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. 2018 Sep 10;2018(9):CD012453. doi: 10.1002/14651858.CD012453.pub2

Corradini 2006.

Methods 4‐arm, non‐blinded, parallel‐group RCT, with unclear duration of treatment and 20 months duration of follow‐up
Participants Location: Italy, 1 site
Setting of recruitment and treatment: university hospital
Sample size: 48
  • Number randomised: 23 in antifungal group, 25 in no antifungal group

  • Number completed: as per number randomised


Participant (baseline) characteristics:
  • Age: not reported

  • Gender: not reported

  • Main diagnosis: nasal polyposis with evidence of fungal infection

  • Presence of allergic fungal rhinosinusitis: 0% with AFRS

  • Presence of eosinophilic CRS: not reported

  • Polyps status: 100% with polyps

  • Previous sinus surgery status: not reported

  • Other important effect modifiers, if applicable:

    • Aspirin sensitivity: 15 (77%) of 89 randomised

    • Complete aspirin triad syndrome: 18 (20%) of 89 randomised


Inclusion criteria: nasal polyposis with fungal infection. Confirmed via medical history and physical examination, skin prick tests, measurement of specific IgE and nasal lavage.
Exclusion criteria: patients with nasal polyps but without evidence of fungal infection
Interventions Intervention (n = 23): amphotericin B (50 mg × 15 mL of 5% glucose solution), inhalation
  • 0.24 mL/day (equal to 0.8 mg of amphotericin B) 6 times/week for 1 month, followed by

  • 0.16 mL/day (equal to 0.5 mg of amphotericin B) 6 times/week as the maintenance dose (treatment duration is not well defined)


Comparator group (n = 25): no antifungal treatment
Use of additional interventions (common to both treatment arms):
Medical polypectomy: 40 mg of triamcinolone retard intramuscularly 3 times every 10 days (total dose 120 mg)
Lysine acetylsalicylate (LAS): after a nasal provocation test with LAS patients were treated with LAS inhalation (4 mg/day; 6 times/week) (treatment duration at this dose is assumed to be 19 months)
Outcomes Outcomes of interest in the review:
Primary outcomes: none reported
Secondary outcomes: none reported
Other outcomes reported by the study:
Polyp recurrence at 20 months, sensitisation to allergens
Funding sources No information provided
Declarations of interest No information provided
Notes Adverse effects were not reported as an outcome but there is one statement reading "LAS and amphotericin B treatment was well tolerated by all patients and no adverse reactions were observed.”
This paper presents a 4‐arm study
Group A: surgical endoscopic transnasal ethmoidectomy then topical endonasal treatment with LAS – this group is not included as all participants underwent surgery
Group B: medical polypectomy with triamcinolone retard IM, then topical endonasal treatment with LAS (included in this review)
Group C: surgical endoscopic transnasal ethmoidectomy then topical endonasal treatment with LAS and amphotericin B – this group is not included as all patients underwent surgery
Group D: medical polypectomy with triamcinolone retard IM, then topical endonasal treatment with LAS and amphotericin B (included in this review)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "were randomly assigned"
Comment: no information about methods used
Allocation concealment (selection bias) Unclear risk Comment: no information provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: 4 different treatment arms with different treatment regimens. Blinding is not likely to have been completed.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: blinding of outcome assessment was reported but it was assumed that it was not completed as there is no mention of blinding nor placebo control in the paper
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: it appears that all of the people who were randomised were included in the results. No discussion of withdrawals, which is surprising in a 20‐month study.
Selective reporting (reporting bias) Low risk Comment: no published protocol on ClinicalTrials.gov or European Trials Register. It appears that all of the outcomes presented in the methods are reported in the results section.
Other bias (non‐validated instrument) Unclear risk Comment: no outcomes of interest for this review. Standard endoscopy and imaging instruments presumed to have been used, but no further information.
Other bias Low risk Comment: no other bias identified