlation analysis of the change of CRP level and and brain structure and function | To explore the relationship between intestinal inflammation and brain function influenced by acupuncture | Week 12 |
| Correlation analysis of intestinal flora and brain structure and function | To explore the relationship between intestinal flora and brain-gut axis | Week 12 |
| D007410 | Intestinal Diseases |