Skip to main content
. 2018 Sep 10;2018(9):CD012453. doi: 10.1002/14651858.CD012453.pub2

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
  • Number randomised: 36 in intervention, 34 in comparison

  • Number completed: 32 in intervention, 32 in comparison


Participant (baseline) characteristics:
  • Mean age (age range): group 1: 51 (17 to 75); group 2: 46 (13 to 79)

  • Gender (F/M): 35 (54.7%)/29 (45.3%)

  • Main diagnosis: chronic rhinosinusitis without nasal polyps

  • Presence of allergic fungal rhinosinusitis: 0%

  • Presence of eosinophilic CRS: not reported

  • Polyps status: 0% with polyps [Exclusion criterion]

  • Previous sinus surgery status: 0% [Exclusion criterion]

  • Other important effect modifiers, if applicable (e.g. aspirin sensitivity, comorbidities of asthma): none reported


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
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.
Outcomes Outcomes of interest in the review:
Primary outcomes:
  • Health‐related quality of life, disease‐specific, measured using the Chinese version of Rhinosinusitis Outcome Measures 31 (CRSOM‐31), measured at baseline, 2 weeks and 4 weeks. Unclear range (standard RSOM‐31 range is 0 to 755), lower = better quality of life


Secondary outcomes:
  • Endoscopy (overall score): nasal endoscopy scored by the Lund endoscopic system. The endoscopic findings including oedema, discharge, polyps, crusting and scarring were graded from 0 (normal) to 2 (severely diseased). Range 0 to 10; higher = worse.


Other outcomes reported by the study:
  • Fungal and bacterial cultures

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