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
Exclusion criteria of the trial
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Interventions |
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
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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 |
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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. |