Efficacy on cytological findings. i.e. ASC-US, LSIL, ASC-H, and HSIL of an environment modifying vaginal gel – novel management for the prevention of cervical cancer: a subanalysis of a randomized controlled trial

Objectives The present clinical trial aimed to study the effect of a treatment with SAM vaginal gel on cytopathological findings. SAM vaginal gel is a medical device containing adsorptive silicon dioxide and an antioxidative citric acid/selenium combination.

Patients and methods 216 women aged 25-60 years participated in this study at three colposcopy centers. They were randomized to either receive an intravaginal daily dose of SAM gel for three 28-days periods or be followed-up clinically without intervention. The outcome was cytological efficacy, analyzed as regression, remission, persistence and progression. At baseline, all participants had colposcopy-guided biopsies. At 3 months, they had a cervical smear for cytology, hr-HPV and p16/Ki-67 (CINtec^® Plus) test; at 6 months, they had a cervical smear for cytology and p16/Ki-67 (CINtec^® Plus) test only.

Results Regression of cytopathological findings at 3 months, were observed in 77 out of 108 patients (71.3 %) in the SAM gel arm, whereas a similar finding was seen only in 27 out of 108 (25.0 %) in the control arm. The combination of regression and progression of cytopathological findings was in favor of patients treated with SAM gel at 3 months in the low risk and in the high-risk group and sustained at 6 months.

Conclusions SAM vaginal gel enhances regression with a significantly decreased progression rate (6.5 %) compared to the strategy of ‘watchful waiting’ (18.5 %) over a period of 3 months in cytopathological findings, thus offering an active management to prevent cervical cancer.

Publication History

Article published online:
07 October 2020