Details

Autor(en) / Beteiligte

• Liu, Baoyan
• Wu, Jiani
• Yan, Shiyan
• Zhou, Kehua
• He, Liyun
• Fang, Jianqiao
• Fu, Wenbin
• Li, Ning
• Su, Tongsheng
• Sun, Jianhua
• Zhang, Wei
• Yue, Zenghui
• Zhang, Hongxing
• Zhao, Jiping
• Zhou, Zhongyu
• Song, Hujie
• Wang, Jian
• Liu, Li'an
• Wang, Linpeng
• Lv, Xiaoying
• Yang, Xiaofang
• Liu, Yan
• Sun, Yuanjie
• Wang, Yang
• Qin, Zongshi
• Zhou, Jing
• Liu, Zhishun

Titel

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

Ist Teil von

• The American journal of gastroenterology, 2021-05, Vol.116 (5), p.1024-1035

Ort / Verlag

United States: Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins

Erscheinungsjahr

2021

Quelle

MEDLINE

Beschreibungen/Notizen

• This multicenter, randomized, noninferiority trial compared electroacupuncture with prucalopride for the treatment of severe chronic constipation (SCC). 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. 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. 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).