| Methods |
Randomised, parallel, double‐blind comparison of amantadine with PB. The trial took place during an outbreak of influenza in the winter of 1968 to 1969 in Japan
Study duration: at least 7 days
Patient, provider and outcome assessor method of blinding was unclear
Dropouts were not stated
Co‐interventions and other potential confounders: concomitant administration of antipyretics. An analyses with patients who received concomitant antipyretics was also performed |
| Participants |
Of the 737 participants, 155 participants of both genders met the inclusion criteria. 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
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; stimulation/insomnia; dizziness; arrhythmia |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
The author states "patients were given amantadine or PB according to randomly distributed individual code of the double‐blind method", although the randomisation method is not described |
| Allocation concealment (selection bias) |
Unclear risk |
Concealment is not described |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Although there were no missing outcome data, the author states that "only patients with Hong Kong influenza in whom medication was started within 2 days were included in statistical analysis". "In order to exclude the possible influence of concomitantly administered antipyretics on the defervescent effect of amantadine the same analysis was performed with 134 Hong Kong influenza patients who had received no concomitant antipyretics" |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
The author states "patients were given amantadine or PB according to randomly distributed individual code of the double‐blind method". Nevertheless, the specific people who are blinded are not listed |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
The author states "patients were given amantadine or PB according to randomly distributed individual code of the double‐blind method". Nevertheless, the specific people who are blinded are not listed |
