Percutaneous Electrical Nerve Field Stimulation for Drug-Refractory Pediatric Cyclic Vomiting Syndrome

Abstract

Background: Cyclic vomiting syndrome (CVS) is a disabling condition frequently refractory to pharmacologic therapy. The aim of this study was to evaluate the effects of noninvasive, auricular percutaneous electrical nerve field stimulation (PENFS) as prophylactic therapy for pediatric CVS. Methods: Children 8–18 years with drug-refractory CVS were prospectively enrolled from a tertiary care CVS clinic. Subjects received 6 consecutive weeks of PENFS. CVS severity was quantified by episode frequency and duration score (range 0–25) at baseline and at extended follow-up (4–6 months after end of therapy). Response was classified as ≥50% improvement in either frequency or duration of attacks at extended follow-up. Subjects also completed validated surveys of nausea, disability, and global response. Results: Thirty subjects completed the study. Median (interquartile range, IQR) age was 10.5 (8.5–15.5) years; 60% were female. At follow-up, 80% met criteria for treatment response with a median (IQR) response duration of 113 (61–182) days. The frequency-duration score improved from baseline median (IQR) 12.0 (9.0–16.0) to 3.0 (1.0–6.0) at follow-up, P < 0.0001. Median (IQR) nausea and disability scores decreased from baseline to week 6: 2.1 (1.3–2.7) to 0.9 (0–1.6), P = 0.003 and 47.5 (41.0–53.0) to 38.0 (16.0–51.0), P = 0.001, respectively. At end of therapy, 66% and 55% patients reported global response of at least “moderately better” and “a good deal better,” respectively. There were no serious side effects. Conclusions: This study suggests long-term benefits of PENFS for children with CVS. PENFS improves several disabling aspects of CVS, including episode frequency, duration, and functional disability.

A multicenter registry study on percutaneous electrical nerve field stimulation for pediatric disorders of gut–brain interaction

“…While the reliability of the long‐term follow‐up data beyond 6 months can be questioned, the results of the primary outcome and 3‐month follow‐ups included a fairly large cohort and is highly consistent with prior studies. These data replicate a prior randomized trial in pediatric DGBI, showing significant treatment effects compared to sham for 2–3 months and more recent, open‐label data 12,25,27,44 . The results may also be skewed, perhaps underestimated, since data was not systematically collected after the end of therapy at 4 weeks due to majority not returning to clinic after the 4th device placement.…”

“…Unfortunately, the significant number of patients lost to extended follow‐up makes it difficult to understand the long‐term sustainability of PENFS. The increase in API and NSS scores among females at the 6‐ and 12‐month mark likely indicates that repeat PENFS courses are necessary, supported by recent data on median response duration of 113 days in pediatric cyclic vomiting syndrome 27 . On the contrary, a prior PENFS study noted sustained benefits up to 12 months post treatment 20 .…”

“…The increase in API and NSS scores among females at the 6-and 12month mark likely indicates that repeat PENFS courses are necessary, supported by recent data on median response duration of 113 days in pediatric cyclic vomiting syndrome. 27 On the contrary, a prior PENFS study noted sustained benefits up to 12 months post treatment. 20 To our knowledge, there are no comparable long-term data with other auricular neurostimulation modalities or auricular acupuncture.…”

“…These data replicate a prior randomized trial in pediatric DGBI, showing significant treatment effects compared to sham for 2-3 months and more recent, open-label data. 12,25,27,44 The results may also be skewed, perhaps underestimated, since data was not systematically collected after the end of therapy at 4 weeks due to majority not returning to clinic after the 4th device placement. Another important limitation is that we did not control for any other interventions such as medication changes or dosing adjustment that could have been given during PENFS.…”

Opinion: Percutaneous electrical nerve field stimulation compared to standard medical therapy in adolescents with functional abdominal pain disorders

“…Despite the high prevalence of these disorders and the considerable negative impact on quality of life in children, no drug has ever received regulatory (FDA) approval for chronic abdominal pain in children or adolescents. Until now, no device had ever received clearance by the FDA, but several studies, including the one reported by Santucci et al have consistently demonstrated the efficacy of PENFS for DGBIs in children ( 1 – 7 ). Pediatric gastroenterologists, like many other pediatric subspecialists, still resort to using “off-label” medications to try to alleviate pain, in hopes of improving the lives of children and their families.…”