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

Condition(s) targeted: Constipation

Intervention: Deep needle on ST25 (bilateral) with electric stimulator (Device); Lactulose (Drug); Huatuo brand needle, LH202H electric stimulator (Device)

Phase: Phase 3

Status: Recruiting

Sponsored by: Ministry of Science and Technology of the People´s Republic of China

Official(s) and/or principal investigator(s):
Zhishun Liu, M.D., Study Director, Affiliation: Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences

Overall contact:
Zhishun Liu, M.D., Phone: 8610-010-88001124, Email: liuzhishun@yahoo.com.cn

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. Our objectives are to normalize the syndrome differentiation, point selection, technical procedure, and electric acupuncture parameters, which provide high level evidence-based proofs for acupuncture clinical treatments. We 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 our study will help promote the development of the standardization of acupuncture.

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

Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Number of complete spontaneous bowel movement (CSBM) per week

Secondary outcome: The number of subjects that had CSBM over 4 times per week,and self-evaluation on symptoms by patient

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, the most frequently used treatment is catharsis, which deals with the symptom. This therapy is effective in the short-term for general functional constipation, whereas the effect is poor in colonic slow transit constipation. 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. Traditional Chinese Medicine diagnosis and treatment has its own advantages in treating functional constipation, but the therapeutic effect of treating colonic slow transit constipation is still uncertain. Although constipation is relieved to a certain extent, the patient also suffers from abdominal pain during defecation. Chinese herbs, such as Radix et Rhizoma Rhei, or Cassia angustifolia Vahl, are laxatives which also provide short-term effects. Long-term administration of the Chinese herbs will affect the regulation of Meissner's plexus, Auerbach's plexus, and gastrointestinal hormones, as well as make the digestive system depend on laxatives.

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, especially for the type of slow colonic transit functional constipation.

Clinical practice shows that acupuncture meets this need. The acupuncture therapy is safe and effective especially for slow colonic transit functional constipation，and the therapeutic effects are still present several months after the treatment has been completed.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

- Hemiplegic patients due to stroke should be able to take care of themselves (Barthel

Index≥50), and they can walk or use cane to walk 20m. And they are diagnosed as functional constipation before stroke.

- 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, enteroparalysis, 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

Zhishun Liu, M.D., Phone: 8610-010-88001124, Email: liuzhishun@yahoo.com.cn

Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing 100053, China; Recruiting
Zhishun Liu, M.D., Phone: 8610-010-88001124, Email: liuzhishun@yahoo.com.cn
Jinna Yu, M.D., Phone: 8610-010-88001413, Email: yujinnaa@sina.com
Jinna Yu, M.D., Sub-Investigator

Starting date: April 2008
Ending date: December 2009
Last updated: September 17, 2009