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

Overview

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.

Detailed 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.

Interventions

• Other "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group
  Patients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV12 and bilateral ST36 and GB41 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, GB41, SP4, KI3, LI11, SJ4 and GB26 were selected for acupuncture and CV4 and bilateral SP6 and GB34 were selected
• Other "Nourishing spleen and kidney with warmth" Acupuncture Group
  Patients receiving acupuncture and mild moxibustion, whom were treated 2 times per week for 12 weeks and followed up for 40 weeks. The first group of acupoints is that CV4 and Bilateral ST37, SP6, SP4, KI3 and LI11 were selected for acupuncture and CV12 and bilateral ST36 were selected for moxibustion. The second group of acupoints is that CV12 and Bilateral ST36, SP4, KI3 and LI11 were selected for acupuncture and CV4 and bilateral SP6 were selected for moxibustion. These two groups are alterna

Primary outcome measures

• The proportion of recurrences [Time frame: Week 52]

Secondary outcome measures (12)

• Number of recurrences [Time frame: Week 52]
• Time of recurrences [Time frame: Week 52]
• Crohn's disease activity index （CDAI）score [Time frame: Week 0, 6, 12, 24, 36 and 52]
• Patient Reported Outcome （PRO2） [Time frame: Week 0, 6, 12, 24, 36 and 52]
• First laboratory tests [Time frame: Week 0, 6, 12, 24, 36 and 52]
• Second laboratory tests [Time frame: Week 0, 6, 12, 24, 36 and 52]
• Third laboratory tests [Time frame: Week 0, 6, 12, 24, 36 and 52]
• Inflammatory bowel disease questionnaire (IBDQ) [Time frame: Week 0, 12, 24, 36 and 52]
• Hospital anxiety and depression scale (HADS) [Time frame: Week 0, 12, 24, 36 and 52]
• The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [Time frame: Week 0, 12, 24, 36 and 52]
• Colonoscopy or small bowel MR evaluation [Time frame: Week 0 and 52]
• Expectation of acupuncture treatment [Time frame: Week 0]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Research Institute of Acupuncture and Meridian — Shanghai

Publications

• Dolinger M, Torres J, Vermeire S. Crohn's disease. Lancet. 2024 Mar 23;403(10432):1177-1191. doi: 10.1016/S0140-6736(23)02586-2. Epub 2024 Mar 1. PMID 38437854
• Roda G, Chien Ng S, Kotze PG, Argollo M, Panaccione R, Spinelli A, Kaser A, Peyrin-Biroulet L, Danese S. Crohn's disease. Nat Rev Dis Primers. 2020 Apr 2;6(1):22. doi: 10.1038/s41572-020-0156-2. PMID 32242028
• Greuter T, Vavricka SR. Extraintestinal manifestations in inflammatory bowel disease - epidemiology, genetics, and pathogenesis. Expert Rev Gastroenterol Hepatol. 2019 Apr;13(4):307-317. doi: 10.1080/17474124.2019.1574569. Epub 2019 Feb 20. PMID 30791773
• Ng SC, Leung WK, Shi HY, Li MK, Leung CM, Ng CK, Lo FH, Hui YT, Tsang SW, Chan YK, Loo CK, Chan KH, Hui AJ, Chow WH, Harbord M, Ching JY, Lee M, Chan V, Tang W, Hung IF, Ho J, Lao WC, Wong MT, Sze SF, Shan EH, Lam BC, Tong RW, Mak LY, Wong SH, Wu JC, Chan FK, Sung JJ. Epidemiology of Inflammatory Bowel Disease from 1981 to 2014: Results from a Territory-Wide Population-Based Registry in Hong Kong. PMID 27416041
• Zheng JJ, Zhu XS, Huangfu Z, Gao ZX, Guo ZR, Wang Z. Crohn's disease in mainland China: a systematic analysis of 50 years of research. Chin J Dig Dis. 2005;6(4):175-81. doi: 10.1111/j.1443-9573.2005.00227.x. PMID 16246226
• Kaplan GG. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150. Epub 2015 Sep 1. PMID 26323879
• Bonovas S, Fiorino G, Allocca M, Lytras T, Nikolopoulos GK, Peyrin-Biroulet L, Danese S. Biologic Therapies and Risk of Infection and Malignancy in Patients With Inflammatory Bowel Disease: A Systematic Review and Network Meta-analysis. Clin Gastroenterol Hepatol. 2016 Oct;14(10):1385-1397.e10. doi: 10.1016/j.cgh.2016.04.039. Epub 2016 May 14. PMID 27189910
• Esters P, Dignass A. Complementary therapies in inflammatory bowel diseases. Curr Drug Targets. 2014;15(11):1079-88. doi: 10.2174/1389450115666140903112802. PMID 25182607

Identifiers

NCT: NCT06553053 · ZYS2024-04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗