TY - JOUR
T1 - Intranasal Corticosteroid Therapy
T2 - Systematic Review and Meta-analysis of Reported Safety and Adverse Effects in Adults
AU - Donaldson, Angela M.
AU - Choby, Garret
AU - Kim, Daniel H.
AU - Marks, Lisa A.
AU - Lal, Devyani
N1 - Publisher Copyright:
© American Academy of Otolaryngology–Head and Neck Surgery Foundation 2020.
PY - 2020/12
Y1 - 2020/12
N2 - Objectives: To address concerns related to the safety profile of both Food and Drug Administration (FDA)–approved and non–FDA-approved intranasal corticosteroid (INCS) use in the adult population. Data Source: Systematic review of MEDLINE, PubMed, and EMBASE databases using a comprehensive search strategy including all INCS formulations and adverse events. The study design was developed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Additional sources were identified from study references of relevant articles. Review Methods: A structured literature search was conducted. Each study was graded for level of evidence using the Oxford Centre for Evidence-Based Medicine. Extracted data included population size, study design, drug (dosage, route, and frequency), presence of hypothalamus pituitary axis suppression, ocular symptoms, and treatment-related adverse events. Results: A total of 60 studies met inclusion criteria. The studies included use of INCS as metered nasal sprays, drops, injections, aerosols, and irrigations. There were no persistent abnormalities in cortisol level or intraocular pressure change. Meta-analysis of epistaxis showed a significantly increased risk in the FDA-approved treatment group in comparison with control (risk ratio 1.56; 95% confidence interval, 1.13-2.14; P =.007). Conclusions: Overall, it appears that the use of both FDA and published non-FDA application of INCS are safe in the adult population. Meta-analysis demonstrated an increased risk of epistaxis in patients using INCS compared with placebo. Otherwise, there was no significant difference between in adults in the treatment group and placebo group. As an important caveat, the interpretation of safety of nonstandard INCS is restricted to delivery methods and dosages published in the literature.
AB - Objectives: To address concerns related to the safety profile of both Food and Drug Administration (FDA)–approved and non–FDA-approved intranasal corticosteroid (INCS) use in the adult population. Data Source: Systematic review of MEDLINE, PubMed, and EMBASE databases using a comprehensive search strategy including all INCS formulations and adverse events. The study design was developed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Additional sources were identified from study references of relevant articles. Review Methods: A structured literature search was conducted. Each study was graded for level of evidence using the Oxford Centre for Evidence-Based Medicine. Extracted data included population size, study design, drug (dosage, route, and frequency), presence of hypothalamus pituitary axis suppression, ocular symptoms, and treatment-related adverse events. Results: A total of 60 studies met inclusion criteria. The studies included use of INCS as metered nasal sprays, drops, injections, aerosols, and irrigations. There were no persistent abnormalities in cortisol level or intraocular pressure change. Meta-analysis of epistaxis showed a significantly increased risk in the FDA-approved treatment group in comparison with control (risk ratio 1.56; 95% confidence interval, 1.13-2.14; P =.007). Conclusions: Overall, it appears that the use of both FDA and published non-FDA application of INCS are safe in the adult population. Meta-analysis demonstrated an increased risk of epistaxis in patients using INCS compared with placebo. Otherwise, there was no significant difference between in adults in the treatment group and placebo group. As an important caveat, the interpretation of safety of nonstandard INCS is restricted to delivery methods and dosages published in the literature.
KW - adverse effect
KW - complication
KW - corticosteroid
KW - intranasal steroid
KW - nasal steroid
KW - side effect
KW - topical steroid
KW - toxicity
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U2 - 10.1177/0194599820931455
DO - 10.1177/0194599820931455
M3 - Review article
C2 - 32539494
AN - SCOPUS:85087972319
SN - 0194-5998
VL - 163
SP - 1097
EP - 1108
JO - Otolaryngology - Head and Neck Surgery (United States)
JF - Otolaryngology - Head and Neck Surgery (United States)
IS - 6
ER -