| Study characteristics |
| Methods |
RCT
Double‐blinded |
| Participants |
Number of participants eligible: 654
Number of participants randomised: 525
Number of participants evaluated: 525
Number of dropouts: not specified
Setting: 7 paediatric practices in the USA
Age: 4 to 17 years
Diagnosis: clinical tonsillitis or pharyngitis, throat cultures
Inclusion criteria: clinical tonsillopharyngitis and throat cultures strongly positive for GABHS
Exclusion criteria: concurrent enrolment of siblings, 2 or more sore throats in previous 6 months, treated with antibiotic in previous 2 weeks, throat culture negative for GABHS |
| Interventions |
Groups: cephalexin 27 mg/kg 4 times per day (n = 263); penicillin 27 mg/kg 4 times per day (n = 262)
Duration of treatment: 10 days
Duration of follow‐up: 32 to 35 days |
| Outcomes |
Clinical outcomes: clinical failure (not defined) at 32 to 35 days
Clinical relapse (new infection with different serotype)
Bacteriological outcomes
Antistreptolysin‐O titres
Anti‐DNase B titres |
| Notes |
Funding: grant from Lilly Research Laboratories, Indianapolis, IN, USA
Ethics approval: not mentioned
ITT analysis on 525 participants completing the protocol, no information on dropouts |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Reported as "randomised", but no description of randomisation sequence |
| Allocation concealment (selection bias) |
Unclear risk |
"The participants were assigned...on a random schedule supplied by Eli Lilly and Co." |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
"...the physician and parents were not appraised as to who was in which group." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No description of dropouts, 525 of 525 randomised participants reported
ITT analysis for clinical outcome |
| Selective reporting (reporting bias) |
Unclear risk |
Only clinical (and bacteriological) failure reported, no symptoms specified.
No reporting of adverse events |
| Other bias |
High risk |
Funding: grant from Lilly Research Laboratories, Indianapolis, IN, USA |
