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

Brown 2003.

Methods This was a randomised, double‐blind, placebo‐controlled, parallel‐group trial.
Participants This trial was conducted in Australia.
The participants were adults aged 18 to 63 years.
The total number of participants was 68.
The total number of participants in the treatment group was 35 (22 men).
The total number of participants in the control group was 33 (18 men).
The species of insect venom that the participants were allergic to was Myrmecia pilosula (M. pilosula) venom (ant venom).
Inclusion criteria of the trial
  • History of 1 or more Mueller grade II to IV reactions to ant venom (M. pilosula) and a positive intradermal skin test to M. pilosula venom


Exclusion criteria of the trial
  • ACE inhibitor or β‐blockers therapy

  • Hypertension

  • Heart disease

  • Poorly‐controlled lung disease

  • People with negative skin tests

Interventions
  • Treatment: subcutaneous injections of VIT


VIT Manufacturer: NSL Health Ltd., Melbourne, Australia
Duration: 4 to 5 months
Updosing: Outpatient cluster hyposensitisation regimen (10 visits)
Maintenance dose: 100 µg monthly
  • Control: subcutaneous placebo (histamine acid phosphate)

Outcomes Outcomes of the trial
1. Systemic reaction to insect sting challenge            
2. Fatal systemic reaction to insect sting challenge             
3. Adverse events to immunotherapy             
Notes This study was funded by NSL Health Ltd. (VIT manufacturer), the Department of Health and Human Services Tasmania, and Royal Hobart Research Foundation.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number‐based sequential allocation was done by a third party.
Allocation concealment (selection bias) Low risk This was done by a third party.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Participants lost to follow up or excluded were accounted for along with participants followed to designated follow‐up periods (0 out of 35 participants in the treatment group and 4 out of 33 participants in the control group).
Selective reporting (reporting bias) Low risk The specified outcomes in the methodology were reported in the results section.
Other bias Low risk
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Packs were identical in appearance, and contents containing placebo or lyophilised venom were dispensed. Early unblinding meant that 12 of 35 VIT‐treated participants were unblinded at the time of the sting challenge; however, outcomes were similar in this group to the other 23 who had blinded sting challenges.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The outcome assessors were blinded.