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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508482
• Other study ID #: 2006BAI12B05-1
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2007
• Last updated: May 22, 2014
• Start date: April 2008
• Est. completion date: November 2011

Study information

• Verified date: May 2014
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

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.

Drug:
• Lactulose
20-30ml, once a day before breakfast, for the whole study except the run-in period

Other:
• shallow needling
Huatuo brand needle (0.30×25mm). The usage of EA apparatus and treatment course were the same as deep needling group.

Locations

Country	Name	City	State
China	Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Time to the First Spontaneous Bowel Movement After the First Treatment		counting by hours	No
Secondary	Percentage of the Usage of Emergency Drugs		over 4 weeks of treatment	No
Secondary	Percentage of the Usage of Emergency Drugs		at the 4th week of follow-up	No
Secondary	Percentage of the Usage of Emergency Drugs		at the 12th week of follow-up	No