Silicon dioxide vaginal gel and short‐term high‐risk human papillomavirus
DNA
detectability: A randomized controlled trial
Julia M. Hecken, Clemens B. Tempfer, Katrin Klaus, Jan Scheich, Günther A. Rezniczek Abstract
Introduction
Intravaginal products, including silicon dioxide‐based gels, are marketed to support short‐term high‐risk human papillomavirus (hrHPV) clearance or loss of detectability, but independent randomized evidence testing these short‐term claims against observation is limited. We evaluated whether daily intravaginal silicon dioxide‐based gel treatment increases the proportion of women with no detectable cervical hrHPV DNA compared with observation alone.
Material and Methods
This prospective, single‐center, parallel‐group, randomized, open‐label controlled trial included women with PCR‐confirmed cervical hrHPV infection and no indication for immediate treatment. Participants were randomized 1:1 to 3 months of self‐administered daily intravaginal gel treatment or observation alone. The primary outcome was absence of detectable cervical hrHPV DNA by PCR at 3 months. Secondary outcomes during the randomized study period were patient‐reported satisfaction and adverse events. Trial registration:
Results
Between November 2022 and January 2025, 242 women were randomized, with 121 allocated to each group. Primary‐endpoint data were available for 208 women. At 3 months, hrHPV DNA was not detected in 18/99 women (18%) in the gel treatment group and 23/109 women (21%) in the observation group (absolute risk difference −2.9 percentage points, 95% CI −14 to 8; p = 0.60). A reduced post hoc adjusted sensitivity analysis did not materially change the interpretation of the primary comparison. Patient‐reported adverse events were more frequent in the gel treatment group than in the observation group (32/99 [32%] vs. 2/106 [2%]; absolute risk difference 30 percentage points, 95% CI 21 to 40; p < 0.001). Satisfaction scores were high in both groups but lower with gel treatment.
Conclusions
In this randomized trial, 3 months of daily intravaginal silicon dioxide‐based gel treatment did not improve short‐term loss of detectable cervical hrHPV DNA compared with observation alone. The trial did not reproduce the large short‐term virologic benefit suggested by prior product‐related studies. The findings do not support routine use of this intervention solely to promote short‐term hrHPV non‐detectability in women without an indication for immediate treatment, particularly given the higher frequency of local adverse events.