Ludvigsen 1983.
Methods | Study type: individual RCT Randomisation method: computer‐based randomisation Blinding: double‐blind Intention‐to‐treat analysis used: not used |
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Participants |
Inclusion criteria of the trial
Exclusion criteria of the trial
Number of randomised participants: 30 in total (betamethasone N = 15, hydrocortisone N = 15, but 1 of the participants in the latter group proved to be too young to be included, and the results were not used) Number of dropouts: 1 participant was excluded after randomisation because of their young age (not considered a dropout); 1 participant was lost to follow up (considered a dropout, 3%) Sex: 17 males, 12 females Mean age (range): 49.9 (19 to 82) years Country: Denmark |
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Interventions |
Treatment
Comparator/s
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Outcomes |
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Notes | Participants used drugs for 3 weeks or until complete healing. Outcomes were assessed at 3 weeks. Scores were calculated only for those who had the symptom | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A computer programme was used to give the randomization code, which was stratified into blocks of 10 with a restriction against more than three successive patients receiving the same therapy" |
Allocation concealment (selection bias) | Unclear risk | Quote: "randomization code, which was stratified into blocks of 10 with a restriction against more than three successive patients receiving the same therapy" |
Similarity of the study groups (selection bias) | Low risk | Quote: "No statistically significant difference in patient classification of mean age, sex distribution and initial symptom score distribution was found between the two treatment groups but there was a numerically lower mean age in the HCB‐treated group" 44 years versus 56 years |
Blinding of participants (performance bias) | Unclear risk | The study was "double‐blind"; this was not reported in detail. The participants were given Locoid® or Diproderm®, and it was not reported if the packages were 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) | Unclear risk | Predefined outcomes were reported, but they were assessed as scores only for those who had the symptom |
Other bias | Low risk | No other bias was identified |