Effect of Acupuncture on Quiescent Crohn's Disease

Study Overview
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Brief Summary
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To observe the clinical effect of acupuncture on quiescent Crohn's disease

Detailed Description
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To observe the effect of acupuncture on maintaining remission of quiescent Crohn's disease

Official Title
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Effect of Acupuncture on Quiescent Crohn's Disease

Conditions
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Inflammatory Bowel Diseases, Crohn Disease

Intervention / Treatment
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* Other: acupuncture
* Other: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 16-70; 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; Patients with more than 2 disease relapses in the past year; 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; those who did not use anti-TNF alpha and other agents within 3 months before entering the study; those who have never experienced acupuncture; patients signing informed consent. Exclusion Criteria: patients who are recently pregnant or in pregnancy or lactation; patients with serious organic diseases; patients diagnosed as psychosis; 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; severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations; there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications; patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year; there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture group<br>Receiving acupuncture and moxibustion treatment | Other: acupuncture<br>* 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.<br>|
| Sham Comparator: sham acupuncture group<br>Receiving sham acupuncture and sham moxibustion treatment | Other: Sham acupuncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, Crohn's disease