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. 2012 Oct 17;2012(10):CD008838. doi: 10.1002/14651858.CD008838.pub2

Oude Elberink 2006.

Methods This was a randomised, open‐label, controlled, parallel‐group trial.
Participants This trial was conducted in the Netherlands.
The participants were adults aged 18 to 65 years.
The total number of participants was 91.
The total number of participants in the treatment group was 47.
The total number of participants in the control group was 44.
No distribution by gender was reported.
The species of insect venom that the participants were allergic to was yellowjacket.
Inclusion criteria of the trial
  • History of 1 or more anaphylactic reactions after yellowjacket stings and positive intradermal or serum IgE test


Exclusion criteria of the trial
  • β‐blocker therapy or if there was a need to carry an EpiPen for other reasons

  • Mastocytosis

  • Serious medical or surgical illness

  • Pregnancy

Interventions
  • Treatment: subcutaneous injections of VIT


VIT Manufacturer: ALK‐Abelló
Duration: 1 year
Updosing: Modified semi‐rush schedule over approximately 6 weeks
Maintenance dose: 100 µg every 6 weeks
  • Control: EpiPen

Outcomes Outcomes of the trial
1. Systemic reaction to accidental insect sting 
2. Quality of life assessment using "Burden of Treatment" questionnaire at 1 year      
Notes This is part of the same study reported in the Oude Elberink 2001 and 2002 publications. This study was funded by ALK‐Abelló (VIT manufacturer).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A minimisation computer program was used. Participants were stratified for age and time of reaction.
Allocation concealment (selection bias) Low risk This was done by a third party.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 4 of 47 participants were lost to follow up in the treatment group; 3 of 44 participants were lost to follow up in the control group.
Selective reporting (reporting bias) Low risk The specified outcomes in the methodology were either reported in the results section or provided by the authors as the original dataset.
Other bias Low risk No other sources of bias were detected or suspected.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and personnel were not blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Outcome assessors were not blinded.