Electroacupuncture vs Prucalopride for Severe Chronic Constipation: A Multicenter, Randomized, Controlled, Noninferiority Trial.

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).

• 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
• Journal: The American journal of gastroenterology (Am J Gastroenterol) Vol. 116 Issue 5 Pg. 1024-1035 (05 01 2021) ISSN: 1572-0241 [Electronic] United States
• PMID: 33273258 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 by The American College of Gastroenterology.

Chemical References

• Benzofurans
• Laxatives
• prucalopride

Topics

• Benzofurans (therapeutic use)
• China
• Chronic Disease
• Constipation (therapy)
• Electroacupuncture (methods)
• Equivalence Trials as Topic
• Female
• Humans
• Laxatives (therapeutic use)
• Male
• Middle Aged