The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation

The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation - a Multi-center, Randomized Controlled Trial

The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe functional constipation compared with sham acupuncture, used as placebo; the secondary purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.

Chronic functional constipation is a common disease. To date there has not specific therapy on chronic functional constipation. Systematic reviews indicate that acupuncture is probably effective for the disease, but the evidence is limited. Recently, we have finished a multi-center clinical trial of individualized deep electro-acupuncture (EA) for chronic functional constipation (n=460, Registration ID: NCT00508482) which preliminarily showed EA was effective.

This multi-center large-sample randomized controlled clinical trial of acupuncture for severe functional constipation is designed to confirm the efficacy and safety of EA.

This project is conducted by Chinese experts, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for chronic functional constipation.

Inclusion Criteria:

• meeting the diagnosis of Rome III criteria for chronic functional constipation;
• severe chronic constipation: two or fewer spontaneous complete bowel movements per week for more than 3 months;
• 18-75 years old;
• no use of medicine for constipation during the two weeks before enrollment (except rescue medication);
• no acupuncture treatment for constipation in recent 3 months;
• never joined any other trial in process in 3 months;
• volunteered to join this research and signed the informed consent.

Exclusion Criteria:

• Irritable bowel syndrome (IBS) and constipation caused by endocrine, metabolic, nervous or postoperative diseases or drugs;
• constipation accompanied by serious cardiovascular, hepatic, renal, or psychiatric disease, cognitive dysfunction or aphasia, or severe dystrophy affecting the cooperation for examination or treatment;
• pregnant women or women in lactation period
• constipation accompanied by abdominal aneurysm, hepatosplenomegaly, etcetera;
• bleeding disorders, or regular anticoagulant drug users, such as warfarin and heparin, etcetera;
• cardiac pacemaker carrier.