Van't Veen 1998.
Methods | Study type: individual RCT Randomisation method: not mentioned Blinding: no (open‐label trial) Intention‐to‐treat analysis used: yes |
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Participants |
Inclusion criteria of the trial
Exclusion criteria of the trial
Number of randomised participants: 69 in total (betamethasone N = 34, ketoconazole N = 35) Number of dropouts: 0 Sex: 33 males, 36 females Mean age (range): betamethasone arm = 45.6 (20 to 75) years, ketoconazole arm = 40.1 (18 to 73) years Country: the Netherlands |
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Interventions |
Treatment
Comparator/s
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Outcomes |
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Notes | "72 patients gave written informed consent and entered the wash‐out period, but 2 had spontaneous remission and 1 withdrew for a non‐study‐related reason leaving 69 patients randomized". The results were given in figures and not in exact numbers. We approximated the numbers from figures, where feasible | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | This was not reported in detail Quote: "randomly allocated" |
Allocation concealment (selection bias) | Unclear risk | This was not reported in detail Quote: "randomly allocated" |
Similarity of the study groups (selection bias) | Low risk | Quote: "The groups were very well matched for demography and clinical characteristics" |
Blinding of participants (performance bias) | High risk | This was an open‐label study |
Blinding of care providers (performance bias) | High risk | This was an open‐label study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | This was an open‐label study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The dropout rate was acceptable |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported, albeit not sufficiently enough for use in the meta‐analysis |
Other bias | Unclear risk | 1 author was affiliated to Glaxo‐Wellcome (The Netherlands) BV, and Glaxo‐Wellcome provided all products Quote: "Financial support for the study was generously provided by Glaxo‐Wellcome (The Netherlands) BV" |