Skip to main content
. 2012 Sep 12;2012(9):CD001781. doi: 10.1002/14651858.CD001781.pub3

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
  • Adults and children

  • Refractory warts

  • Warts on the hands or feet

Interventions
  • α‐lactalbumin‐oleic acid in saline (1 drop per lesion)

  • Placebo (saline)


Applied once a day for 3 weeks.
Outcomes Outcomes of the trial
  1. > 75% reduction in wart volume at 2 months

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.