Crohn Disease, Inflammatory Bowel Diseases
Conditions
Keywords
acupuncture, Crohn's disease, brain functional activity
Brief summary
To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity
Detailed description
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
Interventions
OTHERacupuncture
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.
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. 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.
Sponsors
Fudan University
Ruijin Hospital
Shanghai Mental Health Center
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 in remission (CDAI \< 150); 3. 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; 4. those who did not use TNF alpha and other preparations within 3 months before entering the study; 5. those who have never experienced acupuncture; 6. 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 |
|---|---|---|
| Brief Fatigue Inventory (BFI-C) | Week 12 | The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Week 12, 24,52 | The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52. |
| Crohn's disease activity index （CDAI）score | Week 12, 24,36,48,52 | The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit. |
| Inflammatory bowel disease questionnaire (IBDQ) | Week 12, 24 and 52 | The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224. |
| Hospital anxiety and depression scale (HADS) | Week 12, 24 and 52 | 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. |
| Patient Health Questionnaire Depression Scale (PHQ-9) | Week 12, 24 and 52 | 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. |
| Brief Fatigue Inventory (BFI-C) | Week 24,52 | The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90. |
| The proportion of recurrences | Week 52 | Defined as CDAI \> 150 and increase ≥ 70 points or need to adjust drug to control disease condition. |
| Brain functional and structural changes | Week 12 | measured by functional MRI |
| Colonoscopy or small bowel MR evaluation | Week 52 | measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score) |
| Laboratory tests | Week 12, 24, 36, and 52 | Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count (PLT) |
| Generalized Anxiety Disorder (GAD-7) | Week 12, 24 and 52 | 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. |
Countries
China
Outcome results
None listed