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

Golden 2009.

Methods This was a quasi‐randomised, open‐label, controlled, parallel‐group trial.
Participants This trial was conducted in the USA.
The participants were adults aged 21 to 63 years.
The total number of participants was 29.
The total number of participants in the treatment group was 19.
The total number of participants in the control group was 10.
No distribution by gender was reported.
The species of insect venoms that the participants were allergic to were honeybee (7), yellowjacket (2), polistes wasp (2), and mixed vespid (18).
Inclusion criteria of the trial
  • History of a large local reaction to insect sting

  • Wheal > 5 mm and erythema > 10 mm in intradermal test and local induration of ≥ 16 cm in a sting challenge


Exclusion criteria of the trial
  • Use of β‐blockers medication

  • Pregnancy or insufficient measures to avoid pregnancy and previous sting anaphylaxis or VIT

  • Uncontrolled asthma or other medical conditions that might affect the risk or outcome of anaphylaxis

Interventions
  • Treatment: subcutaneous injections of VIT


VIT Manufacturer: ALK‐Abelló
Duration: 12 weeks
Updosing: Used a dose schedule to achieve the maintenance dose in 7 weekly visits
Maintenance dose: 100 µg every 4 weeks
  • Control: no treatment

Outcomes Outcomes of the trial
1. Systemic reaction to insect sting challenge 
2. Fatal systemic reaction to insect sting challenge                    
3. Large local reactions to insect sting challenge (measured by participants at home using study measuring equipment)
4. Adverse events to immunotherapy     
Notes This study was funded by the National Institutes of Health and ALK‐Abelló (VIT manufacturer).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Randomisation was done based on sequence of enrolment, probably using alternation ‐ therefore, this was a quasi‐randomised study.
Allocation concealment (selection bias) High risk This was inadequate.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There were no losses to follow up during the 12‐week period.
Selective reporting (reporting bias) Low risk The specified outcomes in the methodology were reported in the results section.
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.