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. 2023 Jun 14;2023(6):CD001506. doi: 10.1002/14651858.CD001506.pub5

Mainz 2015.

Study characteristics
Methods RCT.
Design: double‐blind, cross‐over design.
Duration: 1st arm of 28 days followed by a 28‐day washout period and then alternative treatment for 28 days.
Location: multicentre in Germany.
Participants 69 people with CF.
Interventions Group 1: HS 6% via PariSinusTM.
Group 2: IS via PariSinusTM.
Outcomes Primary outcome
Sinonasal outcome test (SNOT‐20) upper airway symptoms or disease‐specific QOL.
Secondary outcomes
Rhinoscopy, rhinomanometry, cytokines in nasal lavage.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated but not defined.
Allocation concealment (selection bias) Unclear risk This was stated but not described.
Blinding of participants and personnel (performance bias)
All outcomes High risk No attempt was made to blind the taste of the HS solution.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Stated but not described in detail.
Incomplete outcome data (attrition bias)
All outcomes Low risk All drop outs clearly defined.
Selective reporting (reporting bias) Low risk All outcomes that were stated were described.
Other bias Low risk No other major source of bias detected.