Kousidou 1992.
Methods | Study type: individual RCT Randomisation method: not reported Blinding: double‐blind Intention‐to‐treat analysis used: not reported |
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Participants |
Inclusion criteria of the trial
Exclusion criteria of the trial
Number of randomised participants: 40 in total (hydrocortisone N = 20, ketoconazole N = 20) Number of dropouts: 1 (3%) Sex: 21 males, 19 females Age (mean): 33.7 years Country: Greece |
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Interventions |
Treatment
Comparator/s
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Outcomes |
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Notes | No standard deviations nor exact P values were given in the report. We have approximated the actual numbers from figures | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "They were randomized" |
Allocation concealment (selection bias) | Unclear risk | This was not reported |
Similarity of the study groups (selection bias) | Low risk | Quote: "At the start of treatment, erythema, scaling, and pruritus were present in all patients of both groups without any statistically significant difference in the mean scores" |
Blinding of participants (performance bias) | Unclear risk | Whilst the study was reported to be double‐blind, it was not clear who was blinded |
Blinding of care providers (performance bias) | Unclear risk | Whilst the study was reported to be double‐blind, it was not clear who was blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Whilst the study was reported to be double‐blind, it was not clear who was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The dropout rate was small |
Selective reporting (reporting bias) | Low risk | Predefined outcomes were reported |
Other bias | Unclear risk | 2 authors were affiliated to the pharmaceutical industry |