Botacini 1993.

Study characteristics
Methods	Parallel Randomized Controlled Trial, Category B, Jadad 1
Participants	Two hundred and fifty four women with HPV‐infection whose diagnostic was done by colposcopy, Pap smear, and direct biopsy by colposcopy allocated into five groups: 1) control n=16 2) Podophylin 4%, n=5 3) Podophylin 2%, n=40 4) 5‐Fluorouracil 5%, n=74 5) Meta‐cresol‐sulfonic acid, n=9
Interventions	Patients were randomised to five groups. 1) control (placebo) 2) Podophylin 4%, vaginal gel 5g in 15 applications in alternate days 3) Podophylin 2%, vaginal gel 5g in 15 applications in alternate days 4) 5‐fluorouracil 5%, 2 vaginal applications weekly for 8 weeks 5) Meta‐cresol‐sulfonic acid, in alternate days for 30 days
Outcomes	1) Cure ‐ defined as negative of colposcopy, Pap smear, and direct biopsy by colposcopy. 2) Partial response/ improvement ‐ defined as presence only of positive cytology for HPV infection 3) No response / resistance to the treatment ‐ defined as not alteration of the warts, CIN development or aggravation of lesions to the end of the study
Notes	The follow‐up was done by 12 weeks 110 patients were excluded in the course of treatment because they did not follow the protocol requirement
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "In accordance with the effected treatment patients had been divided randomly in five groups..." Comment: Probably not done because there was no indication of the method used  to distribute the patients,  and because of the great difference of the "n" in each group
Allocation concealment (selection bias)	Unclear risk	Quote:...patients had been divided randomly in five groups..." Comment: Probably not done.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not described Comment: Probably not done.