Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Status: Enrolling

Conditions: Crohn's Disease Relapse; Inflammatory Bowel Diseases

Treatments: Other: "Nourishing spleen and kidney with warmth" Acupuncture Group; Other: "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06553053

ZYS2024-04

Details and patient eligibility

About

The aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of CD and to explore the efficacy mechanism of acupuncture efficacy enhancement.

Full description

Acupuncture has been proven to be an effective and safe treatment for CD. In this trial, based on previous studies, which mainly treated CD from the perspective of spleen and stomach tonification, we explored the therapeutic effect of acupuncture in treating CD from the perspective of tonifying the Shaoyang pivot mechanism to enhance the therapeutic effect.Brain-gut axis dysfunction is one of the important pathogenic mechanisms of CD. This trial attempted to explore the therapeutic targets and efficacy mechanisms of acupuncture to enhance CD by analysing brain-gut axis multi-pathway indicators.

Enrollment: 106 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients with clinical diagnosis consistent with CD;
2. aged 16-75;
3. patients in remission (CDAI < 150 and CRP < 5mg/l, or Faecal calprotectin < 50μg/g, or no ulcer under endoscopy);
4. patients with frequent disease recurrences (≥2) in the past years;
5. patients were not taking medication or were only taking one or more of the following drugs: [mesalazine (≤4g/d), prednisone (≤15mg/d), azathioprine (≤1mg/kg/d)] and prednisone and mesalazine were used for at least 1 month, while azathioprine was used for at least 3 months; or those who had poor response or loss of response to biological preparations (anti-TNF-α, IL-12p40, α4β7);
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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Receiving acupuncture with the function of "harmonizing Shaoyang, nourishing spleen and kidney with warmth"

Treatment:

Other: "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group

Control group

Active Comparator group

Description:

Receiving acupuncture group with the function of "nourishing spleen and kidney with warmth"

Treatment:

Other: "Nourishing spleen and kidney with warmth" Acupuncture Group