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

Shin 2004.

Methods 3‐arm, non‐blinded, parallel‐group trial (unclear randomisation), with 4 weeks duration of treatment and follow‐up
Participants Location: South Korea, single site
Setting of recruitment and treatment: Department of Otolaryngology
Sample size: 41
  • Number randomised: 16 in high‐dose AMB, 14 in low‐dose AMB, 11 in control

  • Number completed: 16 in high‐dose AMB, 14 in low‐dose AMB, 11 in control


Participant (baseline) characteristics:
  • Mean age (years): high‐dose AMB: 44.1; low‐dose AMB: 38.1; control: 41.3

  • Gender (M/F): high‐dose AMB: 8/8; low‐dose AMB: 10/4; control: 7/4

  • Main diagnosis: CRS with nasal polyposis

  • Presence of allergic fungal rhinosinusitis: 0% (all had negative skin prick test)

  • Presence of eosinophilic CRS: not reported

  • Polyps status: 100% with polyps

  • Previous sinus surgery status: not reported

  • Other important effect modifiers, if applicable (e.g. aspirin sensitivity, comorbidities of asthma): 0% with a history of allergy or asthma


Inclusion criteria: diagnosis of CRS was based on the 1996 Task Force on Rhinosinusitis criteria. CT scan of the paranasal sinuses and endoscopy was used to confirm the presence of nasal polyps.
All of the participants had a negative skin prick test and a negative multiple allergosorbent test chemiluminescent assay.
Exclusion criteria: patients who had received systemic or topical steroids or antibiotics or who had a history of allergy, asthma or other systemic diseases
Interventions High‐dose antifungal group 1 (n = 16): amphotericin B dissolved in sterile water at a concentration of 100 mg/L. Intranasal administration of 10 mL of the solution into each nostril twice daily with a syringe. Total daily dose = 4 mg amphotericin B. Treatment duration = 4 weeks.
Low‐dose antifungal group 2 (n = 14): amphotericin B dissolved in sterile water at a concentration of 50 mg/L. Intranasal administration of 10 mL of the solution into each nostril twice daily with a syringe. Total daily dose = 2 mg amphotericin B. Treatment duration = 4 weeks.
Comparator group (n = 11): normal saline, 10 mL of the solution was administered into each nostril twice daily. Treatment duration = 4 weeks.
Use of additional interventions (common to both treatment arms): none listed
Outcomes Outcomes of interest in the review:
No primary outcomes reported
No secondary outcomes reported
Other outcomes reported by the study:
Cytokine protein contents of nasal polyps (IL‐5, IL‐8, INF‐y, RANTES)
Funding sources No information provided
Declarations of interest No information provided
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "Patients were randomly selected based on their willingness to participate”
Comment: it is unclear if this 'randomisation' was to the study (i.e. not an RCT) or to the treatment group. No randomisation methods are given.
Due to a lack of information about baseline characteristics, selection bias is possible
Allocation concealment (selection bias) Unclear risk Comment: no information about allocation concealment. Lack of information about baseline characteristics. Participant selection is possible.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: the study does not mention that it was blinded. There was a control group but the control treatment (intranasal saline) is likely to look different to the intervention groups.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: the study does not mention if the outcome assessment was blinded
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: outcome data were available for all participants who completed. However, the paper does not provide information about the number of people who were potentially eligible for the trial, or who started and did not finish.
Selective reporting (reporting bias) Low risk Comment: no protocol for the trial was available on clinicaltrials.gov or the WHO clinical trials registry
All of the outcomes that were reported in the methods are presented in the results section
Other bias (non‐validated instrument) Unclear risk Comment: no outcomes of interest were reported
Other bias Low risk Comment: no other sources of bias were identified