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. 2017 Apr 24;2017(4):CD010285. doi: 10.1002/14651858.CD010285.pub2
Methods Randomized controlled trial.
Participants Inclusion criteria: aged > 16 years old; give written consent prior to entry; clinical diagnosis of acute PID made when woman had all following: lower abdominal tenderness, adnexal tenderness, and cervical motion tenderness; ≥ 1 of following: oral temperature ≥ 38.3 °C, abnormal cervical discharge, elevated ESR or CRP, and endocervical specimen positive for N gonorrhoeae or C trachomatis.
Exclusion criteria: pregnant or lactation; history of hypersensitivity to penicillin, aminoglycoside, clindamycin, or metronidazole; severe hepatic disease; renal impairment (serum creatinine level > 2 mg/dL), or evidence of ruptured tubo‐ovarian abscess.
Number of women randomized: 44; 22 in each group.
Number of women analyzed: 44; 22 in each group.
Number of withdrawals/exclusions/loss to followup and reasons: 0 reported as lost to follow‐up.
Number of centres: 1.
Age (mean ± SD) (years): group A: 31.2 ± 9.1; group B: 24.9 ± 7.6.
Country: Thailand.
Interventions Group A: (triple therapies) received intravenous therapy of 1 gm of ampicillin every 6 hours plus 5 mg/kg. (not exceed 240 mg) of gentamicin once daily and 500 mg of Metronidazole every 8 hours.
Group B: clindamycin 600 mg IV every 8 h + gentamicin 5 mg/kg not exceeding a maximum dose of 240 mg once daily.
In both groups, parenteral therapies continued until women were afebrile for minimum of 48 h then all women received a regimen of doxycycline 100 mg PO every 12 h to complete a 14‐day course.
Outcomes Primary outcomes: clinical cure; adverse events leading to discontinuation of therapy.
Secondary outcome: length of hospital stay.
Visual analogue scale on day 3 of treatment.
Notes Ethical approval: yes, approval for study obtained from the Ethical Committee of the Faculty of Medicine, Chulalongkorn University before trial was started.
Informed consent: yes, all women gave written consent before entering into study.
Source of funding: not stated, and no conflicts of interest reported.
There were significant baseline imbalances between the 2 groups. Age, infertility, and severity of pain prior to this study significantly lower in group B (clindamycin/gentamicin).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization codes computer‐generated and sealed in envelope, then women were randomly assigned to 1 of the 2 regimens depending on their codes (A or B).
Allocation concealment (selection bias) Unclear risk Not stated by whom allocation concealment was done.
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 All women randomized were analyzed.
Selective reporting (reporting bias) Unclear risk No trial protocol found.
Other bias Unclear risk Not stated.