> Details

Major, Attila Louis; Dvořák, Vladimír; Schwarzová, Jana; Skřivánek, Aleš; Malík, Tomáš; Pluta, Marek; Mayboroda, Ivanna; Grandjean, Etienne Marc

Efficacy and safety of an adsorbent and anti-oxidative vaginal gel on CIN1 and 2, on high-risk HPV, and on p16/Ki-67: a randomized controlled trial

Reference
management

Bookmarks

Remove from
bookmarks

Share this on Whatsapp

Close

Bookmarks



You can manage bookmarks using lists, please log in to your user account for this.
  • Media type: E-Article
  • Title: Efficacy and safety of an adsorbent and anti-oxidative vaginal gel on CIN1 and 2, on high-risk HPV, and on p16/Ki-67: a randomized controlled trial
  • Contributor: Major, Attila Louis; Dvořák, Vladimír; Schwarzová, Jana; Skřivánek, Aleš; Malík, Tomáš; Pluta, Marek; Mayboroda, Ivanna; Grandjean, Etienne Marc
  • imprint: Springer Science and Business Media LLC, 2021
  • Published in: Archives of Gynecology and Obstetrics
  • Language: English
  • DOI: 10.1007/s00404-020-05816-8
  • ISSN: 0932-0067; 1432-0711
  • Origination:
  • Footnote:
  • Description: <jats:title>Abstract</jats:title><jats:sec> <jats:title>Purpose</jats:title> <jats:p>The effect of SAM vaginal gel, a medical device containing adsorptive silicon dioxide and antioxidative sodium selenite and citric acid, on histologically-proven cervical intraepithelial neoplasia type 2 (CIN2) as well as p16 positive CIN1, and on the presence of the onco-marker p16 was investigated.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>216 women aged 25–60 years were randomized to either receive an intravaginal daily dose of SAM gel for three 28-day periods, or be followed-up without intervention. The primary endpoint was efficacy, defined as a combined histological and cytological regression. At baseline and after 3 months participants had: a guided biopsy including p16 immunohistochemical (IHC) staining, only if a lesion was visible at colposcopy; a cervical smear for cytology, high-risk human papillomavirus (hr-HPV) and a p16/Ki-67 test. At 6 months a further cytology and p16/Ki-67 test was performed.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>Regression of CIN lesions was observed in 78 out of 108 patients (72.2%) in the SAM gel arm and in 27 out of 108 patients (25.0%) in the control arm. Similarly, the change in the p16/Ki-67 cytological test status was significantly in favor of the treatment arm. The prevalence of hr-HPV decreased significantly (<jats:italic>p</jats:italic> &lt; 0.001) in the treatment arm, from 87.0% to 39.8%, while it slightly increased in the control arm, from 78.7% to 83.3%. At 6 months the cytological regression in the treatment group and the highly significant effect on p16/Ki-67 was still present.</jats:p> </jats:sec><jats:sec> <jats:title>Conclusion</jats:title> <jats:p>SAM vaginal gel enhances the regression of cervical lesions and clears hr-HPV and p16/Ki-67 in smears significantly, thus offering an active non-destructive management to prevent cervical cancer.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration number</jats:title> <jats:p>ISRCTN11009040, date of registration: 10/12/2019; <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://doi.org/10.1186/ISRCTN11009040">https://doi.org/10.1186/ISRCTN11009040</jats:ext-link>; retrospectively registered.</jats:p> </jats:sec>