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Amphotericin B nasal lavages: not a solution for patients with chronic rhinosinusitis

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Abstract
Background: Chronic rhinosinusitis (CRS) is one of the most common chronic diseases. Recently, it has been suggested that an exaggerated immune response to fungi is crucial in the pathogenesis of the disease. On the basis of this hypothesis, intranasal treatment with amphotericin B should benefit patients with CRS. Data from 2 uncontrolled and 2 controlled trials are conflicting, however. Objective: To clarify the role of intranasal antifungal drugs in the treatment of CRS, we conducted a large, double-blind, placebo-controlled, multicenter study comparing the effectiveness of amphotericin B nasal lavages with placebo. Methods: A total of 116 randomly selected patients with CRS were instructed to instill 25 mL amphotericin B (100 mu g/mL) or placebo to each nostril twice daily for 3 months. Primary outcomes included a reduction in total visual analog scale (VAS) score and nasal endoscopy score. Secondary outcome measures included peak nasal inspiratory flow, polyp score, quality of life (Short Form-36, Rhinosinusitis Outcome Measure-31), and individual VAS scores. Results: Analysis was based on intention to treat and involved all patients randomly assigned. Mean VAS scores, Short Form-36 and Rhinosinusitis Outcome Measure-31 data, peak nasal inspiratory flow values, nasal endoscopy scores, and polyp scores were similar in both treatment groups at the time of randomization, and no significant differences were observed after 13 weeks of treatment. Conclusion: Amphotericin B nasal lavages in the described dosing and time schedule do not reduce clinical signs and symptoms in patients with CRS. Clinical implications: Amphotericin B nasal lavages in the described dosing and time schedule are ineffective and therefore not advised in the treatment of patients with CRS.
Keywords
TRIAL, randomized controlled trial, SINUSITIS, FUNGURIA, POLYPOSIS, ORAL FLUCONAZOLE, BLADDER IRRIGATION, DOUBLE-BLIND, ANTIFUNGAL TREATMENT, fungi, chronic disease, nasal polyps, rhinosinusitis, intranasal administration, amphotericin B, human, prospective study, double-blind method

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MLA
Ebbens, Fenna A, Glenis K Scadding, Lydia Badia, et al. “Amphotericin B Nasal Lavages: Not a Solution for Patients with Chronic Rhinosinusitis.” JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY 118.5 (2006): 1149–1156. Print.
APA
Ebbens, F. A., Scadding, G. K., Badia, L., Hellings, P. W., Jorissen, M., Mullol, J., Cardesin, A., et al. (2006). Amphotericin B nasal lavages: not a solution for patients with chronic rhinosinusitis. JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 118(5), 1149–1156.
Chicago author-date
Ebbens, Fenna A, Glenis K Scadding, Lydia Badia, Peter W Hellings, Mark Jorissen, Joaquim Mullol, Alda Cardesin, et al. 2006. “Amphotericin B Nasal Lavages: Not a Solution for Patients with Chronic Rhinosinusitis.” Journal of Allergy and Clinical Immunology 118 (5): 1149–1156.
Chicago author-date (all authors)
Ebbens, Fenna A, Glenis K Scadding, Lydia Badia, Peter W Hellings, Mark Jorissen, Joaquim Mullol, Alda Cardesin, Claus Bachert, Thibaut Van Zele, Marcel GW Dijkgraaf, Valerie Lund, and Wytske J Fokkens. 2006. “Amphotericin B Nasal Lavages: Not a Solution for Patients with Chronic Rhinosinusitis.” Journal of Allergy and Clinical Immunology 118 (5): 1149–1156.
Vancouver
1.
Ebbens FA, Scadding GK, Badia L, Hellings PW, Jorissen M, Mullol J, et al. Amphotericin B nasal lavages: not a solution for patients with chronic rhinosinusitis. JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY. 2006;118(5):1149–56.
IEEE
[1]
F. A. Ebbens et al., “Amphotericin B nasal lavages: not a solution for patients with chronic rhinosinusitis,” JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, vol. 118, no. 5, pp. 1149–1156, 2006.
@article{2126580,
  abstract     = {Background: Chronic rhinosinusitis (CRS) is one of the most common chronic diseases. Recently, it has been suggested that an exaggerated immune response to fungi is crucial in the pathogenesis of the disease. On the basis of this hypothesis, intranasal treatment with amphotericin B should benefit patients with CRS. Data from 2 uncontrolled and 2 controlled trials are conflicting, however. 
Objective: To clarify the role of intranasal antifungal drugs in the treatment of CRS, we conducted a large, double-blind, placebo-controlled, multicenter study comparing the effectiveness of amphotericin B nasal lavages with placebo. 
Methods: A total of 116 randomly selected patients with CRS were instructed to instill 25 mL amphotericin B (100 mu g/mL) or placebo to each nostril twice daily for 3 months. Primary outcomes included a reduction in total visual analog scale (VAS) score and nasal endoscopy score. Secondary outcome measures included peak nasal inspiratory flow, polyp score, quality of life (Short Form-36, Rhinosinusitis Outcome Measure-31), and individual VAS scores. 
Results: Analysis was based on intention to treat and involved all patients randomly assigned. Mean VAS scores, Short Form-36 and Rhinosinusitis Outcome Measure-31 data, peak nasal inspiratory flow values, nasal endoscopy scores, and polyp scores were similar in both treatment groups at the time of randomization, and no significant differences were observed after 13 weeks of treatment. 
Conclusion: Amphotericin B nasal lavages in the described dosing and time schedule do not reduce clinical signs and symptoms in patients with CRS. 
Clinical implications: Amphotericin B nasal lavages in the described dosing and time schedule are ineffective and therefore not advised in the treatment of patients with CRS.},
  author       = {Ebbens, Fenna A and Scadding, Glenis K and Badia, Lydia and Hellings, Peter W and Jorissen, Mark and Mullol, Joaquim and Cardesin, Alda and Bachert, Claus and Van Zele, Thibaut and Dijkgraaf, Marcel GW and Lund, Valerie and Fokkens, Wytske J},
  issn         = {0091-6749},
  journal      = {JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY},
  keywords     = {TRIAL,randomized controlled trial,SINUSITIS,FUNGURIA,POLYPOSIS,ORAL FLUCONAZOLE,BLADDER IRRIGATION,DOUBLE-BLIND,ANTIFUNGAL TREATMENT,fungi,chronic disease,nasal polyps,rhinosinusitis,intranasal administration,amphotericin B,human,prospective study,double-blind method},
  language     = {eng},
  number       = {5},
  pages        = {1149--1156},
  title        = {Amphotericin B nasal lavages: not a solution for patients with chronic rhinosinusitis},
  url          = {http://dx.doi.org/10.1016/j.jaci.2006.07.058},
  volume       = {118},
  year         = {2006},
}

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