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

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases; Crohn's Disease Relapse
• Interventions: Other: "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group; Other: "Nourishing spleen and kidney with warmth" Acupuncture Group

• Registration Number: NCT06553053
• Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

Brief Summary

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-10
• Study Start: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	"Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group	Receiving acupuncture with the function of "harmonizing Shaoyang, nourishing spleen and kidney with warmth"
Control group	"Nourishing spleen and kidney with warmth" Acupuncture Group	Receiving acupuncture group with the function of "nourishing spleen and kidney with warmth"

Primary Outcome Measures

Name	Time	Method
The proportion of recurrences	Week 52	Defined as CDAI \> 150 and increase ≥ 70 points, or emergency, hospitalization and surgical events due to worsening of CD conditions, or need to adjust drug to control disease condition.

Secondary Outcome Measures

Name	Time	Method
Inflammatory bowel disease questionnaire (IBDQ)	Week 0, 12, 24, 36 and 52	The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224.
Colonoscopy or small bowel MR evaluation	Week 0 and 52	measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score)
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)	Week 0, 12, 24, 36 and 52	The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52.
Hospital anxiety and depression scale (HADS)	Week 0, 12, 24, 36 and 52	The mean change in HADS from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.
Time of recurrences	Week 52	Time to first recurrence will be counted for both groups.
Crohn's disease activity index （CDAI）score	Week 0, 6, 12, 24, 36 and 52	The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit.
Patient Reported Outcome （PRO2）	Week 0, 6, 12, 24, 36 and 52	The outcome is measured by level of abdominal pain (visual analogue scale, VAS) and number of diarrhoea in the past week.
First laboratory tests	Week 0, 6, 12, 24, 36 and 52	serum C-reactive protein (CRP)
Blind questionnaire	Week 6 and 12	measured by patients guessing their grouping
Expectation of acupuncture treatment	Week 0	measured by acupuncture treatment effectiveness expectation questionnaire
Number of recurrences	Week 52	Total number of recurrences. The median number will be counted for both groups.
Second laboratory tests	Week 0, 6, 12, 24, 36 and 52	erythrocyte sedimentation rate (ESR)
Third laboratory tests	Week 0, 6, 12, 24, 36 and 52	platelet count (PLT)

Trial Locations

Locations (1)

Shanghai Research Institute of Acupuncture and Meridian; 🇨🇳 Shanghai, China