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).

中文翻译：

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经皮耳迷走神经刺激可有效治疗功能性消化不良：一项多中心、随机对照研究。

简介 迷走神经刺激 (VNS) 可用于调节胃肠道运动、炎症和伤害感受。然而，目前尚不清楚 VNS 对成年功能性消化不良 (FD) 患者是否有效。我们研究了经皮耳廓 VNS (taVNS) 对 FD 患者的有效性。方法连续纳入符合罗马 IV 标准且改良 FD 症状日记评分≥10 的 FD 患者。患者被随机分配至 10 Hz taVNS（V10 组）、25 Hz taVNS（V25 组）或假手术组，每天两次，每次 30 分钟，持续 4 周。主要结局是第 4 周时的缓解率，定义为与基线相比，改良 FD 症状日记评分降低 ≥5 的患者比例。次要结局包括足够的缓解率和不良事件。结果 共有 300 名患者被随机分为 V10（n = 101）、V25（n = 99）和假手术组（n = 100）。治疗4周后，V10组和V25组的有效率（81.2% vs 75.9% vs 47%，均P < 0.001）和充分缓解率（85.1% vs 80.8% vs 67%，均 P < 0.05）相比与假手术组。V10和V25的缓解率和充分缓解率差异无统计学意义（均P>0.05）。taVNS（10 和 25 Hz）的疗效在随访期间持续到第 8 周和第 12 周。3 组中的不良事件都很轻微且具有可比性（1%-3%）。讨论 我们的研究首先表明，4 周 taVNS（10 和 25 Hz）对于治疗成人 FD 是有效且安全的（clinicaltrials.gov 编号：NCT04668534）。