An Adsorptive and Antioxidant Vaginal Gel Clears High-Risk HPV- and p16/Ki-67-Associated Abnormal Cytological Cervical Findings: A post-hoc Subgroup Analysis of a Prospective Randomized Controlled Trial on CIN2 and p16 Positive CIN1

Objective: To analyze the course of p16/Ki-67-positive abnormal cytological cervical findings and high risk (hr)-HPV- and p16/Ki-67-clearances in women treated with a vaginal gel.Methods: 172 women with a histological diagnosis of CIN2 or p16-positive CIN1 lesions were selected based on a positive cytological p16/Ki-67 test. For 3 months, 75 patients in the active arm (AA) daily administered 5 ml of a vaginal gel. Ninety seven patients in the control arm (CA) underwent no treatment (“watchful waiting”). Endpoints were cytological evolution, p16/Ki-67- and hr-HPV-clearances.Results: At 3 months, cytological regression was observed in 76% (57/75) of patients in the AA compared with 25% (24/97) in the CA. Progression occurred in 5% (4/75) of the AA compared with 15% (15/97) of the CA. The p16/Ki-67 status change was statistically significantly (p < 0.001) in favor of the AA: 77% (58/75) became negative compared to 21% (20/97) in the CA. hr-HPV prevalence decreased significantly (p < 0.001) in the AA from 87 to 44%, while increasing in the CA from 78 to 84%. Cytological regression and p16/Ki-67 changes persisted in the AA at 6 months.Conclusions: The vaginal gel significantly cleared hr-HPV and p16/Ki-67 and was associated with improved cytological findings, thereby potentially offering an effective option against oncogenic risk.Clinical Trial Registration: Identifier: [ISRCTN11009040].

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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

Archives of Gynecology and Obstetrics ◽

10.1007/s00404-020-05816-8 ◽

2020 ◽

Author(s):

Attila Louis Major ◽

Vladimír Dvořák ◽

Jana Schwarzová ◽

Aleš Skřivánek ◽

Tomáš Malík ◽

...

Keyword(s):

High Risk ◽

Controlled Trial ◽

Intraepithelial Neoplasia ◽

Cervical Lesions ◽

Ki 67 ◽

Vaginal Gel ◽

Registration Number ◽

High Risk Hpv ◽

Non Destructive

Abstract Purpose 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. Methods 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. Results 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 (p < 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. Conclusion 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. Trial registration number ISRCTN11009040, date of registration: 10/12/2019; https://doi.org/10.1186/ISRCTN11009040; retrospectively registered.

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Correction to: 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

Archives of Gynecology and Obstetrics ◽

10.1007/s00404-020-05925-4 ◽

2021 ◽

Author(s):

Attila Louis Major ◽

Vladimír Dvořák ◽

Jana Schwarzová ◽

Aleš Skřivánek ◽

Tomáš Malík ◽

...

Keyword(s):

Randomized Controlled Trial ◽

High Risk ◽

Controlled Trial ◽

Efficacy And Safety ◽

Ki 67 ◽

Randomized Controlled ◽

Vaginal Gel ◽

High Risk Hpv

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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

Advances in Therapy ◽

10.1007/s12325-020-01594-6 ◽

2020 ◽

Author(s):

Anna Angela Criscuolo ◽

Francesco Sesti ◽

Emilio Piccione ◽

Pasquale Mancino ◽

Elena Belloni ◽

...

Keyword(s):

High Risk ◽

Observational Study ◽

Therapeutic Efficacy ◽

Hpv Infection ◽

Coriolus Versicolor ◽

Retrospective Observational Study ◽

Vaginal Gel ◽

High Risk Hpv

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288 Efficacy of a multi-ingredient coriolus versicolor-based vaginal gel in high-risk HPV+ patients: results of different studies

10.1136/ijgc-2020-esgo.21 ◽

2020 ◽

Author(s):

Yann Gaslain ◽

Javier Cortés ◽

Damian Dexeus ◽

Santiago Palacios ◽

Clara Gajino ◽

...

Keyword(s):

High Risk ◽

Coriolus Versicolor ◽

Vaginal Gel ◽

High Risk Hpv

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Early and sustained symptom improvement with umeclidinium/vilanterol versus monotherapy in COPD: a post hoc analysis of the EMAX randomised controlled trial

Therapeutic Advances in Respiratory Disease ◽

10.1177/1753466620926949 ◽

2020 ◽

Vol 14 ◽

pp. 175346662092694

Author(s):

Edward M Kerwin ◽

Isabelle H Boucot ◽

Claus F Vogelmeier ◽

Francois Maltais ◽

Ian P Naya ◽

...

Keyword(s):

Rescue Medication ◽

Controlled Trial ◽

Medication Use ◽

Symptom Improvement ◽

Chronic Obstructive ◽

Electronic Diary ◽

Double Blind ◽

Clinical Trial Registration ◽

Bronchodilator Therapy ◽

Post Hoc

Background: In chronic obstructive pulmonary disease (COPD), both the time needed for patients to gain symptom improvement with long-acting bronchodilator therapy and whether an early response is predictive of a sustained response is unknown. This study aimed to investigate how quickly meaningful symptom responses are seen in patients with COPD with bronchodilator therapy and whether these responses are sustained. Methods: Early MAXimisation of bronchodilation for improving COPD stability (EMAX) was a 24-week, double-blind, double-dummy, parallel-group trial that randomised patients to umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol. Daily Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score and rescue salbutamol use were captured via an electronic diary and analysed initially in 4-weekly periods. Post hoc analyses assessed change from baseline in daily E-RS:COPD score and rescue medication use weekly (Weeks 1–8), and association between E-RS:COPD responder status at Weeks 1–4 and later time points. Results: In the intent-to-treat population ( n = 2425), reductions from baseline in E-RS:COPD scores and rescue medication use were apparent from Day 2 with all treatments. Treatment differences for UMEC/VI versus either monotherapy plateaued by Week 4–8 and were sustained at Weeks 21–24; improvements were consistently greater with UMEC/VI. For all treatments, most patients (60–85%) retained their Weeks 1–4 E-RS:COPD responder/non-responder status at Weeks 21−24. Among patients receiving UMEC/VI who were E-RS:COPD responders at Weeks 1–4, 70% were responders at Weeks 21–24. Conclusion: Patients with symptomatic COPD had greater potential for early symptom improvements with UMEC/VI versus either monotherapy. This benefit was generally maintained for 24 weeks. Early monitoring of treatment response can provide clinicians with an early indication of a patient’s likely longer-term response to prescribed bronchodilator treatment and will facilitate appropriate early adjustments in care. Clinical Trial Registration: NCT03034915, 2016-002513-22 (EudraCT Number). The reviews of this paper are available via the supplemental material section.

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