Schmidt 1981.
Study characteristics | ||
Methods | This study was carried out in a secondary care setting. This study was blinded. Intention‐to‐treat analysis was not carried out. This study was conducted in Denmark. |
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Participants | 60 participants were recruited: 5 dropped out. Inclusion criteria of the trial
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Interventions |
Treatment was applied daily for 6 weeks. |
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Outcomes |
Outcomes of the trial
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Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | This was described as randomised; no details were given. |
Allocation concealment (selection bias) | Unclear risk | This was unclear; no details were given. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | This was unclear. This was described as double‐blind; the placebo appeared to be identical. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | This was unclear; no details were given. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 5/60 participants completed. The results for 5 dropouts (2/30 Verrumal and 3/30 placebo) "could not be analysed" (page 1). No reasons were given. Also, it was not stated how many participants were randomised to each group – it was presumed that there were 30 in each group. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |