Crohn's Disease Relapse, Inflammatory Bowel Diseases
Conditions
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.
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 for moxibustion. These two groups are alternate. After deqi sensation was even reinforcing and reducing. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. During each treatment, acupuncture and mild moxibustion are performed simultaneously, both lasting for 30 minutes.
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 alternate. After deqi sensation was even reinforcing and reducing. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. During each treatment, acupuncture and mild moxibustion are performed simultaneously, both lasting for 30 minutes.
Sponsors
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of recurrences | Week 52 | Total number of recurrences. The median number will be counted for both groups. |
| 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) |
| 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) |
| 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. |
| 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. |
| 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. |
| Colonoscopy or small bowel MR evaluation | Week 0 and 52 | measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score) |
| Expectation of acupuncture treatment | Week 0 | measured by acupuncture treatment effectiveness expectation questionnaire |
| Blind questionnaire | Week 6 and 12 | measured by patients guessing their grouping |
Countries
China
Contacts
CONTACTBao Chunhui, MD, PhD
PRINCIPAL_INVESTIGATORBao Chunhui, MD, PhD
Shanghai University of TCM
Outcome results
None listed