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NCT Number: NCT00508482

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

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

deep needling

Other

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

Lactulose

Drug

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

Other names: Lactulose produced by Solvay Pharmaceuticals BV

shallow needling

Other

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

Primary outcomes

  1. 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

    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 outcomes

  1. Change of Mean Value of Straining During Defecating

    Time frame: over 4 weeks of treatment

    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.

  2. Change of Mean Value of Incomplete Evacuation

    Time frame: over 4 weeks of treatment

    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.

  3. Change of Mean Value of Stool Consistency

    Time frame: over 4 weeks of treatment

    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.

  4. Change of Mean Value of Abdominal Distention

    Time frame: over 4 weeks of treatment

    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.

  5. Change of Mean Value of Cleveland Clinic Score

    Time frame: over 4 weeks of treatment

    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.

  6. Time to the First Spontaneous Bowel Movement After the First Treatment

    Time frame: counting by hours

  7. Percentage of the Usage of Emergency Drugs

    Time frame: over 4 weeks of treatment

  8. Percentage of the Usage of Emergency Drugs

    Time frame: at the 4th week of follow-up

  9. Percentage of the Usage of Emergency Drugs

    Time frame: at the 12th week of follow-up

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Collaborators

  • Ministry of Science and Technology of the People´s Republic of China

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 30, 2007
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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