Baoyan Liu1, Jiani Wu1, Shiyan Yan2, Kehua Zhou3, Liyun He2, Jianqiao Fang4, Wenbin Fu5, Ning Li6, Tongsheng Su7, Jianhua Sun8, Wei Zhang9, Zenghui Yue10, Hongxing Zhang11, Jiping Zhao12, Zhongyu Zhou13, Hujie Song14, Jian Wang15, Li'an Liu16, Linpeng Wang17, Xiaoying Lv2, Xiaofang Yang18, Yan Liu19, Yuanjie Sun1, Yang Wang1, Zongshi Qin1, Jing Zhou1, Zhishun Liu1. 1. Department of Acupuncture and Moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China. 2. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China. 3. Catholic Health System Internal Medicine Training Program, University at Buffalo, Buffalo, New York, USA. 4. Department of Acupuncture and Moxibustion, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. 5. Department of Acupuncture and Moxibustion, Guangdong Province Hospital of Traditional Chinese Medicine, Guangzhou, China. 6. Department of Acupuncture and Moxibustion, West China Hospital of Sichuan University, Chengdu, China. 7. Department of Acupuncture and Moxibustion, Shaanxi Province Hospital of Traditional Chinese Medicine, Xi'an, China. 8. Department of Acupuncture and Moxibustion, Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing, China. 9. Department of Acupuncture and Moxibustion, The First Hospital of Hunan University of Chinese Medicine, Changsha, China. 10. Department of Acupuncture and Moxibustion, Hengyang Hospital Affiliated to Hunan University of Chinese Medicine, Hengyang, China. 11. Wuhan Hospital of Traditional Chinese and Western Medicine, Wuhan, China. 12. Department of Acupuncture and Moxibustion, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China. 13. Department of Acupuncture and Moxibustion, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China. 14. Xi'an TCM Brain Disease Hospital, Xi'an, China. 15. Department of Acupuncture and Moxibustion, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China. 16. Department of Acupuncture and Moxibustion, Hiser Medical Group, Qingdao, China. 17. Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China. 18. College of Acupuncture and Orthopedics, Guizhou University of Traditional Chinese Medicine, Guiyang, China. 19. Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.
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).
RCT Entities:
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).