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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT00508482
First received: July 26, 2007
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Constipation
Other: deep needling
Drug: Lactulose
Other: shallow needling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation

Resource links provided by NLM:


Further study details as provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • Change of Mean Weekly Spontaneous Bowel Movements [ Time Frame: over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change of Mean Value of Straining During Defecating [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • Change of Mean Value of Incomplete Evacuation [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • Change of Mean Value of Stool Consistency [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • Change of Mean Value of Abdominal Distention [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • Change of Mean Value of Cleveland Clinic Score [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • Time to the First Spontaneous Bowel Movement After the First Treatment [ Time Frame: counting by hours ] [ Designated as safety issue: No ]
  • Percentage of the Usage of Emergency Drugs [ Time Frame: over 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Percentage of the Usage of Emergency Drugs [ Time Frame: at the 4th week of follow-up ] [ Designated as safety issue: No ]
  • Percentage of the Usage of Emergency Drugs [ Time Frame: at the 12th week of follow-up ] [ Designated as safety issue: No ]

Enrollment: 475
Study Start Date: April 2008
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: deep needling group
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

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.

Other Names:
  • acupuncture
  • electroacupuncture
Active Comparator: lactulose group
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
20-30ml, once a day before breakfast, for the whole study except the run-in period
Other Name: Lactulose produced by Solvay Pharmaceuticals BV
Active Comparator: shallow needling group
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
Huatuo brand needle (0.30×25mm). The usage of EA apparatus and treatment course were the same as deep needling group.
Other Names:
  • acupuncture
  • electroacupuncture

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508482

Locations
China, Beijing
Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Ministry of Science and Technology of the People´s Republic of China
Investigators
Study Director: Zhishun Liu, M.D. Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences
  More Information

No publications provided

Responsible Party: Liu Zhishun, Chief of the Acupuncture Department, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT00508482     History of Changes
Other Study ID Numbers: 2006BAI12B05-1
Study First Received: July 26, 2007
Results First Received: November 28, 2012
Last Updated: May 22, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Acupuncture
Functional constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014