Schilling 1998.
Methods | Randomised, parallel, unblinded trial. Rimantadine and zanamivir were compared for prophylaxis of influenza A. The trial began in November 1996. The participants were volunteer residents of a nursing home for veterans and their spouses Drug administration: 14 days The number of respiratory illness was monitored until January 1997 | |
Participants | 65 volunteers of both sexes received zanamivir and 23 rimantadine Age range: 50 to 95 years old and 75% older than 65 years of age The participants were volunteers residents of a nursing home for veterans and their spouses Inclusion criteria: volunteers living in a unit of the nursing home where outbreak of influenza was declared Exclusion criteria: symptoms of new respiratory illness within the previous 7 days of the declared outbreak | |
Interventions | Rimantadine: 100 mg/dose, 1 x/day, during 14 days. Zanamivir: 10 mg inhaled bid and 4.4 mg intranasally bid | |
Outcomes | Clinical and laboratory‐proven influenza A | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The authors stated that it was a "randomised unblinded study" but the randomisation method is not described |
Allocation concealment (selection bias) | Unclear risk | Concealment is not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There is insufficient reporting of exclusions. It is stated that "six volunteers receiving zanamivir withdrew. One withdrew due to mild adverse effects". The other reasons for withdrawal are not clear. It is also unclear if there were withdrawals among the rimantadine group |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Although it was a "randomised unblinded study", the review authors judge that the outcome is not likely to be influenced by the lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Although it was a "randomised unblinded study", the review authors judge that the outcome is not likely to be influenced by the lack of blinding |
ACM: acetaminophen AE: adverse effects bid: twice a day CF: complement fixation CNS: central nervous system d: day GI: gastrointestinal HI: haemagglutination inhibition NC: not clear PB: placebo SCr: serum creatinine STGO: aspartate aminotransferase