Crohn Disease, Inflammatory Bowel Diseases
Conditions
Keywords
acupuncture, Crohn's disease
Brief summary
To observe the clinical effect of acupuncture on quiescent Crohn's disease
Detailed description
To observe the effect of acupuncture on maintaining remission of quiescent Crohn's disease
Interventions
OTHERacupuncture
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.
OTHERSham acupuncture
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.
Sponsors
Fudan University
Shanghai University of Traditional Chinese Medicine
Ruijin Hospital
Indiana University School of Medicine
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. aged 16-70; 2. Patients with disease in remission: CDAI \<150 and at least one of the following: serum C-reactive protein \<5mg/L, fecal calprotectin \<50μg/g or no ulcers on endoscopy; 3. Patients with more than 2 disease relapses in the past year; 4. patients were not taking medication or were only taking one or more of the following drugs: \[prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)\] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months; 5. those who did not use anti-TNF alpha and other agents within 3 months before entering the study; 6. those who have never experienced acupuncture; 7. patients signing informed consent.
Exclusion criteria
1. patients who are recently pregnant or in pregnancy or lactation; 2. patients with serious organic diseases; 3. patients diagnosed as psychosis; 4. patients who take antibiotics, probiotics, traditional Chinese medicine and other drugs at the same time, or who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial; 5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations; 6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications; 7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year; 8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of clinical relapse rates | Week 48 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of relapses | Week 48 | Difference in the number of relapses between groups during the trial. |
| Moderate to severe clinical relapse rate | Week 48 | Defined as CDAI score ≥ 220; Differences in moderate to severe clinical recurrence rates between groups during the trial. |
| The mean change of CDAI from baseline | Week 12, 24, 36 and 48 | Difference in the mean change of CDAI from baseline between groups |
| The mean change of serum CRP level from baseline | Week 12, 24, 36 and 48 | Difference in the mean change of serum CRP level from baseline between groups |
| The mean change of Inflammatory Bowel Disease Questionnaire (IBDQ) | Week 12 and 24 | Quality of life assessment for Crohn's disease. The score ranges from 32 to 224, and the higher the score, the better the outcome. |
| The mean change of the Hospital anxiety and depression scale (HADS) | Week 12 and 24 | Psychological factors (Anxiety and depression) assessment for CD. The score ranges from 0 to 21, and the higher the score, the worse the outcome. |
| Time of first relapse | Week 48 | Difference in time to first relapse between groups during the trial. |
| The mean change of Crohn's disease endoscopic index of severity (CDEIS) | Week 48 | Intestinal inflammation performance. The score ranges from 0 to 44, and the higher the score, the worse the outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intestinal microbiota | Week 12 | Changes in the structure and diversity of fecal microbiota detected by 16S rDNA sequencing. |
| Analysis of the association between gut microbes, brain imaging and behavior | Week 12 | 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. |
| Acupuncture efficacy prediction | Week 48 | 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. |
| Disease recurrence prediction | Week 0 | 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. |
| brain structural and functional changes | Week 12 | brain functional and structural changes reflected by fMRI |
Countries
China
Outcome results
None listed