Efficacy and Safety of Acupuncture for Functional Constipation

Study Overview
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Brief Summary
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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. .

Detailed Description
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functional constipation,acupuncture,effects and safety,pragmatic RCT

Official Title
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Efficacy and Safety of Acupuncture for Functional Constipation: a Multi-center Randomized Controlled Trial

Conditions
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Constipation

Intervention / Treatment
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* Other: acupuncture
* Drug: mosapride citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who has been diagnosed with functional constipation according to Rome Ⅲ criteria Patients who are aged 18-75 years old Stop medication or acupuncture (if any) 1 week before randomization and uninvolved in other trials Sign the informed consent out of one's own will Exclusion Criteria: Secondary constipation Patients with consciousness impairment, psychotic patients or patients unable to express clearly Patients with malignant tumor in progressive stage, severe wasting disease and liable to be infected and bleed Patients with severe cardiovascular disease, hepatic injury, renal damage, digestive disease or hematological diseases Women in pregnancy and lactation period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture at ST25 and BL25<br>the points formula of back-shu point combination with front-mu point. | Other: acupuncture<br>* 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.<br>* Other names: acupuncture and moxibustion;|
| Experimental: Acupuncture at LI11 and ST37<br>the points formula of He-points | Other: acupuncture<br>* 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.<br>* Other names: acupuncture and moxibustion;|
| Experimental: Acupuncture at ST25, BL25, LI11 and ST37<br>the formula of He-point,back-shu point and front-mu point | Other: acupuncture<br>* 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.<br>* Other names: acupuncture and moxibustion;|
| Active Comparator: medicine<br>oral use of mosapride citrate | Drug: mosapride citrate<br>* 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal<br>* Other names: mosapride citrate,made in China;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 Defecation straining Severe defecation straining Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings. [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 Defecation straining Severe defecation straining Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings. [the average score of one week at the 8th week]-[the average score of one week at baseline] | baseline and at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Functional constipation