Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is primarily aimed to compare the effect and safety of electro-acupuncture and prucalopride for severe chronic constipation: if the short-term effect of electro-acupuncture is no inferior to prucalopride? Besides, the investigators will also mainly confirm the superiority of electro-acupuncture: if the effect of electro-acupuncture can last for 3~6 months? Then, assess the patients' acceptance of electro-acupuncture.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborator: Ministry of Science and Technology of the People´s Republic of China
• Treatments: Prucalopride; Serotonin

Criteria

Inclusion Criteria:

1. meeting Rome Ⅲ criteria for diagnosing functional constipation;

2. severe chronic constipation (two or fewer CSBMs per week for more than 3 months）;

3. the weekly mean CSBMs are no more than 2 times during the 2-week baseline

4. aged from 18 to 75 years old

5. no use of drugs for constipation (emergency treatments should be excepted) during at least 2 weeks before enrollment; no acupuncture treatment for constipation in the previous 1 month; never joined any other trial in progress;

6. volunteered to join this research and signed the informed consent

Exclusion Criteria:

1. irritable bowel syndrome, organic constipation or secondary constipation caused by endocrine, metabolic, nervous, postoperative diseases, or by drugs;

2. mushy stool or watery stool are showed more than once during baseline when defecating spontaneously without any laxative (Bristol stool type 6 or 7);

3. history of pelvic floor dysfunction;

4. taking medicine in progress which can induce constipation;

5. severe hemorrhoid or anal fissure;

6. constipation with serious cardiovascular, hepatic or renal diseases, cognitive dysfunction, abdominal aortic aneurysm or hepatosplenomegaly, aphasia, mental disorders, or illness which affects the cooperation for examination and treatment;

7. women in gestation or lactation period;

8. blood coagulation disorders or using anticoagulants regularly such as Warfarin and Heparin;

9. cardiac pacemaker carrier.