OBJECTIVE: To evaluate the efficacy of Anti Viral 2 (AV2) in the regression of moderate and severe colposcopic lesions, when com- pared to placebo. MATERIALS AND METHODS: Women, aged over 18 years with a colposcopic diagnosis of moderate to severe dysplasia were randomized to receive either two applications of AV2 or placebo within four days. Both examining physician and patients were blinded to the treatment option. Follow-up colposcopy was performed on days 11, 2 1, and 60. RESULTS:A total of 50 patients were enrolled in this study. There was no statistically significant difference in screening entry criteria between the two groups. The results showed that the application of AV2 yielded a reduction of more than 50% for 21 out of 28 (75%) patients who received the active treatment versus a 0% for the comparable placebo group (p < 0.00 1). CONCLUSIONS: The authors conclude that AV2 can have a place in the treatment of colposcopically-detected cervical lesions. Due to the proven broad spectrum antiviral activity of AV2, a plausible explanation is that the lesions regress due to deactivation of the virus. Further trials with larger numbers and detailed cytology and histology are needed to confirm these results.
RCT Entities:
OBJECTIVE: To evaluate the efficacy of Anti Viral 2 (AV2) in the regression of moderate and severe colposcopic lesions, when com- pared to placebo. MATERIALS AND METHODS:Women, aged over 18 years with a colposcopic diagnosis of moderate to severe dysplasia were randomized to receive either two applications of AV2 or placebo within four days. Both examining physician and patients were blinded to the treatment option. Follow-up colposcopy was performed on days 11, 2 1, and 60. RESULTS: A total of 50 patients were enrolled in this study. There was no statistically significant difference in screening entry criteria between the two groups. The results showed that the application of AV2 yielded a reduction of more than 50% for 21 out of 28 (75%) patients who received the active treatment versus a 0% for the comparable placebo group (p < 0.00 1). CONCLUSIONS: The authors conclude that AV2 can have a place in the treatment of colposcopically-detected cervical lesions. Due to the proven broad spectrum antiviral activity of AV2, a plausible explanation is that the lesions regress due to deactivation of the virus. Further trials with larger numbers and detailed cytology and histology are needed to confirm these results.