Liang 2008.
Methods | 2‐arm, double‐blinded, single‐centre, parallel‐group RCT, with 4 weeks duration of treatment and follow‐up | |
Participants |
Location: Taiwan, 1 site Setting of recruitment and treatment: outpatient ENT clinic Sample size: 70
Participant (baseline) characteristics:
Inclusion criteria: people over 12 years old with a diagnosis of CRS based on the definition included in a report published by the Chronic Rhinosinusitis Task Force in 2003. The inclusion criteria were typical nasal symptoms for > 12 weeks, nasal endoscopy that showed mucosal swelling or purulent discharge and positive findings on sinus x‐ray films. Exclusion criteria: nasal polyps, pregnant or immunocompromised, history of sinus surgery, or had taken antibiotics or antifungal agents within 1 week before enrolling in the study |
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Interventions |
Intervention (n = 36): amphotericin B, 20 mg of amphotericin B in 500 mL of normal saline, used as a nasal irrigation using a Sanvic SH903 pulsatile irrigator, 250 mL for each nostril, once daily. Total daily dose = 20 mg amphotericin B. Treatment duration = 4 weeks. Comparator group (n = 34): placebo (with a yellowish dye), 4 mL of placebo solution in 500 mL of normal saline, used as a nasal irrigation using a Sanvic SH903 pulsatile irrigator, 250 mL for each nostril, once daily. Treatment duration = 4 weeks. Use of additional interventions (common to both treatment arms): Patients were NOT allowed to use oral antibiotics, oral antifungals, oral steroids or oral antihistamines. Participants were also told not to use nasal sprays. |
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Outcomes |
Outcomes of interest in the review: Primary outcomes:
Secondary outcomes:
Other outcomes reported by the study:
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Funding sources | No information provided | |
Declarations of interest | No information provided | |
Notes | Non‐parametric tests were used for quality of life score and endoscopic scores | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly allocated" Comment: not enough information to determine whether this was a low risk of bias |
Allocation concealment (selection bias) | Unclear risk | Comment: not enough information to determine |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind" Comment: although there is a lack of information the paper does explain how the placebo solution was made to look like the amphotericin solution (addition of dye) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "double‐blind" Comment: not enough information to determine whether the outcome measure of nasal endoscopy was completed by someone who had knowledge of the treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: the dropout rate was low at 6/70 (8.6%). There was no difference in the dropout rate or reasons for dropout between the 2 groups. |
Selective reporting (reporting bias) | Low risk | Comment: no protocol could be found on clinicaltrials.gov or the Chinese clinical trial registry. Results for all outcomes as presented in the methods sections are presented in the results as median values with ranges. |
Other bias (non‐validated instrument) | Low risk | Comment: the study used the RSOM‐31 instrument for health‐related quality of life and the paper did provide the reference to the validation paper relating to the validation of the Chinese version. It is not clear what the scoring system used was. The Lund‐Mackay endonasal scoring system is a validated, widely used scale. References are given for the validation papers. |
Other bias | Low risk | Comment: no additional sources of bias were identified |