Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): acupuncture; Prucalopride
Intervention type(s): Procedure; Drug
Intervention description(s): Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 minutes, 5 times/week for the first 2 weeks and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.; Prucalopride Succinate will be taken orally at the dose of 2mg/day in the morning before breakfast. Each treatment cycle will be given for continuous 32 weeks.
Other intervention name(s): eletro-acupuncture; serotonin 5-HT(4) receptor agonist
Intervention MeSH terms: Prucalopride; Serotonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: severe chronic constipation; randomized controlled; electro-acupuncture; prucalopride