Skip to main content
. 2022 Sep 5;2022(9):CD013877. doi: 10.1002/14651858.CD013877.pub3

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
  • Number randomised: 54 to intervention, 54 to comparator

  • Number completed: 50 in intervention, 50 in comparator


Participants:
  • Patients who have recently recovered from proven COVID‐19 infection, suffering from anosmia or hyposmia


Baseline characteristics:
  • Age: intervention group: median 28.0 years (IQR 20.5 to 38.0); control group: median 30.0 years (IQR 22.5 to 39.0)

  • Gender: intervention group: 24 (48%) male, 26 (52%) female; control group: 22 (44%) male, 28 (56%) female

  • Olfactory function at baseline: baseline smell score reported with VAS (0 to 10); intervention group: median 2.0 (IQR 0.5 to 5.0); control group: median 2.0 (IQR 1.0 to 5.0)

  • Diagnosis of olfactory dysfunction at baseline: self‐reported, no psychophysical testing

  • Duration of symptoms: all participants had between 10 and 28 days of olfactory disturbance at baseline (confirmed with study authors)


Inclusion criteria for the study:
  • Aged 18 years or older

  • Confirmed case of COVID‐19 (positive PCR)

  • Subsequent recovery (2 negative PCR)

  • Acute onset of anosmia/hyposmia, with or without loss of taste

  • Hospitalised or home isolated


Exclusion criteria for the study:
  • Use of nasal steroids for other co‐morbidities

  • Previous chronic rhinological pathology

  • Use of systemic steroids for other systemic disease

  • Anosmia that improved before recovery from COVID‐19

  • Pregnancy

  • Loss to follow‐up

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
Outcomes Outcomes of interest in the review:
Primary outcomes:
Presence of normal olfactory function
  • Patient reported "complete normal smell sensation", using a VAS score of 0 to 10, where score 10 = completely normal smell sensation. Participants were recommended some substances to use when self‐assessing their olfactory function, such as mint, coffee and garlic. Assessed at baseline, 1 week, 2 weeks and 3 weeks.

  • Psychophysical testing not assessed


Serious adverse effects 
  • Not assessed


Change in sense of smell
  • Patient reported sense of smell, using a VAS score of 0 to 10, where 0 = total loss of smell and 10 = completely normal smell sensation. Participants were recommended some substances to use when self‐assessing their olfactory function, such as mint, coffee and garlic. Assessed at baseline, 1 week, 2 weeks and 3 weeks.

  • Psychophysical testing not assessed


Secondary outcomes:
Prevalence of parosmia
  • Not assessed


Change in sense of taste
  • Not assessed


Disease‐related quality of life
  • Not assessed


Other adverse effects (including nosebleeds/bloody discharge)
  • Not assessed


Other outcomes reported by the study:
None reported
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.