Clinical trial NCT00508482: A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation
Official title: A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Keywords: Acupuncture
Functional constipation
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2007-07-30
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Mean Weekly Spontaneous Bowel Movements
timeFrame: over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up
Secondary outcomes:
measure: Change of Mean Value of Straining During Defecating
timeFrame: over 4 weeks of treatment
measure: Change of Mean Value of Incomplete Evacuation
timeFrame: over 4 weeks of treatment
measure: Change of Mean Value of Stool Consistency
timeFrame: over 4 weeks of treatment
measure: Change of Mean Value of Abdominal Distention
timeFrame: over 4 weeks of treatment
measure: Change of Mean Value of Cleveland Clinic Score
timeFrame: over 4 weeks of treatment
measure: Time to the First Spontaneous Bowel Movement After the First Treatment
timeFrame: counting by hours
measure: Percentage of the Usage of Emergency Drugs
timeFrame: over 4 weeks of treatment
measure: Percentage of the Usage of Emergency Drugs
timeFrame: at the 4th week of follow-up
measure: Percentage of the Usage of Emergency Drugs
timeFrame: at the 12th week of follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
name: Zhishun Liu, M.D.
role: STUDY_DIRECTOR
References:
citation: Wu J, Liu B, Li N, Sun J, Wang L, Wang L, Cai Y, Ye Y, Liu J, Wang Y, Liu Z. Effect and safety of deep needling and shallow needling for functional constipation: a multicenter, randomized controlled trial. Medicine (Baltimore). 2014 Dec;93(28):e284. doi: 10.1097/MD.0000000000000284.