NCT00508482

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 475 (actual)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Constipation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-09-01
• Completion: 2011-11-01
• First posted: 2007-07-30
• Last updated: 2014-06-04
• Results posted: 2013-03-15

Locations

1 site across 1 country: China