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
Participant (baseline) characteristics:
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
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 |