Gustafsson 2004.
Study characteristics | ||
Methods | This study was carried out in a secondary care setting. This study was blinded. Intention‐to‐treat analysis was not applicable. This study was conducted in Sweden. |
|
Participants | 40 participants were recruited: None dropped out. Inclusion criteria of the trial
|
|
Interventions |
Applied once a day for 3 weeks. |
|
Outcomes |
Outcomes of the trial
|
|
Notes | The trial converted to open‐label after the first 3 months. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | This was described as randomised, and a randomisation code was mentioned, but no further details were given. |
Allocation concealment (selection bias) | Unclear risk | No details were given. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Bottles of the intervention were coded, but no further details were given. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (page 2665): "The randomisation code was broken one month after all patients had completed three weeks of the randomly assigned treatment." Comment: This was probably adequate. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 40 participants entered the trial; 34 were available for follow up at the end of the trial. There were no withdrawals from the first phase of the study. There were 2/40 withdrawals from the second phase – who were lost to follow up (LFU) (1 from each of the original 2 groups). No reasons were given for dropouts. Comment: This was unlikely to introduce a high risk of risk of bias. |
Selective reporting (reporting bias) | Low risk | All outcomes (lesion volume and number of lesions) were reported. |