| Methods |
Randomised, parallel, double‐blind comparison of amantadine with PB. This trial took place during an outbreak of influenza in Japan
Study duration: 7 days
Patient, provider and outcome assessor method of blinding is unclear
Dropouts: none
Co‐interventions and other potential confounders were not observed |
| Participants |
There were 355 participants. Although the proportions are not cited, it is stated that the groups are comparable in the following criteria: sex, age, influenza vaccination history, distribution and geometric mean of HI and CF titre in acute sera, interval between onset of symptoms and start of treatment and maximum body temperature before the treatment
158 participants of both genders met the age criteria. 91 children were cases of clinical influenza with serological confirmation. The proportion of males and females was not stated
Inclusion criteria: respiratory symptoms evident within the 2nd day of illness
Disease stage: clinical symptoms within 2nd day of illness |
| Interventions |
Amantadine: 50 mg/d (1 to 2 years old); 100 mg/d (3 to 5 years old); 150 mg/d (6 to 10 years old), by oral route, for 7 days |
| Outcomes |
Fever up to 4th day. AE: nausea/vomiting; diarrhoea; exanthema; malaise; muscular, limb pain; headache; dyspnoea; cyanosis; stimulation/insomnia; dizziness; arrhythmia |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
It was stated that "amantadine or PB was given to the patient at random", although randomisation method is not described |
| Allocation concealment (selection bias) |
Unclear risk |
Concealment is not described |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
There were no missing patients, although "four cases were shown to be influenza B and were excluded from statistical analysis" |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Although "amantadine or PB was given to the patient at random by double‐blind method" the specific people who are blinded are not listed |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Although "amantadine or PB was given to the patient at random by double‐blind method" the specific people who are blinded are not listed |
