Hersle 1996.
Methods | Study type: individual RCT Randomisation method: not reported Blinding: double‐blind Intention‐to‐treat analysis used: no |
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Participants |
Inclusion criteria of the trial
Exclusion criteria of the trial
Number of randomised participants: 54 in total (the initial assignment numbers were not reported by treatment group; at 4 weeks, 27 participants were treated with mometasone, and 22 participants were treated with ketoconazole) Number of dropouts: 5 (9%) Sex: 40 males, 14 females Mean age (range): 58 (22 to 85) years Country: Sweden |
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Interventions |
Treatment
Comparator/s
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Outcomes |
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Notes | Participants and investigators evaluated reduction of pruritus, scaling, and erythema scores, but numerical information of these was not reported. We approximated the numbers from figures. The actual number of participants randomised to each group was unknown | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, but not reported in sufficient detail |
Allocation concealment (selection bias) | Unclear risk | No information was provided |
Similarity of the study groups (selection bias) | Unclear risk | No information was provided |
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 | Unclear risk | The actual number of participants randomised to each group was unknown. The dropout rate was 10%, but the study did not report if this was balanced between groups |
Selective reporting (reporting bias) | Unclear risk | The primary outcomes were not prespecified in detail, yet the outcomes reported were those that are usually used in such studies |
Other bias | Unclear risk | The pharmaceutical industry supported the study |