To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity
1. Effect of acupuncture on symptoms (functional gastrointestinal symptoms, Fatigue, insomnia, depression, anxiety and perceived stress)of CD 2. Effect of acupuncture on brain functional activity of CD
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and 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.
Patients receiving sham acupuncture and sham mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and 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.
Shanghai Research Institute of Acupuncture and Meridian
Shanghai, China
Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine
Shanghai, China
Brief Fatigue Inventory (BFI-C)
The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90.
Time frame: Week 12
Brief Fatigue Inventory (BFI-C)
The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90.
Time frame: Week 24,52
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52.
Time frame: Week 12, 24,52
Crohn's disease activity index (CDAI)score
The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit.
Time frame: Week 12, 24,36,48,52
Inflammatory bowel disease questionnaire (IBDQ)
The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224.
Time frame: Week 12, 24 and 52
Hospital anxiety and depression scale (HADS)
The mean change in HADS from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.
Time frame: Week 12, 24 and 52
Patient Health Questionnaire Depression Scale (PHQ-9)
The mean change in PHQ-9 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 27.
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Time frame: Week 12, 24 and 52
Generalized Anxiety Disorder (GAD-7)
The mean change in gad-7 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.
Time frame: Week 12, 24 and 52
The proportion of recurrences
Defined as CDAI \> 150 and increase ≥ 70 points or need to adjust drug to control disease condition.
Time frame: Week 52
Brain functional and structural changes
measured by functional MRI
Time frame: Week 12
Colonoscopy or small bowel MR evaluation
measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score)
Time frame: Week 52
Laboratory tests
Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count (PLT)
Time frame: Week 12, 24, 36, and 52