| Methods |
Randomised, parallel, double‐blind, trial in which amantadine was used as prophylaxis in naturally occurring acute respiratory illness. Amantadine was compared to PB. The trial took place between February 1965 to June 1965
The method of blinding is unclear
Study duration: 18 weeks
Withdrawal was the same for the 2 groups ‐ discharge from school (19%). The proportion was not stated |
| Participants |
There were 293 participants from both sexes (proportion not stated), from 8 to 19 years of age. The participants were volunteers at a school for intellectually handicapped but educable children. Sera pairs tests were obtained in 237 children. Exclusion criteria: children receiving tranquillisers, sympathomimetic amines or anticonvulsives
Co‐morbid conditions: intellectually handicapped children |
| Interventions |
Amantadine: 1 to 2.5 mg/kg (pre‐puberal: 60 mg/dose, 2 x/d, during the first week and 1 x/d during the rest of the period of the study. Older children: 100 mg/dose, 2 x/d, during the first week and 1 x/d during the rest of the period of the study |
| Outcomes |
4‐fold rises in CF and/or HI tilter against A2/AA/1/65 |
| Notes |
8 to 19 years old |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Authors stated "volunteers were assigned to amantadine or the PB group by randomisation", although randomisation method is not described |
| Allocation concealment (selection bias) |
Unclear risk |
Concealment is not clearly described |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
It is stated that "The rate of withdrawal ... (the same for the two groups) was small. The reason for withdrawal was discharge from school" |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Although it was "a double‐blind study", the specific people who are blinded are not listed |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Although the trial is described as "a double‐blind study", the specific people who are blinded are not listed |
