Carpinelo 1988.
Study characteristics | ||
Methods | Parallel Randomized Controlled Trial, Category B, Jadad "0" | |
Participants | Sixty‐eight men, sexual partners of women with cervical dysplasia, cervical intraepithelial neoplasia (CIN), carcinoma in situ or severe Condylomatous atypia allocated into 2 groups:1) Group CO2 laser, n =41, and 2) Group 5‐fluorouracil plus CO2 laser, n=27. | |
Interventions | 1)CO2 Laser; 2)CO2 Laser plus adjuvant 5‐FU 5% for 30 days beginning a week after the laser therapy |
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Outcomes | Recurrence of lesion described as any evidence of HPV (even 1 lesion) after treatment | |
Notes | Patients in the CO2 Group were followed for a mean of 4.1 months, while those in the CO2 Laser plus adjuvant 5‐FU 5% were followed for a mean of 4.0 mouths | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "All randomised 68 patients evaluated in this study received magnified penile surface‐carbon dioxide laser therapy as described above. Of the patients 41 were treated with magnified penile surface‐carbon dioxide laser therapy alone and 27 treated with a regimen of adjuvant 5 per cent 5‐Fluorouracil applied to the penile shaft every other night for 1 month beginning 1 week after the laser therapy. Comment: Probably not done |
Allocation concealment (selection bias) | Unclear risk | Quote: "All randomised 68 patients evaluated..." Comment: Probably not done |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described Comment: Probably not done |