Efficacy of a <i>Coriolus</i><i>versicolor</i>-Based Vaginal Gel in Human Papillomavirus-Positive Women Older Than 40 Years: A Sub-Analysis of PALOMA Study
In the PALOMA trial, Papilocare<sup>®</sup> demonstrated efficacy in repairing low-grade cervical lesions related to human papillomavirus (HPV). This sub-analysis aimed to evaluate its efficacy in repairing these cervical lesions and clearing HPV in women aged older than 40 years. This w...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-09-01
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| Series: | Journal of Personalized Medicine |
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| Online Access: | https://www.mdpi.com/2075-4426/12/10/1559 |
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| author | Santiago Palacios Gil-Antuñano Luis Serrano Cogollor Andrés C. López Díaz Silvia P. González Rodríguez Damián Dexeus Carter Cristina Centeno Mediavilla Pluvio Coronado Martín Jesús de la Fuente Valero José A. López Fernández Cristina Vanrell Barbat Javier Cortés Bordoy |
| author_facet | Santiago Palacios Gil-Antuñano Luis Serrano Cogollor Andrés C. López Díaz Silvia P. González Rodríguez Damián Dexeus Carter Cristina Centeno Mediavilla Pluvio Coronado Martín Jesús de la Fuente Valero José A. López Fernández Cristina Vanrell Barbat Javier Cortés Bordoy |
| author_sort | Santiago Palacios Gil-Antuñano |
| collection | DOAJ |
| description | In the PALOMA trial, Papilocare<sup>®</sup> demonstrated efficacy in repairing low-grade cervical lesions related to human papillomavirus (HPV). This sub-analysis aimed to evaluate its efficacy in repairing these cervical lesions and clearing HPV in women aged older than 40 years. This was a multicenter, randomized, open-label, parallel-group, controlled clinical trial. Patients with low-degree HPV-dependent cervical lesions receiving 6-month treatment with the vaginal gel were compared to those with a watchful waiting approach. Among the 41 women analyzed (aged 47.7 years), 31 presented high-risk (HR) oncogenic HPV subtypes, and 14 had 16-18-31 HPV genotypes. After 6 months, normalized cytology and concordant colposcopy were achieved by a greater percentage of treated women. The difference was significant in the total population (92.3% vs. 50.0%, <i>p</i> = 0.007), and HR-HPV subpopulation (90.5% vs. 33.3%, <i>p</i> = 0.003). In the HR HPVs-16-18-31 subpopulation, the values were 75.0% and 40.0% (<i>p</i> = 0.293). In the total population, 61.5% of treated patients obtained HPV clearance, compared to 50.0% in the control group. Regarding the HR-HPV subpopulation, these values were 66.7% and 44.4%, respectively. Papilocare<sup>®</sup> demonstrated significant efficacy in repairing low-degree HPV-related cervical lesions and a positive trend to clear HPV in women older than 40 years old in comparison to the watchful waiting approach. |
| first_indexed | 2024-03-09T19:58:55Z |
| format | Article |
| id | doaj.art-5effc8bfd0764888baf9091cda7b8e29 |
| institution | Directory Open Access Journal |
| issn | 2075-4426 |
| language | English |
| last_indexed | 2024-03-09T19:58:55Z |
| publishDate | 2022-09-01 |
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| series | Journal of Personalized Medicine |
| spelling | doaj.art-5effc8bfd0764888baf9091cda7b8e292023-11-24T00:48:28ZengMDPI AGJournal of Personalized Medicine2075-44262022-09-011210155910.3390/jpm12101559Efficacy of a <i>Coriolus</i><i>versicolor</i>-Based Vaginal Gel in Human Papillomavirus-Positive Women Older Than 40 Years: A Sub-Analysis of PALOMA StudySantiago Palacios Gil-Antuñano0Luis Serrano Cogollor1Andrés C. López Díaz2Silvia P. González Rodríguez3Damián Dexeus Carter4Cristina Centeno Mediavilla5Pluvio Coronado Martín6Jesús de la Fuente Valero7José A. López Fernández8Cristina Vanrell Barbat9Javier Cortés Bordoy10Instituto Palacios, Salud y Medicina de la Mujer, C. Antonio Acuña, 9, 28009 Madrid, SpainObstetrics and Gynaecology Unit, HM Gabinete Velázquez, C. de Jorge Juan, 19, 1°, 28001 Madrid, SpainObstetrics and Gynaecology Department, Hospital Quironsalud, Av. Imperio Argentina, 1, 29004 Málaga, SpainObstetrics and Gynaecology Unit, HM Gabinete Velázquez, C. de Jorge Juan, 19, 1°, 28001 Madrid, SpainClínica Ginecológica Women’s CD, C. Gironella, 6, Planta 2 (Edificio 3), 08017 Barcelona, SpainClínica Diatros, Crta. de Santa Creu de Calafell, 100, 08850 Gavà, SpainGynecological Oncology Unit, Hospital Clínico San Carlos, C. del Prof Martín Lagos, 28040 Madrid, SpainObstetrics and Gynaecology Department, Hospital Universitario Infanta Leonor, Av. Gran Vía del Este, 80, 28031 Madrid, SpainObstetrics and Gynaecology Department, Hospital General Universitario, C. Pintor Baeza, 11, 03010 Alicante, SpainSTI Unit, Hospital de la Santa Creu i Sant Pau, C. Sant Antoni Maria Claret, 167, 08025 Barcelona, SpainPrivate Practice, C. Alfonso el Magnánimo, 29, 07004 Palma, SpainIn the PALOMA trial, Papilocare<sup>®</sup> demonstrated efficacy in repairing low-grade cervical lesions related to human papillomavirus (HPV). This sub-analysis aimed to evaluate its efficacy in repairing these cervical lesions and clearing HPV in women aged older than 40 years. This was a multicenter, randomized, open-label, parallel-group, controlled clinical trial. Patients with low-degree HPV-dependent cervical lesions receiving 6-month treatment with the vaginal gel were compared to those with a watchful waiting approach. Among the 41 women analyzed (aged 47.7 years), 31 presented high-risk (HR) oncogenic HPV subtypes, and 14 had 16-18-31 HPV genotypes. After 6 months, normalized cytology and concordant colposcopy were achieved by a greater percentage of treated women. The difference was significant in the total population (92.3% vs. 50.0%, <i>p</i> = 0.007), and HR-HPV subpopulation (90.5% vs. 33.3%, <i>p</i> = 0.003). In the HR HPVs-16-18-31 subpopulation, the values were 75.0% and 40.0% (<i>p</i> = 0.293). In the total population, 61.5% of treated patients obtained HPV clearance, compared to 50.0% in the control group. Regarding the HR-HPV subpopulation, these values were 66.7% and 44.4%, respectively. Papilocare<sup>®</sup> demonstrated significant efficacy in repairing low-degree HPV-related cervical lesions and a positive trend to clear HPV in women older than 40 years old in comparison to the watchful waiting approach.https://www.mdpi.com/2075-4426/12/10/1559<i>Coriolus versicolor</i>human papillomaviruscervical lesionsclearancehigh riskvaginal gel |
| spellingShingle | Santiago Palacios Gil-Antuñano Luis Serrano Cogollor Andrés C. López Díaz Silvia P. González Rodríguez Damián Dexeus Carter Cristina Centeno Mediavilla Pluvio Coronado Martín Jesús de la Fuente Valero José A. López Fernández Cristina Vanrell Barbat Javier Cortés Bordoy Efficacy of a <i>Coriolus</i><i>versicolor</i>-Based Vaginal Gel in Human Papillomavirus-Positive Women Older Than 40 Years: A Sub-Analysis of PALOMA Study Journal of Personalized Medicine <i>Coriolus versicolor</i> human papillomavirus cervical lesions clearance high risk vaginal gel |
| title | Efficacy of a <i>Coriolus</i><i>versicolor</i>-Based Vaginal Gel in Human Papillomavirus-Positive Women Older Than 40 Years: A Sub-Analysis of PALOMA Study |
| title_full | Efficacy of a <i>Coriolus</i><i>versicolor</i>-Based Vaginal Gel in Human Papillomavirus-Positive Women Older Than 40 Years: A Sub-Analysis of PALOMA Study |
| title_fullStr | Efficacy of a <i>Coriolus</i><i>versicolor</i>-Based Vaginal Gel in Human Papillomavirus-Positive Women Older Than 40 Years: A Sub-Analysis of PALOMA Study |
| title_full_unstemmed | Efficacy of a <i>Coriolus</i><i>versicolor</i>-Based Vaginal Gel in Human Papillomavirus-Positive Women Older Than 40 Years: A Sub-Analysis of PALOMA Study |
| title_short | Efficacy of a <i>Coriolus</i><i>versicolor</i>-Based Vaginal Gel in Human Papillomavirus-Positive Women Older Than 40 Years: A Sub-Analysis of PALOMA Study |
| title_sort | efficacy of a i coriolus i i versicolor i based vaginal gel in human papillomavirus positive women older than 40 years a sub analysis of paloma study |
| topic | <i>Coriolus versicolor</i> human papillomavirus cervical lesions clearance high risk vaginal gel |
| url | https://www.mdpi.com/2075-4426/12/10/1559 |
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