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 18, 2013
Last verified: May 2013
  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
Procedure: Individually acupuncture
Drug: Lactulose
Procedure: shallow acupuncture
Phase 3

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:
  • Spontaneous Defecations/Week From Baseline to the 4th Week [ Time Frame: baseline and the 4th week ] [ Designated as safety issue: Yes ]
    times of defecation in one week without help of medicines or hands


Secondary Outcome Measures:
  • Degree of Straining During Defecation (Constipation-related Symptoms by Patient) [ Time Frame: baseline and the 4th week ] [ Designated as safety issue: Yes ]
    one of constipation-related symptoms assessed by patients,the average score of one week in the 4th week. It ranges from 0 to 4. '0' means no such symptom and '4' means very severe symptom.

  • Spontaneous Defecations/Week at the 8th Week [ Time Frame: baseline and the 8th week ] [ Designated as safety issue: No ]
    defecation (without help of medicines or hands) times in the 8th week

  • Spontaneous Defecations/Week at the 16th Week [ Time Frame: baseline and the 16th week ] [ Designated as safety issue: No ]
    times of defecation without help of medication or hands at the 16th week

  • Symptoms Assessed by Doctor at the 4th Week [ Time Frame: baseline and the 4th week ] [ Designated as safety issue: Yes ]
    Constipation Scale is a scale about constipation-related symptoms assessment made by the doctors. There are eight items(the score was summed up by the 8 items). It ranges from '0' to '30'. '0' means none of symptoms and '30' means very severe symptoms.

  • Sensation of Incomplete Evacuation(Constipation-related Symptoms by Patient) [ Time Frame: baseline and the 4th week ] [ Designated as safety issue: Yes ]
    one of constipation-related symptoms assessed by patients, the average score of one week in the 4th week. It ranges from 0 to 4,among them '0' means no such symptom and '4' means very severe symptom.

  • Form of Faeces(Constipation-related Symptoms by Patient) [ Time Frame: baseline and the 4th week ] [ Designated as safety issue: Yes ]
    one of constipation-related symptoms assessed by patients,the average score of one week in the 4th week. It ranges from 0 to 4,among them '0' means normal faeces and '4' means very hard faeces.

  • Abdominal Distention(Constipation-related Symptoms by Patient) [ Time Frame: baseline and the 4th week ] [ Designated as safety issue: Yes ]
    one of constipation-related symptoms assessed by patients,the average score of one week in the 4th week.It ranges from 0 to4,among them '0' means no such symptom and '4' means very severe symptom.


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: Individually acupuncture group

Individually needle on ST25 tianshui (bilateral) with electric stimulator. Insert the needle (75 mm, Huatuo brand)about 1.5-2.5cun vertically until the tip of needle hits the abdominal peritoneum (the doctor feels like the needle hitting something a little bit hard and the patient feels obvious dragging pain ) with no hand technique of the needle. Then put the electrode on the handle of the needle on both sides and the parameter is constant amplitude, 2/15Hz frequency, and the current intensity is adjusted to the abdominal muscles shiver slightly and the patient feels trivial pain. Leave the needles for 30min.

Once a day, five time a week, four weeks.

Procedure: Individually acupuncture

Huatuo brand needle (75mm, 30#), 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:
  • Huatuo brand needle
  • LH202H electric stimulator
Active Comparator: Active drug group
Lactulose oral solution, oral administration, 20-30ml The patient takes before breakfast. The treatment continues for four weeks.
Drug: Lactulose
20-30ml, before breakfast, and continues for four weeks
Other Name: Lactulose produced by Solvay Pharmaceuticals BV
Active Comparator: shallow acupuncture group

Acupuncture: ST-25 tianshui (bilaterally), 25 mm filiform needle (Huatuo brand, 30#), vertically, depth: 2 mm); the acupuncture technique is superficial acupuncture and parameter of electric stimulator is the same as Group A.

Course: once a day, five times a week, four weeks

Procedure: shallow acupuncture
Huatuo brand needle (25 mm, 30#) Electric stimulator parameter is constant wave, 2/15Hz, the current intensity is the patient's abdominal muscles shiver slightly and the the patient feels trivial pain.
Other Names:
  • Huatuo brand needle
  • LH202H electric stimulator

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:

  • Patients are diagnosed by specialists in the department of anus and intestine,or the department of gastroenterology according to the diagnostic criteria of functional constipation.
  • Age between 18 to 75 years old
  • Conscious, favorable general condition, cooperate with examination and treatment
  • Volunteer to join this research and sign the written informed consent prior to receiving treatment
  • Provide address and phone number, and cooperate with long-term follow-up

Exclusion Criteria:

  • Irritable bowel syndrome, or constipation caused by tumor, inflammation, medication, endocrine, or metabolic diseases
  • Age younger than 18 years old, or older than 75 years old
  • Known serious cardiovascular disease, hepatic injury, or renal damage; serious cognitive dysfunction; aphasia, serious mental disorder; malnutrition, poor general condition, unable to cooperate with examination or treatment
  • Pregnancy or breast-feeding woman
  • Abdominal aneurysm, abnormal splenohepatomegaly, enteroparesis, partial intestinal obstruction, celiac tuberculosis
  • Coagulation disorders, or constantly use anticoagulant drugs, such as heparin
  • Patients with cardiac pacemaker
  • Patients who is seriously afraid of needles
  • Patients who did not fill in constipation diary card in the baseline evaluation period, or not volunteer to join this research program
  • No contact method, unable to cooperate with follow-up
  Contacts and Locations
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 18, 2013
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 April 16, 2014