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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Receiving acupuncture with the function of "harmonizing Shaoyang, nourishing spleen and kidney with warmth" |
|
| Control group | Active Comparator | Receiving acupuncture group with the function of "nourishing spleen and kidney with warmth" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of recurrences | 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. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of recurrences | Total number of recurrences. The median number will be counted for both groups. | Week 52 |
| Time of recurrences | Time to first recurrence will be counted for both groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of acupuncture on brain network connectivity properties | Gray matter structure of the brain，functional connectivity and network properties of brain networks and local activity in brain regions were measured in an attempt to analyze the correlation between changes in these indicators after acupuncture intervention and the efficacy of acupuncture. | Week 0 and 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bao Chunhui, MD, PhD | Contact | +862164395973 | baochunhui789@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Bao Chunhui, MD, PhD | Shanghai University of TCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Research Institute of Acupuncture and Meridian | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38437854 | Background | 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. | |
| 32242028 | Background | 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. |
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|
| "Nourishing spleen and kidney with warmth" Acupuncture Group | Other | 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. |
|
| Week 52 |
| Crohn's disease activity index （CDAI）score | The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit. | Week 0, 6, 12, 24, 36 and 52 |
| Patient Reported Outcome （PRO2） | The outcome is measured by level of abdominal pain (visual analogue scale, VAS) and number of diarrhoea in the past week. | Week 0, 6, 12, 24, 36 and 52 |
| First laboratory tests | serum C-reactive protein (CRP) | Week 0, 6, 12, 24, 36 and 52 |
| Second laboratory tests | erythrocyte sedimentation rate (ESR) | Week 0, 6, 12, 24, 36 and 52 |
| Third laboratory tests | platelet count (PLT) | Week 0, 6, 12, 24, 36 and 52 |
| Inflammatory bowel disease questionnaire (IBDQ) | The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224. | Week 0, 12, 24, 36 and 52 |
| Hospital anxiety and depression scale (HADS) | 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. | Week 0, 12, 24, 36 and 52 |
| The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52. | Week 0, 12, 24, 36 and 52 |
| Colonoscopy or small bowel MR evaluation | measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score) | Week 0 and 52 |
| Expectation of acupuncture treatment | measured by acupuncture treatment effectiveness expectation questionnaire | Week 0 |
| Blind questionnaire | measured by patients guessing their grouping | Week 6 and 12 |
| Salivary cortisol | Salivary cortisol is measured by ELISA to analyze effect of acupuncture on HPA axis function. | Week 0 and 12 |
| α-Salivary Amylase | α-Salivary Amylase is measured by ELISA to analyze effect of acupuncture on HPA axis function. | Week 0 and 12 |
| Serum cortisol | Serum cortisol is measured by ELISA to analyze effect of acupuncture on HPA axis function. | Week 0 and 12 |
| Effect of acupuncture on autonomic nervous activity | The effect of acupuncture on autonomic function was recorded by DMS300-4AL. | Week 0 and 12 |
| Effect of acupuncture on intestinal inflammation levels function | Intestinal inflammation levels are measured by C-reactive protein and plasma concentrations of tumour necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and IL-6. | Week 0 and 12 |
| Effect of acupuncture on intestinal mucosal barrier function | Intestinal mucosal barrier function are measured by concentrations of lipopolysaccharide (LPS), Diamine oxidase (DAO) and D-lactate. | Week 0 and 12 |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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