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| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
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A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25 has the same effect as lactulose in unaided self-defecation frequency of a week and has better effect in symptoms improvement (in press). The object is to evaluate whether acupuncture is effective for functional constipation. As an explanatory research, it took one single point as its intervention and sham acupuncture as its control group (patients were blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture is more effective than routine treatment. Acupuncture prescriptions used in this trial are individually prescribed according to syndrome differentiation, which can improve clinical effect. .
functional constipation,acupuncture,effects and safety,pragmatic RCT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture at ST25 and BL25 | Experimental | the points formula of back-shu point combination with front-mu point. |
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| Acupuncture at LI11 and ST37 | Experimental | the points formula of He-points |
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| Acupuncture at ST25, BL25, LI11 and ST37 | Experimental | the formula of He-point,back-shu point and front-mu point |
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| medicine | Active Comparator | oral use of mosapride citrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the SBMs From Baseline at Week 4 | [average number of spontaneous bowel movements in a week at week 4]-[average number of spontaneous bowel movements in a week at baseline] | baseline and at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Bristol Stool Scale at the 4th Week | Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 4th week-the Bristol Stool Scale at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LIU Zhishun, phD | Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.5 Beixiange Street, Xuanwu District | Beijing | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22759406 | Derived | Li Y, Zheng H, Zeng F, Zhou SY, Zhong F, Zheng HB, Chen M, Jing XH, Cai YY, Jia BH, Zhu B, Liu ZS. Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial. Trials. 2012 Jul 3;13:104. doi: 10.1186/1745-6215-13-104. |
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Nine enrolled participants refused to join in the trial after signing the informed consent. So they were excluded from the trial.
The participants were recruited through the inpatients and outpatients settings in the 8 hospitals.We also recruited the participants through television and newspapers advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture at ST25 and BL25 | the points formula of back-shu point combination with front-mu point. acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. |
| FG001 | Acupuncture at LI11 and ST37 | the points formula of He-points acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. |
| FG002 | Acupuncture at ST25, BL25, LI11 and ST37 | the formula of He-point,back-shu point and front-mu point acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. |
| FG003 | Medicine | oral use of mosapride citrate mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture at ST25 and BL25 | the points formula of back-shu point combination with front-mu point. acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of the SBMs From Baseline at Week 4 | [average number of spontaneous bowel movements in a week at week 4]-[average number of spontaneous bowel movements in a week at baseline] | Posted | Mean | 95% Confidence Interval | times per week | baseline and at 4 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture at ST25 and BL25 | the points formula of back-shu point combination with front-mu point. acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye discomfort | Eye disorders | Non-systematic Assessment |
Unblinding of participants in the acupuncture and mosapride groups;an insufficient duration to assess the long term effect or risks;a missing assessment of electrocardiograms for possible cardiovascular harm of mosapride
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liu Zhishun | Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences | 8610-010-88001124 | liuzhishun@aliyun.com |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D009071 | Moxibustion |
| C062720 | mosapride |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| mosapride citrate | Drug | 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal |
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| baseline and at 4 weeks |
| Change From Baseline in Difficulty Degree of Defecation at the 4th Week | This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3. 0-Without difficulty
[the average score of one week at the 4th week]-[the average score of one week at baseline] | baseline and at 4 weeks |
| Changes of the SBMs From Baseline at Week 8 | [average number of spontaneous bowel movements in a week at week 8]-[average number of spontaneous bowel movements in a week at baseline] | baseline and at 8 weeks |
| Change From Baseline in the Bristol Stool Scale at the 8th Week | Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 8th week-the Bristol Stool Scale at baseline. | baseline and at 8 weeks |
| Change From Baseline in Difficulty Degree of Defecation at the 8th Week | This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3. 0-Without difficulty
[the average score of one week at the 8th week]-[the average score of one week at baseline] | baseline and at 8 weeks |
| BG001 | Acupuncture at LI11 and ST37 | the points formula of He-points acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. |
| BG002 | Acupuncture at ST25, BL25, LI11 and ST37 | the formula of He-point,back-shu point and front-mu point acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. |
| BG003 | Medicine | oral use of mosapride citrate mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of functional constipation | Mean | Standard Deviation | months |
|
| Received Traditional Chinese Medicine therapies | Number | participants |
|
| SBMs | SBMs, spontaneous bowel movements. | Mean | Standard Deviation | times per week |
|
| Bristol scale | Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. | Mean | Standard Deviation | units on a scale |
|
| Degree of straining during defecation | This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3. Zero means defecating with no effort and 3 means defecating with great effort. A 0 score is considered a better than 3 for outcome. Patients score for themselves according to their own feelings. | Number | participants |
|
| OG001 | Acupuncture at LI11 and ST37 | the points formula of He-points acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. |
| OG002 | Acupuncture at ST25, BL25, LI11 and ST37 | the formula of He-point,back-shu point and front-mu point acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. |
| OG003 | Medicine | oral use of mosapride citrate mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal |
|
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| Secondary | Change From Baseline in the Bristol Stool Scale at the 4th Week | Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 4th week-the Bristol Stool Scale at baseline. | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and at 4 weeks |
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| Secondary | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3. 0-Without difficulty
[the average score of one week at the 4th week]-[the average score of one week at baseline] | Posted | Number | participants | baseline and at 4 weeks |
|
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|
|
| Secondary | Changes of the SBMs From Baseline at Week 8 | [average number of spontaneous bowel movements in a week at week 8]-[average number of spontaneous bowel movements in a week at baseline] | Posted | Mean | 95% Confidence Interval | times per week | baseline and at 8 weeks |
|
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| Secondary | Change From Baseline in the Bristol Stool Scale at the 8th Week | Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 8th week-the Bristol Stool Scale at baseline. | Posted | Mean | Full Range | units on a scale | baseline and at 8 weeks |
|
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| Secondary | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3. 0-Without difficulty
[the average score of one week at the 8th week]-[the average score of one week at baseline] | Posted | Number | participants | baseline and at 8 weeks |
|
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|
| 0 |
| 168 |
| 3 |
| 168 |
| EG001 | Acupuncture at LI11 and ST37 | the points formula of He-points acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. | 0 | 172 | 3 | 172 |
| EG002 | Acupuncture at ST25, BL25, LI11 and ST37 | the formula of He-point,back-shu point and front-mu point acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. | 0 | 165 | 6 | 165 |
| EG003 | Medicine | oral use of mosapride citrate mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal | 0 | 170 | 6 | 170 |
| Irregular menstruation | Reproductive system and breast disorders | Non-systematic Assessment |
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| Common cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Joint pains | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Fundus hemorrhage | Eye disorders | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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