1. Electroacupuncture vs Prucalopride for Severe Chronic Constipation: A Multicenter, Randomized, Controlled, Noninferiority Trial
- Author
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Zhishun Liu, Liyun He, Hongxing Zhang, Linpeng Wang, Zhongyu Zhou, Tongsheng Su, Xiaoying Lv, Jianhua Sun, Jiping Zhao, Zenghui Yue, Yang Wang, Yan Liu, Jiani Wu, Jianqiao Fang, Shiyan Yan, Zongshi Qin, Wenbin Fu, Ning Li, Liʼan Liu, Xiaofang Yang, Kehua Zhou, Jing Zhou, Yuanjie Sun, Jian Wang, Baoyan Liu, Hujie Song, and Wei Zhang
- Subjects
medicine.medical_specialty ,education.field_of_study ,Chronic constipation ,Prucalopride ,Hepatology ,Electroacupuncture ,business.industry ,medicine.medical_treatment ,Population ,Gastroenterology ,Confidence interval ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,Defecation ,030211 gastroenterology & hepatology ,education ,business ,Adverse effect ,medicine.drug - Abstract
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.lww.com/AJG/B776).
- Published
- 2020
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