Abdelalim 2021.
Study characteristics | ||
Methods | Two‐arm, non‐blinded, parallel‐group randomised controlled trial with 3 weeks' duration of treatment and follow‐up | |
Participants |
Location: Egypt, single‐centre study Setting of recruitment and treatment: recruited at Benha University Hospital Sample size: 108
Participants:
Baseline characteristics:
Inclusion criteria for the study:
Exclusion criteria for the study:
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Interventions |
Intervention group: Topical corticosteroid spray (mometasone furoate nasal spray), 2 puffs (100 µg) once daily in each nostril for 3 weeks Comparator group: No intervention Use of additional interventions in both groups: Olfactory training was recommended to both groups, in the form of sniffing of rose, lemon and clove for 20 seconds each, twice a day |
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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 | No financial support was reported for the study | |
Declarations of interest | No conflict of interest was declared | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The participants in this study were randomly assigned to two groups (simple 1:1 randomisation)". Comment: correspondence from the author confirmed that adequate methods were used (random selection of groups from an envelope). |
Allocation concealment (selection bias) | Unclear risk | Comment: no information was provided regarding concealment of allocation. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: open‐label study, with no placebo group. Participants were aware of their allocation. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: open‐label study, with no placebo group. The only outcome assessed was self‐reported by the (unblinded) participants. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: few dropouts (7.4%) and balanced across the groups. Two participants in each group may have been excluded due to non‐adherence to the trial protocol (intervention group: 1 discontinued treatment, 1 used treatment inconsistently, control group: 2 received other medications). However, the impact of this on the results was not felt to be sufficient to result in high risk of bias. |
Selective reporting (reporting bias) | Low risk | Comment: trial protocol accessed on clinical trial registry, and no further outcomes were planned. |
Other bias | Low risk | Comment: no other source of bias detected. |