Effect of electroacupuncture versus prucalopride for ultra-severe chronic constipation: Secondary analysis of a randomized controlled trial

BACKGROUND: To explore the effect and safety of electroacupuncture (EA) compared to prucalopride in patients with ultra-severe chronic constipation (USCC), a condition defined by the absence of weekly complete spontaneous bowel movements (CSBMs). METHODS: This study was a secondary analysis using data from a multicenter, non-inferiority randomized controlled trial, involving patients with USCC. Participants received either EA or prucalopride treatment. The primary outcome was the mean weekly CSBMs from weeks 1 to 8. Secondary outcomes included the mean weekly CSBMs, the proportion of overall and weekly responders, changes in straining and stool consistency scores, Patient Assessment of Constipation Quality of Life (PAC-QOL) scores, and the proportion of patients using rescue medication. RESULTS: A total of 317 participants with USCC were included (151 in the EA group and 166 in the prucalopride group). From weeks 1 to 8, both groups showed similar increases in the CSBMs (difference: -0.02; 95% confidence interval [CI], -0.34 to 0.30, P < 0.001 for noninferiority). However, during weeks 1 to 2, the prucalopride group showed greater effects than the EA group in increasing CSBMs, alleviating defecation difficulties, and improving stool consistency. The EA group experienced fewer adverse events (AEs) than the prucalopride group. CONCLUSIONS: In participants with USCC, EA showed improvements in CSBMs, defecation-related symptoms, and quality of life that were comparable to those observed with prucalopride. The effects of EA might persist for 24 weeks, and EA exhibited a superior safety profile. TRIAL REGISTRATION NUMBER: NCT02047045 (ClinicalTrials.gov).