Syed 2000.
Study characteristics | ||
Methods | Parallel Randomizad Controlled Trial, Category A, Jadad 5 | |
Participants | Sixty women aged over 17 years (ranging 18 and 50, mean of 24,6 years) with 312 intravaginal warts (mean of 5.2) allocated in 2 groups with 30 patient in each group | |
Interventions | 5 FU 1% (4g) intravaginal 3 times in the week at bedtime for 4 weeks Placebo |
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Outcomes | Cure ‐ defined as total condyloma regression with absence of clinic signals by colposcopic and negative PCR and Shoutern Blot for HPV Improvement ‐ defined as 50% or more regression of lesions Failure ‐ defined as regression of less 50% of lesions Side effects ‐ presence of erosion or edema or inflammation or local discomfort or dysuria or local hypersensitivity |
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Notes | It were excluded from the study pregnant women, nurses, external condyloma, malignant disease, known hypersensitivity to fluoride pirimidine or hidroxietilcelulose, HIV positive individuals, heart disease, liver disease, lung disease, renal disease, associated STD, use of immunosuppressive or antiviral drugs in the last 2 months or intravaginal medication 8 weeks prior to the selection for study Bicentric (USAand Paquistan) Follow‐up period was of 16 weeks |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients enlisted for the study were randomly assigned to numbers 1‐60 sequentially to receive either active or placebo gel treatment..." Comment: Probably done |
Allocation concealment (selection bias) | Low risk | Quote: "Each patient had received a pre‐code tube 15g (active or placebo) with graduated vaginal applicators (disposable), and instructions how to insert 4g of the trial medication deep into the vagina once a bedtime on every day (1,3,5) per week" Comment: Probably done due to description of the way it was performed. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "In a double‐blind manner, pre‐coded trial preparation (15g), with graduated (4ml, correspond to 4g) vaginal applicators (disposable) were allocated to each patient." Comment: Probably done |