Acupuncture Treatment for Active Crohn's Disease

NCT ID: NCT02559037

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2019-11-30

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acupuncture-moxibustion group

Receiving acupuncture and moxibustion treatment.

Group Type: EXPERIMENTAL

Acupuncture and moxibustion

Intervention Type: DEVICE

Acupuncture acupoints: CV12, bilateral ST36, ST37, SP6, SP9, SP4, LR3 and LI3. Disposable acupuncture auxiliary device and 0.30*40mm or 0.30*25mm acupuncture needles (hwato, suzhou medical supplies factory co., LTD.) were used. The needles were directly inserted 20-30mm into the skin and elicited a de-qi sensation. The needle was kept for 30 min.

Moxibustion acupoints: bilateral ST25 and ST36. Using mild-warm moxibustion, The surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint. Moxibustion and acupuncture were performed at the same time, once every other day, three times a week, a total of 12 weeks of treatment. After the treatment, subjects were followed up in the weeks 24, 36 and 48.

Sham acupuncture-moxibustion group

Receiving sham acupuncture and sham moxibustion.

Group Type: SHAM_COMPARATOR

Sham acupuncture and moxibustion

Intervention Type: DEVICE

The acupoints used are same to the experimental group. Same disposable acupuncture auxiliary device and 0.35 * 40mm acupuncture needle (flat and blunt needle tip, Hwato, Suzhou Medical Supplies Factory Co., Ltd.) was selected. When the needle was pricked to the acupoint, it did not penetrating into the skin. The subject only felt slight pain and do not have the de-qi sensation.

Sham moxibustion : by using the same moxa stick, The surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint. Sham acupuncture and sham moxibustion were performed at the same time. They were treated once every other day, three times a week, a total of 12 weeks. After the treatment, subjects were followed up in the weeks 24, 36 and 48.

Interventions

Acupuncture and moxibustion

Acupuncture acupoints: CV12, bilateral ST36, ST37, SP6, SP9, SP4, LR3 and LI3. Disposable acupuncture auxiliary device and 0.30*40mm or 0.30*25mm acupuncture needles (hwato, suzhou medical supplies factory co., LTD.) were used. The needles were directly inserted 20-30mm into the skin and elicited a de-qi sensation. The needle was kept for 30 min.

Moxibustion acupoints: bilateral ST25 and ST36. Using mild-warm moxibustion, The surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint. Moxibustion and acupuncture were performed at the same time, once every other day, three times a week, a total of 12 weeks of treatment. After the treatment, subjects were followed up in the weeks 24, 36 and 48.

Intervention Type: DEVICE

Sham acupuncture and moxibustion

The acupoints used are same to the experimental group. Same disposable acupuncture auxiliary device and 0.35 * 40mm acupuncture needle (flat and blunt needle tip, Hwato, Suzhou Medical Supplies Factory Co., Ltd.) was selected. When the needle was pricked to the acupoint, it did not penetrating into the skin. The subject only felt slight pain and do not have the de-qi sensation.

Sham moxibustion : by using the same moxa stick, The surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint. Sham acupuncture and sham moxibustion were performed at the same time. They were treated once every other day, three times a week, a total of 12 weeks. After the treatment, subjects were followed up in the weeks 24, 36 and 48.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Indiana University School of Medicine

OTHER

Sponsor Role: collaborator

Changhai Hospital

OTHER

Sponsor Role: collaborator

Shanghai Institute of Acupuncture, Moxibustion and Meridian

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huangan Wu, MD,PhD

Role: STUDY_CHAIR

Shanghai University of TCM

Locations

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Shanghai, Shanghai Municipality, China

Countries

China

References

Bao C, Wu L, Wang D, Chen L, Jin X, Shi Y, Li G, Zhang J, Zeng X, Chen J, Liu H, Wu H. Acupuncture improves the symptoms, intestinal microbiota, and inflammation of patients with mild to moderate Crohn's disease: A randomized controlled trial. EClinicalMedicine. 2022 Feb 12;45:101300. doi: 10.1016/j.eclinm.2022.101300. eCollection 2022 Mar.

Reference Type: DERIVED

PMID: 35198926 (View on PubMed)

Other Identifiers

ZYS2015-02

Identifier Type: -

Identifier Source: org_study_id