Yildiz 2021.
Study characteristics | ||
Methods | Three‐arm, (presumed), non‐blinded, parallel‐group RCT with 30 days duration of treatment and follow‐up | |
Participants |
Location: Turkey, single‐centre study Setting of recruitment and treatment: recruited from hospital inpatients Sample size: 150
Participants:
Baseline characteristics:
Inclusion criteria for the study:
Exclusion criteria for the study:
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Interventions |
Intervention group A: Saline irrigation: 10 mL of hypertonic saline (tonicity not reported) was administered to each nostril, twice daily for 1 month Intervention group B: Saline irrigation with steroid spray: saline irrigation was administered, as above, together with nasal steroid spray (triamcinolone acetonide 0.055%), 2 puffs to each nostril twice daily Comparator group: No intervention Use of additional interventions in both groups: None reported |
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Outcomes |
Outcomes of interest in the review: Primary outcomes: Presence of normal olfactory function
Serious adverse effects
Change in sense of smell
Secondary outcomes: Prevalence of parosmia
Change in sense of taste
Disease‐related quality of life
Other adverse effects (including nosebleeds/bloody discharge)
Other outcomes reported by the study: None reported |
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Funding sources | The authors declared that this study has received no financial support | |
Declarations of interest | No conflict of interest was declared by the authors | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: described as a single‐centre randomised controlled trial, but methods only state that participants "were divided into 3 equal groups". |
Allocation concealment (selection bias) | Unclear risk | Comment: no details are provided on allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: one intervention included no treatment, therefore not possible to blind participants to treatment. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: one intervention included no treatment, therefore not possible to blind participants to treatment. Outcomes all reported using subjective reporting measure by the participants themselves. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no information provided on the number of dropouts. |
Selective reporting (reporting bias) | Unclear risk | Comment: no trial registration. Limited data in the methods of the trial, therefore unable to assess appropriately. |
Other bias | High risk | Comment: unclear method for assessing olfactory function. Authors report using a subjective olfactory capability score, but not reported whether all odours were used consistently for all patients, and how patients would judge their olfactory ability across the different odours. Duration of olfactory disturbance is reported, but it is not clear what was used to judge recovery from olfactory disturbance. Unclear how patients recorded the duration of their symptoms when telephone follow‐up was only conducted on day 15 and 30, but duration of symptoms is reported in days. No information on daily diary/questionnaire to monitor symptoms. |
CT: computerised tomography; IQR interquartile range; PCR polymerase chain reaction; RCT: randomised controlled trial; SD: standard deviation; UPSIT: University of Pennsylvania Smell Identification Test; VAS visual analogue scale