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. |
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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. |
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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. |
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Notes |
Ethical approval: not stated. Informed consent: not stated. Source of funding: not stated, and no conflicts of interest reported. |
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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. |