慢性胰腺炎慢性疼痛患者经皮颈部迷走神经调节：一项随机假对照临床试验。
Cervical transcutaneous vagal neuromodulation in chronic pancreatitis patients with chronic pain: A randomised sham controlled clinical trial.
机构信息
Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.
Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
出版信息
PLoS One. 2021 Feb 26;16(2):e0247653. doi: 10.1371/journal.pone.0247653. eCollection 2021.
BACKGROUND & AIMS: Chronic abdominal pain is the primary symptom of chronic pancreatitis, but unfortunately it is difficult to treat. Vagal nerve stimulation studies have provided evidence of anti-nociceptive effect in several chronic pain conditions. We investigated the pain-relieving effects of transcutaneous vagal nerve stimulation in comparison to sham treatment in chronic pancreatitis patients.
METHODS
We conducted a randomised double-blinded, sham-controlled, crossover trial in patients with chronic pancreatitis. Patients were randomly assigned to receive a two-week period of cervical transcutaneous vagal nerve stimulation using the gammaCore device followed by a two-week sham stimulation, or vice versa. We measured clinical and experimental endpoints before and after each treatment. The primary clinical endpoint was pain relief, documented in a pain diary using a visual analogue scale. Secondary clinical endpoints included Patients' Global Impression of Change score, quality of life and Brief Pain Inventory questionnaire. Secondary experimental endpoints included cardiac vagal tone and heart rate.
RESULTS
No differences in pain scores were seen in response to two weeks transcutaneous vagal nerve stimulation as compared to sham treatment (difference in average pain score (visual analogue scale): 0.17, 95%CI (-0.86;1.20), P = 0.7). Similarly, no differences were seen for secondary clinical endpoints, except from an increase in the appetite loss score (13.9, 95%CI (0.5:27.3), P = 0.04). However, improvements in maximum pain scores were seen for transcutaneous vagal nerve stimulation and sham treatments as compared to their respective baselines: vagal nerve stimulation (-1.3±1.7, 95%CI (-2.21:-0.42), P = 0.007), sham (-1.3±1.9, 95%CI (-2.28:-0.25), P = 0.018). Finally, heart rate was decreased after two weeks transcutaneous vagal nerve stimulation in comparison to sham treatment (-3.7 beats/min, 95%CI (-6.7:-0.6), P = 0.02).
CONCLUSION
In this sham-controlled crossover study, we found no evidence that two weeks transcutaneous vagal nerve stimulation induces pain relief in patients with chronic pancreatitis.
TRIAL REGISTRATION NUMBER
The study is registered at NCT03357029; www.clinicaltrials.gov.
背景与目的
慢性腹痛是慢性胰腺炎的主要症状，但遗憾的是，这种疼痛难以治疗。迷走神经刺激研究已经为几种慢性疼痛疾病的抗伤害感受作用提供了证据。我们研究了经皮迷走神经刺激与假刺激相比在慢性胰腺炎患者中的镇痛效果。
方法
我们对慢性胰腺炎患者进行了一项随机、双盲、假对照、交叉试验。患者被随机分配接受为期两周的颈部经皮迷走神经刺激治疗（使用 gammaCore 设备），随后进行两周的假刺激治疗，或者反之。我们在每次治疗前后测量临床和实验终点。主要临床终点是疼痛缓解，使用视觉模拟量表（VAS）在疼痛日记中记录。次要临床终点包括患者整体变化评分、生活质量和简明疼痛量表问卷。次要实验终点包括心脏迷走神经张力和心率。
结果
与假刺激相比，两周的经皮迷走神经刺激在疼痛评分上没有差异（平均疼痛评分差异（VAS）：0.17，95%CI（-0.86；1.20），P = 0.7）。同样，除了食欲丧失评分增加（13.9，95%CI（0.5：27.3），P = 0.04）外，其他次要临床终点也没有差异。然而，与各自的基线相比，经皮迷走神经刺激和假刺激治疗都能改善最大疼痛评分：迷走神经刺激（-1.3±1.7，95%CI（-2.21：-0.42），P = 0.007），假刺激（-1.3±1.9，95%CI（-2.28：-0.25），P = 0.018）。最后，与假刺激相比，两周的经皮迷走神经刺激后心率下降（-3.7 次/分钟，95%CI（-6.7：-0.6），P = 0.02）。
结论
在这项假对照交叉研究中，我们没有发现两周的经皮迷走神经刺激能缓解慢性胰腺炎患者的疼痛。
试验注册号
该研究在 NCT03357029 注册；www.clinicaltrials.gov。
Zotero 插件