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. 2017 Apr 24;2017(4):CD010285. doi: 10.1002/14651858.CD010285.pub2
Methods Randomized controlled trial.
Participants Inclusion criteria: women aged ≥ 16 years, inpatients and outpatients; intrauterine infection, uterine adnexitis, bartholinitis, or bartholin's abscess.
Exclusion criteria: age < 16 years; premedication with ciprofloxacin or cefroxadine; women improving with other treatments; allergy to cephem or pyridonecarboxylic acid; taking theophylline or fenbufen, severe problems in the heart, liver, or kidneys; women with epilepsy; pregnant or breastfeeding; rejection by the doctor.
Number of women randomized: total: 253; group A: 124; group B: 129.
Number of women analyzed: total: 209; group A: 104; group B: 105.
Number of withdrawals/exclusions/loss to follow‐up and reasons: total: 44; group A: 20; group B: 24. No reasons presented.
Number of centres: 55.
Age (years): only presented as frequencies within age groups.
Country: Japan.
Interventions Group A: ciprofloxacin 200 mg PO + dummy cefroxadine placebo, 3 times daily for 7 consecutive days.
Group B: cefroxadine 250 mg PO + dummy ciprofloxacin placebo, 3 times daily for 7 consecutive days.
Outcomes Primary outcomes: clinical cure at 7th day of treatment: excellent: clinical marked improvement and clearance of bacteria; good: clear clinical improvement; poor: no clear clinical improvement; adverse events.
Secondary outcome: local tenderness around uterus.
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 2 ciprofloxacin and 2 cefroxadine each with dummy placebo were arranged for 7‐day‐use and numbered. Numbers randomly assigned. 4 series of numbered medicine packed in a box. Then, some boxes were delivered to every institution.
Allocation concealment (selection bias) Unclear risk Having used numbered series of medicine to women consecutively.
Block size of 4 and might be too small for concealment.
Blinding of participants and personnel (performance bias) All outcomes Low risk Double‐dummy placebo method.
Blinding of outcome assessment (detection bias) All outcomes Low risk Double‐blind method.
Incomplete outcome data (attrition bias) All outcomes Low risk Attrition < 20%.
Selective reporting (reporting bias) Unclear risk No trial protocol found.
Other bias Unclear risk Not stated.