PURPOSE OF THE STUDY.
Many families are wary of giving artificial sweetener in high doses to their children. This objective of this study was to determine whether oral viscous budesonide (OVB) using Neocate Nutra, a hypoallergenic nutritional supplement, as a delivery vehicle is at least as efficacious as OVB mixed with Splenda at healing eosinophilic esophagitis (EoE).
Patients with EoE treated with OVB at the Boston Children’s Hospital Eosinophilic Gastrointestinal Disorder program between June 2008 and June 2013. Diagnosis was based on consensus recommendations.
This was a retrospective chart review. No dietary or medication changes were made between OVB initiation and follow-up endoscopy. The primary outcome measured was histologic response defined as change in peak eosinophil count to <15 eosinophils per high-power field (eos/HPF) after at least 10 weeks of therapy.
Forty-six children were treated with OVB mixed with Splenda (10 packets per milligram budesonide) and 14 with Neocate Nutra (2.5 cm3 per milligram budesonide). The 2 groups were not significantly different in their demographic or clinical characteristics. On follow-up endoscopy, 30 of 46 patients on Splenda and 13 of 14 patients on Neocate Nutra achieved histologic response. Mean pre- and posttreatment peak eosinophil counts for the Splenda group were 59.5 eos/HPF (range 20–180 ) and 25.5 eos/HPF (range 0–200 ), respectively. Mean pre- and posttreatment peak eosinophil counts for the Neocate Nutra group were 62 eos/HPF (range 20–120 ) and 9 eos/HPF (range 0–100 ), respectively. The odds ratio of success with Neocate Nutra as compared with Splenda was 6.93 (95% confidence interval 0.83–57.91, P = .0728), demonstrating noninferiority of Neocate Nutra.
OVB-Neocate Nutra is at least as effective as OVB-Splenda at treating children with EoE.
Although Splenda is generally considered to be safe, consumers are increasingly drawn to “natural” and “organic” products despite lack of clear evidence that the artificial sweetener has harmful effects in humans. Neocate Nutra, a medical food, is an amino acid–based powder prepared into a semisolid (puree consistency) for infants with feeding difficulties and food allergies. Use of Neocate Nutra as mixing agent to create a viscous budesonide slurry provides a potential alternative to the standard recipe with Splenda. Limitations include a small study sample and use of retrospective chart review, limiting assessment of medication compliance and nonuniform intervals between endoscopies.
- Copyright © 2015 by the American Academy of Pediatrics