Martens 1993

Methods	Randomized controlled trial.
Participants	Inclusion criteria: non‐pregnant, non‐lactating women using a reliable form of contraception and who fulfilled the diagnostic criteria for uncomplicated PID. Diagnostic inclusion criteria for uncomplicated PID were all the following: direct lower abdominal tenderness with or without rebound tenderness, cervical motion tenderness, and adnexal tenderness. Plus ≥ 1 of the following: recent positive endocervical culture for N gonorrhoeae or C trachomatis, temperature > 38 °C), WBC count > 10,000/mm3, leukocytic endocervical discharge. Exclusion criteria: pelvic infection severe enough to require parenteral antimicrobial therapy or if surgical intervention within the next 24 h was anticipated; evidence of a pelvic abscess by ultrasonography or clinical examination; if pain had been present for > 2 weeks; allergy to study medications; major gastrointestinal, renal, or hepatic disorders; used other antimicrobial agents within the previous 2 weeks; IUD in place; or alcohol or drug abusers. Number of women randomized: total: 295; group A: 150; group B: 145. Number of women analyzed: total: 249; group A: 128; group B: 121. Number of withdrawals/exclusions/loss to follow‐up and reasons: 46 women excluded from analysis due to protocol violations or loss to follow‐up. Number of centres: 16. Age (mean ± SD) (years): group A: 25.9 ± 5.8; group B: 26.0 ± 6.8. Country: US.
Interventions	Group A: ofloxacin 400 mg PO every 12 h for 10 days. Group B: cefoxitin 2 g IM + probenecid 1 g PO, followed by doxycycline 100 mg PO every 12 h for 10 days.
Outcomes	Primary outcomes: clinical cure: complete resolution of tenderness; clinical improvement: partial resolution of tenderness without the need for additional antibiotic therapy. Secondary outcomes: microbial cure of C trachomatis, microbial cure of N gonorrhoeae.
Notes	Ethical approval: yes, "with approval from their respective institutional review boards." Informed consent: yes, "the subjects were enrolled after giving informed consent." Source of funding: supported in part by a grant from Ortho Pharmaceutical Corporation, Raritan, New Jersey. No conflicts of interest declared.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	After obtaining informed consent, women given a computer‐generated randomization code number and assigned to either treatment regimen using 1:1 ratio.
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	46/295 women excluded from analysis due to protocol violations or loss to follow‐up (< 20%).
Selective reporting (reporting bias)	Unclear risk	No study protocol found.
Other bias	Unclear risk	Not stated.