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

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

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.

Study design: this trial is a multi-central randomized controlled trial which contains 14 centers. Random sequences will be generated by the clinical evaluating center of China Academy of Chinese Medical Sciences. Subjects are patients who have severe chronic constipation.

Sample size evaluation: Sample size will be based on the proportion of patients having mean complete spontaneous bowel movements (CSBMs) no less than 3 times per week. The proportion is 31.67% in our phase I clinical trial by using electro-acupuncture, and 30.9% in another trial by using prucalopride.The total sample size is 560.

Periods and primary outcome: participants will be assessed at baseline for 2 weeks, treated for 8 weeks, and followed up for 24 weeks. Primary outcome is the proportion of patients having mean CSBMs/week no less than 3 times over the latter 6-week treatment.

Quality control: the study is a randomized controlled trial; participants were included strictly; evaluators and statisticians are blinded; quality control officers of 3 different levels will supervise this trial.

Data management: this trial will use the Remote Dara Capture (RDC) system for data entering and Data Verification Plan (DVP) for data examining.

Statistical analysis: Intention-To-Treat (ITT) analysis will be used in this study. One-sided test (non-inferiority) will be used for testing the primary outcomes; meanwhile, two-sided test will be used for evaluating other outcomes. A P value equal to or less than 0.05 is considered to indicate statistical significance.

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.