Transcutaneous Auricular Vagal Nerve Stimulation Is Effective for the Treatment of Functional Dyspepsia: A Multicenter, Randomized Controlled Study

Shi, Xin1,2; Zhao, Lina3; Luo, Hui1,2; Deng, Hui4; Wang, Xiangping1,2; Ren, Gui1,2; Zhang, Linhui1,2; Tao, Qin1,2; Liang, Shuhui1,2; Liu, Na5; Huang, Xiaojun6; Zhang, Xiaoyin7; Yang, Xuejuan4; Sun, Jinbo4; Qin, Wei4; Kang, Xiaoyu1,2; Han, Ying1,2; Pan, Yanglin1,2; Fan, Daiming1,2

2024-03-01

10.14309/ajg.0000000000002548

AMERICAN JOURNAL OF GASTROENTEROLOGY   影响因子和分区

0002-9270

1572-0241

INTRODUCTION: Vagal nerve stimulation (VNS) can be used to modulate gastrointestinal motility, inflammation, and nociception. However, it remains unclear whether VNS is effective in adult patients with functional dyspepsia (FD). We investigated the effectiveness of transcutaneous auricular VNS (taVNS) in patients with FD. METHODS: Consecutive patients with FD meeting Rome IV criteria with modified FD Symptom Diary score >= 10 were enrolled. Patients were randomly allocated to 10-Hz taVNS (V10 group), 25-Hz taVNS (V25 group), or sham group, with 30 minutes of treatment twice a day for 4 weeks. The primary outcome was the response rate at week 4, defined as the proportion of patients whose modified FD Symptom Diary score was reduced >= 5 when compared with the baseline. Secondary outcomes included adequate relief rate and adverse events. RESULTS: A total of 300 patients were randomized to V10 (n = 101), V25 (n = 99), and sham groups (n = 100). After 4 weeks of treatment, V10 and V25 groups had a higher response rate (81.2% vs 75.9% vs 47%, both P < 0.001) and adequate relief rate (85.1% vs 80.8% vs 67%, both P < 0.05) compared with the sham group. There was no significant difference between V10 and V25 in response rate and adequate relief rate (both P > 0.05). The efficacy of taVNS (both 10 and 25 Hz) lasted at week 8 and week 12 during follow-up period. Adverse events were all mild and comparable among the 3 groups (1%-3%). DISCUSSION: Our study firstly showed that 4-week taVNS (both 10 and 25 Hz) was effective and safe for the treatment of adult FD (clinicaltrials.gov number: NCT04668534).

functional dyspepsia transcutaneous auricular vagal nerve stimulation

SCI

英语

其他

Gastroenterology & Hepatology

Gastroenterology & Hepatology

WOS:001236991100008

LIPPINCOTT WILLIAMS & WILKINS

CLINICAL MEDICINE

Web of Science

1.Fourth Mil Med Univ, Natl Clin Res Ctr Digest Dis, State Key Lab Canc Biol, Xian, Peoples R China
2.Fourth Mil Med Univ, Xijing Hosp Digest Dis, Xian, Peoples R China
3.Fourth Mil Med Univ, Xijing Hosp, Dept Radiotherapy, Xian, Peoples R China
4.Xidian Univ, Engn Res Ctr Mol Neuro Imaging, Sch Life Sci & Technol, Intelligent Noninvas Neuromodulat & Transformat Jo, Xian, Peoples R China
5.Xi An Jiao Tong Univ, Affiliated Hosp 2, Dept Gastroenterol, Xian, Peoples R China
6.Lanzhou Univ, Dept Gastroenterol, Hosp 2, Lanzhou, Peoples R China
7.Southern Univ Sci & Technol, Peoples Hosp Shenzhen 3, Natl Clin Res Ctr Infect Dis, Dept Gastroenterol,Affiliated Hosp 2, Shenzhen, Peoples R China

Shi, Xin,Zhao, Lina,Luo, Hui,et al. Transcutaneous Auricular Vagal Nerve Stimulation Is Effective for the Treatment of Functional Dyspepsia: A Multicenter, Randomized Controlled Study[J]. AMERICAN JOURNAL OF GASTROENTEROLOGY,2024,119(3).

Shi, Xin.,Zhao, Lina.,Luo, Hui.,Deng, Hui.,Wang, Xiangping.,...&Fan, Daiming.(2024).Transcutaneous Auricular Vagal Nerve Stimulation Is Effective for the Treatment of Functional Dyspepsia: A Multicenter, Randomized Controlled Study.AMERICAN JOURNAL OF GASTROENTEROLOGY,119(3).

Shi, Xin,et al."Transcutaneous Auricular Vagal Nerve Stimulation Is Effective for the Treatment of Functional Dyspepsia: A Multicenter, Randomized Controlled Study".AMERICAN JOURNAL OF GASTROENTEROLOGY 119.3(2024).