Effectiveness of electroacupuncture versus prucalopride for women with severe chronic constipation: secondary analysis of a randomized controlled trial.

Abstract

Electroacupuncture (EA) is a component alternative therapy for severe chronic constipation (SCC). Women are more vulnerable to SCC and gender might impact the response of patients with functional gastrointestinal disorders to therapy. We performed this secondary analysis to explore the effectiveness and safety of EA compared with prucalopride among women with SCC. Based on a multicenter, randomized, noninferiority trial, 446 female patients were randomly assigned to receive 28-session EA (n = 222) over 8weeks with 24-week follow-up without treatment or to receive prucalopride (n = 224) over 32 consecutive weeks. The primary outcome was the proportion of overall complete spontaneous bowel movements (CSBMs) responders over weeks 1-8, defined as at least three CSBMs per week, and more than an increase of one CSBM from baseline meanwhile for at least 6weeks during an 8-week treatment period. Secondary outcomes measure sustained CSBM responder, weekly responders, change from baseline in mean weekly CSBMs and SBMs, straining and stool consistency, quality of life, and adverse events (AEs). The proportion of overall responders was 25.23% in the EA group, similar to 25.89% in the prucalopride group, with a between-group difference of - 0.67% (95% CI, - 8.80 to 7.40%; P = 0.872) during an 8-week treatment. In the secondary outcomes, EA and prucalopride groups had no significant difference, except that EA was inferior to prucalopride in improving SBMs. The AEs were less in the EA group than the prucalopride group. EA may be a promising and safe treatment for women with SCC; its effect could sustain 24weeks after treatment stopped.