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

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.

Inclusion criteria

• patients with clinical diagnosis consistent with CD;
• aged 16-75;
• patients in remission (CDAI < 150 and CRP < 5mg/l, or Faecal calprotectin < 50μg/g, or no ulcer under endoscopy);
• patients with frequent disease recurrences (≥2) in the past years;
• 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);
• those who have never experienced acupuncture;
• patients signing informed consent.

Exclusion criteria

• patients who are recently pregnant or in pregnancy or lactation;
• patients with serious organic diseases;
• patients diagnosed as psychosis;
• 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;
• severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
• there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
• patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
• there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.