Effect of Acupuncture on Quiescent Crohn’s Disease

Overview

To observe the clinical effect of acupuncture on quiescent Crohn's disease

Full Title of Study: “Effect of Acupuncture on Quiescent Crohn’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2021

Detailed Description

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

Interventions

  • Other: acupuncture
    • 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.
  • Other: Sham 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.

Arms, Groups and Cohorts

  • Experimental: acupuncture group
    • Receiving acupuncture and moxibustion treatment
  • Sham Comparator: sham acupuncture group
    • Receiving sham acupuncture and sham moxibustion treatment

Clinical Trial Outcome Measures

Primary Measures

  • The proportion of clinical recurrences
    • Time Frame: Week 48
    • Defined as CDAI > 150 and increased by ≥70 points; or emergency, hospitalization or surgical event due to CD exacerbation; or escalation of base medication based on exacerbation (e.g., temporary addition of glucocorticoids)

Secondary Measures

  • Mean time of recurrence
    • Time Frame: Week 48
    • The mean duration of disease recurrence during follow-up.
  • The mean change of CDAI from baseline
    • Time Frame: Week 12, 24, 36 and 48
    • Difference in the mean change of CDAI from baseline between groups
  • The mean change of Inflammatory Bowel Disease Questionnaire (IBDQ)
    • Time Frame: Week 12 and 24
    • Quality of life assessment for Crohn’s disease. The score ranges from 32 to 224, and the higher the score, the better the outcome.
  • The mean change of the Hospital anxiety and depression scale (HADS)
    • Time Frame: Week 12 and 24
    • Psychological factors (Anxiety and depression) assessment for CD. The score ranges from 0 to 21, and the higher the score, the worse the outcome.
  • The mean change of Crohn’s disease endoscopic index of severity (CDEIS)
    • Time Frame: Week 48
    • Intestinal inflammation performance. The score ranges from 0 to 44, and the higher the score, the worse the outcome.

Participating in This Clinical Trial

Inclusion Criteria

1. aged 16-70; 2. 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; 3. Patients with more than 2 disease relapses in the past year; 4. 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; 5. those who did not use anti-TNF alpha and other agents within 3 months before entering the study; 6. those who have never experienced acupuncture; 7. 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.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shanghai Institute of Acupuncture, Moxibustion and Meridian
  • Collaborator
    • Fudan University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Huangan Wu, MD, PhD, Study Chair, Shanghai Research Institute of Acupuncture and Meridian
  • Overall Contact(s)
    • Chunhui Bao, MD, PhD, +862164395973, baochunhui789@126.com

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