Silicon dioxide, sodium selenite and citric acid vaginal gel, HPV infection, and cervical preinvasive disease: a narrative review.

Abstract

Cervical cancer continues to be a major public health concern, particularly in low- and middle-income countries. It is mainly caused by persistent infection with human papillomavirus (HPV). Screening has been the most effective strategy to reduce mortality, but over the last 2 decades, vaccination has emerged as an important adjunct, helping to decrease incidence and mortality. Given the natural history of HPV infection, most low-grade lesions will spontaneously resolve over time; therefore, observation is the preferred approach for low-grade squamous intraepithelial lesions. Some authors have suggested that this period without intervention may cause anxiety among patients and physicians. A vaginal gel containing 10.0 mg of silicon dioxide, 24.8 mg citric acid, and 0.25 mg selenium per dose, marketed as DeflaGyn, Deflamin, or Deflamed, has been approved in Europe, the United Arab Emirates, Uzbekistan, and Colombia. A literature search was conducted to identify all published clinical trials on DeflaGyn. As of January 2025, 6 studies have been published: 1 retrospective study, 1 randomized clinical trial (RCT) with 2 post hoc analyses, 1 prospective non-randomized trial, and 1 in vitro study. A methodological risk-of-bias assessment was performed, revealing a number of domains with high or unknown risk of bias in the RCT and its post hoc analyses. This review aims to summarize the available evidence and perform a critical analysis of the research. Current evidence is insufficient to support its use for treating HPV infection or dysplasia.