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. |
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Interventions |
Group A: moxifloxacin 400 mg once daily for 14 days. Group B: ofloxacin 400 mg twice daily + metronidazole 500 mg PO twice daily. |
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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. |
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Notes |
Ethical approval: yes. Informed consent: yes, women gave written informed consent. 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) | 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. |