Efficacy and safety of budesonide in the treatment of eosinophilic esophagitis: Updated systematic review and meta-analysis of randomized and non-randomized studies Journal Article


Authors: Rawla, P.; Sunkara, T.; Thandra, K. C.; Gaduputi, V.
Article Title: Efficacy and safety of budesonide in the treatment of eosinophilic esophagitis: Updated systematic review and meta-analysis of randomized and non-randomized studies
Abstract: Background and Objective: Eosinophilic esophagitis (EE) is an immune/antigen-driven inflammation that causes esophageal dysfunction. Budesonide has shown promising effect in the management of EE in multiple studies, and we therefore conducted this systematic review/meta-analysis to assess budesonide efficacy and safety in order to provide more updated and robust evidence. Methods: In April 2018, we conducted a systematic electronic search through four databases: PubMed, Scopus, Web of Science (ISI), and Cochrane Central. All original studies reporting the efficacy of budesonide in the treatment of EE were included in our meta-analysis. The Cochrane Collaboration tool was employed to assess the risk of bias among included randomized controlled trials, while the Newcastle–Ottawa Scale was used for non-randomized studies. Results: A total of 12 studies including 555 participants were included in our review. Budesonide showed marked efficacy at the level of histological response compared to placebo [risk ratio (RR) (95% confidence interval (CI)) 11.93 (4.82–29.50); p > 0.001]. Analysis of randomized and non-randomized studies revealed considerable reduction in eosinophil count, with a mean difference (MD) (95% CI) of − 69.41 (− 105.31 to − 33.51; p < 0.001) and 46.85 (33.93–59.77; p < 0.001), respectively. Similarly, there was a marked improvement in the clinical symptoms via the analysis of randomized and non-randomized studies, with an RR (95% CI) of 1.72 (1.22–2.41; p = 0.002) and MD (95% CI) of 2.45 (0.76–4.15; p = 0.005), respectively. Conclusion: Budesonide showed significant effect at all treatment endpoints. However, since budesonide carries a risk of candidiasis and our inferences are based only on a small number of included studies, more research is warranted to clarify these results. © 2018, The Author(s).
Keywords: treatment response; review; placebo; drug efficacy; drug safety; incidence; information retrieval; systematic review; medline; cochrane library; candidiasis; meta analysis; infection risk; randomized controlled trial (topic); budesonide; eosinophil count; eosinophilic esophagitis; pharmaceutical care; human; priority journal; scopus; web of science; newcastle-ottawa scale
Journal Title: Drugs in R&D
Volume: 18
Issue: 4
ISSN: 1174-5886
Publisher: Springer International Publishing Ag  
Date Published: 2018-12-01
Start Page: 259
End Page: 269
Language: English
DOI: 10.1007/s40268-018-0253-9
PROVIDER: scopus
PMCID: PMC6277325
PUBMED: 30387081
DOI/URL:
Notes: Drugs R D -- Export Date: 2 January 2019 -- Review -- CODEN: DRDDF C2 - 30387081 -- Source: Scopus
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  1. Krishna Chaitanya Thandra
    10 Thandra