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In this study, a 14-week, single blinded, randomized controlled clinical trial will be conducted to determine whether acupuncture could have significant benefits than sham acupuncture for IBS.
This is a single blinded randomized sham controlled clinical trial with two arms. 120 IBS patients will be recruited. The study will cooperate with Hong Kong Baptist University, and University of Toronto. After a 2-week run-in period, eligible subjects will be randomly assigned to one of two arms, acupuncture (AC) arm and sham acupuncture (SAC) arm. Each eligible subject will go through a 2-wk run-in-period, 6-wk treatment period and follow by a 6-wk of follow-up period. Five visits in total were scheduled for each subject in week 0, week 2, week 5, week 8 and week 14.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental | Electro-acupuncture will be conducted for 2 sessions per week over 6 consecutive weeks. Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into scalp acupuncture points (Baihui, Toulinqi) or straightly into body acupuncture points (Taichong, Zhangmen, Sanyinjiao, Zhongwan, Guanyuan, Tianshu, Zusanli). Electroacupuncture will be applied to the abdominal points at fast and dispersed waves through electric needle stimulator (ES-160 6-Channel Programmable Electro-acupuncture) for 30 min. The intensity is adjusted to a level at which patients feel comfortable. |
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| sham-acupuncture group | Placebo Comparator | Sham-acupuncture will be conducted for 2 sessions per week over 6 consecutive weeks. Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at the same way as in the acupuncture group but on sham-acupuncture points (Sham-Baihui, Sham-Toulinqi, Sham-Taichong, Sham-Zhangmen, Sham-Sanyinjiao, Sham-Zhongwan, Sham-Guanyuan, Sham-Tianshu, Sham-Zusanli). The sham points are non-acupuncture points nor located on meridians |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into scalp acupuncture points (Baihui, Toulinqi) or straightly into body acupuncture points (Taichong, Zhangmen, Sanyinjiao, Zhongwan, Guanyuan, Tianshu, Zusanli). Electroacupuncture will be applied to the abdominal points at fast and dispersed waves through electric needle stimulator (ES-160 6-Channel Programmable Electro-acupuncture) for 30 min. The intensity is adjusted to a level at which patients feel comfortable. |
| Measure | Description | Time Frame |
|---|---|---|
| Change on IBS-symptom severity scale | Value from 0-500. The higher the score, the more severe the symptoms. When there is lowering of the sore between baseline and treatments, it indicates clinical improvement. | 0,8,14 weeks |
| Change on Hamilton Depression Rating Scale (HAMD-17) | Value from 0-57. Scoring 8-16: mild depression, 17-23: moderate depression, over 24: severe depression. When there is lowering of the sore between baseline and treatments, it indicates improvement on depressive symptoms. | 0,8,14 weeks |
| Change on Clinical Global Impression-severity (CGI-S) | Rating from 1-7, the higher rate indicates more severe of the mental problem. The subject is rated by researcher from his clinical experience. When there is lowering of the rating between baseline and treatments, it indicates improvement. | 0,8,14 weeks |
| Change on Self-Rating Depression Scale (SDS) | Value from 20-80. Scoring 50-69: depression, over 70: severe depression. When there is lowering of the sore between baseline and treatments, it indicates improvement. | 0,8,14 weeks |
| Change on IBS Quality of Life (IBS-QoL) | Value from 35-170. The higher the score, the lower the quality of life. When there is lowering of the sore between baseline and treatments, it indicates improvement. | 0,8,14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Zhong, MD., Ph.D | Contact | 852-34116523 | ldzhong0305@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaoxiang Bian, MD., Ph.D | Hong Kong Chinese Medicine Clinical Study Centre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linda Zhong | Recruiting | Kowloon Tong | Kowloon | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34526079 | Derived | Zhong LLD, Lam TF, Yang W, Zheng Y, Lyu Z, Bian Z. Electro-acupuncture for irritable bowel syndrome patients: study protocol for a single-blinded randomized sham-controlled clinical trial. Trials. 2021 Sep 15;22(1):619. doi: 10.1186/s13063-021-05563-4. |
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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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single-blinded, randomized, sham-controlled clinical trial
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Subjects of both groups will be randomly assigned to receive either electro-acupuncture or control (sham) treatment. For randomization, simple, complete non-sequential random numbers will be generated in advance by a computer program in a block of four, and kept by the principal investigator. After a patient's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist by the PI. This arrangement will ensure that the clinical assessor and participants are blinded to the allocation.
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| Sham-acupuncture | Device | Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at the same way as in the acupuncture group but on sham-acupuncture points (Sham-Baihui, Sham-Toulinqi, Sham-Taichong, Sham-Zhangmen, Sham-Sanyinjiao, Sham-Zhongwan, Sham-Guanyuan, Sham-Tianshu, Sham-Zusanli). The sham points are non-acupuncture points nor located on meridians |
|
| D004066 | Digestive System Diseases |