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| Name | Class |
|---|---|
| Beijing University of Chinese Medicine | OTHER |
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The trial aims to examine the efficacy and safety of acupuncture in the treatment of refractory irritable bowel syndrome (IBS). The investigators will include 170 participants to receive acupuncture plus usual care or sham acupuncture plus usual care. Twelve sessions of acupuncture will be delivered to participants over a period of 4 weeks. The primary outcome is defined as proportion of participants with adequate relief of global IBS symptoms at week 8, which is defined as >50% reduction in IBS-SSS scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture plus usual care | Experimental | Acupuncture will be given on the basis of usual care. A total of 12 sessions of acupuncture will be given over a period of 4 weeks. |
|
| Sham acupuncture plus usual care | Sham Comparator | Sham acupuncture refers to acupuncture at sham points. Sham acupuncture will be given on the basis of usual care. A total of 12 sessions of sham acupuncture will be given over a period of 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Acupuncture will be given for a total of 12 session over 4 weeks. Acupuncture at acupoints Tianshu (ST25), Shangjuxu (ST37), Zusanli (ST36), and Neiguan (PC6) bilaterally will be given. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants with adequate relief of global IBS symptoms | Adequate relief of global IBS symptoms will be defined as a >50% reduction in the IBS symptom severity scale (IBS-SSS). | 4 weeks after randomization (week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| IBS symptom severity scale | The IBS symptom severity scale (IBS-SSS) has a total of 500 points. The score ranges from 0 to 500; higher scores indicating more severe symptoms; a score over 300 indicates severe symptoms. | Baseline (week 0), week 2, 4, 6, 8 |
| Weekly bowel movements |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with adverse events | Side effect of acupuncture or sham acupuncture will be recorded. | Week 4 and 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Chen, MD, PhD | Contact | 028-87765705 | cm@cdutcm.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhi-Gang Li, MD | Beijing University of Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Chengdu University of Traditional Chinese Medicine | Recruiting | Chengdu | Sichuan | 610075 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42394258 | Derived | Zhao J, Li X, Dong JX, Yang JY, Li ZG, Zhu L. Influence of Emotional Disorders on the Efficacy of Acupuncture in Refractory Diarrhea-Predominant Irritable Bowel Syndrome: A Secondary Analysis of a Randomized Controlled Trial. J Integr Complement Med. 2026 Jul 2:27683605261461176. doi: 10.1177/27683605261461176. Online ahead of print. | |
| 34518248 |
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Conditional share, the principle investigator will ask for the reasons to use the data.
After the completing the study for 2 years
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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 |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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The total number of bowel movements in a week. |
| Baseline (week 0), week 2, 4, 6, 8 |
| Work and Social Adjustment Scale | The Work and Social Adjustment Scale (WSAS) measures the effect of IBS on ability to work and manage at home, participate in social and private leisure activities and maintain relationships. It has five domains scored 0 (not affected) to 8 (severely affected), with a total possible score of 40. | Baseline (week 0), week 2, 4, 6, 8 |
| Irritable Bowel Syndrome Quality of Life Instrument | Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) is a condition-specific measure for assessing health-related QoL among persons with irritable bowel syndrome. The IBS-QOL had eight subscales. The IBS-QOL and its subscales were both scored on a range of 0-100 with higher scores suggestive of better QOL. | Baseline (week 0), week12, and month12 |
| Bristol Stool Form Scale | The Bristol Stool Form Scale is a tool that is used for the assessment of stool consistency. Scores 1-2 indicate constipation, scores 3-5 indicate normal stool; scores 6-7 indicate diarrhea. | Baseline, weeks 2, 4, 6 and 8. |
| Self-Rating Anxiety Scale (SAS) | The SAS is a self rating scale for the assessment of the severity of anxiety. | Baseline, weeks 2, 4. |
| Self-Rating Depression Scale (SDS) | The SDS is a self rating scale for the assessment of the severity of depression. | Baseline, weeks 2, 4. |
| Zhao J, Chen M, Wang X, Ye K, Shi S, Li H, Wang J, Chen X, Ni J, Wei Q, Shi Y, Hu Y, Sun J, Li D, Liu S, Li Z, Zheng H, Yu SG. Efficacy of acupuncture in refractory irritable bowel syndrome: study protocol for a randomised controlled trial. BMJ Open. 2021 Sep 13;11(9):e045655. doi: 10.1136/bmjopen-2020-045655. |
| D004066 | Digestive System Diseases |