Methods |
Prophylaxis randomised double blind placebo‐controlled trial carried out at the University of Texas |
Participants |
Participants were 444 healthy students aged 18 to 24 who were followed up for 6 weeks on the basis weekly of self‐reporting. The trial was commenced on week 7 (? mid‐February) 1978 during an epidemic of influenza A/USSR/90/77 virus |
Interventions |
Students were randomised to receive either amantadine (100 mg), or rimantadine (100 mg), or placebo (not specified) tablets twice daily |
Outcomes |
Efficacy: cases were defined on the basis of paired sera and clinical symptoms. Viral isolation from throat swabs was additionally carried out |
Notes |
The practices of randomisation, allocation and concealment are not defined, making it impossible to assess methodological rigour. Analysis on the basis of intention‐to‐treat was not carried out and the overall quality of reporting is poor (with no complete details of reasons for drop‐out). This study was probably commenced at of just after the peak of influenza transmission with a consequent possible underestimation of the efficacy of prophylaxis interventions (due to late commencement of prophylaxis) |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |