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.
1. A randomized controlled trial. 2. Acupuncture and moxibustion treatment, placebo control. 3. To observe the efficacy and safety of acupuncture and moxibustion treatment versus placebo controlled for Crohn's disease. 4. To observe the effect on the regulation of intestinal microbiota in Crohn's disease. 5. To observe the effect on the regulation of peripheral immunity in Crohn's disease. 6. To observe the effect on the regulation of brain function and structure in Crohn's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
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.
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.
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Shanghai, Shanghai Municipality, China
The proportion of patients with clinical remission
Defined as Crohn's disease activity Index (CDAI) \< 150 and decrease \> 70
Time frame: Week 12
The proportion of patients with clinical remission
Defined as CDAI \< 150 and decrease \> 70
Time frame: Week 24, 36 and 48
The proportion of patients with clinical response
Defined as CDAI decrease \> 70
Time frame: Week 12, 24, 36 and 48
the mean change of CDAI from baseline
Difference in the mean change of CDAI from baseline between groups
Time frame: Week 12, 24, 36 and 48
Laboratory tests for disease activity
C-reaction protein, mg/L
Time frame: Week 12, 24, 36 and 48
Laboratory tests for disease activity
Erythrocyte sedimentation rate, mm/h
Time frame: Week 12, 24, 36 and 48
Laboratory tests for disease activity
blood platelet level, L
Time frame: Week 12, 24, 36 and 48
Quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ)
QOL assessment for Crohn's disease
Time frame: Week 12 and 24
Psychological factors on the Hospital anxiety and depression scale (HADS)
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Anxiety and depression assessment for CD
Time frame: Week 12 and 24
The mean change of Crohn's disease endoscopic index of severity (CDEIS)
Intestinal inflammation performance
Time frame: Week 48
Fecal calprotectin tests for disease activity
Intestinal inflammation assessment
Time frame: Week 12
Histological scores for pathogenic manifestations
Hematoxylin-eosin staining and Histological scores
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Week 12