Chan 2015.
Methods | Parallel group RCT | |
Participants | 62 children aged 6 to 18 with mild OSA (OAHI 1 to 5 per hour) | |
Interventions | Mometasone 100 µg per nostril for 4 months; comparison against placebo for 4 months | |
Outcomes | AHI, tonsil and adenoid size, nasal symptoms; measured after 4 months | |
Notes | Enrolment period: May 2006 to March 2008 Funding sources: study medication and placebo were provided by Schering‐Plough; design and conduct of the study was done by the investigator without funding. Declaration of interest: Dr. Yun Wing received a honorarium for serving as a part‐time paid consultant for Renascence Therapeutics. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The allocation was based on a computer‐generated randomisation list with varying block sizes." |
Allocation concealment (selection bias) | Low risk | "The children were allocated to receive mometasone furoate (MF) or placebo, using double‐blinded randomisation with a sealed opaque envelope method." |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Corticosteroids (MF) and placebo were provided in numbered identical containers. The appearances of the active drug and placebo were indistinguishable." "The PSG data were scored and interpreted by an experienced sleep technologist who was blinded to the subjects’ group allocation." "An otorhinolaryngologist, who was blinded to the group allocation and PSG result of the participants, performed the [upper airway] examination." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 12/62 children (7 intervention, 5 placebo) dropped out; 5 children (3 intervention, 2 placebo) withdrew because of side effects; 7 children (4 intervention, 3 placebo) were lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | No study protocol or trial registration were available, but outcomes appeared to be complete. |
Other bias | Low risk | None. |