| Methods |
Randomised, parallel, double‐blind comparison of 2 different doses of rimantadine with PB. The trial took place during an outbreak of influenza A/H3N2 during 1993
Study duration: 8 weeks
Dropouts: 62% withdrew because of side effects, death, discharge, hospitalisation, physician's request and refusal to continue participation
Co‐interventions and other potential confounders were not observed |
| Participants |
A total of 328 participants, 275 females and 53 males were included
Inclusion criteria: residents of 10 nursing homes who agreed to participate in the study
Exclusion criteria: patients with significant renal or hepatic disease
Disease stage: rimantadine was administered as prophylaxis |
| Interventions |
Rimantadine: 100 mg/d; rimantadine: 200 mg/d; PB. Ratio: 2:2:1. Duration: up to 8 weeks |
| Outcomes |
Death. AEs: dry mouth, drowsiness/fatigue, headache, irritability, dizziness/light headedness, nausea/vomiting, abdominal pain, body weakness or disability, confusion, depression, impaired concentration, insomnia or sleeplessness, loss of appetite, rash or allergic reaction, seizure or clonic twitching |
| Notes |
3 groups: rimantadine 100 amantadine 200 and PB |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Although the authors state that the participants were randomly assigned to receive active medication (100 or 200 mg of rimantadine per day) or placebo, the randomisation method is not described |
| Allocation concealment (selection bias) |
Unclear risk |
Concealment is not described |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Authors stated that an "increased risk of withdrawal from the study only on the basis of perceived side effects was demonstrated among participants in both groups receiving active medication, especially the 200 mg/day group, compared with the placebo group; however, these associations were not statistically significant". The reasons for missing outcome data are likely to be related to true outcome |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
It is stated that "staff and residents were blinded to group assignment" |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
No blinding is stated. The outcome is likely to be influenced by lack of blinding |
