{"title":"经皮耳迷走神经刺激对慢性便秘的影响：一项多中心随机对照研究。","authors":"Tangyi Liu, Zeyu Wang, Yunling Li, Xiaoyu Kang, Xiangping Wang, Gui Ren, Yong Lv, Jing Li, Yaling Liu, Shuhui Liang, Xin Wang, Xiaojun Huang, Xiaoyin Zhang, Jun Wang, Yongzhan Nie, Hui Luo, Jinbo Sun, Wei Qin, Ying Han, Yanglin Pan","doi":"10.1002/ueg2.70041","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to investigate the efficacy of transcutaneous auricular vagal nerve stimulation (taVNS) in adult patients with chronic constipation.</p><p><strong>Design: </strong>Consecutive patients who met the Rome IV criteria for chronic constipation were enrolled and randomly assigned to either the taVNS group or the sham-taVNS group. Treatment consisted of 30 min of therapy twice a day for 4 weeks. The primary outcome was the response rate at week 1-4, defined as the proportion of patients with a weekly complete spontaneous bowel movement (CSBM) of ≥ 3 and weekly excessive use of rescue medication ≤ 3 times. Secondary outcomes included spontaneous bowel movements, anxiety and depression scores, abdominal symptoms, and adverse events.</p><p><strong>Results: </strong>The study was terminated due to lack of efficacy revealed by the interim analysis. A total of 106 patients were randomized, with 52 participants in the taVNS group and 54 participants in the sham-taVNS group. After 4 weeks of treatment, the response rates were 17% (9/52) in the taVNS group and 19% (10/54) in the sham-taVNS group. There was no significant difference between the two groups in intention-to-treat (ITT) analysis (RR 0.92, 95% CI 0.30-2.80, p = 1) or in the per-protocol (PP) analysis. No serious adverse events were reported.</p><p><strong>Conclusion: </strong>Our study did not support the effectiveness of 4-week 25 Hz taVNS for the treatment of adult chronic constipation patients.</p><p><strong>Trial registration: </strong>clinicaltrials.gov number: NCT05723731.</p>","PeriodicalId":23444,"journal":{"name":"United European Gastroenterology Journal","volume":" ","pages":""},"PeriodicalIF":5.8000,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation: A Multicenter, Randomized Controlled Study.\",\"authors\":\"Tangyi Liu, Zeyu Wang, Yunling Li, Xiaoyu Kang, Xiangping Wang, Gui Ren, Yong Lv, Jing Li, Yaling Liu, Shuhui Liang, Xin Wang, Xiaojun Huang, Xiaoyin Zhang, Jun Wang, Yongzhan Nie, Hui Luo, Jinbo Sun, Wei Qin, Ying Han, Yanglin Pan\",\"doi\":\"10.1002/ueg2.70041\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>The objective of this study was to investigate the efficacy of transcutaneous auricular vagal nerve stimulation (taVNS) in adult patients with chronic constipation.</p><p><strong>Design: </strong>Consecutive patients who met the Rome IV criteria for chronic constipation were enrolled and randomly assigned to either the taVNS group or the sham-taVNS group. Treatment consisted of 30 min of therapy twice a day for 4 weeks. The primary outcome was the response rate at week 1-4, defined as the proportion of patients with a weekly complete spontaneous bowel movement (CSBM) of ≥ 3 and weekly excessive use of rescue medication ≤ 3 times. Secondary outcomes included spontaneous bowel movements, anxiety and depression scores, abdominal symptoms, and adverse events.</p><p><strong>Results: </strong>The study was terminated due to lack of efficacy revealed by the interim analysis. A total of 106 patients were randomized, with 52 participants in the taVNS group and 54 participants in the sham-taVNS group. After 4 weeks of treatment, the response rates were 17% (9/52) in the taVNS group and 19% (10/54) in the sham-taVNS group. There was no significant difference between the two groups in intention-to-treat (ITT) analysis (RR 0.92, 95% CI 0.30-2.80, p = 1) or in the per-protocol (PP) analysis. 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引用次数: 0
摘要
目的：探讨经皮耳迷走神经刺激（taVNS）治疗成人慢性便秘的疗效。设计：连续招募符合慢性便秘罗马IV标准的患者，并随机分配到taVNS组或假taVNS组。治疗为每次30分钟，每天2次，连续4周。主要终点是第1-4周的缓解率，定义为每周完全自发排便(CSBM)≥3次和每周过度使用抢救药物≤3次的患者比例。次要结局包括自发排便、焦虑和抑郁评分、腹部症状和不良事件。结果：由于中期分析显示缺乏疗效，本研究终止。106例患者被随机分组，其中52例为taVNS组，54例为假taVNS组。治疗4周后，taVNS组有效率为17%(9/52)，假taVNS组有效率为19%（10/54）。两组在意向治疗（ITT）分析（RR 0.92, 95% CI 0.30-2.80, p = 1）或按方案（PP）分析中无显著差异。无严重不良事件报告。结论：我们的研究不支持4周25 Hz taVNS治疗成人慢性便秘患者的有效性。试验注册：clinicaltrials.gov号码：NCT05723731。
Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation: A Multicenter, Randomized Controlled Study.
Objective: The objective of this study was to investigate the efficacy of transcutaneous auricular vagal nerve stimulation (taVNS) in adult patients with chronic constipation.
Design: Consecutive patients who met the Rome IV criteria for chronic constipation were enrolled and randomly assigned to either the taVNS group or the sham-taVNS group. Treatment consisted of 30 min of therapy twice a day for 4 weeks. The primary outcome was the response rate at week 1-4, defined as the proportion of patients with a weekly complete spontaneous bowel movement (CSBM) of ≥ 3 and weekly excessive use of rescue medication ≤ 3 times. Secondary outcomes included spontaneous bowel movements, anxiety and depression scores, abdominal symptoms, and adverse events.
Results: The study was terminated due to lack of efficacy revealed by the interim analysis. A total of 106 patients were randomized, with 52 participants in the taVNS group and 54 participants in the sham-taVNS group. After 4 weeks of treatment, the response rates were 17% (9/52) in the taVNS group and 19% (10/54) in the sham-taVNS group. There was no significant difference between the two groups in intention-to-treat (ITT) analysis (RR 0.92, 95% CI 0.30-2.80, p = 1) or in the per-protocol (PP) analysis. No serious adverse events were reported.
Conclusion: Our study did not support the effectiveness of 4-week 25 Hz taVNS for the treatment of adult chronic constipation patients.
期刊介绍：
United European Gastroenterology Journal (UEG Journal) is the official Journal of the United European Gastroenterology (UEG), a professional non-profit organisation combining all the leading European societies concerned with digestive disease. UEG’s member societies represent over 22,000 specialists working across medicine, surgery, paediatrics, GI oncology and endoscopy, which makes UEG a unique platform for collaboration and the exchange of knowledge.
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