Crombleholme 1987

Methods	Randomized controlled trial.
Participants	Inclusion criteria: hospitalized women aged ≥ 18 years with a documented or clinical diagnosis of mixed aerobic‐anaerobic PID. Exclusion criteria: pregnant or lactating; allergy to penicillins, cephalosporins, aminoglycosides, or metronidazole; impaired renal function (serum creatinine > 1.8 mg/100 mL); family history of glycogen storage disease or recurrent hypoglycaemia; history of unstable cardiovascular, hepatic, renal, or neurological disease. Number of women randomized: 44; 22 in each group. Number of women analyzed: 42; 21 in each group. Number of withdrawals/exclusions/loss to follow‐up and reasons: 1 women in group A with a clinical diagnosis of PID and a right adnexal mass excluded. Laparoscopy revealed a right ovarian cyst, no visual evidence of infection, and essentially no growth from cervical and endometrial cultures. 1 woman in group B with a clinical diagnosis of PID excluded; she left the hospital against medical advice on the third hospital day. Number of centres: 1. Age (mean ± SD) (years): group A: 27.7 ± 6.9; group B: 29.0 ± 12.1. Country: US.
Interventions	Group A: ampicillin 2 g + sulbactam 1 g IV every 6 h. Group B: metronidazole 15 mg/kg IV every 6 h + gentamicin 1.5 mg/kg IV every 8 h. Therapy continued until women became afebrile and were without clinical signs of infection for 48 h or until clinical judgement dictated cessation of therapy. Range of treatment 3‐11 days.
Outcomes	Primary outcome: clinical cure defined as absence of fever, without clinical signs of infections for 48 h or until clinical judgement.
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	1 woman missing in each group.
Selective reporting (reporting bias)	Unclear risk	No study protocol found.
Other bias	Unclear risk	Not stated.