Efficacy of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial

• Published in: Clinical gastroenterology and hepatology Vol. 18; no. 9; pp. 1987 - 1994.e2
• Main Authors: Krasaelap, Amornluck, Sood, Manu R., Li, B.U.K., Unteutsch, Rachel, Yan, Ke, Nugent, Melodee, Simpson, Pippa, Kovacic, Katja
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2020
• Subjects: Controlled; FAPDs; Neuromodulation; PENFS; PENFS; FDA; GI; PFSD; IQR; Neuromodulation; QPGS; FAPD; IBS-C; NNT; IBS-M; IBS; FAPDs; Controlled
• ISSN: 1542-3565; 1542-7714
• DOI: 10.1016/j.cgh.2019.10.012

Auricular neurostimulation therapy, in which a noninvasive device delivers percutaneous electrical nerve field stimulation (PENFS) to the external ear, is effective in pediatric patients with functional abdominal pain disorders. Preclinical studies showed that PENFS modulates central pain pathways and attenuates visceral hyperalgesia. We evaluated the efficacy of PENFS in adolescents with irritable bowel syndrome (IBS). We analyzed data from pediatric patients with IBS who participated in a double-blind trial at a tertiary care gastroenterology clinic from June 2015 through November 2016. Patients were randomly assigned to groups that received PENFS (n = 27; median age, 15.3 y; 24 female) or a sham stimulation (n = 23; median age, 15.6 y; 21 female), 5 days/week for 4 weeks. The primary endpoint was number of patients with a reduction of 30% or more in worst abdominal pain severity after 3 weeks. Secondary endpoints were reduction in composite abdominal pain severity score, reduction in usual abdominal pain severity, and improvement in global symptom based on a symptom response scale (–7 to +7; 0 = no change) after 3 weeks. Reductions of 30% or more in worst abdominal pain were observed in 59% of patients who received PENFS vs 26% of patients who received the sham stimulation (P = .024). The patients who received PENFS had a composite pain median score of 7.5 (interquartile range [IQR], 3.6–14.4) vs 14.4 for the sham group (IQR, 4.5–39.2) (P = .026) and a usual pain median score of 3.0 (IQR, 3.0–5.0) vs 5.0 in the sham group (IQR, 3.0–7.0) (P = .029). A symptom response scale score of 2 or more was observed in 82% of patients who received PENFS vs 26% of patients in the sham group (P ≤ .001). No significant side effects were reported. Auricular neurostimulation reduces abdominal pain scores and improves overall wellbeing in adolescents with IBS. PENFS is a noninvasive treatment option for pediatric patients with functional bowel disorders. ClinicalTrials.gov no: NCT02367729