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| Name | Class |
|---|---|
| Fudan University | OTHER |
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Multidisciplinary techniques such as multimodal neuroimaging, microbiology, and bioinformatics were applied to study the differences in correlation characteristics between gut microbes, functional brain networks, and peripheral inflammation among patients with active Crohn's disease (CD), CD in remission, and healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental | Subjects in this group will receive real acupuncture combined with real moxibustion. |
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| Sham group | Sham Comparator | Subjects in this group will receive sham acupuncture combined with sham moxibustion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture treatment | Other | We selected acupoints including Zhongwan (CV12) and bilateral Shangjuxu (ST37), Sanyinjiao (SP6), Gongsun (SP4), Taichong (LR3), Taixi (KI3), Hegu (LI4), and Quchi (LI11)17 according to the World Health Organization standard. Single-use 0.30×40 mm or 0.30×25 mm acupuncture needles (Hwato, Suzhou, China) 27,28 were vertically inserted into each acupoint to 20-30 mm depth to obtain a deqi sensation (a soreness, distention, numbness or heaviness sensation). Bilateral Zusanli (ST36) and Tianshu (ST25) were selected for moxibustion. Pure moxa sticks (diameter: 2.8 cm; Hanyi, Nanyang, China) were ignited and fixed on a moxibustion stand at a distance of 3-5 cm to the surface of acupoints. The temperature of skin surface at the acupoints was maintained at 43 ± 1°C and monitored with a miniature infrared thermometer (Fluke 62, Fluke Corporation, Everett, WA, USA). Acupuncture and moxibustion were concomitantly performed for 30 min. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Acupuncture on Crohn's Disease Activity Index (CDAI) | Difference in Crohn's Disease Activity Index (CDAI) from baseline at 12 weeks was used for between-group assessment. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Acupuncture on Anxiety and Depression | Differences in Hospital Anxiety Depression Scale (HADS) scores from baseline at 12 weeks were used for between-group assessment. | Week 12 |
| Effects of Acupuncture on Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huangan Wu, PhD, MD | Shanghai Institute of Acupuncture, Moxibustion and Meridian | Study Chair |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Subjects, efficacy assessors and statisticians were blinded.
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| Sham acupuncture | Other | Sham acupuncture needles (0.35×40 mm) with flat tips (Hwato, Suzhou, China) were inserted towards the same acupoints to induce slight pain but without penetrating the skin. Sham moxibustion was made by igniting the same type of moxa sticks but fixing them at a distance of 8-10 cm from the skin of acupoints to maintain the temperature at 37 ± 1°C. Sham acupuncture and moxibustion were concomitantly performed for 30 min. |
|
Differences in Inflammatory Bowel Disease Questionnaire (IBDQ) scores from baseline at 12 weeks were used for between-group assessment.
| Week 12 |
| Effect of acupuncture on intestinal inflammation | Differences in serum C-reactive protein levels and faecal calprotectin levels from baseline at 12 weeks were used for between-group assessment. | Week 12 |
| Effects of acupuncture on gut microbiota | This includes the alpha and beta diversity of gut microbes and the abundance of flora at each level. | Week 12 |
| Effects of acupuncture on the functional activity of brain networks | Including brain network graph theory properties, connection strength. | Week 12 |
| Effects of acupuncture on intestinal inflammation | Including intestinal barrier function, peripheral Th1/Th17-related inflammatory factors. | Week 12 |
| Effect of Acupuncture on Brain Imaging-Gut Microbiological Correlations | The effect of acupuncture was observed by constructing correlations between brain imaging parameters and gut microbiology and gut inflammation levels. | Week 12 |
| Safety evaluation (number of participants with abnormal reactions to acupuncture and moxibustion treatment) | Abnormal reactions after acupuncture and moxibustion, such as bleeding, hematoma, scald, dizziness and other phenomena. | Week 12 |
| Safety evaluation (number of participants with abnormal routine blood tests) | Routine blood tests, which mainly include the number of red blood cells, white blood cells and platelets per litre of blood. | Week 12 |
| Safety evaluation (number of participants with abnormal Liver function tests) | Liver function tests, mainly including peripheral blood concentrations of alanine aminotransferase (U/L), glutamine aminotransferase (U/L), gamma-glutamyl transpeptidase (U/L), alkaline phosphatase (U/L), total bilirubin (μmol/L), direct bilirubin (μmol/L), indirect bilirubin (μmol/L), total protein (g/L), albumin (g/L) and globulin (g/L). | Week 12 |
| Safety evaluation (number of participants with abnormal Renal function tests) | Renal function tests, mainly including tests of creatinine (μmol/L) and urea nitrogen (mmol/L) concentrations in peripheral blood. | Week 12 |
| D007410 | Intestinal Diseases |