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
Participant (baseline) characteristics:
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 |