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Therapeutic Efficacy of a Coriolus versicolor-Based Vaginal Gel in Women with Cervical Uterine High-Risk HPV Infection: A Retrospective Observational Study

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Abstract

Introduction

A Coriolus versicolor-based vaginal gel is available for treating women with cervical uterine high-risk human papillomavirus (HPV) infection through re-epithelizing and re-balancing microbiota actions.

Methods

A longitudinal retrospective observational study was performed to evaluate efficacy and safety of the gel. Women treated with Coriolus versicolor-based vaginal gel were compared with women not treated with the gel. Both groups were monitored for HPV infection by an HPV DNA test, Pap smear (cytology) and colposcopy at baseline and after 6 months.

Results

Overall, 183 high-risk HPV positive women were enrolled (97 treated and 86 controls). After 6 months, the HPV DNA test became negative in 67.0% versus 37.2% of treated and controls, respectively (p < 0.0001). Furthermore, 76.1% versus 40.8% registered a colposcopy improvement (p = 0.0005) and 60.4% versus 40.8% showed a remission (p = 0.05), for treated versus controls, respectively. Regarding to cytology, 78.5% of treated versus 37.7% of controls registered an improvement, while 70.8% of treated versus 34.8% of controls had a remission (p < 0.0001 for both variables). At multivariate analyses adjusted for age, smoking habit, and use of estroprogestinic pill, compared to controls, women treated with the gel showed a significantly higher likelihood to experience the clearence of HPV DNA (OR 4.81; 95% 2.43–9.53), and remission at colposcopy (OR 2.30; 95% 1.00–5.31), and cytology (OR 5.13; 95% 2.40–10.96) at 6 months. No adverse event was reported during the follow-up.

Conclusions

The use of a Coriolus versicolor-based vaginal gel in high-risk HPV patients is safe and effective based on all examined tests.

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Acknowledgements

We thank the participants of the study.

Funding

Assistance for statistical analysis and medical writing was provided by CORESEARCH – Center for Outcomes Research and clinical Epidemiology (Antonio Nicolucci, Maria Chiara Rossi, Giusi Graziano, and Riccarda Memmo) through an unconditional grant from Shionogi, Italy. CORESEARCH also funded the journal’s Rapid Service fee.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Compliance with Ethics Guidelines

The study was approved by the Independent Ethics Committee of Polyclinic Tor Vergata Foundation, protocol n. 167/19. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 (5). Informed consent was obtained from all patients for being included in the study.

Disclosures

The authors Anna Angela Criscuolo, Francesco Sesti, Emilio Piccione, Pasquale Mancino, Elena Belloni, Cetty Gullo and Marco Ciotti have nothing to disclose.

Data Availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Authors and Affiliations

  1. Section of Gynecology and Obstetrics, Department of Surgical Sciences, University of Rome Tor Vergata, Rome, Italy

    Anna Angela Criscuolo, Francesco Sesti, Emilio Piccione, Elena Belloni & Cetty Gullo

  2. Department of Obstetrics Gynecology and Neurology, University La Sapienza, Rome, Italy

    Pasquale Mancino

  3. Virology Unit, Laboratory of Clinical Microbiology and Viroloy, Polyclinic Tor Vergata, Rome, Italy

    Marco Ciotti

Authors
  1. Anna Angela Criscuolo
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  2. Francesco Sesti
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Corresponding author

Correspondence to Marco Ciotti.

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Criscuolo, A.A., Sesti, F., Piccione, E. et al. Therapeutic Efficacy of a Coriolus versicolor-Based Vaginal Gel in Women with Cervical Uterine High-Risk HPV Infection: A Retrospective Observational Study. Adv Ther 38, 1202–1211 (2021). https://doi.org/10.1007/s12325-020-01594-6

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