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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Shanghai University of Traditional Chinese Medicine | OTHER |
| Ruijin Hospital | OTHER |
| Indiana University |
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To observe the clinical effect of acupuncture on quiescent Crohn's disease
To observe the effect of acupuncture on maintaining remission of quiescent Crohn's disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture group | Experimental | Receiving acupuncture and moxibustion treatment |
|
| sham acupuncture group | Sham Comparator | Receiving sham acupuncture and sham moxibustion treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of clinical relapse rates | Defined as a CDAI score of >150 with an increase of ≥70 points from baseline, or the need for CD surgery, or new CD medications. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of first relapse | Difference in time to first relapse between groups during the trial. | Week 48 |
| Number of relapses | Difference in the number of relapses between groups during the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| brain structural and functional changes | brain functional and structural changes reflected by fMRI | Week 12 |
| Intestinal microbiota | Changes in the structure and diversity of fecal microbiota detected by 16S rDNA sequencing. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huangan Wu, MD, PhD | Shanghai Research Institute of Acupuncture and Meridian | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Research Institute of Acupuncture and Meridian | Shanghai | 200030 | China |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| OTHER |
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|
| Sham acupuncture | Other | Patients receiving sham acupuncture and sham mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. Same Hwato acupuncture device was used to blind the subjects, but do not puncturing into the skin and do not have the deqi sensation. The surface temperature of acupoints was maintained at 37℃± 1℃ for moxibustion. |
|
| Week 48 |
| Moderate to severe clinical relapse rate | Defined as CDAI score ≥ 220; Differences in moderate to severe clinical recurrence rates between groups during the trial. | Week 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 |
| The mean change of serum CRP level from baseline | Difference in the mean change of serum CRP level from baseline between groups | Week 12, 24, 36 and 48 |
| The mean change of Inflammatory Bowel Disease Questionnaire (IBDQ) | Quality of life assessment for Crohn's disease. The score ranges from 32 to 224, and the higher the score, the better the outcome. | Week 12 and 24 |
| The mean change of the Hospital anxiety and depression scale (HADS) | Psychological factors (Anxiety and depression) assessment for CD. The score ranges from 0 to 21, and the higher the score, the worse the outcome. | Week 12 and 24 |
| The mean change of Crohn's disease endoscopic index of severity (CDEIS) | Intestinal inflammation performance. The score ranges from 0 to 44, and the higher the score, the worse the outcome. | Week 48 |
| Week 12 |
| Analysis of the association between gut microbes, brain imaging and behavior | The pearson correlation and linear regression models were applied to establish the association between gut microbes, brain function and structure and behavior in an attempt to explore the relationship between the gut microbe-gut-brain axis in patients with CD in remission. | Week 12 |
| Acupuncture efficacy prediction | Deep learning algorithms such as artificial neural networks and support vector machines were applied to construct and validate an acupuncture efficacy prediction model based on MRI changes in high and low response patients in the acupuncture group, and to screen for brain neuroimaging markers that predict the effectiveness of acupuncture in delaying CD disease recurrence. | Week 48 |
| Disease recurrence prediction | Differences in brain structure and functional activity between remitting CD patients with high relapse and remitting CD patients with low relapse as well as healthy subjects were measured, and deep learning algorithms such as artificial neural networks and support vector machines were applied to construct and validate diagnostic models of the disease and screen for brain imaging markers that predict disease recurrence in remitting CD. | Week 0 |