Acupuncture Treatment for Active Crohn's Disease

Not Applicable

Completed

• Conditions: Crohn's Disease
• Interventions: Device: Sham acupuncture and moxibustion; Device: Acupuncture and moxibustion

• Registration Number: NCT02559037
• Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2015-04-01
• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Primary Completion: 2018-12-31
• Study Completion: 2019-11-30
• Status Verified: 2019-12
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. meet the diagnostic criteria of Crohn's disease;
2. age 16-70 years old;
3. patients with mild or moderate disease (150<CDAI<450) and evidence of active inflammation: serum C-reactive protein concentration ≥5 mg/L, fecal calprotectin concentration ≥250 μg/g, or obvious endoscopic evidence of ulcerations during the screening period of past 4 weeks;
4. patients who were not responsive, intolerant, dependent, or refused to use any one of the following medications: mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), and anti-TNF-α agents;
5. did not take or take one or more of the following drugs: prednisone <15 mg/d for at least one month, azathioprine (<1 mg/kg/d), methotrexate (<15 mg/week), or mesalazine (<4 g/d) for at least 3 months;
6. no history of use of anti-TNF-alpha or other biological agents within 3 months immediately preceding the enrolment in the study;
7. no previous history of receiving acupuncture;
8. provision of written informed consent.

Exclusion Criteria

1. Pregnant or lactating women, and those desirous of conceiving in the near future;
2. patients with severe organic diseases;
3. patients with mental illness;
4. patients receiving antibiotics, probiotics, prebiotics, traditional Chinese medicine, or other drugs;
5. patients with multiple comorbid conditions that require long-term therapy with drugs, which may affect the outcome measures;
6. patients with severe extraintestinal manifestations, such as severe skin diseases, eye diseases, or thromboembolic diseases;
7. severe intestinal fistula, abdominal abscess, intestinal stenosis and intestinal obstruction, perianal abscess, gastrointestinal bleeding, bowel perforation, or other complications;
8. patients with short bowel syndrome;
9. patients with a history of abdominal or gastrointestinal surgery in the past six months;
10. patients with skin diseases or defects at the sites of acupuncture that prevents the application of acupuncture.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham acupuncture-moxibustion group	Sham acupuncture and moxibustion	Receiving sham acupuncture and sham moxibustion.
Acupuncture-moxibustion group	Acupuncture and moxibustion	Receiving acupuncture and moxibustion treatment.

Primary Outcome Measures

Name	Time	Method
The proportion of patients with clinical remission	Week 12	Defined as Crohn's disease activity Index (CDAI) \< 150 and decrease \> 70

Secondary Outcome Measures

Name	Time	Method
the mean change of CDAI from baseline	Week 12, 24, 36 and 48	Difference in the mean change of CDAI from baseline between groups
Quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ)	Week 12 and 24	QOL assessment for Crohn's disease
The proportion of clinical recurrences	Week 24，36 and 48	Defined as CDAI \> 150 and increased by ≥70 points or need to adjust drug to control active disease
The proportion of patients with clinical response	Week 12, 24, 36 and 48	Defined as CDAI decrease \> 70
The proportion of patients with clinical remission	Week 24, 36 and 48	Defined as CDAI \< 150 and decrease \> 70
Laboratory tests for disease activity	Week 12, 24, 36 and 48	blood platelet level, L
Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)	Week 12, 24，36 and 48	Eg. acupuncture related bleeding, hematoma, fainting needle, etc; moxibustion related burns, blistering, etc
Psychological factors on the Hospital anxiety and depression scale (HADS)	Week 12 and 24	Anxiety and depression assessment for CD
The mean change of Crohn's disease endoscopic index of severity (CDEIS)	Week 48	Intestinal inflammation performance
Fecal calprotectin tests for disease activity	Week 12	Intestinal inflammation assessment
Histological scores for pathogenic manifestations	Week 48	Hematoxylin-eosin staining and Histological scores
Subgroup analysis of the main outcome measure	Week 12	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.

Trial Locations

Locations (1)

Shanghai Institute of Acupuncture, Moxibustion and Meridian; 🇨🇳 Shanghai, Shanghai, China