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The effects of nasal lavage with betamethasone cream post-endoscopic sinus surgery: clinical trial

Published online by Cambridge University Press:  12 September 2017

B Dawson*
Affiliation:
Department of Otolaryngology, Head and Neck Surgery, Gold Coast University Hospital, Southport, Australia
I Gutteridge
Affiliation:
Department of Otolaryngology, Head and Neck Surgery, Gold Coast University Hospital, Southport, Australia
A Cervin
Affiliation:
Otolaryngology (Rhinology), Faculty of Medicine and Biomedical Sciences, School of Medicine, University of Queensland, Herston, Australia Department of ENT, Head and Neck Surgery, Royal Brisbane and Women's Hospital, Herston, Australia Otolaryngology, Centre for Clinical Research, University of Queensland, Herston, Australia Faculty of Medicine, Lund University, Sweden
D Robinson
Affiliation:
Department of Otolaryngology, Head and Neck Surgery, Gold Coast University Hospital, Southport, Australia
*
Address for correspondence: Dr Blake Dawson, Department of Otolaryngology, Head and Neck Surgery, Gold Coast University Hospital, 1 Hospital Blvd, Southport, QLD 4215, Australia E-mail: blakedaw@gmail.com

Abstract

Background:

Steroid nasal irrigation for chronic rhinosinusitis patients following endoscopic sinus surgery reduces symptom recurrence. There are minimal safety data to recommend this treatment. This study evaluated the safety of betamethasone nasal irrigation by measuring its impact on endogenous cortisol levels.

Methods:

Participants performed daily betamethasone nasal irrigation for six weeks. The impact on pre- and post-intervention serum and 24-hour urinary free cortisol was assessed. Efficacy was evaluated using the 22-item Sino-Nasal Outcome Test.

Results:

Thirty participants completed the study (16 females and 14 males; mean age = 53.9 ± 15.6 years). Serum cortisol levels were unchanged (p = 0.28). However, 24-hour urinary free cortisol levels decreased (47.5 vs 41.5 nmol per 24 hours; p = 0.025). Sino-Nasal Outcome Test scores improved (41.13 ± 21.94 vs 23.4 ± 18.17; p < 0.001). The minimal clinical important difference was reached in 63 per cent of participants.

Conclusion:

Daily betamethasone nasal irrigation is an efficacious treatment modality not associated with changes in morning serum cortisol levels. The changes in 24-hour urinary free cortisol levels are considered clinically negligible. Hence, continued use of betamethasone nasal irrigation remains a viable and safe treatment option for chronic rhinosinusitis patients following functional endoscopic sinus surgery.

Type
Main Articles
Copyright
Copyright © JLO (1984) Limited 2017 

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Footnotes

Presented as a poster at the Australian Society of Otolaryngology Head and Neck Surgery Annual Scientific Meeting, 6–8 March 2016, Sydney, Australia, and orally at the European Academy of Allergy and Clinical Immunology Congress, 12 June 2016, Vienna, Austria.

References

1 Fokkens, WJ, Lund, VJ, Mullol, J, Bachert, C, Alobid, I, Baroody, F et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinol Suppl 2012;50:1298 CrossRefGoogle ScholarPubMed
2 Avila, P. Epidemiology of chronic rhinosinusitis. In: Akdis, CA, Hellings, PW, Agache, I, eds. Global Atlas of Allergic Rhinitis and Chronic Rhinosinusitis. Zurich: European Academy of Allergy and Clinical Immunology, 2015;307–8Google Scholar
3 Harvey, R. Clinical features of chronic rhinosinusitis. In: Akdis, CA, Hellings, PW, Agache, I, eds. Global Atlas of Allergic Rhinitis and Chronic Rhinosinusitis. Zurich: European Academy of Allergy and Clinical Immunology, 2015;314–15Google Scholar
4 Stevens, W, Schleimer, R. Chronic rhinosinusitis - mechanisms. In: Akdis, CA, Hellings, PW, Agache, I, eds. Global Atlas of Allergic Rhinitis and Chronic Rhinosinusitis. Zurich: European Academy of Allergy and Clinical Immunology, 2015;284–6Google Scholar
5 Suh, JD, Kennedy, DW. Treatment options for chronic rhinosinusitis. Proc Am Thorac Soc 2011;8:132–40Google Scholar
6 Pujols, L, López-Chacón, M, Roca-Ferrer, J. Topical and systemic corticosteroids in chronic rhinosinusitis. In: Akdis, CA, Hellings, PW, Agache, I, eds. Global Atlas of Allergic Rhinitis and Chronic Rhinosinusitis. Zurich: European Academy of Allergy and Clinical Immunology 2015;346–9Google Scholar
7 Van Zele, T. Interfacing medical and surgical management of chronic rhinosinusitis. In: Akdis, CA, Hellings, PW, Agache, I, eds. Global Atlas of Allergic Rhinitis and Chronic Rhinosinusitis. Zurich: European Academy of Allergy and Clinical Immunology, 2015;361–2Google Scholar
8 Fandino, M, Macdonald, KI, Lee, J, Witterick, IJ. The use of postoperative topical corticosteroids in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis. Am J Rhinol Allergy 2013;27:146–57Google ScholarPubMed
9 Snidvongs, K, Kalish, L, Sacks, R, Sivasubramaniam, R, Cope, D, Harvey, RJ. Sinus surgery and delivery method influence the effectiveness of topical corticosteroids for chronic rhinosinusitis: systematic review and meta-analysis. Am J Rhinol Allergy 2013;27:221–33Google Scholar
10 Jang, DW, Lachanas, VA, Segel, J, Kountakis, SE. Budesonide nasal irrigations in the postoperative management of chronic rhinosinusitis. Int Forum Allergy Rhinol 2013;3:708–11CrossRefGoogle ScholarPubMed
11 Bhalla, RK, Payton, K, Wright, ED. Safety of budesonide in saline sinonasal irrigations in the management of chronic rhinosinusitis with polyposis: lack of significant adrenal suppression. J Otolaryngol Head Neck Surg 2008;37:821–5Google ScholarPubMed
12 Sachanandani, NS, Piccirillo, JF, Kramper, MA, Thawley, SE, Vlahiotis, A. The effect of nasally administered budesonide respules on adrenal cortex function in patients with chronic rhinosinusitis. Arch Otolaryngol Head Neck Surg 2009;135:303–7Google Scholar
13 Snidvongs, K, Pratt, E, Chin, D, Sacks, R, Earls, P, Harvey, RJ. Corticosteroid nasal irrigations after endoscopic sinus surgery in the management of chronic rhinosinusitis. Int Forum Allergy Rhinol 2012;2:415–21Google Scholar
14 Findlay, CA, Macdonald, JF, Wallace, AM, Geddes, N, Donaldson, MD. Childhood Cushing's syndrome induced by betamethasone nose drops, and repeat prescriptions. BMJ 1998;317:739–40CrossRefGoogle ScholarPubMed
15 Homer, JJ, Gazis, TG. Cushing's syndrome induced by betamethasone nose drops. In rhinological disease betamethasone should be regarded as systemic corticosteroid. BMJ 1999;318:1355 Google Scholar
16 Malozowski, S, Purucker, M, Worobec, A. Cushing's syndrome induced by betamethasone nose drops. Children taking intranasal corticosteroids should be monitored for growth retardation. BMJ 1999;318:1355 Google Scholar
17 Gazis, AG, Homer, JJ, Henson, DB, Page, SR, Jones, NS. The effect of six weeks topical nasal betamethasone drops on the hypothalamo-pituitary-adrenal axis and bone turnover in patients with nasal polyposis. Clin Otolaryngol Allied Sci 1999;24:495–8Google Scholar
18 Fowler, PD, Gazis, AG, Page, SR, Jones, NS. A randomized double-blind study to compare the effects of nasal fluticasone and betamethasone on the hypothalamo-pituitary-adrenal axis and bone turnover in patients with nasal polyposis. Clin Otolaryngol Allied Sci 2002;27:489–93Google Scholar
19 Harvey, RJ, Debnath, N, Srubiski, A, Bleier, B, Schlosser, RJ. Fluid residuals and drug exposure in nasal irrigation. Otolaryngol Head Neck Surg 2009;141:757–61CrossRefGoogle ScholarPubMed
20 Therapeutic Goods Administration: Product and Consumer Medicine Information. Product information: Diprosone® OV (optimised vehicle) cream and ointment. In: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=pi&q=Diprosone [12 May 2015]Google Scholar
21 Hopkins, C, Gillett, S, Slack, R, Lund, VJ, Browne, JP. Psychometric validity of the 22-item sinonasal outcome test. Clin Otolaryngol 2009;34:447–54Google Scholar
22 Rudmik, L, Soler, ZM, Mace, JC, DeConde, AS, Schlosser, RJ, Smith, TL. Using preoperative SNOT-22 score to inform patient decision for endoscopic sinus surgery. Laryngoscope 2015;125:1517–22Google Scholar
23 Henley, DE, Lightman, SL. Cardio-metabolic consequences of glucocorticoid replacement: relevance of ultradian signalling. Clin Endocrinol (Oxf) 2014;80:621–8Google Scholar
24 Fan, Y, Ma, L, Pippins, J, Limb, S, Xu, Y, Sahajwalla, CG. Impact of study design on the evaluation of inhaled and intranasal corticosteroids' effect on hypothalamic-pituitary-adrenal axis function, part I: general overview of HPA axis study design. J Pharm Sci 2013;102:3513–27Google Scholar
25 Lipworth, BJ, Seckl, JR. Measures for detecting systemic bioactivity with inhaled and intranasal corticosteroids. Thorax 1997;52:476–82Google Scholar
26 Wilson, AM, McFarlane, LC, Lipworth, BJ. Effects of repeated once daily dosing of three intranasal corticosteroids on basal and dynamic measures of hypothalamic-pituitary-adrenal-axis activity. J Allergy Clin Immunol 1998;101:470–4Google Scholar
27 Wang, C, Lou, H, Lou, W, Zhang, L. The efficacy and safety of a short course of budesonide inhalation suspension via transnasal nebulization in chronic rhinosinusitis with nasal polyps [in Chinese]. Lin Chung Er Bi Yan Hou Tou Jing Wai Ke Za Zhi 2012;26:347–50Google Scholar
28 Welch, KC, Thaler, ER, Doghramji, LL, Palmer, JN, Chiu, AG. The effects of serum and urinary cortisol levels of topical intranasal irrigations with budesonide added to saline in patients with recurrent polyposis after endoscopic sinus surgery. Am J Rhinol Allergy 2010;24:26–8Google Scholar