Abstract
BackgroundAcupuncture is safe and may be effective for severe chronic constipation. The World Gastroenterology Organisation recommends prucalopride for patients for whom previous laxative use failed to provide satisfactory relief.Methods/designIn this prospective, multi-centre, randomised controlled trial, five hundred sixty patients with severe chronic constipation (two or less spontaneous complete bowel movements per week) from 14 centres will be randomised to receive either electroacupuncture or prucalopride. Participants in the electroacupuncture group will receive electroacupuncture for eight weeks, while participants in the control group will take prucalopride (2 mg once daily) for 32 weeks. The primary outcome measure is the proportion of patients having ≥3 spontaneous, complete bowel movements per week, averaged over week three to eight. The secondary outcome measures include eight items, including the proportion of patients having ≥3 spontaneous, complete bowel movements per week averaged over week 9–32, the proportion of patients with one or more increases in spontaneous, complete bowel movements per week from baseline, mean Bristol Stool Scale, etc. Statistical analysis will include the CMH test, nonparametric tests and t tests.DiscussionWe aimed to compare the effect of electroacupuncture versus prucalopride for severe chronic constipation. The limitation of this study is that participants and acupuncturists will not be blinded.Trial registrationClinicalTrials.gov Identifier: NCT02047045.
Highlights
Acupuncture is safe and may be effective for severe chronic constipation
We aimed to compare the effect of electroacupuncture versus prucalopride for severe chronic constipation
Inclusion criteria: 1) Primary chronic constipation meeting the Rome III criteria, with ≤2 SCBMs
Summary
Acupuncture is safe and may be effective for severe chronic constipation. The World Gastroenterology Organisation recommends prucalopride for patients for whom previous laxative use failed to provide satisfactory relief. Severe chronic constipation is defined as two or fewer spontaneous, complete bowel movements (SCBMs) per week, hard stool and a sensation of straining during defecation [4]. Due to their widespread use, laxatives are an available choice for constipated patients. A high level of dissatisfaction has been reported for laxatives; evidence supporting the lasting effect of laxatives is limited [5,6,7].
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