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Electroacupuncture vs Prucalopride for Severe Chronic Constipation A Multicenter, Randomized, Controlled, Noninferiority Trial 电针灸与普芦卡必利对严重慢性便秘：一项多中心随机对照非劣试验 10.14309/ajg.0000000000001050 12-03, Article Abstract & Authors:展开 Abstract:收起
INTRODUCTION: This multicenter, randomized, noninferiority trial compared electroacupuncture with prucalopride for the treatment of severe chronic constipation (SCC).
METHODS: Participants with SCC (≤ 2 mean weekly complete spontaneous bowel movements [CSBMs]) were randomly assigned to receive either 28-session electroacupuncture over 8 weeks with follow-up without treatment over 24 weeks or prucalopride (2 mg/d before breakfast) over 32 weeks. The primary outcome was the proportion of participants with ≥3 mean weekly CSBMs over weeks 3–8, based on the modified intention-to-treat population, with −10% as the noninferior margin.
RESULTS: Five hundred sixty participants were randomized, 280 in each group. Electroacupuncture was noninferior to prucalopride for the primary outcome (36.2% vs 37.8%, with a difference of −1.6% [95% confidence interval, −8% to 4.7%], P < 0.001 for noninferiority); almost the same results were found in the per-protocol population. The proportions of overall CSBM responders through weeks 1–8 were similar in the electroacupuncture and prucalopride groups (24.91% vs 25.54%, with a difference of −0.63% [95% confidence interval, −7.86% to 6.60%, P = 0.864]). Except during the first 2-week treatment, no between-group differences were found in outcomes of excessive straining, stool consistency, and quality of life. Adverse events occurred in 49 (17.69%) participants in the electroacupuncture group and 123 (44.24%) in the prucalopride group. One non-treatment-related serious adverse event was recorded in the electroacupuncture group.
DISCUSSION: Electroacupuncture was noninferior to prucalopride in relieving SCC with a good safety profile. The effects of 8-week electroacupuncture could sustain for 24 weeks after treatment. Electroacupuncture is a promising noninferior alternative for SCC (see Visual Abstract, http://links./AJG/B776).
First Authors:
Baoyan Liu Correspondence Authors:
Zhishun Liu All Authors:
Baoyan Liu,Jiani Wu,Shiyan Yan,Kehua Zhou,Liyun He,Jianqiao Fang,Wenbin Fu,Ning Li,Tongsheng Su,Jianhua Sun,Wei Zhang,Zenghui Yue,Hongxing Zhang,Jiping Zhao,Zhongyu Zhou,Hujie Song,Jian Wang,Li'an Liu,Linpeng Wang,Xiaoying Lv,Xiaofang Yang,Yan Liu,Yuanjie Sun,Yang Wang,Zongshi Qin,Jing Zhou,Zhishun Liu
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