Acupuncture for Chronic Constipation

Study Overview
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Brief Summary
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Since there have been few advances for constipation in laxative treatment in the last 50 years, this study is designed to evaluate the efficacy and safety of acupuncture for patients with chronic constipation based on the theory of traditional Chinese Medicine.

Detailed Description
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Although many people regard regular defecation as important factor to maintain healthy, constipation is still a common problem in general population. Because the symptoms cause serious impairment of life quality, laxatives are commonly prescribed for people and over prescribing of laxatives is also common. Despite the large sums spent on laxatives, there have been few advances in laxative treatment in the last 50 years and there have been minimal research addressing the problem. Since there is unsatisfactory effect by current pharmacologic therapies and preventive strategies, we look forward to the practice of traditional Chinese medicine, which had abundant clinical experiences and medical records in the past of thousands years ago. Therefore we aim to do the research to create the evidence of acupuncture on the safety, efficacy and quality of life for chronic constipation.

Official Title
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Randomised Controlled Trial of Acupuncture for Patients With Chronic Constipation

Conditions
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Chronic Constipation

Intervention / Treatment
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* Procedure: (electro)acupuncture
* Procedure: sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men or non-pregnant women who are at least 20 years old who meet any one of the following three criteria: 1.the one who meets RomeIII criteria; 2.at least once a week of enema/suppository in past three months; 3.laxative use in more than half time of last three months Exclusion Criteria: known colorectal cancer, anal abscess, anal fissure, rectocele, inflammatory bowel disease, megacolon or mechanical bowel obstruction unknown cause of gastrointestinal bleeding or acute infection history of alcohol or drug abuser women who are pregnant, as determined by a urine pregnancy test history of adverse reaction to (electro)acupuncture received herb or acupuncture therapy within one month prior to enrollment

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: A<br> | Procedure: (electro)acupuncture<br>* Frequency of electrostimulation: 15Hz; Duration of electrostimulation: 20min;<br>* Other names: electroacupuncture;|
| Sham Comparator: S<br> | Procedure: sham acupuncture<br>* Superficial acupuncture needle stimulation at non-acupoints with TENS applied for seconds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score of questionnaire of constipation symptoms |  | every month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score of questionnaire of quality of life |  | every month | 
| amount of laxative use |  | every week | 
| frequency of enema/suppository use/digital maneuver |  | every week | 
| stool amount |  | every week | 
| stool consistency |  | every week | 
| overall efficacy |  | 2 month | 
| safety (adverse event) |  | every week | 
| frequency of spontaneous bowel movement |  | every week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic constipation, electroacupuncture, randomized controlled trial