Malhotra 2003

Methods	Randomized controlled trial.
Participants	Inclusion criteria: women with first episode of PID. Exclusion criteria: women with recurrent PID or with previous antibiotic therapy. Number of women randomized: 165. Number of women analyzed: 153 women; group A: 52; group B: 48; group C: 53. Number of withdrawals/exclusions/loss to follow‐up and reasons: group A: 3 women excluded from analysis; group B: 7; group C: 2. Number of centres: 1. Age (mean ±SD) (years): group A without women excluded from analysis: 25.6 ± 3.9; group B without women excluded from analysis: 25.8 ± 3.2; group C without women excluded from analysis: 25.5 ± 4.9. Country: India.
Interventions	Group A: ciprofloxacin 500 mg + tinidazole 600 mg (Table Brakke, Franko India Pharma, Mumbai, India) twice daily for 7 days. Group B: fluconazole 150 mg (1 tablet) + azithromycin 1 g (1 tablet) + secnidazole 2 g (2 tablets) (Fas‐3 kit Lyka, Mumbai, India). Advised to take azithromycin on empty stomach in the morning, secnidazole with or after food and fluconazole in the evening. Group C: doxycycline 100 mg twice daily + metronidazole 200 mg 3 times daily for 1 week. The 2 drugs were available in the hospital pharmacy free of cost.
Outcomes	Primary outcome: clinical cure: women assessed at the first visit by a severity score (Modified Severity Score of Soper 1988) the findings at the first examination and severity score noted in the Performa filled for every woman. The women were asked to report after 1 week and 4 weeks. Repeat gynaecological examination and severity score were performed and recorded in the Performa. All women were advised to report within 3 days if there was no improvement in symptoms, any deterioration in their condition, or inability to carry on with the oral therapy when they were hospitalized. Clinical cure defined as at least 70% reduction in severity score, no more than mild abdominal pain, and no recurrence of symptoms or signs of PID within 4 weeks of therapy. Treatment failure defined as < 20% decrease in tenderness score. Modified ITT (cases that were not PID were excluded). Group A: 52. Group B: 48. Group C: 53.
Notes	Ethical approval: yes, the departmental ethical committee approved the study. Informed consent: yes, verbal informed consent taken from all the women. 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	Using a computer‐generated number, all women were randomized to 1 of 3 treatment groups initially, and later it was a block randomization to equalize the group.
Allocation concealment (selection bias)	Unclear risk	Not reported by whom allocation was done and how.
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Unfortunately we could not get similar looking packs from the market so the assignment was not concealed from the investigator."
Blinding of outcome assessment (detection bias) All outcomes	High risk	"Unfortunately we could not get similar looking packs from the market so the assignment was not concealed from the investigator."
Incomplete outcome data (attrition bias) All outcomes	Low risk	12/165 women excluded from analysis.
Selective reporting (reporting bias)	Unclear risk	No study protocol found.
Other bias	Unclear risk	Not stated.