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. 2017 Apr 24;2017(4):CD010285. doi: 10.1002/14651858.CD010285.pub2
Methods Randomized, parallel‐group study.
Participants Inclusion criteria: women aged 14‐45 years with acute uncomplicated PID based on presence of all the following symptoms and signs: pelvic discomfort, direct lower abdominal tenderness, adnexal and cervical motion tenderness on bimanual vaginal examination, and pelvic pain for < 30 days, as well as ≥ 1 of the following signs: pyrexia (rectal, tympanic, or oral temperature > 38.8 °C or axillary temperature > 37.5 °C), elevated CRP > 6 mg/L, WBC > 10,500/mm3, and a normal ultrasonographic scan.
Exclusion criteria: urinary tract infection; complicated PID (such as tubo‐ovarian abscess); endometriosis; pelvic pain > 30 days; history of antibiotic therapy within last week; previous failure to adhere to antibiotic treatment; other causes of abdominopelvic pain such as appendicitis, diverticulitis, or ovarian cysts; oral intolerance, defined as 1 episode of vomiting after the first oral medication administration; and delivery, abortion, or surgery within the last month.
Number of women randomized: 1156.
Number of women analyzed: group A: 578; group B: 578.
Number of withdrawals/exclusions/loss to follow‐up and reasons: group A: 18 women lost (oral intolerance n = 2; non‐compliance n = 5; worsening of pain n = 3; tubo‐ovarian abscess n = 2; urinary tract infection n = 2; other n = 4); group B: 35 women lost (oral intolerance n = 4; non‐compliance n = 18; worsening of pain n = 2; tubo‐ovarian abscess n = 2; urinary tract infection n = 4; other n = 5).
Number of centres: 4.
Age (mean ± SD) (years): group A: 30.3 ± 3.7; group B: 29.3 ± 3.5.
Country: Turkey.
Interventions Group A: moxifloxacin 400 mg once daily for 14 days.
Group B: ofloxacin 400 mg twice daily + metronidazole 500 mg PO twice daily.
Outcomes Clinical cure, microbiological cure, adverse effects.
Primary outcome: clinical cure, defined as a ≥ 60% reduction in the total pain score at day 21 compared with baseline and the absence of pelvic discomfort and tenderness, temperature < 37.8 °C, and WBC < 10,000/mm3 on day 21.
Notes Ethical approval: yes.
Informed consent: yes, women gave written informed consent.
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) Low risk Used random‐numbers table.
Allocation concealment (selection bias) Low risk Assigned treatments written on cards and sealed in secure opaque envelopes numbered in sequence.
Blinding of participants and personnel (performance bias) All outcomes High risk Investigators not blinded to the procedure allocation. Moxifloxacin group received just 1 tablet, whereas ofloxacin + metronidazole group received 4 tablets daily. No placebo was added to mask groups.
Blinding of outcome assessment (detection bias) All outcomes High risk 7 days after drug treatment at secondary visits (day 21), all women underwent a secondary evaluation by the same physician who allocated women.
Incomplete outcome data (attrition bias) All outcomes Low risk From 1156 women, 53 lost to follow‐up.
Selective reporting (reporting bias) Low risk Trial registered in ClinicalTrial.gov (NCT01799356).
Other bias Unclear risk Risk of potential bias unclear.