Effect of Acupuncture on Quiescent Crohn's Disease

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

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease
• Intervention / Treatment: Other: acupuncture; Other: Sham acupuncture

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200030
    • Shanghai Research Institute of Acupuncture and Meridian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture group; Receiving acupuncture and moxibustion treatment	Other: acupuncture; 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.
Sham Comparator: sham acupuncture group; Receiving sham acupuncture and sham moxibustion treatment	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. 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
brain structural and functional changes	brain functional and structural changes reflected by fMRI	Week 12
Intestinal microbiota	Changes in the structure and diversity of fecal microbiota detected by 16S rDNA sequencing.	Week 12
Analysis of the association between gut microbes, brain imaging and behavior	The pearson correlation and linear regression models were applied to establish the association between gut microbes, brain function and structure and behavior in an attempt to explore the relationship between the gut microbe-gut-brain axis in patients with CD in remission.	Week 12
Acupuncture efficacy prediction	Deep learning algorithms such as artificial neural networks and support vector machines were applied to construct and validate an acupuncture efficacy prediction model based on MRI changes in high and low response patients in the acupuncture group, and to screen for brain neuroimaging markers that predict the effectiveness of acupuncture in delaying CD disease recurrence.	Week 48
Disease recurrence prediction	Differences in brain structure and functional activity between remitting CD patients with high relapse and remitting CD patients with low relapse as well as healthy subjects were measured, and deep learning algorithms such as artificial neural networks and support vector machines were applied to construct and validate diagnostic models of the disease and screen for brain imaging markers that predict disease recurrence in remitting CD.	Week 0

Collaborators and Investigators

• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Collaborators: Fudan University; Ruijin Hospital; Shanghai University of Traditional Chinese Medicine; Indiana University School of Medicine
• Investigators: Study Chair: Huangan Wu, MD, PhD, Shanghai Research Institute of Acupuncture and Meridian

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: acupuncture; Crohn's disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: ZYS2015-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No