AIM: The aim of this study was to estimate short and long term effectiveness of a topical treatment for cervical ectropion with 5 mg of deoxyribonucleic acid (DRNA). METHODS: A randomized case-control study was carried out. Two-hundred and twenty patients, colposcopically diagnosed with cervical ectropion, were consecutively enrolled and randomly divided into 2 groups: treated (group 1) and controls (group 2). The therapeutic plan consisted of DRNA 5 mg vaginal suppositories, administered for 15 days monthly; subsequently posology was reduced gradually. Both groups underwent a clinical and colposcopical follow-up on the 1st, 4th, 10th and 22nd months after the first examination. At the end of the study, the size of ectropion was considered a parameter of re-epithelialization and provided a criterion of treatment effectiveness. According to this protocol, subjects were defined improved, stable or worsened. Statistical analysis including Pearson chi2 tests, Fisher's exact tests, Yate's corrected chi2 and relative-risk (95% CI) was performed. RESULTS: Of the 220 enrolled patients, 140 completed the study protocol: 76 treated and 64 controls. Outcomes after treatment and follow-up consisted of: 74 (97.4%) improved in group 1, against 2 cases (3.1%) in group 2. High statistical significance was reported comparing outcome frequencies in the 2 groups (P<0.0001). CONCLUSIONS: This study shows a significant reduction (P<0.0001) in cervical ectropion size between cases (topical treatment with DRNA 5 mg) and controls. A follow-up of 22 months confirmed the persistence and effectiveness of this medical approach.
RCT Entities:
AIM: The aim of this study was to estimate short and long term effectiveness of a topical treatment for cervical ectropion with 5 mg of deoxyribonucleic acid (DRNA). METHODS: A randomized case-control study was carried out. Two-hundred and twenty patients, colposcopically diagnosed with cervical ectropion, were consecutively enrolled and randomly divided into 2 groups: treated (group 1) and controls (group 2). The therapeutic plan consisted of DRNA 5 mg vaginal suppositories, administered for 15 days monthly; subsequently posology was reduced gradually. Both groups underwent a clinical and colposcopical follow-up on the 1st, 4th, 10th and 22nd months after the first examination. At the end of the study, the size of ectropion was considered a parameter of re-epithelialization and provided a criterion of treatment effectiveness. According to this protocol, subjects were defined improved, stable or worsened. Statistical analysis including Pearson chi2 tests, Fisher's exact tests, Yate's corrected chi2 and relative-risk (95% CI) was performed. RESULTS: Of the 220 enrolled patients, 140 completed the study protocol: 76 treated and 64 controls. Outcomes after treatment and follow-up consisted of: 74 (97.4%) improved in group 1, against 2 cases (3.1%) in group 2. High statistical significance was reported comparing outcome frequencies in the 2 groups (P<0.0001). CONCLUSIONS: This study shows a significant reduction (P<0.0001) in cervical ectropion size between cases (topical treatment with DRNA 5 mg) and controls. A follow-up of 22 months confirmed the persistence and effectiveness of this medical approach.