A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation

Study Overview
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Brief Summary
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The purpose of this study is to re-evaluate the therapeutic superiority and safety of acupuncture treatment using high quality and large sampled clinical research. The investigators want to provide a preferred treatment protocol, which is effective, safe, and easy to use in clinical practice. This research also clarifies that the insertion depth is a key factor in the therapeutic effect of acupuncture. The results of the study will help promote the development of the standardization of acupuncture.

Detailed Description
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Functional constipation is a high morbidity disease. The life-long treatment of functional constipation can seriously impact a patient's quality of life. At present, one of the most frequently used treatment is catharsis, which deals with the symptom. There are three main problems with catharsis. First, there are no long-lasting effects once the patient stops taking medication. Second, there are many side effects, including abdominal pain with defecation and diarrhea. Third, long-term use of irritant laxatives will not only make the constipation become refractory and complex; but also, this type of medicine can harm the enteric nervous system, cause melanosis coli, or even carcinoma of colon. Therefore, a therapy that is safe with minimal side effects and good short-term and long-term effects is urgently needed in functional constipation treatment. Clinical practice shows that acupuncture may meets this need to some extent. The acupuncture therapy is safe and effective and the therapeutic effects are still present several months after the treatment has been completed.

Official Title
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A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation

Conditions
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Constipation

Intervention / Treatment
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* Other: deep needling
* Drug: Lactulose
* Other: shallow needling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: meeting the diagnosis of Rome III criteria; aged from 18 to 75 years old; no use of medicine for constipation about 2 weeks before the enrollment, no acupuncture treatment for constipation in the previous 3 months, and never joined any other trial in progress in the previous 3 months; volunteered to join this trial and signed the informed consent form Exclusion Criteria: irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs; constipation with serious cardiovascular, hepatic or renal diseases, cognitive dysfunction, aphasia, mental disorders, or illness which affects the cooperation for examination and treatment; women in gestation or lactation period; abdominal aortic aneurysm or hepatosplenomegaly, etc.; blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin; cardiac pacemaker carrier.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: deep needling group<br>Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location, were used. After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 20 60mm until piercing into the muscle layer. Paired alligator clips of the electric acupuncture (EA) apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1 1mA. Participant's abdominal muscle twitching mildly showed the proper dose. Patients were treated once a day, five times a week for continuous 4 weeks. | Other: deep needling<br>* Huatuo brand needle (0.35×75mm), LH202H electric stimulator, parameter is constant wave, 2/15Hz, and current intensity is the abdominal muscles shiver slightly and the patient feels trivial pain. Once a day, five times a week, four weeks.<br>* Other names: electroacupuncture;|
| Active Comparator: lactulose group<br>Lactulose Oral Solution was taken orally at the dose of 20 30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed. | Drug: Lactulose<br>* 20-30ml, once a day before breakfast, for the whole study except the run-in period<br>* Other names: Lactulose produced by Solvay Pharmaceuticals BV;|
| Active Comparator: shallow needling group<br>Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5 9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group. | Other: shallow needling<br>* Huatuo brand needle (0.30×25mm). The usage of EA apparatus and treatment course were the same as deep needling group.<br>* Other names: electroacupuncture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Mean Weekly Spontaneous Bowel Movements | Spontaneous bowel movements per week were assessed every week during 4 weeks of treatment according to patients' diaries. Weekly spontaneous bowel movements were also assessed at the 4th and 12th week of follow-up according to patients' diaries. | over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Mean Value of Straining During Defecating | Score of straining during defecating was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of straining during defecating over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of straining during defecating by covariance because the data had significant difference among three groups at baseline. | over 4 weeks of treatment | 
| Change of Mean Value of Incomplete Evacuation | Score of incomplete evacuation was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of incomplete evacuation over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. | over 4 weeks of treatment | 
| Change of Mean Value of Stool Consistency | Score of stool consistency was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of stool consistency over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of stool consistency by covariance because the data had significant difference among three groups at baseline. | over 4 weeks of treatment | 
| Change of Mean Value of Abdominal Distention | Score of abdominal distention was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of abdominal distention over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of abdominal distention by covariance because the data had significant difference among three groups at baseline. | over 4 weeks of treatment | 
| Change of Mean Value of Cleveland Clinic Score | Cleveland Clinic Score was assessed by doctors which contains eight items about constipation-related symptoms. Score ranges from '0' to '30'. '0' means none of symptoms and '30' means very severe symptoms. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. | over 4 weeks of treatment | 
| Time to the First Spontaneous Bowel Movement After the First Treatment |  | counting by hours | 
| Percentage of the Usage of Emergency Drugs |  | over 4 weeks of treatment | 
| Percentage of the Usage of Emergency Drugs |  | at the 4th week of follow-up | 
| Percentage of the Usage of Emergency Drugs |  | at the 12th week of follow-up | 

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