| Study characteristics |
| Methods |
RCT
Double‐blinded
Double‐dummy |
| Participants |
Number of enrolled participants: 96
Number of participants evaluated: 87
Number of dropouts: 9 (9%)
Setting: 3 institutions (regular clinics + emergency rooms)
Age: > 16 years
Diagnosis: throat culture
Inclusion criteria: acute sore throat suggestive of acute streptococcal pharyngitis and/or tonsillitis, throat culture positive for GABHS
Exclusion criteria: pregnancy, breastfeeding, antibiotic other than study drugs during the trial period, inadequate folate reserves, malabsorption syndrome, haemolytic anaemia, anticonvulsant therapy (dilantin, primidone), antibiotic 1 week preceding acute streptococcal infection, renal insufficiency, abnormal liver function, low platelets, total white cells, neutrophils, haemoglobin, haematocrit; glucose‐6‐phosphate dehydrogenase deficiency, systemic lupus erythematosus, history of idiosyncratic or allergic reactions to any of the drugs |
| Interventions |
Groups: sulfamethoxazole (SMZ) 400 mg and trimethoprim (TMP) 80 mg 2 tablets 4 times per day (n = 48); penicillin G 250 mg 1 tablet 4 times per day (n = 48)
Duration of therapy: 10 days
Duration of follow‐up: 28 days |
| Outcomes |
No clinical outcomes reported
Adverse effects
Bacteriological outcomes
Urinalysis
Creatinine
Liver function: serum glutamic oxaloacetic transaminase (SGOT) or aspartate transaminase (AST) |
| Notes |
Funding: medication supplied by Hoffmann‐La Roche Inc.
Ethics approval: not mentioned |
| 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; "both groups were evenly matched as to age, sex, physical condition, and concurrent diagnoses." |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
"all test medications were supplied in individually coded bottles of identical appearance and were administered according to the randomised double blind code." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
9 dropouts: lost to follow‐up, failed to take medication, or negative on strep A tests (not specified per group)
No ITT analysis |
| Selective reporting (reporting bias) |
Unclear risk |
Cure rates reported, not individual symptoms.
Adverse events mentioned but not tested. |
| Other bias |
Unclear risk |
Funding: medication supplied by Hoffmann‐La Roche Inc. |
