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To observe the safety and efficacy of moxibustion on diarrhea-predominant irritable bowel syndrome and evaluation by Magnetic Resonance Imaging (MRI), Event related potential (ERP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxibustion group | Experimental | Receiving moxibustion treatment |
|
| Sham moxibustion group | Sham Comparator | Receiving sham moxibustion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moxibustion | Device | Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral). using mild-warm moxibustion，the surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24. |
| Measure | Description | Time Frame |
|---|---|---|
| Total efficacy (Adequate relief responder) | The ratio of the number of responders and the total number of participants in each group. Adequate relief responder is the participant who considered effective treatment in the self-assessment. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Total efficacy (Adequate relief responder) | Differences in Adequate relief responder between groups | Week 12, 18 and 24 |
| Symptom severity score (SSS) | Differences in the mean changes of SSS score from baseline between groups |
| Measure | Description | Time Frame |
|---|---|---|
| Brain structures （gray matter, white matter）MRI | Week 6 | |
| resting-state functional MRI | Analysis with methods of regional homogeneity，ALFF/fALFF，functional connectivity. | Week 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huangan Wu, MD,PhD | Shanghai University of TCM | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Institute of Acupuncture, Moxibustion and Meridian | Shanghai | Shanghai Municipality | 200030 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35222693 | Derived | Bao C, Wu L, Shi Y, Shi Z, Jin X, Shen J, Li J, Hu Z, Chen J, Zeng X, Zhang W, Ma Z, Weng Z, Li J, Liu H, Wu H. Long-term effect of moxibustion on irritable bowel syndrome with diarrhea: a randomized clinical trial. Ther Adv Gastroenterol. 2022 Feb 23;15:17562848221075131. doi: 10.1177/17562848221075131. eCollection 2022. | |
| 27776494 |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D009071 | Moxibustion |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Sham moxibustion | Device | Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral); using sham mild-warm moxibustion，the surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24. |
|
| Week 6, 12, 18 and 24 |
| The proportion of responder to SSS | The differences of the proportion of responders between groups. Defined the SSS score decreased more than 50 points from baseline as responder. | Week 6, 12, 18 and 24 |
| Bristol stool form scale (BSS) | Differences in the mean changes of BSS score from baseline between groups | Week 6, 12, 18 and 24 |
| Quality of life questionnaire (IBS-QOL) | Differences in the mean changes of IBS-QOL score from baseline between groups | Week 6 |
| hospital anxiety and depression score (HADS) | Differences in the mean changes of HADS score from baseline between groups | Week 6 |
| Self-rating anxiety scale (SAS) | Differences in the mean changes of SAS score from baseline between groups | Week 6 |
| Self-rating Depression Scale (SDS) | Differences in the mean changes of SDS score from baseline between groups | Week 6 |
| Diarrhea frequency per day | Differences in the mean changes of Diarrhea frequency per day from baseline between groups | Week 6, 12, 18 and 24 |
| Urgency of defecation | Differences in the mean changes of Urgency of defecation from baseline | Week 6, 12, 18 and 24 |
| Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0) | Eg.moxibustion related burns, blistering, etc | Week 6, 12, 18 and 24 |
| Magnetic Resonance Spectroscopy (MRS) | The ratio of glutamate complex (Glx) peak area and creatine ratio (Cr) of the cingulate cortex and insula. | Week 6 |
| Event-related potentials (ERP) | Measurement of brain resting state energy atlas and the amplitude changes of each major components during the task and latency. | Week 6 |
| Intestinal microbiota changes | Fecal microbial structural and diversity changes | Week 6 |
| Brain-gut microbiota interaction | Multiple regression analysis to establish the association between intestinal microbiota and brain | Week 6 |
| Shanghai Traditional Chinese Medicine-Integrated Hospital, Shanghai University of Traditional Chinese Medicine |
| Shanghai |
| Shanghai Municipality |
| 200082 |
| China |
| Yueyang Integrated Chinese and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | 200437 | China |
| Bao C, Zhang J, Liu J, Liu H, Wu L, Shi Y, Li J, Hu Z, Dong Y, Wang S, Zeng X, Wu H. Moxibustion treatment for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016 Oct 24;16(1):408. doi: 10.1186/s12906-016-1386-4. |
| D004066 | Digestive System Diseases |