Treatment with an intravaginal gel containing siliceous dioxide, selenite, and citric acid to promote regression of ASC-US, LSIL, ASC-H, HSIL, p16/Ki67 status and improve clearance of hr-HPV in cervical specimens

Abstract

Objective: An intravaginal gel containing highly dispersed silicon dioxide (SiO2) and an anti-oxidative combination of citric acid and sodium selenite was tested for its ability to promote regression of abnormal cytological findings and its influence on hr-HPV status and tumor markers p16/Ki67 (CINtec® PLUS test).Patients and methods: A control study was performed, including women (n=100) diagnosed with conspicuous cervical smears (ASC-US, LSIL, ASC-H, or HSIL). The gel was applied for 3x28 days. After three months, participants were analyzed for Pap status, hr-HPV strains, and expression of tumor markers p16/Ki67. Three months later, Pap testing and p16/Ki67 analysis were repeated. The results were compared to those of 106 women who met the same inclusion criteria but did not obtain any treatment.Results: After six months, cytological Pap findings were improved in 80.9% of the participants in the treated group, and the clearing of hr-HPV was observed in 53% of cases. Only 5.3% were tested p16/Ki67 positive after six months in comparison to 75.0% at baseline. In the comparison group, 37.1% of the Pap smears and 18.6% of the CinTec results were improved, but no hr-HPV clearance was observed. The improvements were highly significant for the treatment. Conclutions: The vaginal gel containing SiO2 sodium selenite, and citric acid may support the healing of conspicuous cytological findings and clearance of hr-HPV.