Ciraru‐Vigneron 1989

Methods	Randomized controlled trial.
Participants	Inclusion criteria: not stated. Exclusion criteria: required systemic or local antibiotic therapy other than those specified in the protocol; pregnant or likely to become pregnant; or allergic to penicillins or cephalosporins. Number of women randomized: 165 women; group A: 78; group B: 87. Number of women analyzed: 152 women; group A: 70; group B: 82. Number of withdrawals/exclusions/loss to follow‐up and reasons: group A: 8; group B: 5 due to poor compliance. Number of centres: 8. Age (mean) (years): group A: 26.9; group B: 25.1. Country: France.
Interventions	Group A: amoxicillin 1 g IV + clavulanic acid 200 mg (Augmentin 1.2 g), 3 or 4 times daily until clinical and laboratory findings improved, after which 4‐6 tablets containing amoxicillin 500 mg + clavulanic acid 125 mg (Augmentin 625 mg) per tablet. Group B: amoxicillin or ampicillin 3‐4 g daily, with an aminoglycoside (gentamicin 160 mg, dibekacin 150 mg, or tobramycin 150 mg) + metronidazole 1.5 g daily parenterally. Subsequent conversion was to oral combination of amoxicillin or ampicillin 2‐3 g + metronidazole 1‐1.5 g daily.
Outcomes	Primary outcomes: excellent response defined as resolution of physical findings with continued improvements in laboratory values; favourable response equate with a favourable course, allowing the persistence of ≥ 1 clinical signs or abnormal laboratory values (or both); failure defined as absence of therapeutic efficacy or of a favourable course after at least 6 days of therapy that a change in management, either surgery or an alternative antibiotic treatment was warranted.
Notes	Ethical approval: not stated. Informed consent: not stated. Source of funding: not stated, and no conflicts of interest reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated.
Allocation concealment (selection bias)	Unclear risk	Not stated.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated.
Incomplete outcome data (attrition bias) All outcomes	Low risk	152/165 women included in the analysis.
Selective reporting (reporting bias)	Unclear risk	No trial protocol found.
Other bias	Unclear risk	Not stated.