Beatriz Aristizabal

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

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.

Efficacy of topical treatments for high-risk human papillomavirus in preventing CIN II+ lesions: a systematic review

This study aimed to systematically review the literature regarding topical therapies for reducing the risk of cervical intra-epithelial neoplasia (CIN) grade 2 or higher (CIN II+) lesions among women with high-risk human papillomavirus (HPV) infection and histologically confirmed CIN I or either no cervical lesions. We conducted a systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered the protocol in PROSPERO (CRD42024629608). We searched Ovid MEDLINE, Ovid EMBASE, Cochrane Central, and ClinicalTrials.gov from inception through December 16, 2024 for randomized controlled trials evaluating any cervical topical treatment in women with high-risk HPV and, at most, CIN I. The primary outcome was progression to histologically confirmed CIN II+. Secondary outcomes were treatment-related adverse events. Of 305 records, 19 full-text articles were reviewed. Finally, 16 trials were assessed. None met all our eligibility criteria, with some trials being excluded for multiple reasons. Twelve were excluded due to an inadequate study population (included women with CIN II+, lacked histologic confirmation of lesion grade, or lacked confirmatory high-risk HPV testing), 4 used inappropriate interventions, and 2 did not include a placebo or watchful waiting comparator. Although many studies reported HPV clearance or cytologic regression, none were powered or designed to assess progression to CIN II+. The current evidence from randomized trials is insufficient to determine whether topical cervical therapies reduce the risk of progression to CIN II+ in women with high-risk HPV infection. Future trials should prioritize histologic outcomes and adhere to current management protocols to establish the clinical utility of such therapies.